Cosentyx

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



 

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1. NAME OF THE MEDICINAL PRODUCT 
 

Cosentyx 150 mg powder for solution for injection 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 

Each vial of powder contains 150 mg secukinumab. After reconstitution, 1 ml of solution contains 

150 mg secukinumab. 

 

Secukinumab is a recombinant fully human monoclonal antibody produced in Chinese Hamster Ovary 

(CHO) cells. 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 
 

Powder for solution for injection 

 

The powder is a white solid lyophilisate. 

 

 

4. CLINICAL PARTICULARS 
 

4.1 Therapeutic indications 

 

Adult plaque psoriasis 

 

Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are 

candidates for systemic therapy. 

 
Paediatric plaque psoriasis 

 

Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in children and 

adolescents from the age of 6 years who are candidates for systemic therapy. 

 

Psoriatic arthritis 

 

Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active 

psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic 

drug (DMARD) therapy has been inadequate (see section 5.1). 

 

Axial spondyloarthritis (axSpA) 

 

Ankylosing spondylitis (AS, radiographic axial spondyloarthritis) 

Cosentyx is indicated for the treatment of active ankylosing spondylitis in adults who have responded 

inadequately to conventional therapy. 

 

Non-radiographic axial spondyloarthritis (nr-axSpA) 

Cosentyx is indicated for the treatment of active non-radiographic axial spondyloarthritis with 

objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic 

resonance imaging (MRI) evidence in adults who have responded inadequately to non-steroidal 

anti-inflammatory drugs (NSAIDs). 
 



 

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4.2 Posology and method of administration 

 

Cosentyx is intended for use under the guidance and supervision of a physician experienced in the 

diagnosis and treatment of conditions for which Cosentyx is indicated. 

 

Posology 

 

Adult plaque psoriasis 

The recommended dose is 300 mg of secukinumab by subcutaneous injection with initial dosing at 

weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. Each 300 mg dose is given as two 

subcutaneous injections of 150 mg. 

 

Paediatric plaque psoriasis (adolescents and children from the age of 6 years) 

The recommended dose is based on body weight (Table 1) and administered by subcutaneous injection 

with initial dosing at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. Each 75 mg 

dose is given as one subcutaneous injection of 75 mg. Each 150 mg dose is given as one subcutaneous 

injection of 150 mg. Each 300 mg dose is given as two subcutaneous injections of 150 mg. 

 

Table 1 Recommended dose for paediatric plaque psoriasis 

 

Body weight at time of dosing Recommended Dose 

<25 kg 75 mg 

25 to <50 kg 75 mg 

≥50 kg 150 mg (*may be increased to 300 mg) 

*Some patients may derive additional benefit from the higher dose. 

 

Psoriatic arthritis 

For patients with concomitant moderate to severe plaque psoriasis or who are anti-TNFα inadequate 

responders (IR), the recommended dose is 300 mg by subcutaneous injection with initial dosing at 

weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. Each 300 mg dose is given as two 

subcutaneous injections of 150 mg. 

 

For other patients, the recommended dose is 150 mg by subcutaneous injection with initial dosing at 

weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. Based on clinical response, the dose 

can be increased to 300 mg. 

 

Axial spondyloarthritis (axSpA) 

Ankylosing spondylitis (AS, radiographic axial spondyloarthritis) 

The recommended dose is 150 mg by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3 and 

4, followed by monthly maintenance dosing. Based on clinical response, the dose can be increased to 

300 mg. Each 300 mg dose is given as two subcutaneous injections of 150 mg. 

 

Non-radiographic axial spondyloarthritis (nr-axSpA) 

The recommended dose is 150 mg by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3 and 

4, followed by monthly maintenance dosing. 

 

For all of the above indications, available data suggest that a clinical response is usually achieved 

within 16 weeks of treatment. Consideration should be given to discontinuing treatment in patients 

who have shown no response by 16 weeks of treatment. Some patients with an initial partial response 

may subsequently improve with continued treatment beyond 16 weeks. 

 

Special populations 

 

Elderly patients (aged 65 years and over) 

No dose adjustment is required (see section 5.2). 

 



 

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Renal impairment / hepatic impairment 

Cosentyx has not been studied in these patient populations. No dose recommendations can be made. 

 

Paediatric population 

The safety and efficacy of Cosentyx in children with plaque psoriasis below the age of 6 years have 

not been established. 

 

The safety and efficacy of Cosentyx in children below the age of 18 years in other indications have not 

yet been established. No data are available. 

 

Method of administration 

 

Cosentyx is to be administered by subcutaneous injection. If possible, areas of the skin that show 

psoriasis should be avoided as injection sites. The powder for solution for injection must be 

reconstituted before use. 

 

The reconstitution, dose preparation and administration of the powder for solution for injection is to be 

done by a healthcare professional. For instructions on reconstitution of the medicinal product before 

administration, see section 6.6 and the Instructions for Use in the package leaflet. 

 

4.3 Contraindications 
 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 

 

Clinically important, active infection, e.g. active tuberculosis (see section 4.4). 

 

4.4 Special warnings and precautions for use 

 

Traceability 

 

In order to improve the traceability of biological medicinal products, the name and the batch number 

of the administered product should be clearly recorded. 

 

Infections 

 

Secukinumab has the potential to increase the risk of infections. Serious infections have been observed 

in patients receiving secukinumab in the post-marketing setting. Caution should be exercised when 

considering the use of secukinumab in patients with a chronic infection or a history of recurrent 

infection. 

 

Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection 

occur. If a patient develops a serious infection, the patient should be closely monitored and 

secukinumab should not be administered until the infection resolves. 

 

In clinical studies, infections have been observed in patients receiving secukinumab (see section 4.8). 

Most of these were mild or moderate upper respiratory tract infections such as nasopharyngitis and did 

not require treatment discontinuation. 

 

Related to the mechanism of action of secukinumab, non-serious mucocutaneous candida infections 

were more frequently reported for secukinumab than placebo in the psoriasis clinical studies (3.55 per 

100 patient years for secukinumab 300 mg versus 1.00 per 100 patient years for placebo) (see 

section 4.8). 

 

No increased susceptibility to tuberculosis was reported from clinical studies. However, secukinumab 

should not be given to patients with active tuberculosis. Anti-tuberculosis therapy should be 

considered prior to initiation of secukinumab in patients with latent tuberculosis. 

 



 

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Inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) 

 

Cases of new or exacerbations of inflammatory bowel disease have been reported with secukinumab 

(see section 4.8). Secukinumab is not recommended in patients with inflammatory bowel disease. If a 

patient develops signs and symptoms of inflammatory bowel disease or experiences an exacerbation of 

pre-existing inflammatory bowel disease, secukinumab should be discontinued and appropriate 

medical management should be initiated. 

 

Hypersensitivity reactions 

 

In clinical studies, rare cases of anaphylactic reactions have been observed in patients receiving 

secukinumab. If an anaphylactic or other serious allergic reactions occur, administration of 

secukinumab should be discontinued immediately and appropriate therapy initiated. 

 

Vaccinations 

 

Live vaccines should not be given concurrently with secukinumab. 

 

Patients receiving secukinumab may receive concurrent inactivated or non-live vaccinations. In a 

study, after meningococcal and inactivated influenza vaccinations, a similar proportion of healthy 

volunteers treated with 150 mg of secukinumab and those treated with placebo were able to mount an 

adequate immune response of at least a 4-fold increase in antibody titres to meningococcal and 

influenza vaccines. The data suggest that secukinumab does not suppress the humoral immune 

response to the meningococcal or influenza vaccines. 

 

Prior to initiating therapy with Cosentyx, it is recommended that paediatric patients receive all 

age-appropriate immunisations as per current immunisation guidelines. 

 

Concomitant immunosuppressive therapy 

 

In psoriasis studies, the safety and efficacy of secukinumab in combination with immunosuppressants, 

including biologics, or phototherapy have not been evaluated. Secukinumab was administered 

concomitantly with methotrexate (MTX), sulfasalazine and/or corticosteroids in arthritis studies 

(including in patients with psoriatic arthritis and ankylosing spondylitis). Caution should be exercised 

when considering concomitant use of other immunosuppressants and secukinumab (see also 

section 4.5). 

 

4.5 Interaction with other medicinal products and other forms of interaction 
 

Live vaccines should not be given concurrently with secukinumab (see also section 4.4). 

 

In a study in adult subjects with plaque psoriasis, no interaction was observed between secukinumab 

and midazolam (CYP3A4 substrate). 

 

No interaction was seen when secukinumab was administered concomitantly with methotrexate 

(MTX) and/or corticosteroids in arthritis studies (including in patients with psoriatic arthritis and axial 

spondyloarthritis). 

  



 

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4.6 Fertility, pregnancy and lactation 
 

Women of childbearing potential 

 

Women of childbearing potential should use an effective method of contraception during treatment 

and for at least 20 weeks after treatment. 

 

Pregnancy 

 

There are no adequate data from the use of secukinumab in pregnant women. 

 

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity 

(see section 5.3). As a precautionary measure, it is preferable to avoid the use of Cosentyx during 

pregnancy. 

 

Breast-feeding 

 

It is not known whether secukinumab is excreted in human milk. Immunoglobulins are excreted in 

human milk and it is not known if secukinumab is absorbed systemically after ingestion. Because of 

the potential for adverse reactions in nursing infants from secukinumab, a decision on whether to 

discontinue breast-feeding during treatment and up to 20 weeks after treatment or to discontinue 

therapy with Cosentyx must be made taking into account the benefit of breast-feeding to the child and 

the benefit of therapy to the woman. 

 

Fertility 

 

The effect of secukinumab on human fertility has not been evaluated. Animal studies do not indicate 

direct or indirect harmful effects with respect to fertility. 

 

4.7 Effects on ability to drive and use machines 
 

Cosentyx has no or negligible influence on the ability to drive and use machines. 

 

4.8 Undesirable effects 
 

Summary of the safety profile 

 

The most frequently reported adverse drug reactions (ADRs) are upper respiratory tract infections 

(most frequently nasopharyngitis, rhinitis). 

 

Tabulated list of adverse reactions 

 

ADRs from clinical studies and post-marketing reports (Table 2) are listed by MedDRA system organ 

class. Within each system organ class, the ADRs are ranked by frequency, with the most frequent 

reactions first. Within each frequency grouping, adverse drug reactions are presented in order of 

decreasing seriousness. In addition, the corresponding frequency category for each adverse drug 

reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); 

uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known 

(cannot be estimated from the available data). 

 

Over 18,000 patients have been treated with secukinumab in blinded and open-label clinical studies in 

various indications (plaque psoriasis, psoriatic arthritis, axial spondyloarthritis and other autoimmune 

conditions), representing 30,565 patient years of exposure. Of these, over 11,700 patients were 

exposed to secukinumab for at least one year. The safety profile of secukinumab is consistent across 

all indications. 

 



 

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Table 2 List of adverse reactions in clinical studies1) and post-marketing experience 
 

System Organ Class Frequency Adverse reaction 

Infections and 

infestations 

Very common Upper respiratory tract infections 

Common Oral herpes 

Tinea pedis 

Uncommon Oral candidiasis 

Otitis externa 

Lower respiratory tract infections 

Not known Mucosal and cutaneous candidiasis (including 

oesophageal candidiasis) 

Blood and lymphatic 

system disorders 

Uncommon Neutropenia 

Immune system 

disorders 

Rare Anaphylactic reactions 

Nervous system 

disorders 

Common Headache 

Eye disorders Uncommon Conjunctivitis 

Respiratory, thoracic 

and mediastinal 

disorders 

Common Rhinorrhoea 

Gastrointestinal 

disorders 

Common Diarrhoea 

Common Nausea 

Uncommon Inflammatory bowel disease 

Skin and subcutaneous 

tissue disorders 

Uncommon Urticaria 

Rare Exfoliative dermatitis2) 

General disorders and 

administration site 

conditions 

Common Fatigue 

1) Placebo-controlled clinical studies (phase III) in plaque psoriasis, PsA, AS and nr-axSpA patients 

exposed to 300 mg, 150 mg, 75 mg or placebo up to 12 weeks (psoriasis) or 16 weeks (PsA, AS and 

nr-axSpA) treatment duration 
2) Cases were reported in patients with psoriasis diagnosis 

 

Description of selected adverse reactions 

 

Infections 

In the placebo-controlled period of clinical studies in plaque psoriasis (a total of 1,382 patients treated 

with secukinumab and 694 patients treated with placebo for up to 12 weeks), infections were reported 

in 28.7% of patients treated with secukinumab compared with 18.9% of patients treated with placebo. 

The majority of infections consisted of non-serious and mild to moderate upper respiratory tract 

infections, such as nasopharyngitis, which did not necessitate treatment discontinuation. There was an 

increase in mucosal or cutaneous candidiasis, consistent with the mechanism of action, but the cases 

were mild or moderate in severity, non-serious, responsive to standard treatment and did not 

necessitate treatment discontinuation. Serious infections occurred in 0.14% of patients treated with 

secukinumab and in 0.3% of patients treated with placebo (see section 4.4). 

 

Over the entire treatment period (a total of 3,430 patients treated with secukinumab for up to 52 weeks 

for the majority of patients), infections were reported in 47.5% of patients treated with secukinumab 

(0.9 per patient-year of follow-up). Serious infections were reported in 1.2% of patients treated with 

secukinumab (0.015 per patient-year of follow-up). 

 

Infection rates observed in psoriatic arthritis and axial spondyloarthritis (ankylosing spondylitis and 

non-radiographic axial spondyloarthritis) clinical studies were similar to those observed in the 

psoriasis studies. 

 



 

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Neutropenia 

In psoriasis phase III clinical studies, neutropenia was more frequently observed with secukinumab 

than with placebo, but most cases were mild, transient and reversible. Neutropenia <1.0-0.5x109/l 

(CTCAE grade 3) was reported in 18 out of 3,430 (0.5%) patients on secukinumab, with no dose 

dependence and no temporal relationship to infections in 15 out of 18 cases. There were no reported 

cases of more severe neutropenia. Non-serious infections with usual response to standard care and not 

requiring discontinuation of secukinumab were reported in the remaining 3 cases. 

 

The frequency of neutropenia in psoriatic arthritis and axial spondyloarthritis (ankylosing spondylitis 

and non-radiographic axial spondyloarthritis) was similar to psoriasis. 

 

Rare cases of neutropenia <0.5x109/l (CTCAE grade 4) were reported. 
 

Hypersensitivity reactions 

In clinical studies, urticaria and rare cases of anaphylactic reaction to secukinumab were observed (see 

also section 4.4). 

 

Immunogenicity 

In psoriasis, psoriatic arthritis and axial spondyloarthritis (ankylosing spondylitis and non-

radiographic axial spondyloarthritis) clinical studies, less than 1% of patients treated with 

secukinumab developed antibodies to secukinumab up to 52 weeks of treatment. About half of the 

treatment-emergent anti-drug antibodies were neutralising, but this was not associated with loss of 

efficacy or pharmacokinetic abnormalities. 

 

Paediatric population 

 

Undesirable effects in paediatric patients from the age of 6 years with plaque psoriasis 

The safety of secukinumab was assessed in two phase III studies in paediatric patients with plaque 

psoriasis. The first study (paediatric study 1) was a double-blind, placebo-controlled study of 

162 patients from 6 to less than 18 years of age with severe plaque psoriasis. The second study 

(paediatric study 2) is an open-label study of 84 patients from 6 to less than 18 years of age with 

moderate to severe plaque psoriasis. The safety profile reported in these two studies was consistent 

with the safety profile reported in adult plaque psoriasis patients. 

 

Reporting of suspected adverse reactions 

 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 

professionals are asked to report any suspected adverse reactions via the national reporting system 

listed in Appendix V. 

 

4.9 Overdose 

 

Doses up to 30 mg/kg (approximately 2000 to 3000 mg) have been administered intravenously in 

clinical studies without dose-limiting toxicity. In the event of overdose, it is recommended that the 

patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic 

treatment be instituted immediately. 

 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

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5. PHARMACOLOGICAL PROPERTIES 
 

5.1 Pharmacodynamic properties 
 

Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC10 

 

Mechanism of action 

 

Secukinumab is a fully human IgG1/κ monoclonal antibody that selectively binds to and neutralises 

the proinflammatory cytokine interleukin-17A (IL-17A). Secukinumab works by targeting IL-17A and 

inhibiting its interaction with the IL-17 receptor, which is expressed on various cell types including 

keratinocytes. As a result, secukinumab inhibits the release of proinflammatory cytokines, chemokines 

and mediators of tissue damage and reduces IL-17A-mediated contributions to autoimmune and 

inflammatory diseases. Clinically relevant levels of secukinumab reach the skin and reduce local 

inflammatory markers. As a direct consequence treatment with secukinumab reduces erythema, 

induration and desquamation present in plaque psoriasis lesions. 

 

IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune 

responses. IL-17A plays a key role in the pathogenesis of plaque psoriasis, psoriatic arthritis and axial 

spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis) and is 

up-regulated in lesional skin in contrast to non-lesional skin of plaque psoriasis patients and in 

synovial tissue of psoriatic arthritis patients. The frequency of IL-17-producing cells was also 

significantly higher in the subchondral bone marrow of facet joints from patients with ankylosing 

spondylitis. Increased numbers of IL-17A producing lymphocytes have also been found in patients 

with non-radiographic axial spondyloarthritis. Inhibition of IL-17A was shown to be effective in the 

treatment of ankylosing spondylitis, thus establishing the key role of this cytokine in axial 

spondyloarthritis. 

 

Pharmacodynamic effects 

 

Serum levels of total IL-17A (free and secukinumab-bound IL-17A) are initially increased in patients 

receiving secukinumab. This is followed by a slow decrease due to reduced clearance of 

secukinumab-bound IL-17A, indicating that secukinumab selectively captures free IL-17A, which 

plays a key role in the pathogenesis of plaque psoriasis. 

 

In a study with secukinumab, infiltrating epidermal neutrophils and various neutrophil-associated 

markers that are increased in lesional skin of plaque psoriasis patients were significantly reduced after 

one to two weeks of treatment. 

 

Secukinumab has been shown to lower (within 1 to 2 weeks of treatment) levels of C-reactive protein, 

which is a marker of inflammation. 

 

Clinical efficacy and safety 

 

Adult plaque psoriasis 

The safety and efficacy of secukinumab were assessed in four randomised, double-blind, 

placebo-controlled phase III studies in patients with moderate to severe plaque psoriasis who were 

candidates for phototherapy or systemic therapy [ERASURE, FIXTURE, FEATURE, JUNCTURE]. 

The efficacy and safety of secukinumab 150 mg and 300 mg were evaluated versus either placebo or 

etanercept. In addition, one study assessed a chronic treatment regimen versus a “retreatment as 

needed” regimen [SCULPTURE]. 

 

Of the 2,403 patients who were included in the placebo-controlled studies, 79% were biologic-naive, 

45% were non-biologic failures and 8% were biologic failures (6% were anti-TNF failures, and 2% 

were anti-p40 failures). Approximately 15 to 25% of patients in phase III studies had psoriatic arthritis 

(PsA) at baseline. 

 



 

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Psoriasis study 1 (ERASURE) evaluated 738 patients. Patients randomised to secukinumab received 

150 mg or 300 mg doses at weeks 0, 1, 2, 3 and 4, followed by the same dose every month. Psoriasis 

study 2 (FIXTURE) evaluated 1,306 patients. Patients randomised to secukinumab received 150 mg or 

300 mg doses at weeks 0, 1, 2, 3 and 4, followed by the same dose every month. Patients randomised 

to etanercept received 50 mg doses twice per week for 12 weeks followed by 50 mg every week. In 

both study 1 and study 2, patients randomised to receive placebo who were non-responders at week 12 

then crossed over to receive secukinumab (either 150 mg or 300 mg) at weeks 12, 13, 14, and 15, 

followed by the same dose every month starting at week 16. All patients were followed for up to 

52 weeks following first administration of study treatment. 

 

Psoriasis study 3 (FEATURE) evaluated 177 patients using a pre-filled syringe compared with placebo 

after 12 weeks of treatment to assess the safety, tolerability, and usability of secukinumab 

self-administration via the pre-filled syringe. Psoriasis study 4 (JUNCTURE) evaluated 182 patients 

using a pre-filled pen compared with placebo after 12 weeks of treatment to assess the safety, 

tolerability, and usability of secukinumab self-administration via the pre-filled pen. In both study 3 

and study 4, patients randomised to secukinumab received 150 mg or 300 mg doses at weeks 0, 1, 2, 3 

and 4, followed by the same dose every month. Patients were also randomised to receive placebo at 

weeks 0, 1, 2, 3 and 4, followed by the same dose every month. 

 

Psoriasis study 5 (SCULPTURE) evaluated 966 patients. All patients received secukinumab 150 mg or 

300 mg doses at weeks 0, 1, 2, 3, 4, 8 and 12 and then were randomised to receive either a 

maintenance regimen of the same dose every month starting at week 12 or a “retreatment as needed” 

regimen of the same dose. Patients randomised to “retreatment as needed” did not achieve adequate 

maintenance of response and therefore a fixed monthly maintenance regimen is recommended. 

 

The co-primary endpoints in the placebo and active-controlled studies were the proportion of patients 

who achieved a PASI 75 response and IGA mod 2011 “clear” or “almost clear” response versus 

placebo at week 12 (see Tables 3 and 4). The 300 mg dose provided improved skin clearance 

particularly for “clear” or “almost clear” skin across the efficacy endpoints of PASI 90, PASI 100, and 

IGA mod 2011 0 or 1 response across all studies with peak effects seen at week 16, therefore this dose 

is recommended. 

 



 

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Table 3 Summary of PASI 50/75/90/100 & IGA⃰ mod 2011 “clear” or “almost clear” clinical 

response in psoriasis studies 1, 3 and 4 (ERASURE, FEATURE and JUNCTURE) 

 
 Week 12 Week 16 Week 52 

 Placebo 150 mg 300 mg 150 mg 300 mg 150 mg 300 mg 

Study 1 

Number of patients 246 244 245 244 245 244 245 

PASI 50 response n (%) 22 
(8.9%) 

203 

(83.5%) 

222 

(90.6%) 

212 

(87.2%) 

224 

(91.4%) 

187 

(77%) 

207 

(84.5%) 

PASI 75 response n (%) 11 
(4.5%) 

174 

(71.6%)** 

200 

(81.6%)** 

188 

(77.4%) 

211 

(86.1%) 

146 

(60.1%) 

182 

(74.3%) 

PASI 90 response n (%) 3 (1.2%) 95 
(39.1%)** 

145 

(59.2%)** 

130 

(53.5%) 

171 

(69.8%) 

88 

(36.2%) 

147 

(60.0%) 

PASI 100 response n (%) 2 (0.8%) 31 
(12.8%) 

70 

(28.6%) 

51 

(21.0%) 

102 

(41.6%) 

49 

(20.2%) 

96 

(39.2%) 

IGA mod 2011 “clear” or 

“almost clear” response 

n (%) 

6 

(2.40%) 

125 

(51.2%)** 

160 

(65.3%)** 

142 

(58.2%) 

180 

(73.5%) 

101 

(41.4%) 

148 

(60.4%) 

Study 3 
Number of patients  59 59 58 - - - - 

PASI 50 response n (%) 3 (5.1%) 51 
(86.4%) 

51 

(87.9%) 

- - - - 

PASI 75 response n (%) 0 (0.0%) 41 
(69.5%)** 

44 

(75.9%)** 

- - - - 

PASI 90 response n (%) 0 (0.0%) 27 
(45.8%) 

35 

(60.3%) 

- - - - 

PASI 100 response n (%) 0 (0.0%) 5 
(8.5%) 

25 

(43.1%) 

- - - - 

IGA mod 2011 “clear” or 

“almost clear” response 

n (%) 

0 (0.0%) 31 

(52.5%)** 

40 

(69.0%)** 

- - - - 

Study 4 
Number of patients  61 60 60 - - - - 

PASI 50 response n (%) 5 (8.2%) 48 
(80.0%) 

58 

(96.7%) 

- - - - 

PASI 75 response n (%) 2 (3.3%) 43 
(71.7%)** 

52 

(86.7%)** 

- - - - 

PASI 90 response n (%) 0 (0.0%) 24 
(40.0%) 

33 

(55.0%) 

- - - - 

PASI 100 response n(%) 0 (0.0%) 10 
(16.7%) 

16 

(26.7%) 

- - - - 

IGA mod 2011 “clear” or 

“almost clear” response 

n (%) 

0 (0.0%) 32 

(53.3%)** 

44 

(73.3%)** 

- - - - 

* The IGA mod 2011 is a 5-category scale including “0 = clear”, “1 = almost clear”, “2 = mild”, “3 = 

moderate” or “4 = severe”, indicating the physician’s overall assessment of the psoriasis severity focusing 

on induration, erythema and scaling. Treatment success of “clear” or “almost clear” consisted of no signs of 

psoriasis or normal to pink colouration of lesions, no thickening of the plaque and none to minimal focal 

scaling. 

** p values versus placebo and adjusted for multiplicity: p<0.0001. 

 



 

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Table 4 Summary of clinical response on psoriasis study 2 (FIXTURE) 

 
 Week 12 Week 16 Week 52 

 Placebo 150 mg 300 mg  Etanercept 150 mg 300 mg  Etanercept 150 mg 300 mg  Etanercept 

Number of 

patients 

324 327 323 323 327 323 323 327 323 323 

PASI 50 
response 

n (%) 

49 
(15.1%) 

266 
(81.3%) 

296 
(91.6%) 

226 
(70.0%) 

290 
(88.7%) 

302 
(93.5%) 

257 (79.6%) 249 
(76.1%) 

274 
(84.8%) 

234 (72.4%) 

PASI 75 
response 

n (%) 

16 
(4.9%) 

219 
(67.0%)

** 

249 
(77.1%)

** 

142 
(44.0%) 

247 
(75.5%) 

280 
(86.7%) 

189 (58.5%) 215 
(65.7%) 

254 
(78.6%) 

179 (55.4%) 

PASI 90 
response 

n (%) 

5 (1.5%) 137 
(41.9%) 

175 
(54.2%) 

67 (20.7%) 176 
(53.8%) 

234 
(72.4%) 

101 (31.3%) 147 
(45.0%) 

210 
(65.0%) 

108 (33.4%) 

PASI 100 
response 

n (%) 

0 (0%) 47 
(14.4%) 

78 
(24.1%) 

14 (4.3%) 84 
(25.7%) 

119 
(36.8%) 

24 (7.4%) 65 
(19.9%) 

117 
(36.2%) 

32 (9.9%) 

IGA mod 
2011 “clear” 

or “almost 

clear” 
response 

n (%) 

9 (2.8%) 167 
(51.1%)

** 

202 
(62.5%)

** 

88 (27.2%) 200 
(61.2%) 

244 
(75.5%) 

127 (39.3%) 168 
(51.4%) 

219 
(67.8%) 

120 (37.2%) 

** p values versus etanercept: p=0.0250 

 

In an additional psoriasis study (CLEAR) 676 patients were evaluated. Secukinumab 300 mg met the 

primary and secondary endpoints by showing superiority to ustekinumab based on PASI 90 response 

at week 16 (primary endpoint), speed of onset of PASI 75 response at week 4, and long-term PASI 90 

response at week 52. Greater efficacy of secukinumab compared to ustekinumab for the endpoints 

PASI 75/90/100 and IGA mod 2011 0 or 1 response (“clear” or “almost clear”) was observed early 

and continued through to week 52. 

 

Table 5 Summary of clinical response on CLEAR study 

 
 Week 4 Week 16 Week 52 

 Secukinumab 
300 mg 

Ustekinumab* Secukinumab 

300 mg 

Ustekinumab* Secukinumab 

300 mg 

Ustekinumab* 

Number of 

patients 

334 335 334 335 334 335 

PASI 75 

response n (%) 
166 (49.7%)** 69 (20.6%) 311 (93.1%) 276 (82.4%) 306 (91.6%) 262 (78.2%) 

PASI 90 

response n (%) 

70 (21.0%) 18 (5.4%) 264 (79.0%)** 192 (57.3%) 250 

(74.9%)*** 

203 (60.6%) 

PASI 100 

response n (%) 

14 (4.2%) 3 (0.9%) 148 (44.3%) 95 (28.4%) 150 (44.9%) 123 (36.7%) 

IGA mod 2011 

“clear” or 

“almost clear” 

response n (%) 

128 (38.3%) 41 (12.2%) 278 (83.2%) 226 (67.5%) 261 (78.1%) 213 (63.6%) 

* Patients treated with secukinumab received 300 mg doses at weeks 0, 1, 2, 3 and 4, followed by the same dose 

every 4 weeks until week 52. Patients treated with ustekinumab received 45 mg or 90 mg at weeks 0 and 4, then 

every 12 weeks until week 52 (dosed by weight as per approved posology) 

** p values versus ustekinumab: p<0.0001 for primary endpoint of PASI 90 at week 16 and secondary endpoint of PASI 75 

at week 4 

*** p values versus ustekinumab: p=0.0001 for secondary endpoint of PASI 90 at week 52 

 

Secukinumab was efficacious in systemic treatment-naive, biologic-naive, biologic/anti-TNF-exposed 

and biologic/anti-TNF-failure patients. Improvements in PASI 75 in patients with concurrent psoriatic 

arthritis at baseline were similar to those in the overall plaque psoriasis population. 

 

Secukinumab was associated with a fast onset of efficacy with a 50% reduction in mean PASI by 

week 3 for the 300 mg dose. 

 



 

13 

Figure 1 Time course of percentage change from baseline of mean PASI score in study 1 

(ERASURE) 

 

                        
 
 

 

 

 

Specific locations/forms of plaque psoriasis 

In two additional placebo-controlled studies, improvement was seen in both nail psoriasis 

(TRANSFIGURE, 198 patients) and palmoplantar plaque psoriasis (GESTURE, 205 patients). In the 

TRANSFIGURE study, secukinumab was superior to placebo at week 16 (46.1% for 300 mg, 38.4% 

for 150 mg and 11.7% for placebo) as assessed by significant improvement from baseline in the Nail 

Psoriasis Severity Index (NAPSI %) for patients with moderate to severe plaque psoriasis with nail 

involvement. In the GESTURE study, secukinumab was superior to placebo at week 16 (33.3% for 

300 mg, 22.1% for 150 mg, and 1.5% for placebo) as assessed by significant improvement of ppIGA 0 

or 1 response (“clear” or “almost clear”) for patients with moderate to severe palmoplantar plaque 

psoriasis. 

 

A placebo-controlled study evaluated 102 patients with moderate to severe scalp psoriasis, defined as 

having a Psoriasis Scalp Severity Index (PSSI) score of ≥12, an IGA mod 2011 scalp only score of 3 

or greater and at least 30% of the scalp surface area affected. Secukinumab 300 mg was superior to 

placebo at week 12 as assessed by significant improvement from baseline in both the PSSI 90 response 

(52.9% versus 2.0%) and IGA mod 2011 0 or 1 scalp only response (56.9% versus 5.9%). 

Improvement in both endpoints was sustained for secukinumab patients who continued treatment 

through to week 24. 

 

Quality of life/patient-reported outcomes 

Statistically significant improvements at week 12 (studies 1-4) from baseline compared to placebo 

were demonstrated in the DLQI (Dermatology Life Quality Index). Mean decreases (improvements) in 

DLQI from baseline ranged from -10.4 to -11.6 with secukinumab 300 mg, from -7.7 to -10.1 with 

secukinumab 150 mg, versus -1.1 to -1.9 for placebo at week 12. These improvements were 

maintained for 52 weeks (studies 1 and 2). 

 

Forty percent of the participants in studies 1 and 2 completed the Psoriasis Symptom Diary©. For the 

participants completing the diary in each of these studies, statistically significant improvements at 

week 12 from baseline compared to placebo in patient-reported signs and symptoms of itching, pain 

and scaling were demonstrated. 

 

Statistically significant improvements at week 4 from baseline in patients treated with secukinumab 

compared to patients treated with ustekinumab (CLEAR) were demonstrated in the DLQI and these 

improvements were maintained for up to 52 weeks. 

 

PASI % 

change from 

baseline 

Weeks of treatment 

n = number of patients evaluable 

 secukinumab 150 mg (n=243)   secukinumab 300 mg (n=245)    Placebo (n=245) 



 

14 

Statistically significant improvements in patient-reported signs and symptoms of itching, pain and 

scaling at week 16 and week 52 (CLEAR) were demonstrated in the Psoriasis Symptom Diary© in 

patients treated with secukinumab compared to patients treated with ustekinumab. 

 

Statistically significant improvements (decreases) at week 12 from baseline in the scalp psoriasis study 

were demonstrated in patient reported signs and symptoms of scalp itching, pain and scaling compared 

to placebo. 

 

Psoriatic arthritis 

The safety and efficacy of secukinumab were assessed in 1,999 patients in three randomised, 

double-blind, placebo-controlled phase III studies in patients with active psoriatic arthritis (≥3 swollen 

and ≥3 tender joints) despite non-steroidal anti-inflammatory drug (NSAID), corticosteroid or 

disease-modifying anti-rheumatic drug (DMARD) therapy. Patients with each subtype of PsA were 

enrolled in these studies, including polyarticular arthritis with no evidence of rheumatoid nodules, 

spondylitis with peripheral arthritis, asymmetric peripheral arthritis, distal interphalangeal 

involvement and arthritis mutilans. Patients in these studies had a diagnosis of PsA of at least five 

years. The majority of patients also had active psoriasis skin lesions or a documented history of 

psoriasis. Over 61% and 42% of the PsA patients had enthesitis and dactylitis at baseline, respectively. 

For all studies, the primary endpoint was American College of Rheumatology (ACR) 20 response. For 

Psoriatic Arthritis study 1 (PsA study 1) and Psoriatic Arthritis study 2 (PsA study 2), the primary 

endpoint was at week 24. For Psoriatic Arthritis study 3 (PsA study 3), the primary endpoint was at 

week 16 with the key secondary endpoint, the change from baseline in modified Total Sharp Score 

(mTSS), at week 24. 

 

In PsA study 1, PsA study 2 and PsA study 3, 29%, 35% and 30% of patients, respectively, were 

previously treated with an anti-TNFα agent and discontinued the anti-TNFα agent for either lack of 

efficacy or intolerance (anti-TNFα-IR patients). 

 

PsA study 1 (FUTURE 1) evaluated 606 patients, of whom 60.7% had concomitant MTX. Patients 

randomised to secukinumab received 10 mg/kg intravenously at weeks 0, 2, and 4, followed by either 

75 mg or 150 mg subcutaneously every month starting at week 8. Patients randomised to placebo who 

were non-responders at week 16 (early rescue) and other placebo patients at week 24 were crossed 

over to receive secukinumab (either 75 mg or 150 mg subcutaneously) followed by the same dose 

every month. 

 

PsA study 2 (FUTURE 2) evaluated 397 patients, of whom 46.6% had concomitant MTX. Patients 

randomised to secukinumab received 75 mg, 150 mg or 300 mg subcutaneously at weeks 0, 1, 2, 3 and 

4, followed by the same dose every month. Patients randomised to receive placebo who were 

non-responders at week 16 (early rescue) were crossed over to receive secukinumab (either 150 mg or 

300 mg subcutaneously) at week 16 followed by the same dose every month. Patients randomised to 

receive placebo who were responders at week 16 were crossed over to receive secukinumab (either 

150 mg or 300 mg subcutaneously) at week 24 followed by the same dose every month. 

 

PsA study 3 (FUTURE 5) evaluated 996 patients, of whom 50.1% had concomitant MTX. Patients 

were randomised to receive secukinumab 150 mg, 300 mg or placebo subcutaneously at weeks 0, 1, 2, 

3 and 4, followed by the same dose every month, or a once monthly injection of secukinumab 150 mg 

(without loading). Patients randomised to receive placebo who were non-responders at week 16 (early 

rescue) were then crossed over to receive secukinumab (either 150 mg or 300 mg subcutaneously) at 

week 16 followed by the same dose every month. Patients randomised to receive placebo who were 

responders at week 16 were crossed over to receive secukinumab (either 150 mg or 300 mg 

subcutaneously) at week 24 followed by the same dose every month. 

 

Signs and symptoms 

Treatment with secukinumab resulted in significant improvement in measures of disease activity 

compared to placebo at weeks 16 and 24 (see Table 6). 

 



 

15 

Table 6 Clinical response in PsA study 2 and PsA study 3 at week 16 and week 24 

 

 PsA study 2 PsA study 3 

 Placebo 150 mg1 300 mg1 Placebo 150 mg1 300 mg1 

Number of patients 

randomised 

98 100 100 332 220 222 

ACR20 response 

n (%) 

      

Week 16 18 

(18.4%) 

60 

(60.0%***) 

57 

(57.0%***) 

91◊ 

(27.4%) 

122◊ 

(55.5%***) 

139◊ 

(62.6%***) 

Week 24 15◊ 

(15.3%) 

51◊ 

(51.0%***) 

54◊ 

(54.0%***) 

78 

(23.5%) 

117 

(53.2%***) 

141 

(63.5%***) 

ACR50 response 

n (%) 

      

Week 16 6 

(6.1%) 

37 

(37.0%***) 

35 

(35.0%***) 

27 

(8.1%) 

79 

(35.9%*) 

88 

(39.6%*) 

Week 24 7 

(7.1%) 

35 

(35.0%) 

35 

(35.0%**) 

29 

(8.7%) 

86 

(39.1%***) 

97 

(43.7%***) 

ACR70 response 

n (%) 

      

Week 16 2 

(2.0%) 

17 

(17.0%**) 

15 

(15.0%**) 

14 

(4.2%) 

40 

(18.2%***) 

45 

(20.3%***) 

Week 24 1 

(1.0%) 

21 

(21.0%**) 

20 

(20.0%**) 

13 

(3.9%) 

53 

(24.1%***) 

57 

(25.7%***) 

DAS28-CRP       

Week 16 -0.50 -1.45*** -1.51*** -0.63 -1.29* -1.49* 

Week 24 -0.96 -1.58** -1.61** -0.84 -1.57*** -1.68*** 

Number of patients 

with ≥3% BSA 

psoriasis skin 

involvement at 

baseline 

43 

(43.9%) 

58 

(58.0%) 

41 

(41.0%) 

162 

(48.8%) 

125 

(56.8%) 

110 

(49.5%) 

PASI 75 response 

n (%) 

      

Week 16 3 

(7.0%) 

33 

(56.9%***) 

27 

(65.9%***) 

20 

(12.3%) 

75 

(60.0%*) 

77 

(70.0%*) 

Week 24 7 

(16.3%) 

28 

(48.3%**) 

26 

(63.4%***) 

29 

(17.9%) 

80 

(64.0%***) 

78 

(70.9%***) 

PASI 90 response 

n (%) 

      

Week 16 3 

(7.0%) 

22 

(37.9%***) 

18 

(43.9%***) 

15 

(9.3%) 

46 

(36.8%*) 

59 

(53.6%*) 

Week 24 4 

(9.3%) 

19 

(32.8%**) 

20 

(48.8%***) 

19 

(11.7%) 

51 

(40.8%***) 

60 

(54.5%***) 

Dactylitis 

resolution n (%) † 

      

Week 16 10 

(37%) 

21 

(65.6%*) 

26 

(56.5%) 

40 

(32.3%) 

46 

(57.5%*) 

54 

(65.9%*) 

Week 24 4 

(14.8%) 

16 

(50.0%**) 

26 

(56.5%**) 

42 

(33.9%) 

51 

(63.8%***) 

52 

(63.4%***) 



 

16 

Enthesitis 

resolution n (%) ‡ 

      

Week 16 17 

(26.2%) 

32 

(50.0%**) 

32 

(57.1%***) 

68 

(35.4%) 

77 

(54.6%*) 

78 

(55.7%*) 

Week 24 14 

(21.5%) 

27 

(42.2%*) 

27 

(48.2%**) 

66 

(34.4%) 

77 

(54.6%***) 

86 

(61.4%***) 

* p<0.05, ** p<0.01, *** p<0.001; versus placebo 

All p-values are adjusted for multiplicity of testing based on pre-defined hierarchy at week 24 for PsA 

study 2, except for ACR70, Dactylitis and Enthesitis, which were exploratory endpoints and all 

endpoints at week 16. 

All p-values are adjusted for multiplicity of testing based on pre-defined hierarchy at week 16 for PsA 

study 3, except for ACR70 which was an exploratory endpoint and all endpoints at week 24. 

Non-responder imputation used for missing binary endpoint. 

ACR: American College of Rheumatology; PASI: Psoriasis Area and Severity Index; DAS: Disease 

Activity Score; BSA: Body Surface Area 
◊Primary Endpoint 

1Secukinumab 150 mg or 300 mg s.c. at weeks 0, 1, 2, 3, and 4 followed by the same dose every month 

†In patients with dactylitis at baseline (n=27, 32, 46, respectively for PsA study 2 and n=124, 80, 82, 

respectively for PsA study 3) 

‡In patients with enthesitis at baseline (n=65, 64, 56, respectively for PsA study 2 and n=192, 141, 140, 

respectively for PsA study 3) 

 

The onset of action of secukinumab occurred as early as week 2. Statistically significant difference in 

ACR 20 versus placebo was reached at week 3. 

 

The percentage of patients achieving ACR 20 response by visit is shown in Figure 2. 

 

Figure 2 ACR20 response in PsA study 2 over time up to week 52 

 

  
 

 
  

Percentage of 

responders 

Time (Weeks) 



 

17 

 

Similar responses for primary and key secondary endpoints were seen in PsA patients regardless of 

whether they were on concomitant MTX treatment or not. In PsA study 2, at week 24, secukinumab-

treated patients with concomitant MTX use had a higher ACR 20 response (47.7% and 54.4% for 

150 mg and 300 mg, respectively, compared to placebo 20.0%) and ACR 50 response (31.8% and 

38.6% for 150 mg and 300 mg, respectively, compared to placebo 8.0%). Secukinumab-treated 

patients without concomitant MTX use had a higher ACR 20 response (53.6% and 53.6% for 150 mg 

and 300 mg, respectively, compared to placebo 10.4%) and ACR 50 response (37.5% and 32.1% for 

150 mg and 300 mg, respectively, compared to placebo 6.3%). 

 

In PsA study 2, both anti-TNFα-naive and anti-TNFα-IR secukinumab-treated patients had a 

significantly higher ACR 20 response compared to placebo at week 24, with a slightly higher response 

in the anti-TNFα-naive group (anti-TNFα-naive: 64% and 58% for 150 mg and 300 mg, respectively, 

compared to placebo 15.9%; anti-TNFα-IR: 30% and 46% for 150 mg and 300 mg, respectively, 

compared to placebo 14.3%). In the anti-TNFα-IR patients subgroup, only the 300 mg dose showed 

significantly higher response rate for ACR 20 compared to placebo (p<0.05) and demonstrated clinical 

meaningful benefit over 150 mg on multiple secondary endpoints. Improvements in the PASI 75 

response were seen in both subgroups and the 300 mg dose showed statistically significant benefit in 

the anti-TNFα-IR patients. 

 

The number of PsA patients with axial involvement was too small to allow meaningful assessment. 

 

Improvements were shown in all components of the ACR scores, including patient assessment of pain. 

In PsA study 2, the proportion of patients achieving a modified PsA Response Criteria (PsARC) 

response was greater in the secukinumab-treated patients (59.0% and 61.0% for 150 mg and 300 mg, 

respectively) compared to placebo (26.5%) at week 24. 
 

In PsA study 1 and PsA study 2, efficacy was maintained up to week 104. In PsA study 2, among 

200 patients initially randomised to secukinumab 150 mg and 300 mg, 178 (89%) patients were still 

on treatment at week 52. Of the 100 patients randomised to secukinumab 150 mg, 64, 39 and 20 had 

an ACR 20/50/70 response, respectively. Of the 100 patients randomised to secukinumab 300 mg, 64, 

44 and 24 had an ACR 20/50/70 response, respectively. 

 

Radiographic response 

In PsA study 3, inhibition of progression of structural damage was assessed radiographically and 

expressed by the modified Total Sharp Score (mTSS) and its components, the Erosion Score (ES) and 

the Joint Space Narrowing Score (JSN). Radiographs of hands, wrists, and feet were obtained at 

baseline, week 16 and/or week 24 and scored independently by at least two readers who were blinded 

to treatment group and visit number. Secukinumab 150 mg and 300 mg treatment significantly 

inhibited the rate of progression of peripheral joint damage compared with placebo treatment as 

measured by change from baseline in mTSS at week 24 (Table 7). 

 

Inhibition of progression of structural damage was also assessed in PsA study 1 at weeks 24 and 52, 

compared to baseline. Week 24 data are presented in Table 7. 

 



 

18 

Table 7 Change in modified Total Sharp Score in psoriatic arthritis 

 

 PsA study 3 PsA study 1 

 Placebo 

n=296 

secukinumab 

150 mg1 

n=213 

secukinumab 

300 mg1 

n=217 

Placebo 

n=179 

secukinumab 

150 mg2 

n=185 

Total score 

Baseline 

(SD) 

15.0 

(38.2) 

13.5 

(25.6) 

12.9 

(23.8) 

28.4 

(63.5) 

22.3 

(48.0) 

Mean 

change 

at 

Week 24 

0.50 0.13* 0.02* 0.57 0.13* 

*p<0.05 based on nominal, but non adjusted, p-value 
1secukinumab 150 mg or 300 mg s.c. at weeks 0, 1, 2, 3, and 4 followed by the same dose every month 
210 mg/kg at weeks 0, 2 and 4 followed by subcutaneous doses of 75 mg or 150 mg 

 

In PsA study 1, inhibition of structural damage was maintained with secukinumab treatment up to 

week 52. 

 

In PsA study 3, the percentage of patients with no disease progression (defined as a change from 

baseline in mTSS of ≤0.5) from randomisation to week 24 was 80.3%, 88.5% and 73.6% for 

secukinumab 150 mg, 300 mg and placebo, respectively. An effect of inhibition of structural damage 

was observed in anti-TNFα-naïve and anti-TNFα-IR patients and in patients treated with and without 

concomitant MTX. 
 

In PsA study 1, the percentage of patients with no disease progression (defined as a change from 

baseline in mTSS of ≤0.5) from randomisation to week 24 was 82.3% in secukinumab 10 mg/kg 

intravenous load – 150 mg subcutaneous maintenance and 75.7% in placebo. The percentage of 

patients with no disease progression from week 24 to week 52 for secukinumab 10 mg/kg intravenous 

load – followed by 150 mg subcutaneous maintenance and for placebo patients who switched to 75 mg 

or 150 mg subcutaneous every 4 weeks at week 16 or week 24 was 85.7% and 86.8%, respectively. 

 

Physical function and health-related quality of life 

In PsA study 2 and PsA study 3, patients treated with secukinumab 150 mg (p=0.0555 and p<0.0001) 

and 300 mg (p=0.0040 and p<0.0001) showed improvement in physical function compared to patients 

treated with placebo as assessed by Health Assessment Questionnaire-Disability Index (HAQ-DI) at 

week 24 and week 16, respectively. Improvements in HAQ-DI scores were seen regardless of previous 

anti-TNFα exposure. Similar responses were seen in PsA study 1. 

 

Secukinumab-treated patients reported significant improvements in health-related quality of life as 

measured by the Short Form-36 Health Survey Physical Component Summary (SF-36 PCS) score 

(p<0.001). There were also statistically significant improvements demonstrated in exploratory 

endpoints assessed by the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) 

scores for 150 mg and 300 mg compared to placebo (7.97, 5.97 versus 1.63, respectively) and these 

improvements were maintained up to week 104 in PsA study 2. 

 

Similar responses were seen in PsA study 1 and efficacy was maintained up to week 52. 

  



 

19 

 

Axial spondyloarthritis (axSpA) 

Ankylosing spondylitis (AS) / Radiographic axial spondyloarthritis 

The safety and efficacy of secukinumab were assessed in 816 patients in three randomised, 

double-blind, placebo-controlled phase III studies in patients with active ankylosing spondylitis (AS) 

with a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4 despite non-steroidal 

anti-inflammatory drug (NSAID), corticosteroid or disease-modifying anti-rheumatic drug (DMARD) 

therapy. Patients in Ankylosing Spondylitis study 1 (AS study 1) and Ankylosing Spondylitis study 2 

(AS study 2) had a diagnosis of AS for a median of 2.7 to 5.8 years. For both studies, the primary 

endpoint was at least a 20% improvement in Assessment of Spondyloarthritis International Society 

(ASAS 20) criteria at week 16. 

 

In Ankylosing Spondylitis study 1 (AS study 1), Ankylosing Spondylitis study 2 (AS study 2), and 

Ankylosing Spondylitis study 3 (AS study 3), 27.0%, 38.8%, and 23.5% of patients, respectively, were 

previously treated with an anti-TNFα agent and discontinued the anti-TNFα agent for either lack of 

efficacy or intolerance (anti-TNFα-IR patients). 

 

AS study 1 (MEASURE 1) evaluated 371 patients, of whom 14.8% and 33.4% used concomitant 

MTX or sulfasalazine, respectively. Patients randomised to secukinumab received 10 mg/kg 

intravenously at weeks 0, 2, and 4, followed by either 75 mg or 150 mg subcutaneously every month 

starting at week 8. Patients randomised to placebo who were non-responders at week 16 (early rescue) 

and all other placebo patients at week 24 were crossed over to receive secukinumab (either 75 mg or 

150 mg subcutaneously), followed by the same dose every month. 

 

AS study 2 (MEASURE 2) evaluated 219 patients, of whom 11.9% and 14.2% used concomitant 

MTX or sulfasalazine, respectively. Patients randomised to secukinumab received 75 mg or 150 mg 

subcutaneously at weeks 0, 1, 2, 3 and 4, followed by the same dose every month. At week 16, 

patients who were randomised to placebo at baseline were re-randomised to receive secukinumab 

(either 75 mg or 150 mg subcutaneously) every month. 

 

AS study 3 (MEASURE 3) evaluated 226 patients, of whom 13.3% and 23.5% used concomitant 

MTX or sulfasalazine, respectively. Patients randomised to secukinumab received 10 mg/kg 

intravenously at weeks 0, 2, and 4, followed by either 150 mg or 300 mg subcutaneously every month. 

At week 16, patients who were randomised to placebo at baseline were re-randomised to receive 

secukinumab (either 150 mg or 300 mg subcutaneously) every month. The primary endpoint was 

ASAS 20 at week 16. Patients were blinded to the treatment regimen up to week 52, and the study 

continued to week 156. 

 

Signs and symptoms: 

In AS study 2, treatment with secukinumab 150 mg resulted in greater improvement in measures of 

disease activity compared with placebo at week 16 (see Table 8). 

 



 

20 

Table 8 Clinical response in AS study 2 at week 16 

 

Outcome (p-value versus placebo) 

Placebo 

(n = 74) 

75 mg 

(n = 73) 

150 mg 

(n = 72) 

ASAS 20 response, % 28.4 41.1 61.1*** 

ASAS 40 response, % 10.8 26.0 36.1*** 

hsCRP, (post-BSL/BSL ratio) 1.13 0.61 0.55*** 

ASAS 5/6, % 8.1 34.2 43.1*** 

ASAS partial remission, % 4.1 15.1 13.9 

BASDAI 50, % 10.8 24.7* 30.6** 

ASDAS-CRP major improvement 4.1 15.1* 25.0*** 

* p<0.05, ** p<0.01, *** p<0.001; versus placebo 

All p-values adjusted for multiplicity of testing based on pre-defined hierarchy, except BASDAI 50 

and ASDAS-CRP 

Non-responder imputation used for missing binary endpoint 

 

ASAS: Assessment of SpondyloArthritis International Society Criteria; BASDAI: Bath Ankylosing 

Spondylitis Disease Activity Index; hsCRP: high-sensitivity C-reactive protein; ASDAS: Ankylosing 

Spondylitis Disease Activity Score; BSL: baseline 

 

The onset of action of secukinumab 150 mg occurred as early as week 1 for ASAS 20 and week 2 for 

ASAS 40 (superior to placebo) in AS study 2. 

 

ASAS 20 responses were improved at week 16 in both anti-TNFα-naïve patients (68.2% versus 

31.1%; p<0.05) and anti-TNFα-IR patients (50.0% versus 24.1%; p<0.05) for secukinumab 150 mg 

compared with placebo, respectively. 

 

In AS study 1 and AS study 2, secukinumab-treated patients (150 mg in AS study 2 and both regimens 

in AS study 1) demonstrated significantly improved signs and symptoms at week 16, with comparable 

magnitude of response and efficacy maintained up to week 52 in both anti-TNFα-naive and 

anti-TNFα-IR patients. In AS study 2, among 72 patients initially randomised to secukinumab 150 mg, 

61 (84.7%) patients were still on treatment at week 52. Of the 72 patients randomised to secukinumab 

150 mg, 45 and 35 had an ASAS 20/40 response, respectively. 

 

In AS study 3, patients treated with secukinumab (150 mg and 300 mg) demonstrated improved signs 

and symptoms, and had comparable efficacy responses regardless of dose that were superior to 

placebo at week 16 for the primary endpoint (ASAS 20). Overall, the efficacy response rates for the 

300 mg group were consistently greater compared to the 150 mg group for the secondary endpoints. 

During the blinded period, the ASAS 20 and ASAS 40 responses were 69.7% and 47.6% for 150 mg 

and 74.3% and 57.4% for 300 mg at week 52, respectively. The ASAS 20 and ASAS 40 responses 

were maintained up to week 156 (69.5% and 47.6% for 150 mg versus 74.8% and 55.6% for 300 mg). 

Greater response rates favouring 300 mg were also observed for ASAS partial remission (ASAS PR) 

response at week 16 and were maintained up to week 156. Larger differences in response rates, 

favouring 300 mg over 150 mg, were observed in anti-TNFα-IR patients (n=36) compared to 

anti-TNFα-naïve patients (n=114). 

 

Spinal mobility: 

Patients treated with secukinumab 150 mg showed improvements in spinal mobility as measured by 

change from baseline in BASMI at week 16 for both AS study 1 (-0.40 versus -0.12 for placebo; 

p=0.0114) and AS study 2 (-0.51 versus -0.22 for placebo; p=0.0533). These improvements were 

sustained up to week 52. 

 



 

21 

Physical function and health-related quality of life: 

In AS study 1 and study 2, patients treated with secukinumab 150 mg showed improvements in health-

related quality of life as measured by AS Quality of Life Questionnaire (ASQoL) (p=0.001) and SF-36 

Physical Component Summary (SF-36PCS) (p<0.001). Patients treated with secukinumab 150 mg also 

showed statistically significant improvements on exploratory endpoints in physical function as 

assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI) compared to placebo (-2.15 

versus -0.68), and in fatigue as assessed by the Functional Assessment of Chronic Illness Therapy-

Fatigue (FACIT-Fatigue) scale compared to placebo (8.10 versus 3.30). These improvements were 

sustained up to week 52. 

 

Non-radiographic axial spondyloarthritis (nr-axSpA) 

The safety and efficacy of secukinumab were assessed in 555 patients in one randomised, 

double-blind, placebo-controlled phase III study (PREVENT), consisting of a 2-year core phase and a 

2-year extension phase, in patients with active non-radiographic axial spondyloarthritis (nr-axSpA) 

fulfilling the Assessment of Spondyloarthritis International Society (ASAS) classification criteria for 

axial spondyloarthritis (axSpA) with no radiographic evidence of changes in the sacroiliac joints that 

would meet the modified New York criteria for ankylosing spondylitis (AS). Patients enrolled had 

active disease, defined as a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4, a 

Visual Analogue Scale (VAS) for total back pain of ≥40 (on a scale of 0-100 mm), despite current or 

previous non-steroidal anti-inflammatory drug (NSAID) therapy and increased C-reactive protein 

(CRP) and/or evidence of sacroiliitis on Magnetic Resonance Imaging (MRI). Patients in this study 

had a diagnosis of axSpA for a mean of 2.1 to 3.0 years and 54% of the study participants were 

female. 

 

In the PREVENT study, 9.7% of patients were previously treated with an anti-TNFα agent and 

discontinued the anti-TNFα agent for either lack of efficacy or intolerance (anti-TNFα-IR patients). 

 

In the PREVENT study, 9.9% and 14.8% of patients used concomitant MTX or sulfasalazine, 

respectively. In the double-blind period, patients received either placebo or secukinumab for 52 weeks. 

Patients randomised to secukinumab received 150 mg subcutaneously at weeks 0, 1, 2, 3 and 4 

followed by the same dose every month, or a once monthly injection of secukinumab 150 mg. The 

primary endpoint was at least 40% improvement in Assessment of Spondyloarthritis International 

Society (ASAS 40) at Week 16 in anti-TNFα-naive patients. 

 

Signs and symptoms: 

In the PREVENT study, treatment with secukinumab 150 mg resulted in significant improvements in 

the measures of disease activity compared to placebo at week 16. These measures include ASAS 40, 

ASAS 5/6, BASDAI score, BASDAI 50, high-sensitivity CRP (hsCRP), ASAS 20 and ASAS partial 

remission response compared to placebo (Table 9). Responses were maintained up to week 52. 

 



 

22 

Table 9 Clinical response in the PREVENT study at week 16 

 

Outcome (p-value versus placebo) Placebo 150 mg1 

Number of anti-TNFα-naive patients 

randomised 

171 164 

ASAS 40 response, % 29.2 41.5* 

Total number of patients randomised 186 185 

ASAS 40 response, % 28.0 40.0* 

ASAS 5/6, % 23.7 40.0* 

BASDAI, LS mean change from baseline score -1.46 -2.35* 

BASDAI 50, % 21.0 37.3* 

hsCRP, (post-BSL/BSL ratio) 0.91 0.64* 

ASAS 20 response, % 45.7 56.8* 

ASAS partial remission, % 7.0 21.6* 

*p<0.05 versus placebo 

All p-values adjusted for multiplicity of testing based on pre-defined hierarchy 

Non-responder imputation used for missing binary endpoint 
1secukinumab 150 mg s.c. at weeks 0, 1, 2, 3, and 4 followed by the same dose every month 

 

ASAS: Assessment of SpondyloArthritis International Society Criteria; BASDAI: Bath Ankylosing 

Spondylitis Disease Activity Index; hsCRP: high-sensitivity C-reactive protein; BSL: baseline; LS: 

Least square 

 

The onset of action of secukinumab 150 mg occurred as early as week 3 for ASAS 40 in anti-TNFα 

naive patients (superior to placebo) in the PREVENT study. The percentage of patients achieving an 

ASAS 40 response in anti-TNFα naive patients by visit is shown in Figure 3. 

 

Figure 3 ASAS 40 responses in anti-TNFα naive patients in the PREVENT study over time 
up to week 16 

 

 
 

 

ASAS 40 responses were also improved at week 16 in anti-TNFα-IR patients for secukinumab 150 mg 

compared with placebo. 

Percentage of 

responders 

Time (Weeks) 

 Secukinumab 150 mg Load  Placebo 



 

23 

 

Physical function and health-related quality of life: 

Patients treated with secukinumab 150 mg showed statistically significant improvements by week 16 

compared to placebo-treated patients in physical function as assessed by the BASFI (week 16: -1.75 

versus -1.01, p<0.05). Patients treated with secukinumab reported significant improvements compared 

to placebo-treated patients by week 16 in health-related quality of life as measured by ASQoL (LS 

mean change: week 16: -3.45 versus -1.84, p<0.05) and SF-36 Physical Component Summary (SF-36 

PCS) (LS mean change: week 16: 5.71 versus 2.93, p<0.05). These improvements were sustained up 

to week 52. 

 

Spinal mobility: 

Spinal mobility was assessed by BASMI up to week 16. Numerically greater improvements were 

demonstrated in patients treated with secukinumab compared with placebo-treated patients at weeks 4, 

8, 12 and 16. 

 

Inhibition of inflammation in magnetic resonance imaging (MRI): 

Signs of inflammation were assessed by MRI at baseline and week 16 and expressed as change from 

baseline in Berlin SI-joint oedema score for sacroiliac joints and ASspiMRI-a score and Berlin spine 

score for the spine. Inhibition of inflammatory signs in both sacroiliac joints and the spine was 

observed in patients treated with secukinumab. Mean change from baseline in Berlin SI-joint oedema 

score was -1.68 for patients treated with secukinumab 150 mg (n=180) versus -0.39 for the 

placebo-treated patients (n=174) (p<0.05). 

 

Paediatric population 

 

Paediatric plaque psoriasis 

Secukinumab has been shown to improve signs and symptoms, and health-related quality of life in 

paediatric patients 6 years and older with plaque psoriasis (see Tables 11 and 13). 

 

Severe plaque psoriasis 

The safety and efficacy of secukinumab were assessed in a randomised, double-blind, placebo and 

etanercept-controlled phase III study in paediatric patients from 6 to <18 years of age with severe 

plaque psoriasis, as defined by a PASI score ≥20, an IGA mod 2011 score of 4, and BSA involvement 

of ≥10%, who were candidates for systemic therapy. Approximately 43% of the patients had prior 

exposure to phototherapy, 53% to conventional systemic therapy, 3% to biologics, and 9% had 

concomitant psoriatic arthritis. 

 
The paediatric psoriasis study 1 evaluated 162 patients who were randomised to receive low dose 

secukinumab (75 mg for body weight <50 kg or 150 mg for body weight ≥50 kg), high dose 

secukinumab (75 mg for body weight <25 kg, 150 mg for body weight between ≥25 kg and <50 kg, or 

300 mg for body weight ≥50 kg), or placebo at weeks 0, 1, 2, 3, and 4 followed by the same dose 

every 4 weeks, or etanercept. Patients randomised to etanercept received 0.8 mg/kg weekly (up to a 

maximum of 50 mg). Patient distribution by weight and age at randomisation is described in Table 10. 

 

Table 10 Patient distribution by weight and age for paediatric psoriasis study 1 

 

Randomisation 

strata 

Description Secukinumab 

low dose 

n=40 

Secukinumab 

high dose 

n=40 

Placebo 

 

n=41 

Etanercept 

 

n=41 

Total 

 

N=162 

Age 6-<12 years 8 9 10 10 37 

≥12-

<18 years 

32 31 31 31 125 

Weight <25 kg 2 3 3 4 12 

≥25-<50 kg 17 15 17 16 65 

≥50 kg 21 22 21 21 85 

 



 

24 

Patients randomised to receive placebo who were non-responders at week 12 were switched to either 

the secukinumab low or high dose group (dose based on body weight group) and received study drug 

at weeks 12, 13, 14, and 15, followed by the same dose every 4 weeks starting at week 16. The co-

primary endpoints were the proportion of patients who achieved a PASI 75 response and IGA mod 

2011 ‘clear’ or ‘almost clear’ (0 or 1) response at week 12. 

 

During the 12 week placebo-controlled period, the efficacy of both the low and the high dose of 

secukinumab was comparable for the co-primary endpoints. The odds ratio estimates in favour of both 

secukinumab doses were statistically significant for both the PASI 75 and IGA mod 2011 0 or 1 

responses. 

 

All patients were followed for efficacy and safety during the 52 weeks following the first dose. The 

proportion of patients achieving PASI 75 and IGA mod 2011 ‘clear’ or ‘almost clear’ (0 or 1) 

responses showed separation between secukinumab treatment groups and placebo at the first post-

baseline visit at week 4, the difference becoming more prominent at week 12. The response was 

maintained throughout the 52 week time period (see Table 11). Improvement in PASI 50, 90, 100 

responder rates and Children’s Dermatology Life Quality Index (CDLQI) scores of 0 or 1 were also 

maintained throughout the 52 week time period. 

 

In addition, PASI 75, IGA 0 or 1, PASI 90 response rates at weeks 12 and 52 for both secukinumab 

low and high dose groups were higher than the rates for patients treated with etanercept (see Table 11). 

 

Beyond week 12, efficacy of both the low and the high dose of secukinumab was comparable although 

the efficacy of the high dose was higher for patients ≥50 kg. The safety profiles of the low dose and 

the high dose were comparable and consistent with the safety profile in adults. 
 

Table 11 Summary of clinical response in severe paediatric psoriasis at weeks 12 and 52 

(paediatric psoriasis study 1)* 

 

Response 

criterion 

Treatment comparison 'test' 'control' odds ratio  

'test' vs. 'control' n**/m (%) n**/m (%) estimate (95% CI) p-value 

At week 12*** 

PASI 75 secukinumab low dose vs. placebo 32/40 (80.0) 6/41 (14.6) 25.78 (7.08, 114.66) <0.0001 

 secukinumab high dose vs. placebo 31/40 (77.5) 6/41 (14.6) 22.65 (6.31, 98.93) <0.0001 

 secukinumab low dose vs. etanercept 32/40 (80.0) 26/41 (63.4) 2.25 (0.73, 7.38)  

 secukinumab high dose vs. etanercept 31/40 (77.5) 26/41 (63.4) 1.92 (0.64, 6.07)  

IGA 0/1 secukinumab low dose vs. placebo 28/40 (70.0) 2/41 (4.9) 51.77 (10.02, 538.64) <0.0001 

 secukinumab high dose vs. placebo 24/40 (60.0) 2/41 (4.9) 32.52 (6.48, 329.52) <0.0001 

 secukinumab low dose vs. etanercept 28/40 (70.0) 14/41 (34.1) 4.49 (1.60, 13.42)  

 secukinumab high dose vs. etanercept 24/40 (60.0) 14/41 (34.1) 2.86 (1.05, 8.13)  

PASI 90 secukinumab low dose vs. placebo 29/40 (72.5) 1/41 (2.4) 133.67 (16.83, 6395.22) <0.0001 

 secukinumab high dose vs. placebo 27/40 (67.5) 1/41 (2.4) 102.86 (13.22, 4850.13) <0.0001 

 secukinumab low dose vs. etanercept 29/40 (72.5) 12/41 (29.3) 7.03 (2.34, 23.19)  

 secukinumab high dose vs. etanercept 27/40 (67.5) 12/41 (29.3) 5.32 (1.82, 16.75)  

At week 52 

PASI 75 secukinumab low dose vs. etanercept 35/40 (87.5) 28/41 (68.3) 3.12 (0.91, 12.52)  

secukinumab high dose vs. etanercept 35/40 (87.5) 28/41 (68.3) 3.09 (0.90, 12.39)  

IGA 0/1 secukinumab low dose vs. etanercept 29/40 (72.5) 23/41 (56.1) 2.02 (0.73, 5.77)  

secukinumab high dose vs. etanercept 30/40 (75.0) 23/41 (56.1) 2.26 (0.81, 6.62)  

PASI 90 secukinumab low dose vs. etanercept 30/40 (75.0) 21/41 (51.2) 2.85 (1.02, 8.38)  

secukinumab high dose vs. etanercept 32/40 (80.0) 21/41 (51.2) 3.69 (1.27, 11.61)  

* non-responder imputation was used to handle missing values 

** n is the number of responders, m = number of patients evaluable 

*** extended visit window at week 12 

Odds ratio, 95% confidence interval, and p-value are from an exact logistic regression model with treatment 

group, baseline body-weight category and age category as factors 

 

  



 

25 

 

A higher proportion of paediatric patients treated with secukinumab reported improvement in health-

related quality of life as measured by a CDLQI score of 0 or 1 compared to placebo at week 12 (low 

dose 44.7%, high dose 50%, placebo 15%). Over time up to and including week 52 both secukinumab 

dose groups were numerically higher than the etanercept group (low dose 60.6%, high dose 66.7%, 

etanercept 44.4%). 

 

Moderate to severe plaque psoriasis 

Secukinumab was predicted to be effective for the treatment of paediatric patients with moderate 

plaque psoriasis based on the demonstrated efficacy and exposure response relationship in adult 

patients with moderate to severe plaque psoriasis, and the similarity of the disease course, 

pathophysiology, and drug effect in adult and paediatric patients at the same exposure levels. 

 

Moreover, the safety and efficacy of secukinumab was assessed in an open-label, two-arm, 

parallel-group, multicentre phase III study in paediatric patients from 6 to <18 years of age with 

moderate to severe plaque psoriasis, as defined by a PASI score ≥12, an IGA mod 2011 score of ≥3, 

and BSA involvement of ≥10%, who were candidates for systemic therapy. 

 

The paediatric psoriasis study 2 evaluated 84 patients who were randomised to receive low dose 

secukinumab (75 mg for body weight <50 kg or 150 mg for body weight ≥50 kg) or high dose 

secukinumab (75 mg for body weight <25 kg, 150 mg for body weight between ≥25 kg and <50 kg, or 

300 mg for body weight ≥50 kg) at weeks 0, 1, 2, 3, and 4 followed by the same dose every 4 weeks. 

Patient distribution by weight and age at randomisation is described in Table 12. 

 

Table 12 Patient distribution by weight and age for paediatric psoriasis study 2 

 

Sub-groups Description Secukinumab 

low dose 

n=42 

Secukinumab 

high dose 

n=42 

Total 

 

N=84 

Age 6-<12 years 17 16 33 

≥12-<18 years 25 26 51 

Weight <25 kg 4 4 8 

≥25-<50 kg 13 12 25 

≥50 kg 25 26 51 

 

The co-primary endpoints were the proportion of patients who achieved a PASI 75 response and IGA 

mod 2011 ‘clear’ or ‘almost clear’ (0 or 1) response at week 12. 

 

The efficacy of both the low and the high dose of secukinumab was comparable and showed 

statistically significant improvement compared to historical placebo for the co-primary endpoints. The 

estimated posterior probability of a positive treatment effect was 100%. 

 

All patients were followed for efficacy for at least 24 weeks following first administration (see 

Table 13). Efficacy (defined as PASI 75 response and IGA mod 2011 ‘clear’ or ‘almost clear’ [0 or 1]) 

was observed as early as the first post-baseline visit at week 2 and the proportion of patients who 

achieved a PASI 75 response and IGA mod 2011 ‘clear’ or ‘almost clear’ (0 or 1) increased 

throughout the 24 week time period. Improvement in PASI 90 and PASI 100 were also observed at 

week 12 and increased throughout the 24 week time period. 

 

Beyond week 12, efficacy of both the low and the high dose of secukinumab was comparable. The 

safety profiles of the low dose and the high dose were comparable and consistent with the safety 

profile in adults. 

 



 

26 

Table 13 Summary of clinical response in moderate to severe paediatric psoriasis at weeks 12 

and 24 (paediatric psoriasis study 2)* 

 

 Week 12 Week 24 

Secukinumab 

low dose 

Secukinumab 

high dose 

Secukinumab 

low dose 

Secukinumab 

high dose 

Number of patients 42 42 42 42 

PASI 75 response n (%) 39 (92.9%) 39 (92.9%) 40 (95.2%) 40 (95.2%) 

IGA mod 2011 ‘clear’ or ‘almost 
clear’ response n (%) 

33 (78.6%) 35 (83.3%) 37 (88.1%) 39 (92.9%) 

PASI 90 response n (%) 29 (69%) 32 (76.2%) 37 (88.1%) 37 (88.1%) 

PASI 100 response n (%) 25 (59.5%) 23 (54.8%) 28 (66.7%) 28 (66.7%) 

* non-responder imputation was used to handle missing values 

 

These outcomes in the paediatric moderate to severe plaque psoriasis population confirmed the 

predictive assumptions based on the efficacy and exposure response relationship in adult patients, 

mentioned above. 

 

In the low dose group, 50% and 70.7% of patients achieved a CDLQI 0 or 1 score at weeks 12 and 24, 

respectively. In the high dose group, 61.9% and 60.5% achieved a CDLQI 0 or 1 score at weeks 12 

and 24, respectively. 

 

The European Medicines Agency has waived the obligation to submit the results of studies with 

Cosentyx in plaque psoriasis in paediatric patients aged from birth to less than 6 years and in chronic 

idiopathic arthritis for paediatric patients aged from birth to less than 2 years (see section 4.2 for 

information on paediatric use). 

 

The European Medicines Agency has deferred the obligation to submit the results of studies with 

Cosentyx in chronic idiopathic arthritis for paediatric patients aged from 2 years to less than 18 years 

(see section 4.2 for information on paediatric use). 

 

5.2 Pharmacokinetic properties 

 

Most pharmacokinetics properties observed in patients with plaque psoriasis, psoriatic arthritis and 

ankylosing spondylitis were similar. 

 

Absorption 

 

Following a single subcutaneous dose of 300 mg as a liquid formulation in healthy volunteers, 

secukinumab reached peak serum concentrations of 43.2±10.4 μg/ml between 2 and 14 days post dose. 

 

Based on population pharmacokinetic analysis, following a single subcutaneous dose of either 150 mg 
or 300 mg in plaque psoriasis patients, secukinumab reached peak serum concentrations of 

13.7±4.8 µg/ml or 27.3±9.5 µg/ml, respectively, between 5 and 6 days post dose. 

 

After initial weekly dosing during the first month, time to reach the maximum concentration was 

between 31 and 34 days based on population pharmacokinetic analysis. 

 

On the basis of simulated data, peak concentrations at steady-state (Cmax,ss) following subcutaneous 

administration of 150 mg or 300 mg were 27.6 µg/ml and 55.2 µg/ml, respectively. Population 

pharmacokinetic analysis suggests that steady-state is reached after 20 weeks with monthly dosing 

regimens. 

 

Compared with exposure after a single dose, the population pharmacokinetic analysis showed that 

patients exhibited a 2-fold increase in peak serum concentrations and area under the curve (AUC) 

following repeated monthly dosing during maintenance. 

 



 

27 

Population pharmacokinetic analysis showed that secukinumab was absorbed with an average absolute 

bioavailability of 73% in patients with plaque psoriasis. Across studies, absolute bioavailabilities in 

the range between 60 and 77% were calculated. 

 

The bioavailability of secukinumab in PsA patients was 85% on the basis of the population 

pharmacokinetic model. 

 

Distribution 

 

The mean volume of distribution during the terminal phase (Vz) following single intravenous 

administration ranged from 7.10 to 8.60 litres in plaque psoriasis patients, suggesting that 

secukinumab undergoes limited distribution to peripheral compartments. 

 

Biotransformation 

 

The majority of IgG elimination occurs via intracellular catabolism, following fluid-phase or receptor 

mediated endocytosis. 

 

Elimination 

 

Mean systemic clearance (CL) following a single intravenous administration to patients with plaque 
psoriasis ranged from 0.13 to 0.36 l/day. In a population pharmacokinetic analysis, the mean systemic 

clearance (CL) was 0.19 l/day in plaque psoriasis patients. The CL was not impacted by gender. 

Clearance was dose- and time-independent. 

 

The mean elimination half-life, as estimated from population pharmacokinetic analysis, was 27 days in 

plaque psoriasis patients, ranging from 18 to 46 days across psoriasis studies with intravenous 

administration. 

 

Linearity/non-linearity 

 

The single and multiple dose pharmacokinetics of secukinumab in plaque psoriasis patients were 

determined in several studies with intravenous doses ranging from 1x 0.3 mg/kg to 3x 10 mg/kg and 

with subcutaneous doses ranging from 1x 25 mg to multiple doses of 300 mg. Exposure was dose 

proportional across all dosing regimens. 

 

Special populations 

 

Elderly patients 

Based on population pharmacokinetic analysis with a limited number of elderly patients (n=71 for age 

≥65 years and n=7 for age ≥75 years), clearance in elderly patients and patients less than 65 years of 

age was similar. 

 

Patients with renal or hepatic impairment 

No pharmacokinetic data are available in patients with renal or hepatic impairment. The renal 

elimination of intact secukinumab, an IgG monoclonal antibody, is expected to be low and of minor 

importance. IgGs are mainly eliminated via catabolism and hepatic impairment is not expected to 

influence clearance of secukinumab. 

 

Effect of weight on pharmacokinetics 

Secukinumab clearance and volume of distribution increase as body weight increases. 

 

  



 

28 

Paediatric population 

In a pool of the two paediatric studies, patients with moderate to severe plaque psoriasis (6 to less than 

18 years of age) were administered secukinumab at the recommended paediatric dosing regimen. At 

week 24, patients weighing ≥25 and <50 kg had a mean ± SD steady-state trough concentration of 

19.8 ± 6.96 µg/ml (n=24) after 75 mg of secukinumab and patients weighing ≥50 kg had mean ±SD 

trough concentration of 27.3 ± 10.1 µg/ml (n=36) after 150 mg of secukinumab. The mean ± SD 

steady-state trough concentration in patients weighing <25 kg (n=8) was 32.6 ± 10.8 µg/ml at week 24 

after 75 mg dose. 

 

5.3 Preclinical safety data 

 

Non-clinical data revealed no special hazard for humans (adult or paediatric) based on conventional 

studies of safety pharmacology, repeated dose and reproductive toxicity, or tissue cross-reactivity. 

 

Animal studies have not been conducted to evaluate the carcinogenic potential of secukinumab. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 
 

Sucrose 

Histidine 

Histidine hydrochloride monohydrate 

Polysorbate 80 

 

6.2 Incompatibilities 
 

This medicinal product must not be mixed with other medicinal products except those mentioned in 

section 6.6. 

 

6.3 Shelf life 
 

3 years 

 

After reconstitution 

 

Chemical and physical in-use stability has been demonstrated for 24 hours at 2ºC to 8ºC. 

From a microbiological point of view, unless the method of reconstitution precludes the risk of 

microbial contamination, the product should be used immediately. 

 

6.4 Special precautions for storage 

 

Store in a refrigerator (2°C - 8°C). 

For storage conditions after reconstitution of the medicinal product, see section 6.3 

 

6.5 Nature and contents of container 

 

Cosentyx is supplied in a colourless glass vial with a grey coated rubber stopper and aluminium cap 

with a white flip-off component containing 150 mg of secukinumab. 

 

Cosentyx is available in packs containing one vial. 

  



 

29 

 

6.6 Special precautions for disposal and other handling 

 

The single-use vial contains 150 mg secukinumab for reconstitution with sterile water for injections. 

The resulting solution should be clear and colourless to slightly yellow. Do not use if the lyophilised 

powder has not fully dissolved or if the liquid contains easily visible particles, is cloudy or is distinctly 

brown. 

 

Reconstitution 

Cosentyx 150 mg powder for solution for injection must be prepared by a healthcare professional. The 

preparation of the solution for subcutaneous injection must be done without interruption and ensuring 

that aseptic technique is used. The preparation time from piercing the stopper until end of 

reconstitution takes 20 minutes on average and should not exceed 90 minutes. 

1. Bring the vial of powder to room temperature and ensure that the sterile water for injections is at 

room temperature. 

2. Withdraw slightly more than 1.0 ml sterile water for injections into a 1 ml graduated disposable 

syringe and adjust to 1.0 ml. 

3. Remove the plastic cap from the vial. 

4. Insert the syringe needle into the vial containing the powder through the centre of the rubber 

stopper and reconstitute the powder by slowly injecting 1.0 ml of sterile water for injections into 

the vial. The stream of sterile water for injections should be directed onto the powder. 

5. Tilt the vial to an angle of approx. 45° and gently rotate between the fingertips for approx. 

1 minute. Do not shake or invert the vial. 

6. Keep the vial standing at room temperature for a minimum of 10 minutes to allow for 

dissolution. Note that foaming of the solution may occur. 

7. Tilt the vial to an angle of approx. 45° and gently rotate between the fingertips for approx. 

1 minute. Do not shake or invert the vial. 

8. Allow the vial to stand undisturbed at room temperature for approximately 5 minutes. The 

resulting solution should be clear. Its colour may vary from colourless to slightly yellow. Do not 

use if the lyophilised powder has not fully dissolved or if the liquid contains easily visible 

particles, is cloudy or is distinctly brown. 

9. Prepare the required number of vials (2 vials for the 300 mg dose). 

 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements. 

 

Use in the paediatric population 

 

For paediatric patients receiving the 75 mg dose, it is currently recommended to use the single-use vial 

containing 150 mg secukinumab for reconstitution with sterile water for injections. Slightly more than 

0.5 ml of the reconstituted solution for subcutaneous injection have to be withdrawn and the rest of the 

solution must be discarded immediately. Detailed instructions for use are provided in the package 

leaflet. 

 

 

7. MARKETING AUTHORISATION HOLDER 
 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

  



 

30 

 

 

8. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/14/980/001 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 

Date of first authorisation: 15 January 2015 

Date of latest renewal: 03 September 2019 

 

 

10. DATE OF REVISION OF THE TEXT 

 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency http://www.ema.europa.eu. 

 

http://www.ema.europa.eu/


 

31 

1. NAME OF THE MEDICINAL PRODUCT 
 

Cosentyx 150 mg solution for injection in pre-filled syringe 

Cosentyx 300 mg solution for injection in pre-filled syringe 

Cosentyx 150 mg solution for injection in pre-filled pen 

Cosentyx 300 mg solution for injection in pre-filled pen 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 

Cosentyx 150 mg solution for injection in pre-filled syringe 

 

Each pre-filled syringe contains 150 mg secukinumab in 1 ml. 

 

Cosentyx 300 mg solution for injection in pre-filled syringe 

 

Each pre-filled syringe contains 300 mg secukinumab in 2 ml. 

 

Cosentyx 150 mg solution for injection in pre-filled pen 

 

Each pre-filled pen contains 150 mg secukinumab in 1 ml. 

 

Cosentyx 300 mg solution for injection in pre-filled pen 

 

Each pre-filled pen contains 300 mg secukinumab in 2 ml. 

 

Secukinumab is a recombinant fully human monoclonal antibody produced in Chinese Hamster Ovary 

(CHO) cells. 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 
 

Solution for injection (injection) 

 

The solution is clear and colourless to slightly yellow. 

 

 

4. CLINICAL PARTICULARS 
 

4.1 Therapeutic indications 

 

Adult plaque psoriasis 

 

Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are 

candidates for systemic therapy. 

 

Paediatric plaque psoriasis 

 

Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in children and 

adolescents from the age of 6 years who are candidates for systemic therapy. 
  



 

32 

 

Psoriatic arthritis 

 

Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active 

psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic 

drug (DMARD) therapy has been inadequate (see section 5.1). 

 

Axial spondyloarthritis (axSpA) 

 

Ankylosing spondylitis (AS, radiographic axial spondyloarthritis) 

Cosentyx is indicated for the treatment of active ankylosing spondylitis in adults who have responded 

inadequately to conventional therapy. 

 

Non-radiographic axial spondyloarthritis (nr-axSpA) 

Cosentyx is indicated for the treatment of active non-radiographic axial spondyloarthritis with 

objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic 

resonance imaging (MRI) evidence in adults who have responded inadequately to non-steroidal 

anti-inflammatory drugs (NSAIDs). 
 

4.2 Posology and method of administration 

 

Cosentyx is intended for use under the guidance and supervision of a physician experienced in the 

diagnosis and treatment of conditions for which Cosentyx is indicated. 

 

Posology 

 

Adult plaque psoriasis 

The recommended dose is 300 mg of secukinumab by subcutaneous injection with initial dosing at 

weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. Each 300 mg dose is given as one 

subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg. 

 

Paediatric plaque psoriasis (adolescents and children from the age of 6 years) 

The recommended dose is based on body weight (Table 1) and administered by subcutaneous injection 

with initial dosing at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. Each 75 mg 

dose is given as one subcutaneous injection of 75 mg. Each 150 mg dose is given as one subcutaneous 

injection of 150 mg. Each 300 mg dose is given as one subcutaneous injection of 300 mg or as two 

subcutaneous injections of 150 mg. 

 

Table 1 Recommended dose for paediatric plaque psoriasis 

 

Body weight at time of dosing Recommended Dose 

<25 kg 75 mg 

25 to <50 kg 75 mg 

≥50 kg 150 mg (*may be increased to 300 mg) 

*Some patients may derive additional benefit from the higher dose. 

 

The 150 mg solution for injection in pre-filled syringe is not indicated for administration to paediatric 

patients with a weight <50 kg. The 150 mg powder for solution for injection presentation is 

appropriate for administration to this population. 

 

Psoriatic arthritis 

For patients with concomitant moderate to severe plaque psoriasis or who are anti-TNFα inadequate 

responders (IR), the recommended dose is 300 mg by subcutaneous injection with initial dosing at 

weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. Each 300 mg dose is given as one 

subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg. 

 



 

33 

For other patients, the recommended dose is 150 mg by subcutaneous injection with initial dosing at 

weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. Based on clinical response, the dose 

can be increased to 300 mg. 

 

Axial spondyloarthritis (axSpA) 

Ankylosing spondylitis (AS, radiographic axial spondyloarthritis) 

The recommended dose is 150 mg by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3 and 

4, followed by monthly maintenance dosing. Based on clinical response, the dose can be increased to 

300 mg. Each 300 mg dose is given as one subcutaneous injection of 300 mg or as two subcutaneous 

injections of 150 mg. 

 

Non-radiographic axial spondyloarthritis (nr-axSpA) 

The recommended dose is 150 mg by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3 and 

4, followed by monthly maintenance dosing. 

 

For all of the above indications, available data suggest that a clinical response is usually achieved 

within 16 weeks of treatment. Consideration should be given to discontinuing treatment in patients 

who have shown no response by 16 weeks of treatment. Some patients with an initial partial response 

may subsequently improve with continued treatment beyond 16 weeks. 

 

Special populations 

 

Elderly patients (aged 65 years and over) 

No dose adjustment is required (see section 5.2). 

 

Renal impairment / hepatic impairment 

Cosentyx has not been studied in these patient populations. No dose recommendations can be made. 

 

Paediatric population 

The safety and efficacy of Cosentyx in children with plaque psoriasis below the age of 6 years have 

not been established. 

 

The safety and efficacy of Cosentyx in children below the age of 18 years in other indications have not 

yet been established. No data are available. 

 

Method of administration 

 

Cosentyx is to be administered by subcutaneous injection. If possible, areas of the skin that show 

psoriasis should be avoided as injection sites. The solution in the syringe or pen must not be shaken. 

 

After proper training in subcutaneous injection technique, patients may self-inject Cosentyx or be 

injected by a caregiver if a physician determines that this is appropriate. However, the physician 

should ensure appropriate follow-up of patients. Patients or caregivers should be instructed to inject 

the full amount of Cosentyx according to the instructions provided in the package leaflet. 

Comprehensive instructions for administration are given in the package leaflet. 

 

4.3 Contraindications 
 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 

 

Clinically important, active infection, e.g. active tuberculosis (see section 4.4). 

  



 

34 

 

4.4 Special warnings and precautions for use 

 

Traceability 

 

In order to improve the traceability of biological medicinal products, the name and the batch number 

of the administered product should be clearly recorded. 

 

Infections 

 

Secukinumab has the potential to increase the risk of infections. Serious infections have been observed 

in patients receiving secukinumab in the post-marketing setting. Caution should be exercised when 

considering the use of secukinumab in patients with a chronic infection or a history of recurrent 

infection. 

 

Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection 

occur. If a patient develops a serious infection, the patient should be closely monitored and 

secukinumab should not be administered until the infection resolves. 

 

In clinical studies, infections have been observed in patients receiving secukinumab (see section 4.8). 

Most of these were mild or moderate upper respiratory tract infections such as nasopharyngitis and did 

not require treatment discontinuation. 

 

Related to the mechanism of action of secukinumab, non-serious mucocutaneous candida infections 

were more frequently reported for secukinumab than placebo in the psoriasis clinical studies (3.55 per 

100 patient years for secukinumab 300 mg versus 1.00 per 100 patient years for placebo) (see 

section 4.8). 

 

No increased susceptibility to tuberculosis was reported from clinical studies. However, secukinumab 

should not be given to patients with active tuberculosis. Anti-tuberculosis therapy should be 

considered prior to initiation of secukinumab in patients with latent tuberculosis. 

 

Inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) 

 

Cases of new or exacerbations of inflammatory bowel disease have been reported with secukinumab 

(see section 4.8). Secukinumab is not recommended in patients with inflammatory bowel disease. If a 

patient develops signs and symptoms of inflammatory bowel disease or experiences an exacerbation of 

pre-existing inflammatory bowel disease, secukinumab should be discontinued and appropriate 

medical management should be initiated. 

 

Hypersensitivity reactions 

 

In clinical studies, rare cases of anaphylactic reactions have been observed in patients receiving 

secukinumab. If an anaphylactic or other serious allergic reactions occur, administration of 

secukinumab should be discontinued immediately and appropriate therapy initiated. 

 

Latex-sensitive individuals – Cosentyx 150 mg solution for injection in pre-filled syringe and 150 mg 

solution for injection in pre-filled pen only 

 

The removable needle cap of Cosentyx 150 mg solution for injection in pre-filled syringe and 

Cosentyx 150 mg solution for injection in pre-filled pen contains a derivative of natural rubber latex. 

No natural rubber latex has to date been detected in the removable needle cap. Nevertheless, the use of 

Cosentyx 150 mg solution for injection in pre-filled syringe and Cosentyx 150 mg solution for 

injection in pre-filled pen in latex-sensitive individuals has not been studied and there is therefore a 

potential risk of hypersensitivity reactions which cannot be completely ruled out. 

 



 

35 

Vaccinations 

 

Live vaccines should not be given concurrently with secukinumab. 

 

Patients receiving secukinumab may receive concurrent inactivated or non-live vaccinations. In a 

study, after meningococcal and inactivated influenza vaccinations, a similar proportion of healthy 

volunteers treated with 150 mg of secukinumab and those treated with placebo were able to mount an 

adequate immune response of at least a 4-fold increase in antibody titres to meningococcal and 

influenza vaccines. The data suggest that secukinumab does not suppress the humoral immune 

response to the meningococcal or influenza vaccines. 

 

Prior to initiating therapy with Cosentyx, it is recommended that paediatric patients receive all 

age-appropriate immunisations as per current immunisation guidelines. 

 

Concomitant immunosuppressive therapy 

 

In psoriasis studies, the safety and efficacy of secukinumab in combination with immunosuppressants, 

including biologics, or phototherapy have not been evaluated. Secukinumab was administered 

concomitantly with methotrexate (MTX), sulfasalazine and/or corticosteroids in arthritis studies 

(including in patients with psoriatic arthritis and ankylosing spondylitis). Caution should be exercised 

when considering concomitant use of other immunosuppressants and secukinumab (see also 

section 4.5). 

 

4.5 Interaction with other medicinal products and other forms of interaction 
 

Live vaccines should not be given concurrently with secukinumab (see also section 4.4). 

 

In a study in adult subjects with plaque psoriasis, no interaction was observed between secukinumab 

and midazolam (CYP3A4 substrate). 

 

No interaction was seen when secukinumab was administered concomitantly with methotrexate 

(MTX) and/or corticosteroids in arthritis studies (including in patients with psoriatic arthritis and axial 

spondyloarthritis). 

 

4.6 Fertility, pregnancy and lactation 
 

Women of childbearing potential 

 

Women of childbearing potential should use an effective method of contraception during treatment 

and for at least 20 weeks after treatment. 

 

Pregnancy 

 

There are no adequate data from the use of secukinumab in pregnant women. 

 

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity 

(see section 5.3). As a precautionary measure, it is preferable to avoid the use of Cosentyx during 

pregnancy. 

  



 

36 

 

Breast-feeding 

 

It is not known whether secukinumab is excreted in human milk. Immunoglobulins are excreted in 

human milk and it is not known if secukinumab is absorbed systemically after ingestion. Because of 

the potential for adverse reactions in nursing infants from secukinumab, a decision on whether to 

discontinue breast-feeding during treatment and up to 20 weeks after treatment or to discontinue 

therapy with Cosentyx must be made taking into account the benefit of breast-feeding to the child and 

the benefit of therapy to the woman. 

 

Fertility 

 

The effect of secukinumab on human fertility has not been evaluated. Animal studies do not indicate 

direct or indirect harmful effects with respect to fertility. 

 

4.7 Effects on ability to drive and use machines 
 

Cosentyx has no or negligible influence on the ability to drive and use machines. 

 

4.8 Undesirable effects 
 

Summary of the safety profile 

 

The most frequently reported adverse drug reactions (ADRs) are upper respiratory tract infections 

(most frequently nasopharyngitis, rhinitis). 

 

Tabulated list of adverse reactions 

 

ADRs from clinical studies and post-marketing reports (Table 2) are listed by MedDRA system organ 

class. Within each system organ class, the ADRs are ranked by frequency, with the most frequent 

reactions first. Within each frequency grouping, adverse drug reactions are presented in order of 

decreasing seriousness. In addition, the corresponding frequency category for each adverse drug 

reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); 

uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known 

(cannot be estimated from the available data). 

 

Over 18,000 patients have been treated with secukinumab in blinded and open-label clinical studies in 

various indications (plaque psoriasis, psoriatic arthritis, axial spondyloarthritis and other autoimmune 

conditions), representing 30,565 patient years of exposure. Of these, over 11,700 patients were 

exposed to secukinumab for at least one year. The safety profile of secukinumab is consistent across 

all indications. 

 



 

37 

Table 2 List of adverse reactions in clinical studies1) and post-marketing experience 
 

System Organ Class Frequency Adverse reaction 

Infections and 

infestations 

Very common Upper respiratory tract infections 

Common Oral herpes 

Tinea pedis 

Uncommon Oral candidiasis 

Otitis externa 

Lower respiratory tract infections 

Not known Mucosal and cutaneous candidiasis (including 

oesophageal candidiasis) 

Blood and lymphatic 

system disorders 

Uncommon Neutropenia 

Immune system 

disorders 

Rare Anaphylactic reactions 

Nervous system 

disorders 

Common Headache 

Eye disorders Uncommon Conjunctivitis 

Respiratory, thoracic 

and mediastinal 

disorders 

Common Rhinorrhoea 

Gastrointestinal 

disorders 

Common Diarrhoea 

Common Nausea 

Uncommon Inflammatory bowel disease 

Skin and subcutaneous 

tissue disorders 

Uncommon Urticaria 

Rare Exfoliative dermatitis2) 

General disorders and 

administration site 

conditions 

Common Fatigue 

1) Placebo-controlled clinical studies (phase III) in plaque psoriasis, PsA, AS and nr-axSpA patients 

exposed to 300 mg, 150 mg, 75 mg or placebo up to 12 weeks (psoriasis) or 16 weeks (PsA, AS and 

nr-axSpA) treatment duration 
2) Cases were reported in patients with psoriasis diagnosis 

 

Description of selected adverse reactions 

 

Infections 

In the placebo-controlled period of clinical studies in plaque psoriasis (a total of 1,382 patients treated 

with secukinumab and 694 patients treated with placebo for up to 12 weeks), infections were reported 

in 28.7% of patients treated with secukinumab compared with 18.9% of patients treated with placebo. 

The majority of infections consisted of non-serious and mild to moderate upper respiratory tract 

infections, such as nasopharyngitis, which did not necessitate treatment discontinuation. There was an 

increase in mucosal or cutaneous candidiasis, consistent with the mechanism of action, but the cases 

were mild or moderate in severity, non-serious, responsive to standard treatment and did not 

necessitate treatment discontinuation. Serious infections occurred in 0.14% of patients treated with 

secukinumab and in 0.3% of patients treated with placebo (see section 4.4). 

 

Over the entire treatment period (a total of 3,430 patients treated with secukinumab for up to 52 weeks 

for the majority of patients), infections were reported in 47.5% of patients treated with secukinumab 

(0.9 per patient-year of follow-up). Serious infections were reported in 1.2% of patients treated with 

secukinumab (0.015 per patient-year of follow-up). 

 

Infection rates observed in psoriatic arthritis and axial spondyloarthritis (ankylosing spondylitis and 

non-radiographic axial spondyloarthritis) clinical studies were similar to those observed in the 

psoriasis studies. 

 



 

38 

Neutropenia 

In psoriasis phase III clinical studies, neutropenia was more frequently observed with secukinumab 

than with placebo, but most cases were mild, transient and reversible. Neutropenia <1.0-0.5x109/l 

(CTCAE grade 3) was reported in 18 out of 3,430 (0.5%) patients on secukinumab, with no dose 

dependence and no temporal relationship to infections in 15 out of 18 cases. There were no reported 

cases of more severe neutropenia. Non-serious infections with usual response to standard care and not 

requiring discontinuation of secukinumab were reported in the remaining 3 cases. 

 

The frequency of neutropenia in psoriatic arthritis and axial spondyloarthritis (ankylosing spondylitis 

and non-radiographic axial spondyloarthritis) was similar to psoriasis. 

 

Rare cases of neutropenia <0.5x109/l (CTCAE grade 4) were reported. 
 

Hypersensitivity reactions 

In clinical studies, urticaria and rare cases of anaphylactic reaction to secukinumab were observed (see 

also section 4.4). 

 

Immunogenicity 

In psoriasis, psoriatic arthritis and axial spondyloarthritis (ankylosing spondylitis and non-

radiographic axial spondyloarthritis) clinical studies, less than 1% of patients treated with 

secukinumab developed antibodies to secukinumab up to 52 weeks of treatment. About half of the 

treatment-emergent anti-drug antibodies were neutralising, but this was not associated with loss of 

efficacy or pharmacokinetic abnormalities. 

 

Paediatric population 

 

Undesirable effects in paediatric patients from the age of 6 years with plaque psoriasis 

The safety of secukinumab was assessed in two phase III studies in paediatric patients with plaque 

psoriasis. The first study (paediatric study 1) was a double-blind, placebo-controlled study of 

162 patients from 6 to less than 18 years of age with severe plaque psoriasis. The second study 

(paediatric study 2) is an open-label study of 84 patients from 6 to less than 18 years of age with 

moderate to severe plaque psoriasis. The safety profile reported in these two studies was consistent 

with the safety profile reported in adult plaque psoriasis patients. 

 

Reporting of suspected adverse reactions 

 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 

professionals are asked to report any suspected adverse reactions via the national reporting system 

listed in Appendix V. 

 

4.9 Overdose 

 

Doses up to 30 mg/kg (approximately 2000 to 3000 mg) have been administered intravenously in 

clinical studies without dose-limiting toxicity. In the event of overdose, it is recommended that the 

patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic 

treatment be instituted immediately. 

 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

39 

5. PHARMACOLOGICAL PROPERTIES 
 

5.1 Pharmacodynamic properties 
 

Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC10 

 

Mechanism of action 

 

Secukinumab is a fully human IgG1/κ monoclonal antibody that selectively binds to and neutralises 

the proinflammatory cytokine interleukin-17A (IL-17A). Secukinumab works by targeting IL-17A and 

inhibiting its interaction with the IL-17 receptor, which is expressed on various cell types including 

keratinocytes. As a result, secukinumab inhibits the release of proinflammatory cytokines, chemokines 

and mediators of tissue damage and reduces IL-17A-mediated contributions to autoimmune and 

inflammatory diseases. Clinically relevant levels of secukinumab reach the skin and reduce local 

inflammatory markers. As a direct consequence treatment with secukinumab reduces erythema, 

induration and desquamation present in plaque psoriasis lesions. 

 

IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune 

responses. IL-17A plays a key role in the pathogenesis of plaque psoriasis, psoriatic arthritis and axial 

spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis) and is 

up-regulated in lesional skin in contrast to non-lesional skin of plaque psoriasis patients and in 

synovial tissue of psoriatic arthritis patients. The frequency of IL-17-producing cells was also 

significantly higher in the subchondral bone marrow of facet joints from patients with ankylosing 

spondylitis. Increased numbers of IL-17A producing lymphocytes have also been found in patients 

with non-radiographic axial spondyloarthritis. Inhibition of IL-17A was shown to be effective in the 

treatment of ankylosing spondylitis, thus establishing the key role of this cytokine in axial 

spondyloarthritis. 

 

Pharmacodynamic effects 

 

Serum levels of total IL-17A (free and secukinumab-bound IL-17A) are initially increased in patients 

receiving secukinumab. This is followed by a slow decrease due to reduced clearance of 

secukinumab-bound IL-17A, indicating that secukinumab selectively captures free IL-17A, which 

plays a key role in the pathogenesis of plaque psoriasis. 

 

In a study with secukinumab, infiltrating epidermal neutrophils and various neutrophil-associated 

markers that are increased in lesional skin of plaque psoriasis patients were significantly reduced after 

one to two weeks of treatment. 

 

Secukinumab has been shown to lower (within 1 to 2 weeks of treatment) levels of C-reactive protein, 

which is a marker of inflammation. 

 

Clinical efficacy and safety 

 

Adult plaque psoriasis 

The safety and efficacy of secukinumab were assessed in four randomised, double-blind, 

placebo-controlled phase III studies in patients with moderate to severe plaque psoriasis who were 

candidates for phototherapy or systemic therapy [ERASURE, FIXTURE, FEATURE, JUNCTURE]. 

The efficacy and safety of secukinumab 150 mg and 300 mg were evaluated versus either placebo or 

etanercept. In addition, one study assessed a chronic treatment regimen versus a “retreatment as 

needed” regimen [SCULPTURE]. 

  



 

40 

 

Of the 2,403 patients who were included in the placebo-controlled studies, 79% were biologic-naive, 

45% were non-biologic failures and 8% were biologic failures (6% were anti-TNF failures, and 2% 

were anti-p40 failures). Approximately 15 to 25% of patients in phase III studies had psoriatic arthritis 

(PsA) at baseline. 

 

Psoriasis study 1 (ERASURE) evaluated 738 patients. Patients randomised to secukinumab received 

150 mg or 300 mg doses at weeks 0, 1, 2, 3 and 4, followed by the same dose every month. Psoriasis 

study 2 (FIXTURE) evaluated 1,306 patients. Patients randomised to secukinumab received 150 mg or 

300 mg doses at weeks 0, 1, 2, 3 and 4, followed by the same dose every month. Patients randomised 

to etanercept received 50 mg doses twice per week for 12 weeks followed by 50 mg every week. In 

both study 1 and study 2, patients randomised to receive placebo who were non-responders at week 12 

then crossed over to receive secukinumab (either 150 mg or 300 mg) at weeks 12, 13, 14, and 15, 

followed by the same dose every month starting at week 16. All patients were followed for up to 

52 weeks following first administration of study treatment. 

 

Psoriasis study 3 (FEATURE) evaluated 177 patients using a pre-filled syringe compared with placebo 

after 12 weeks of treatment to assess the safety, tolerability, and usability of secukinumab 

self-administration via the pre-filled syringe. Psoriasis study 4 (JUNCTURE) evaluated 182 patients 

using a pre-filled pen compared with placebo after 12 weeks of treatment to assess the safety, 

tolerability, and usability of secukinumab self-administration via the pre-filled pen. In both study 3 

and study 4, patients randomised to secukinumab received 150 mg or 300 mg doses at weeks 0, 1, 2, 3 

and 4, followed by the same dose every month. Patients were also randomised to receive placebo at 

weeks 0, 1, 2, 3 and 4, followed by the same dose every month. 

 

Psoriasis study 5 (SCULPTURE) evaluated 966 patients. All patients received secukinumab 150 mg or 

300 mg doses at weeks 0, 1, 2, 3, 4, 8 and 12 and then were randomised to receive either a 

maintenance regimen of the same dose every month starting at week 12 or a “retreatment as needed” 

regimen of the same dose. Patients randomised to “retreatment as needed” did not achieve adequate 

maintenance of response and therefore a fixed monthly maintenance regimen is recommended. 

 

The co-primary endpoints in the placebo and active-controlled studies were the proportion of patients 

who achieved a PASI 75 response and IGA mod 2011 “clear” or “almost clear” response versus 

placebo at week 12 (see Tables 3 and 4). The 300 mg dose provided improved skin clearance 

particularly for “clear” or “almost clear” skin across the efficacy endpoints of PASI 90, PASI 100, and 

IGA mod 2011 0 or 1 response across all studies with peak effects seen at week 16, therefore this dose 

is recommended. 

 



 

41 

Table 3 Summary of PASI 50/75/90/100 & IGA⃰ mod 2011 “clear” or “almost clear” clinical 

response in psoriasis studies 1, 3 and 4 (ERASURE, FEATURE and JUNCTURE) 

 
 Week 12 Week 16 Week 52 

 Placebo 150 mg 300 mg 150 mg 300 mg 150 mg 300 mg 

Study 1 

Number of patients 246 244 245 244 245 244 245 

PASI 50 response n (%) 22 
(8.9%) 

203 

(83.5%) 

222 

(90.6%) 

212 

(87.2%) 

224 

(91.4%) 

187 

(77%) 

207 

(84.5%) 

PASI 75 response n (%) 11 
(4.5%) 

174 

(71.6%)** 

200 

(81.6%)** 

188 

(77.4%) 

211 

(86.1%) 

146 

(60.1%) 

182 

(74.3%) 

PASI 90 response n (%) 3 (1.2%) 95 
(39.1%)** 

145 

(59.2%)** 

130 

(53.5%) 

171 

(69.8%) 

88 

(36.2%) 

147 

(60.0%) 

PASI 100 response n (%) 2 (0.8%) 31 
(12.8%) 

70 

(28.6%) 

51 

(21.0%) 

102 

(41.6%) 

49 

(20.2%) 

96 

(39.2%) 

IGA mod 2011 “clear” or 

“almost clear” response 

n (%) 

6 

(2.40%) 

125 

(51.2%)** 

160 

(65.3%)** 

142 

(58.2%) 

180 

(73.5%) 

101 

(41.4%) 

148 

(60.4%) 

Study 3 
Number of patients  59 59 58 - - - - 

PASI 50 response n (%) 3 (5.1%) 51 
(86.4%) 

51 

(87.9%) 

- - - - 

PASI 75 response n (%) 0 (0.0%) 41 
(69.5%)** 

44 

(75.9%)** 

- - - - 

PASI 90 response n (%) 0 (0.0%) 27 
(45.8%) 

35 

(60.3%) 

- - - - 

PASI 100 response n (%) 0 (0.0%) 5 
(8.5%) 

25 

(43.1%) 

- - - - 

IGA mod 2011 “clear” or 

“almost clear” response 

n (%) 

0 (0.0%) 31 

(52.5%)** 

40 

(69.0%)** 

- - - - 

Study 4 
Number of patients  61 60 60 - - - - 

PASI 50 response n (%) 5 (8.2%) 48 
(80.0%) 

58 

(96.7%) 

- - - - 

PASI 75 response n (%) 2 (3.3%) 43 
(71.7%)** 

52 

(86.7%)** 

- - - - 

PASI 90 response n (%) 0 (0.0%) 24 
(40.0%) 

33 

(55.0%) 

- - - - 

PASI 100 response n(%) 0 (0.0%) 10 
(16.7%) 

16 

(26.7%) 

- - - - 

IGA mod 2011 “clear” or 

“almost clear” response 

n (%) 

0 (0.0%) 32 

(53.3%)** 

44 

(73.3%)** 

- - - - 

* The IGA mod 2011 is a 5-category scale including “0 = clear”, “1 = almost clear”, “2 = mild”, “3 = 

moderate” or “4 = severe”, indicating the physician’s overall assessment of the psoriasis severity focusing 

on induration, erythema and scaling. Treatment success of “clear” or “almost clear” consisted of no signs of 

psoriasis or normal to pink colouration of lesions, no thickening of the plaque and none to minimal focal 

scaling. 

** p values versus placebo and adjusted for multiplicity: p<0.0001. 

 



 

42 

Table 4 Summary of clinical response on psoriasis study 2 (FIXTURE) 

 
 Week 12 Week 16 Week 52 

 Placebo 150 mg 300 mg  Etanercept 150 mg 300 mg  Etanercept 150 mg 300 mg  Etanercept 

Number of 

patients 

324 327 323 323 327 323 323 327 323 323 

PASI 50 
response 

n (%) 

49 
(15.1%) 

266 
(81.3%) 

296 
(91.6%) 

226 
(70.0%) 

290 
(88.7%) 

302 
(93.5%) 

257 (79.6%) 249 
(76.1%) 

274 
(84.8%) 

234 (72.4%) 

PASI 75 
response 

n (%) 

16 
(4.9%) 

219 
(67.0%)

** 

249 
(77.1%)

** 

142 
(44.0%) 

247 
(75.5%) 

280 
(86.7%) 

189 (58.5%) 215 
(65.7%) 

254 
(78.6%) 

179 (55.4%) 

PASI 90 
response 

n (%) 

5 (1.5%) 137 
(41.9%) 

175 
(54.2%) 

67 (20.7%) 176 
(53.8%) 

234 
(72.4%) 

101 (31.3%) 147 
(45.0%) 

210 
(65.0%) 

108 (33.4%) 

PASI 100 
response 

n (%) 

0 (0%) 47 
(14.4%) 

78 
(24.1%) 

14 (4.3%) 84 
(25.7%) 

119 
(36.8%) 

24 (7.4%) 65 
(19.9%) 

117 
(36.2%) 

32 (9.9%) 

IGA mod 
2011 “clear” 

or “almost 

clear” 
response 

n (%) 

9 (2.8%) 167 
(51.1%)

** 

202 
(62.5%)

** 

88 (27.2%) 200 
(61.2%) 

244 
(75.5%) 

127 (39.3%) 168 
(51.4%) 

219 
(67.8%) 

120 (37.2%) 

** p values versus etanercept: p=0.0250 

 

In an additional psoriasis study (CLEAR) 676 patients were evaluated. Secukinumab 300 mg met the 

primary and secondary endpoints by showing superiority to ustekinumab based on PASI 90 response 

at week 16 (primary endpoint), speed of onset of PASI 75 response at week 4, and long-term PASI 90 

response at week 52. Greater efficacy of secukinumab compared to ustekinumab for the endpoints 

PASI 75/90/100 and IGA mod 2011 0 or 1 response (“clear” or “almost clear”) was observed early 

and continued through to week 52. 

 

Table 5 Summary of clinical response on CLEAR study 

 
 Week 4 Week 16 Week 52 

 Secukinumab 
300 mg 

Ustekinumab* Secukinumab 

300 mg 

Ustekinumab* Secukinumab 

300 mg 

Ustekinumab* 

Number of 

patients 

334 335 334 335 334 335 

PASI 75 

response n (%) 
166 (49.7%)** 69 (20.6%) 311 (93.1%) 276 (82.4%) 306 (91.6%) 262 (78.2%) 

PASI 90 

response n (%) 

70 (21.0%) 18 (5.4%) 264 (79.0%)** 192 (57.3%) 250 

(74.9%)*** 

203 (60.6%) 

PASI 100 

response n (%) 

14 (4.2%) 3 (0.9%) 148 (44.3%) 95 (28.4%) 150 (44.9%) 123 (36.7%) 

IGA mod 2011 

“clear” or 

“almost clear” 

response n (%) 

128 (38.3%) 41 (12.2%) 278 (83.2%) 226 (67.5%) 261 (78.1%) 213 (63.6%) 

* Patients treated with secukinumab received 300 mg doses at weeks 0, 1, 2 3 and 4, followed by the same dose 

every 4 weeks until week 52. Patients treated with ustekinumab received 45 mg or 90 mg at weeks 0 and 4, then 

every 12 weeks until week 52 (dosed by weight as per approved posology) 

** p values versus ustekinumab: p<0.0001 for primary endpoint of PASI 90 at week 16 and secondary endpoint of PASI 75 

at week 4 

*** p values versus ustekinumab: p=0.0001 for secondary endpoint of PASI 90 at week 52 

 

Secukinumab was efficacious in systemic treatment-naive, biologic-naive, biologic/anti-TNF-exposed 

and biologic/anti-TNF-failure patients. Improvements in PASI 75 in patients with concurrent psoriatic 

arthritis at baseline were similar to those in the overall plaque psoriasis population. 

 

Secukinumab was associated with a fast onset of efficacy with a 50% reduction in mean PASI by 

week 3 for the 300 mg dose. 

 



 

43 

Figure 1 Time course of percentage change from baseline of mean PASI score in study 1 

(ERASURE) 

 

                        
 
 

 

 

 

Specific locations/forms of plaque psoriasis 

In two additional placebo-controlled studies, improvement was seen in both nail psoriasis 

(TRANSFIGURE, 198 patients) and palmoplantar plaque psoriasis (GESTURE, 205 patients). In the 

TRANSFIGURE study, secukinumab was superior to placebo at week 16 (46.1% for 300 mg, 38.4% 

for 150 mg and 11.7% for placebo) as assessed by significant improvement from baseline in the Nail 

Psoriasis Severity Index (NAPSI %) for patients with moderate to severe plaque psoriasis with nail 

involvement. In the GESTURE study, secukinumab was superior to placebo at week 16 (33.3% for 

300 mg, 22.1% for 150 mg, and 1.5% for placebo) as assessed by significant improvement of ppIGA 0 

or 1 response (“clear” or “almost clear”) for patients with moderate to severe palmoplantar plaque 

psoriasis. 

 

A placebo-controlled study evaluated 102 patients with moderate to severe scalp psoriasis, defined as 

having a Psoriasis Scalp Severity Index (PSSI) score of ≥12, an IGA mod 2011 scalp only score of 3 

or greater and at least 30% of the scalp surface area affected. Secukinumab 300 mg was superior to 

placebo at week 12 as assessed by significant improvement from baseline in both the PSSI 90 response 

(52.9% versus 2.0%) and IGA mod 2011 0 or 1 scalp only response (56.9% versus 5.9%). 

Improvement in both endpoints was sustained for secukinumab patients who continued treatment 

through to week 24. 

 

Quality of life/patient-reported outcomes 

Statistically significant improvements at week 12 (studies 1-4) from baseline compared to placebo 

were demonstrated in the DLQI (Dermatology Life Quality Index). Mean decreases (improvements) in 

DLQI from baseline ranged from -10.4 to -11.6 with secukinumab 300 mg, from -7.7 to -10.1 with 

secukinumab 150 mg, versus -1.1 to -1.9 for placebo at week 12. These improvements were 

maintained for 52 weeks (studies 1 and 2). 

 

Forty percent of the participants in studies 1 and 2 completed the Psoriasis Symptom Diary©. For the 

participants completing the diary in each of these studies, statistically significant improvements at 

week 12 from baseline compared to placebo in patient-reported signs and symptoms of itching, pain 

and scaling were demonstrated. 

 

Statistically significant improvements at week 4 from baseline in patients treated with secukinumab 

compared to patients treated with ustekinumab (CLEAR) were demonstrated in the DLQI and these 

improvements were maintained for up to 52 weeks. 

 

PASI % change 

from baseline 

Weeks of treatment 

n = number of patients evaluable 

 secukinumab 150 mg (n=243)   secukinumab 300 mg (n=245)    Placebo (n=245) 



 

44 

Statistically significant improvements in patient-reported signs and symptoms of itching, pain and 

scaling at week 16 and week 52 (CLEAR) were demonstrated in the Psoriasis Symptom Diary© in 

patients treated with secukinumab compared to patients treated with ustekinumab. 

 

Statistically significant improvements (decreases) at week 12 from baseline in the scalp psoriasis study 

were demonstrated in patient reported signs and symptoms of scalp itching, pain and scaling compared 

to placebo. 

 

Psoriatic arthritis 

The safety and efficacy of secukinumab were assessed in 1,999 patients in three randomised, 

double-blind, placebo-controlled phase III studies in patients with active psoriatic arthritis (≥3 swollen 

and ≥3 tender joints) despite non-steroidal anti-inflammatory drug (NSAID), corticosteroid or 

disease-modifying anti-rheumatic drug (DMARD) therapy. Patients with each subtype of PsA were 

enrolled in these studies, including polyarticular arthritis with no evidence of rheumatoid nodules, 

spondylitis with peripheral arthritis, asymmetric peripheral arthritis, distal interphalangeal 

involvement and arthritis mutilans. Patients in these studies had a diagnosis of PsA of at least five 

years. The majority of patients also had active psoriasis skin lesions or a documented history of 

psoriasis. Over 61% and 42% of the PsA patients had enthesitis and dactylitis at baseline, respectively. 

For all studies, the primary endpoint was American College of Rheumatology (ACR) 20 response. For 

Psoriatic Arthritis study 1 (PsA study 1) and Psoriatic Arthritis study 2 (PsA study 2), the primary 

endpoint was at week 24. For Psoriatic Arthritis study 3 (PsA study 3), the primary endpoint was at 

week 16 with the key secondary endpoint, the change from baseline in modified Total Sharp Score 

(mTSS), at week 24. 

 

In PsA study 1, PsA study 2 and PsA study 3, 29%, 35% and 30% of patients, respectively, were 

previously treated with an anti-TNFα agent and discontinued the anti-TNFα agent for either lack of 

efficacy or intolerance (anti-TNFα-IR patients). 

 

PsA study 1 (FUTURE 1) evaluated 606 patients, of whom 60.7% had concomitant MTX. Patients 

randomised to secukinumab received 10 mg/kg intravenously at weeks 0, 2, and 4, followed by either 

75 mg or 150 mg subcutaneously every month starting at week 8. Patients randomised to placebo who 

were non-responders at week 16 (early rescue) and other placebo patients at week 24 were crossed 

over to receive secukinumab (either 75 mg or 150 mg subcutaneously) followed by the same dose 

every month. 

 

PsA study 2 (FUTURE 2) evaluated 397 patients, of whom 46.6% had concomitant MTX. Patients 

randomised to secukinumab received 75 mg, 150 mg or 300 mg subcutaneously at weeks 0, 1, 2, 3 and 

4, followed by the same dose every month. Patients randomised to receive placebo who were 

non-responders at week 16 (early rescue) were crossed over to receive secukinumab (either 150 mg or 

300 mg subcutaneously) at week 16 followed by the same dose every month. Patients randomised to 

receive placebo who were responders at week 16 were crossed over to receive secukinumab (either 

150 mg or 300 mg subcutaneously) at week 24 followed by the same dose every month. 

 

PsA study 3 (FUTURE 5) evaluated 996 patients, of whom 50.1% had concomitant MTX. Patients 

were randomised to receive secukinumab 150 mg, 300 mg or placebo subcutaneously at weeks 0, 1, 2, 

3 and 4, followed by the same dose every month, or a once monthly injection of secukinumab 150 mg 

(without loading). Patients randomised to receive placebo who were non-responders at week 16 (early 

rescue) were then crossed over to receive secukinumab (either 150 mg or 300 mg subcutaneously) at 

week 16 followed by the same dose every month. Patients randomised to receive placebo who were 

responders at week 16 were crossed over to receive secukinumab (either 150 mg or 300 mg 

subcutaneously) at week 24 followed by the same dose every month. 

 

Signs and symptoms 

Treatment with secukinumab resulted in significant improvement in measures of disease activity 

compared to placebo at weeks 16 and 24 (see Table 6). 

 



 

45 

Table 6 Clinical response in PsA study 2 and PsA study 3 at week 16 and week 24 

 

 PsA study 2 PsA study 3 

 Placebo 150 mg1 300 mg1 Placebo 150 mg1 300 mg1 

Number of patients 

randomised 

98 100 100 332 220 222 

ACR20 response 

n (%) 

      

Week 16 18 

(18.4%) 

60 

(60.0%***) 

57 

(57.0%***) 

91◊ 

(27.4%) 

122◊ 

(55.5%***) 

139◊ 

(62.6%***) 

Week 24 15◊ 

(15.3%) 

51◊ 

(51.0%***) 

54◊ 

(54.0%***) 

78 

(23.5%) 

117 

(53.2%***) 

141 

(63.5%***) 

ACR50 response 

n (%) 

      

Week 16 6 

(6.1%) 

37 

(37.0%***) 

35 

(35.0%***) 

27 

(8.1%) 

79 

(35.9%*) 

88 

(39.6%*) 

Week 24 7 

(7.1%) 

35 

(35.0%) 

35 

(35.0%**) 

29 

(8.7%) 

86 

(39.1%***) 

97 

(43.7%***) 

ACR70 response 

n (%) 

      

Week 16 2 

(2.0%) 

17 

(17.0%**) 

15 

(15.0%**) 

14 

(4.2%) 

40 

(18.2%***) 

45 

(20.3%***) 

Week 24 1 

(1.0%) 

21 

(21.0%**) 

20 

(20.0%**) 

13 

(3.9%) 

53 

(24.1%***) 

57 

(25.7%***) 

DAS28-CRP       

Week 16 -0.50 -1.45*** -1.51*** -0.63 -1.29* -1.49* 

Week 24 -0.96 -1.58** -1.61** -0.84 -1.57*** -1.68*** 

Number of patients 

with ≥3% BSA 

psoriasis skin 

involvement at 

baseline 

43 

(43.9%) 

58 

(58.0%) 

41 

(41.0%) 

162 

(48.8%) 

125 

(56.8%) 

110 

(49.5%) 

PASI 75 response 

n (%) 

      

Week 16 3 

(7.0%) 

33 

(56.9%***) 

27 

(65.9%***) 

20 

(12.3%) 

75 

(60.0%*) 

77 

(70.0%*) 

Week 24 7 

(16.3%) 

28 

(48.3%**) 

26 

(63.4%***) 

29 

(17.9%) 

80 

(64.0%***) 

78 

(70.9%***) 

PASI 90 response 

n (%) 

      

Week 16 3 

(7.0%) 

22 

(37.9%***) 

18 

(43.9%***) 

15 

(9.3%) 

46 

(36.8%*) 

59 

(53.6%*) 

Week 24 4 

(9.3%) 

19 

(32.8%**) 

20 

(48.8%***) 

19 

(11.7%) 

51 

(40.8%***) 

60 

(54.5%***) 

Dactylitis 

resolution n (%) † 

      

Week 16 10 

(37%) 

21 

(65.6%*) 

26 

(56.5%) 

40 

(32.3%) 

46 

(57.5%*) 

54 

(65.9%*) 

Week 24 4 

(14.8%) 

16 

(50.0%**) 

26 

(56.5%**) 

42 

(33.9%) 

51 

(63.8%***) 

52 

(63.4%***) 



 

46 

Enthesitis 

resolution n (%) ‡ 

      

Week 16 17 

(26.2%) 

32 

(50.0%**) 

32 

(57.1%***) 

68 

(35.4%) 

77 

(54.6%*) 

78 

(55.7%*) 

Week 24 14 

(21.5%) 

27 

(42.2%*) 

27 

(48.2%**) 

66 

(34.4%) 

77 

(54.6%***) 

86 

(61.4%***) 

* p<0.05, ** p<0.01, *** p<0.001; versus placebo 

All p-values are adjusted for multiplicity of testing based on pre-defined hierarchy at week 24 for PsA 

study 2, except for ACR70, Dactylitis and Enthesitis, which were exploratory endpoints and all 

endpoints at week 16. 

All p-values are adjusted for multiplicity of testing based on pre-defined hierarchy at week 16 for PsA 

study 3, except for ACR70 which was an exploratory endpoint and all endpoints at week 24. 

Non-responder imputation used for missing binary endpoint. 

ACR: American College of Rheumatology; PASI: Psoriasis Area and Severity Index; DAS: Disease 

Activity Score; BSA: Body Surface Area 
◊Primary Endpoint 

1Secukinumab 150 mg or 300 mg s.c. at weeks 0, 1, 2, 3, and 4 followed by the same dose every month 

†In patients with dactylitis at baseline (n=27, 32, 46, respectively for PsA study 2 and n=124, 80, 82, 

respectively for PsA study 3) 

‡In patients with enthesitis at baseline (n=65, 64, 56, respectively for PsA study 2 and n=192, 141, 140, 

respectively for PsA study 3) 

 

The onset of action of secukinumab occurred as early as week 2. Statistically significant difference in 

ACR 20 versus placebo was reached at week 3. 

 

The percentage of patients achieving ACR 20 response by visit is shown in Figure 2. 

 

Figure 2 ACR20 response in PsA study 2 over time up to week 52 

 

  
 

 
 

  

Percentage of 

responders 

Time (Weeks) 



 

47 

Similar responses for primary and key secondary endpoints were seen in PsA patients regardless of 

whether they were on concomitant MTX treatment or not. In PsA study 2, at week 24, secukinumab-

treated patients with concomitant MTX use had a higher ACR 20 response (47.7% and 54.4% for 

150 mg and 300 mg, respectively, compared to placebo 20.0%) and ACR 50 response (31.8% and 

38.6% for 150 mg and 300 mg, respectively, compared to placebo 8.0%). Secukinumab-treated 

patients without concomitant MTX use had a higher ACR 20 response (53.6% and 53.6% for 150 mg 

and 300 mg, respectively, compared to placebo 10.4%) and ACR 50 response (37.5% and 32.1% for 

150 mg and 300 mg, respectively, compared to placebo 6.3%). 

 

In PsA study 2, both anti-TNFα-naive and anti-TNFα-IR secukinumab-treated patients had a 

significantly higher ACR 20 response compared to placebo at week 24, with a slightly higher response 

in the anti-TNFα-naive group (anti-TNFα-naive: 64% and 58% for 150 mg and 300 mg, respectively, 

compared to placebo 15.9%; anti-TNFα-IR: 30% and 46% for 150 mg and 300 mg, respectively, 

compared to placebo 14.3%). In the anti-TNFα-IR patients subgroup, only the 300 mg dose showed 

significantly higher response rate for ACR 20 compared to placebo (p<0.05) and demonstrated clinical 

meaningful benefit over 150 mg on multiple secondary endpoints. Improvements in the PASI 75 

response were seen in both subgroups and the 300 mg dose showed statistically significant benefit in 

the anti-TNFα-IR patients. 

 

The number of PsA patients with axial involvement was too small to allow meaningful assessment. 

 

Improvements were shown in all components of the ACR scores, including patient assessment of pain. 

In PsA study 2, the proportion of patients achieving a modified PsA Response Criteria (PsARC) 

response was greater in the secukinumab-treated patients (59.0% and 61.0% for 150 mg and 300 mg, 

respectively) compared to placebo (26.5%) at week 24. 
 

In PsA study 1 and PsA study 2, efficacy was maintained up to week 104. In PsA study 2, among 

200 patients initially randomised to secukinumab 150 mg and 300 mg, 178 (89%) patients were still 

on treatment at week 52. Of the 100 patients randomised to secukinumab 150 mg, 64, 39 and 20 had 

an ACR 20/50/70 response, respectively. Of the 100 patients randomised to secukinumab 300 mg, 64, 

44 and 24 had an ACR 20/50/70 response, respectively. 

 

Radiographic response 

In PsA study 3, inhibition of progression of structural damage was assessed radiographically and 

expressed by the modified Total Sharp Score (mTSS) and its components, the Erosion Score (ES) and 

the Joint Space Narrowing Score (JSN). Radiographs of hands, wrists, and feet were obtained at 

baseline, week 16 and/or week 24 and scored independently by at least two readers who were blinded 

to treatment group and visit number. Secukinumab 150 mg and 300 mg treatment significantly 

inhibited the rate of progression of peripheral joint damage compared with placebo treatment as 

measured by change from baseline in mTSS at week 24 (Table 7). 

 

Inhibition of progression of structural damage was also assessed in PsA study 1 at weeks 24 and 52, 

compared to baseline. Week 24 data are presented in Table 7. 

 



 

48 

Table 7 Change in modified Total Sharp Score in psoriatic arthritis 

 

 PsA study 3 PsA study 1 

 Placebo 

n=296 

secukinumab 

150 mg1 

n=213 

secukinumab 

300 mg1 

n=217 

Placebo 

n=179 

secukinumab 

150 mg2 

n=185 

Total score 

Baseline 

(SD) 

15.0 

(38.2) 

13.5 

(25.6) 

12.9 

(23.8) 

28.4 

(63.5) 

22.3 

(48.0) 

Mean 

change at 

Week 24 

0.50 0.13* 0.02* 0.57 0.13* 

*p<0.05 based on nominal, but non adjusted, p-value 
1secukinumab 150 mg or 300 mg s.c. at weeks 0, 1, 2, 3, and 4 followed by the same dose every month 
210 mg/kg at weeks 0, 2 and 4 followed by subcutaneous doses of 75 mg or 150 mg 

 

In PsA study 1, inhibition of structural damage was maintained with secukinumab treatment up to 

week 52. 

 

In PsA study 3, the percentage of patients with no disease progression (defined as a change from 

baseline in mTSS of ≤0.5) from randomisation to week 24 was 80.3%, 88.5% and 73.6% for 

secukinumab 150 mg, 300 mg and placebo, respectively. An effect of inhibition of structural damage 

was observed in anti-TNFα-naïve and anti-TNFα-IR patients and in patients treated with and without 

concomitant MTX. 
 

In PsA study 1, the percentage of patients with no disease progression (defined as a change from 

baseline in mTSS of ≤0.5) from randomisation to week 24 was 82.3% in secukinumab 10 mg/kg 

intravenous load – 150 mg subcutaneous maintenance and 75.7% in placebo. The percentage of 

patients with no disease progression from week 24 to week 52 for secukinumab 10 mg/kg intravenous 

load – followed by 150 mg subcutaneous maintenance and for placebo patients who switched to 75 mg 

or 150 mg subcutaneous every 4 weeks at week 16 or week 24 was 85.7% and 86.8%, respectively. 

 

Physical function and health-related quality of life 

In PsA study 2 and PsA study 3, patients treated with secukinumab 150 mg (p=0.0555 and p<0.0001) 

and 300 mg (p=0.0040 and p<0.0001) showed improvement in physical function compared to patients 

treated with placebo as assessed by Health Assessment Questionnaire-Disability Index (HAQ-DI) at 

week 24 and week 16, respectively. Improvements in HAQ-DI scores were seen regardless of previous 

anti-TNFα exposure. Similar responses were seen in PsA study 1. 

 

Secukinumab-treated patients reported significant improvements in health-related quality of life as 

measured by the Short Form-36 Health Survey Physical Component Summary (SF-36 PCS) score 

(p<0.001). There were also statistically significant improvements demonstrated in exploratory 

endpoints assessed by the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) 

scores for 150 mg and 300 mg compared to placebo (7.97, 5.97 versus 1.63, respectively) and these 

improvements were maintained up to week 104 in PsA study 2. 

 

Similar responses were seen in PsA study 1 and efficacy was maintained up to week 52. 

  



 

49 

 

Axial spondyloarthritis (axSpA) 

Ankylosing spondylitis (AS) / Radiographic axial spondyloarthritis 

The safety and efficacy of secukinumab were assessed in 816 patients in three randomised, 

double-blind, placebo-controlled phase III studies in patients with active ankylosing spondylitis (AS) 

with a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4 despite non-steroidal 

anti-inflammatory drug (NSAID), corticosteroid or disease-modifying anti-rheumatic drug (DMARD) 

therapy. Patients in Ankylosing Spondylitis study 1 (AS study 1) and Ankylosing Spondylitis study 2 

(AS study 2) had a diagnosis of AS for a median of 2.7 to 5.8 years. For both studies, the primary 

endpoint was at least a 20% improvement in Assessment of Spondyloarthritis International Society 

(ASAS 20) criteria at week 16. 

 

In Ankylosing Spondylitis study 1 (AS study 1), Ankylosing Spondylitis study 2 (AS study 2), and 

Ankylosing Spondylitis study 3 (AS study 3), 27.0%, 38.8%, and 23.5% of patients, respectively, were 

previously treated with an anti-TNFα agent and discontinued the anti-TNFα agent for either lack of 

efficacy or intolerance (anti-TNFα-IR patients). 

 

AS study 1 (MEASURE 1) evaluated 371 patients, of whom 14.8% and 33.4% used concomitant 

MTX or sulfasalazine, respectively. Patients randomised to secukinumab received 10 mg/kg 

intravenously at weeks 0, 2, and 4, followed by either 75 mg or 150 mg subcutaneously every month 

starting at week 8. Patients randomised to placebo who were non-responders at week 16 (early rescue) 

and all other placebo patients at week 24 were crossed over to receive secukinumab (either 75 mg or 

150 mg subcutaneously), followed by the same dose every month. 

 

AS study 2 (MEASURE 2) evaluated 219 patients, of whom 11.9% and 14.2% used concomitant 

MTX or sulfasalazine, respectively. Patients randomised to secukinumab received 75 mg or 150 mg 

subcutaneously at weeks 0, 1, 2, 3 and 4, followed by the same dose every month. At week 16, 

patients who were randomised to placebo at baseline were re-randomised to receive secukinumab 

(either 75 mg or 150 mg subcutaneously) every month. 

 

AS study 3 (MEASURE 3) evaluated 226 patients, of whom 13.3% and 23.5% used concomitant 

MTX or sulfasalazine, respectively. Patients randomised to secukinumab received 10 mg/kg 

intravenously at weeks 0, 2, and 4, followed by either 150 mg or 300 mg subcutaneously every month. 

At week 16, patients who were randomised to placebo at baseline were re-randomised to receive 

secukinumab (either 150 mg or 300 mg subcutaneously) every month. The primary endpoint was 

ASAS 20 at week 16. Patients were blinded to the treatment regimen up to week 52, and the study 

continued to week 156. 

 

Signs and symptoms: 

In AS study 2, treatment with secukinumab 150 mg resulted in greater improvement in measures of 

disease activity compared with placebo at week 16 (see Table 8). 

 



 

50 

Table 8 Clinical response in AS study 2 at week 16 

 

Outcome (p-value versus placebo) 

Placebo 

(n = 74) 

75 mg 

(n = 73) 

150 mg 

(n = 72) 

ASAS 20 response, % 28.4 41.1 61.1*** 

ASAS 40 response, % 10.8 26.0 36.1*** 

hsCRP, (post-BSL/BSL ratio) 1.13 0.61 0.55*** 

ASAS 5/6, % 8.1 34.2 43.1*** 

ASAS partial remission, % 4.1 15.1 13.9 

BASDAI 50, % 10.8 24.7* 30.6** 

ASDAS-CRP major improvement 4.1 15.1* 25.0*** 

* p<0.05, ** p<0.01, *** p<0.001; versus placebo 

All p-values adjusted for multiplicity of testing based on pre-defined hierarchy, except BASDAI 50 

and ASDAS-CRP 

Non-responder imputation used for missing binary endpoint 

 

ASAS: Assessment of SpondyloArthritis International Society Criteria; BASDAI: Bath Ankylosing 

Spondylitis Disease Activity Index; hsCRP: high-sensitivity C-reactive protein; ASDAS: Ankylosing 

Spondylitis Disease Activity Score; BSL: baseline 

 

The onset of action of secukinumab 150 mg occurred as early as week 1 for ASAS 20 and week 2 for 

ASAS 40 (superior to placebo) in AS study 2. 

 

ASAS 20 responses were improved at week 16 in both anti-TNFα-naïve patients (68.2% versus 

31.1%; p<0.05) and anti-TNFα-IR patients (50.0% versus 24.1%; p<0.05) for secukinumab 150 mg 

compared with placebo, respectively. 

 

In AS study 1 and AS study 2, secukinumab-treated patients (150 mg in AS study 2 and both regimens 

in AS study 1) demonstrated significantly improved signs and symptoms at week 16, with comparable 

magnitude of response and efficacy maintained up to week 52 in both anti-TNFα-naive and 

anti-TNFα-IR patients. In AS study 2, among 72 patients initially randomised to secukinumab 150 mg, 

61 (84.7%) patients were still on treatment at week 52. Of the 72 patients randomised to secukinumab 

150 mg, 45 and 35 had an ASAS 20/40 response, respectively. 

 

In AS study 3, patients treated with secukinumab (150 mg and 300 mg) demonstrated improved signs 

and symptoms, and had comparable efficacy responses regardless of dose that were superior to 

placebo at week 16 for the primary endpoint (ASAS 20). Overall, the efficacy response rates for the 

300 mg group were consistently greater compared to the 150 mg group for the secondary endpoints. 

During the blinded period, the ASAS 20 and ASAS 40 responses were 69.7% and 47.6% for 150 mg 

and 74.3% and 57.4% for 300 mg at week 52, respectively. The ASAS 20 and ASAS 40 responses 

were maintained up to week 156 (69.5% and 47.6% for 150 mg versus 74.8% and 55.6% for 300 mg). 

Greater response rates favouring 300 mg were also observed for ASAS partial remission (ASAS PR) 

response at week 16 and were maintained up to week 156. Larger differences in response rates, 

favouring 300 mg over 150 mg, were observed in anti-TNFα-IR patients (n=36) compared to 

anti-TNFα-naïve patients (n=114). 

 

Spinal mobility: 

Patients treated with secukinumab 150 mg showed improvements in spinal mobility as measured by 

change from baseline in BASMI at week 16 for both AS study 1 (-0.40 versus -0.12 for placebo; 

p=0.0114) and AS study 2 (-0.51 versus -0.22 for placebo; p=0.0533). These improvements were 

sustained up to week 52. 

 



 

51 

Physical function and health-related quality of life: 

In AS study 1 and study 2, patients treated with secukinumab 150 mg showed improvements in health-

related quality of life as measured by AS Quality of Life Questionnaire (ASQoL) (p=0.001) and SF-36 

Physical Component Summary (SF-36PCS) (p<0.001). Patients treated with secukinumab 150 mg also 

showed statistically significant improvements on exploratory endpoints in physical function as 

assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI) compared to placebo (-2.15 

versus -0.68), and in fatigue as assessed by the Functional Assessment of Chronic Illness Therapy-

Fatigue (FACIT-Fatigue) scale compared to placebo (8.10 versus 3.30). These improvements were 

sustained up to week 52. 

 

Non-radiographic axial spondyloarthritis (nr-axSpA) 

The safety and efficacy of secukinumab were assessed in 555 patients in one randomised, 

double-blind, placebo-controlled phase III study (PREVENT), consisting of a 2-year core phase and a 

2-year extension phase, in patients with active non-radiographic axial spondyloarthritis (nr-axSpA) 

fulfilling the Assessment of Spondyloarthritis International Society (ASAS) classification criteria for 

axial spondyloarthritis (axSpA) with no radiographic evidence of changes in the sacroiliac joints that 

would meet the modified New York criteria for ankylosing spondylitis (AS). Patients enrolled had 

active disease, defined as a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4, a 

Visual Analogue Scale (VAS) for total back pain of ≥40 (on a scale of 0-100 mm), despite current or 

previous non-steroidal anti-inflammatory drug (NSAID) therapy and increased C-reactive protein 

(CRP) and/or evidence of sacroiliitis on Magnetic Resonance Imaging (MRI). Patients in this study 

had a diagnosis of axSpA for a mean of 2.1 to 3.0 years and 54% of the study participants were 

female. 

 

In the PREVENT study, 9.7% of patients were previously treated with an anti-TNFα agent and 

discontinued the anti-TNFα agent for either lack of efficacy or intolerance (anti-TNFα-IR patients). 

 

In the PREVENT study, 9.9% and 14.8% of patients used concomitant MTX or sulfasalazine, 

respectively. In the double-blind period, patients received either placebo or secukinumab for 52 weeks. 

Patients randomised to secukinumab received 150 mg subcutaneously at weeks 0, 1, 2, 3 and 4 

followed by the same dose every month, or a once monthly injection of secukinumab 150 mg. The 

primary endpoint was at least 40% improvement in Assessment of Spondyloarthritis International 

Society (ASAS 40) at Week 16 in anti-TNFα-naive patients. 

 

Signs and symptoms: 

In the PREVENT study, treatment with secukinumab 150 mg resulted in significant improvements in 

the measures of disease activity compared to placebo at week 16. These measures include ASAS 40, 

ASAS 5/6, BASDAI score, BASDAI 50, high-sensitivity CRP (hsCRP), ASAS 20 and ASAS partial 

remission response compared to placebo (Table 9). Responses were maintained up to week 52. 

 



 

52 

Table 9 Clinical response in the PREVENT study at week 16 

 

Outcome (p-value versus placebo) Placebo 150 mg1 

Number of anti-TNFα-naive patients 

randomised 

171 164 

ASAS 40 response, % 29.2 41.5* 

Total number of patients randomised 186 185 

ASAS 40 response, % 28.0 40.0* 

ASAS 5/6, % 23.7 40.0* 

BASDAI, LS mean change from baseline score -1.46 -2.35* 

BASDAI 50, % 21.0 37.3* 

hsCRP, (post-BSL/BSL ratio) 0.91 0.64* 

ASAS 20 response, % 45.7 56.8* 

ASAS partial remission, % 7.0 21.6* 

*p<0.05 versus placebo 

All p-values adjusted for multiplicity of testing based on pre-defined hierarchy 

Non-responder imputation used for missing binary endpoint 
1secukinumab 150 mg s.c. at weeks 0, 1, 2, 3, and 4 followed by the same dose every month 

 

ASAS: Assessment of SpondyloArthritis International Society Criteria; BASDAI: Bath Ankylosing 

Spondylitis Disease Activity Index; hsCRP: high-sensitivity C-reactive protein; BSL: baseline; LS: 

Least square 

 

The onset of action of secukinumab 150 mg occurred as early as week 3 for ASAS 40 in anti-TNFα 

naive patients (superior to placebo) in the PREVENT study. The percentage of patients achieving an 

ASAS 40 response in anti-TNFα naive patients by visit is shown in Figure 3. 

 

Figure 3 ASAS 40 responses in anti-TNFα naive patients in the PREVENT study over time 
up to week 16 

 

 
 

 

ASAS 40 responses were also improved at week 16 in anti-TNFα-IR patients for secukinumab 150 mg 

compared with placebo. 

Percentage of 

responders 

Time (Weeks) 

 Secukinumab 150 mg Load  Placebo 



 

53 

 

Physical function and health-related quality of life: 

Patients treated with secukinumab 150 mg showed statistically significant improvements by week 16 

compared to placebo-treated patients in physical function as assessed by the BASFI (week 16: -1.75 

versus -1.01, p<0.05). Patients treated with secukinumab reported significant improvements compared 

to placebo-treated patients by week 16 in health-related quality of life as measured by ASQoL (LS 

mean change: week 16: -3.45 versus -1.84, p<0.05) and SF-36 Physical Component Summary (SF-36 

PCS) (LS mean change: week 16: 5.71 versus 2.93, p<0.05). These improvements were sustained up 

to week 52. 

 

Spinal mobility: 

Spinal mobility was assessed by BASMI up to week 16. Numerically greater improvements were 

demonstrated in patients treated with secukinumab compared with placebo-treated patients at weeks 4, 

8, 12 and 16. 

 

Inhibition of inflammation in magnetic resonance imaging (MRI): 

Signs of inflammation were assessed by MRI at baseline and week 16 and expressed as change from 

baseline in Berlin SI-joint oedema score for sacroiliac joints and ASspiMRI-a score and Berlin spine 

score for the spine. Inhibition of inflammatory signs in both sacroiliac joints and the spine was 

observed in patients treated with secukinumab. Mean change from baseline in Berlin SI-joint oedema 

score was -1.68 for patients treated with secukinumab 150 mg (n=180) versus -0.39 for the 

placebo-treated patients (n=174) (p<0.05). 

 

Paediatric population 

 

Paediatric plaque psoriasis 

Secukinumab has been shown to improve signs and symptoms, and health-related quality of life in 

paediatric patients 6 years and older with plaque psoriasis (see Tables 11 and 13). 

 

Severe plaque psoriasis 

The safety and efficacy of secukinumab were assessed in a randomised, double-blind, placebo and 

etanercept-controlled phase III study in paediatric patients from 6 to <18 years of age with severe 

plaque psoriasis, as defined by a PASI score ≥20, an IGA mod 2011 score of 4, and BSA involvement 

of ≥10%, who were candidates for systemic therapy. Approximately 43% of the patients had prior 

exposure to phototherapy, 53% to conventional systemic therapy, 3% to biologics, and 9% had 

concomitant psoriatic arthritis. 

 
The paediatric psoriasis study 1 evaluated 162 patients who were randomised to receive low dose 

secukinumab (75 mg for body weight <50 kg or 150 mg for body weight ≥50 kg), high dose 

secukinumab (75 mg for body weight <25 kg, 150 mg for body weight between ≥25 kg and <50 kg, or 

300 mg for body weight ≥50 kg), or placebo at weeks 0, 1, 2, 3, and 4 followed by the same dose 

every 4 weeks, or etanercept. Patients randomised to etanercept received 0.8 mg/kg weekly (up to a 

maximum of 50 mg). Patient distribution by weight and age at randomisation is described in Table 10. 

 

Table 10 Patient distribution by weight and age for paediatric psoriasis study 1 

 

Randomisation 

strata 

Description Secukinumab 

low dose 

n=40 

Secukinumab 

high dose 

n=40 

Placebo 

 

n=41 

Etanercept 

 

n=41 

Total 

 

N=162 

Age 6-<12 years 8 9 10 10 37 

≥12-

<18 years 

32 31 31 31 125 

Weight <25 kg 2 3 3 4 12 

≥25-<50 kg 17 15 17 16 65 

≥50 kg 21 22 21 21 85 

 



 

54 

Patients randomised to receive placebo who were non-responders at week 12 were switched to either 

the secukinumab low or high dose group (dose based on body weight group) and received study drug 

at weeks 12, 13, 14, and 15, followed by the same dose every 4 weeks starting at week 16. The co-

primary endpoints were the proportion of patients who achieved a PASI 75 response and IGA mod 

2011 ‘clear’ or ‘almost clear’ (0 or 1) response at week 12. 

 

During the 12 week placebo-controlled period, the efficacy of both the low and the high dose of 

secukinumab was comparable for the co-primary endpoints. The odds ratio estimates in favour of both 

secukinumab doses were statistically significant for both the PASI 75 and IGA mod 2011 0 or 1 

responses. 

 

All patients were followed for efficacy and safety during the 52 weeks following the first dose. The 

proportion of patients achieving PASI 75 and IGA mod 2011 ‘clear’ or ‘almost clear’ (0 or 1) 

responses showed separation between secukinumab treatment groups and placebo at the first post-

baseline visit at week 4, the difference becoming more prominent at week 12. The response was 

maintained throughout the 52 week time period (see Table 11). Improvement in PASI 50, 90, 100 

responder rates and Children’s Dermatology Life Quality Index (CDLQI) scores of 0 or 1 were also 

maintained throughout the 52 week time period. 

 

In addition, PASI 75, IGA 0 or 1, PASI 90 response rates at weeks 12 and 52 for both secukinumab 

low and high dose groups were higher than the rates for patients treated with etanercept (see Table 11). 

 

Beyond week 12, efficacy of both the low and the high dose of secukinumab was comparable although 

the efficacy of the high dose was higher for patients ≥50 kg. The safety profiles of the low dose and 

the high dose were comparable and consistent with the safety profile in adults. 
 

Table 11 Summary of clinical response in severe paediatric psoriasis at weeks 12 and 52 

(paediatric psoriasis study 1)* 

 

Response 

criterion 

Treatment comparison 'test' 'control' odds ratio  

'test' vs. 'control' n**/m (%) n**/m (%) estimate (95% CI) p-value 

At week 12*** 

PASI 75 secukinumab low dose vs. placebo 32/40 (80.0) 6/41 (14.6) 25.78 (7.08, 114.66) <0.0001 

 secukinumab high dose vs. placebo 31/40 (77.5) 6/41 (14.6) 22.65 (6.31, 98.93) <0.0001 

 secukinumab low dose vs. etanercept 32/40 (80.0) 26/41 (63.4) 2.25 (0.73, 7.38)  

 secukinumab high dose vs. etanercept 31/40 (77.5) 26/41 (63.4) 1.92 (0.64, 6.07)  

IGA 0/1 secukinumab low dose vs. placebo 28/40 (70.0) 2/41 (4.9) 51.77 (10.02, 538.64) <0.0001 

 secukinumab high dose vs. placebo 24/40 (60.0) 2/41 (4.9) 32.52 (6.48, 329.52) <0.0001 

 secukinumab low dose vs. etanercept 28/40 (70.0) 14/41 (34.1) 4.49 (1.60, 13.42)  

 secukinumab high dose vs. etanercept 24/40 (60.0) 14/41 (34.1) 2.86 (1.05, 8.13)  

PASI 90 secukinumab low dose vs. placebo 29/40 (72.5) 1/41 (2.4) 133.67 (16.83, 6395.22) <0.0001 

 secukinumab high dose vs. placebo 27/40 (67.5) 1/41 (2.4) 102.86 (13.22, 4850.13) <0.0001 

 secukinumab low dose vs. etanercept 29/40 (72.5) 12/41 (29.3) 7.03 (2.34, 23.19)  

 secukinumab high dose vs. etanercept 27/40 (67.5) 12/41 (29.3) 5.32 (1.82, 16.75)  

At week 52 

PASI 75 secukinumab low dose vs. etanercept 35/40 (87.5) 28/41 (68.3) 3.12 (0.91, 12.52)  

secukinumab high dose vs. etanercept 35/40 (87.5) 28/41 (68.3) 3.09 (0.90, 12.39)  

IGA 0/1 secukinumab low dose vs. etanercept 29/40 (72.5) 23/41 (56.1) 2.02 (0.73, 5.77)  

secukinumab high dose vs. etanercept 30/40 (75.0) 23/41 (56.1) 2.26 (0.81, 6.62)  

PASI 90 secukinumab low dose vs. etanercept 30/40 (75.0) 21/41 (51.2) 2.85 (1.02, 8.38)  

secukinumab high dose vs. etanercept 32/40 (80.0) 21/41 (51.2) 3.69 (1.27, 11.61)  

*  non-responder imputation was used to handle missing values 

** n is the number of responders, m = number of patients evaluable 

*** extended visit window at week 12 

Odds ratio, 95% confidence interval, and p-value are from an exact logistic regression model with treatment 

group, baseline body-weight category and age category as factors 

 

  



 

55 

 

A higher proportion of paediatric patients treated with secukinumab reported improvement in health-

related quality of life as measured by a CDLQI score of 0 or 1 compared to placebo at week 12 (low 

dose 44.7%, high dose 50%, placebo 15%). Over time up to and including week 52 both secukinumab 

dose groups were numerically higher than the etanercept group (low dose 60.6%, high dose 66.7%, 

etanercept 44.4%). 

 

Moderate to severe plaque psoriasis 

Secukinumab was predicted to be effective for the treatment of paediatric patients with moderate 

plaque psoriasis based on the demonstrated efficacy and exposure response relationship in adult 

patients with moderate to severe plaque psoriasis, and the similarity of the disease course, 

pathophysiology, and drug effect in adult and paediatric patients at the same exposure levels. 

 

Moreover, the safety and efficacy of secukinumab was assessed in an open-label, two-arm, 

parallel-group, multicentre phase III study in paediatric patients from 6 to <18 years of age with 

moderate to severe plaque psoriasis, as defined by a PASI score ≥12, an IGA mod 2011 score of ≥3, 

and BSA involvement of ≥10%, who were candidates for systemic therapy. 

 

The paediatric psoriasis study 2 evaluated 84 patients who were randomised to receive low dose 

secukinumab (75 mg for body weight <50 kg or 150 mg for body weight ≥50 kg) or high dose 

secukinumab (75 mg for body weight <25 kg, 150 mg for body weight between ≥25 kg and <50 kg, or 

300 mg for body weight ≥50 kg) at weeks 0, 1, 2, 3, and 4 followed by the same dose every 4 weeks. 

Patient distribution by weight and age at randomisation is described in Table 12. 

 

Table 12 Patient distribution by weight and age for paediatric psoriasis study 2 

 

Sub-groups Description Secukinumab 

low dose 

n=42 

Secukinumab 

high dose 

n=42 

Total 

 

N=84 

Age 6-<12 years 17 16 33 

≥12-<18 years 25 26 51 

Weight <25 kg 4 4 8 

≥25-<50 kg 13 12 25 

≥50 kg 25 26 51 

 

The co-primary endpoints were the proportion of patients who achieved a PASI 75 response and IGA 

mod 2011 ‘clear’ or ‘almost clear’ (0 or 1) response at week 12. 

 

The efficacy of both the low and the high dose of secukinumab was comparable and showed 

statistically significant improvement compared to historical placebo for the co-primary endpoints. The 

estimated posterior probability of a positive treatment effect was 100%. 

 

All patients were followed for efficacy for at least 24 weeks following first administration (see 

Table 13). Efficacy (defined as PASI 75 response and IGA mod 2011 ‘clear’ or ‘almost clear’ [0 or 1]) 

was observed as early as the first post-baseline visit at week 2 and the proportion of patients who 

achieved a PASI 75 response and IGA mod 2011 ‘clear’ or ‘almost clear’ (0 or 1) increased 

throughout the 24 week time period. Improvement in PASI 90 and PASI 100 were also observed at 

week 12 and increased throughout the 24 week time period. 

 

Beyond week 12, efficacy of both the low and the high dose of secukinumab was comparable. The 

safety profiles of the low dose and the high dose were comparable and consistent with the safety 

profile in adults. 

 



 

56 

Table 13 Summary of clinical response in moderate to severe paediatric psoriasis at weeks 12 

and 24 (paediatric psoriasis study 2)* 

 

 Week 12 Week 24 

Secukinumab 

low dose 

Secukinumab 

high dose 

Secukinumab 

low dose 

Secukinumab 

high dose 

Number of patients 42 42 42 42 

PASI 75 response n (%) 39 (92.9%) 39 (92.9%) 40 (95.2%) 40 (95.2%) 

IGA mod 2011 ‘clear’ or ‘almost 
clear’ response n (%) 

33 (78.6%) 35 (83.3%) 37 (88.1%) 39 (92.9%) 

PASI 90 response n (%) 29 (69%) 32 (76.2%) 37 (88.1%) 37 (88.1%) 

PASI 100 response n (%) 25 (59.5%) 23 (54.8%) 28 (66.7%) 28 (66.7%) 

* non-responder imputation was used to handle missing values 

 

These outcomes in the paediatric moderate to severe plaque psoriasis population confirmed the 

predictive assumptions based on the efficacy and exposure response relationship in adult patients, 

mentioned above. 

 

In the low dose group, 50% and 70.7% of patients achieved a CDLQI 0 or 1 score at weeks 12 and 24, 

respectively. In the high dose group, 61.9% and 60.5% achieved a CDLQI 0 or 1 score at weeks 12 

and 24, respectively. 

 

The European Medicines Agency has waived the obligation to submit the results of studies with 

Cosentyx in plaque psoriasis in paediatric patients aged from birth to less than 6 years and in chronic 

idiopathic arthritis for paediatric patients aged from birth to less than 2 years (see section 4.2 for 

information on paediatric use). 

 

The European Medicines Agency has deferred the obligation to submit the results of studies with 

Cosentyx in chronic idiopathic arthritis for paediatric patients aged from 2 years to less than 18 years 

(see section 4.2 for information on paediatric use). 

 

5.2 Pharmacokinetic properties 

 

Most pharmacokinetics properties observed in patients with plaque psoriasis, psoriatic arthritis and 

ankylosing spondylitis were similar. 

 

Absorption 

 

Following a single subcutaneous dose of 300 mg as a liquid formulation in healthy volunteers, 

secukinumab reached peak serum concentrations of 43.2±10.4 μg/ml between 2 and 14 days post dose. 

 

Based on population pharmacokinetic analysis, following a single subcutaneous dose of either 150 mg 
or 300 mg in plaque psoriasis patients, secukinumab reached peak serum concentrations of 

13.7±4.8 µg/ml or 27.3±9.5 µg/ml, respectively, between 5 and 6 days post dose. 

 

After initial weekly dosing during the first month, time to reach the maximum concentration was 

between 31 and 34 days based on population pharmacokinetic analysis. 

 

On the basis of simulated data, peak concentrations at steady-state (Cmax,ss) following subcutaneous 

administration of 150 mg or 300 mg were 27.6 µg/ml and 55.2 µg/ml, respectively. Population 

pharmacokinetic analysis suggests that steady-state is reached after 20 weeks with monthly dosing 

regimens. 

 

Compared with exposure after a single dose, the population pharmacokinetic analysis showed that 

patients exhibited a 2-fold increase in peak serum concentrations and area under the curve (AUC) 

following repeated monthly dosing during maintenance. 

 



 

57 

Population pharmacokinetic analysis showed that secukinumab was absorbed with an average absolute 

bioavailability of 73% in patients with plaque psoriasis. Across studies, absolute bioavailabilities in 

the range between 60 and 77% were calculated. 

 

The bioavailability of secukinumab in PsA patients was 85% on the basis of the population 

pharmacokinetic model. 

 

Following a single subcutaneous injection of 300 mg solution for injection in pre-filled syringe in 

plaque psoriasis patients, secukinumab systemic exposure was similar to what was observed 

previously with two injections of 150 mg. 

 

Distribution 

 

The mean volume of distribution during the terminal phase (Vz) following single intravenous 

administration ranged from 7.10 to 8.60 litres in plaque psoriasis patients, suggesting that 

secukinumab undergoes limited distribution to peripheral compartments. 

 

Biotransformation 

 

The majority of IgG elimination occurs via intracellular catabolism, following fluid-phase or receptor 

mediated endocytosis. 

 

Elimination 

 

Mean systemic clearance (CL) following a single intravenous administration to patients with plaque 
psoriasis ranged from 0.13 to 0.36 l/day. In a population pharmacokinetic analysis, the mean systemic 

clearance (CL) was 0.19 l/day in plaque psoriasis patients. The CL was not impacted by gender. 

Clearance was dose- and time-independent. 

 

The mean elimination half-life, as estimated from population pharmacokinetic analysis, was 27 days in 

plaque psoriasis patients, ranging from 18 to 46 days across psoriasis studies with intravenous 

administration. 

 

Linearity/non-linearity 

 

The single and multiple dose pharmacokinetics of secukinumab in plaque psoriasis patients were 

determined in several studies with intravenous doses ranging from 1x 0.3 mg/kg to 3x 10 mg/kg and 

with subcutaneous doses ranging from 1x 25 mg to multiple doses of 300 mg. Exposure was dose 

proportional across all dosing regimens. 

 

Special populations 

 

Elderly patients 

Based on population pharmacokinetic analysis with a limited number of elderly patients (n=71 for age 

≥65 years and n=7 for age ≥75 years), clearance in elderly patients and patients less than 65 years of 

age was similar. 

 

Patients with renal or hepatic impairment 

No pharmacokinetic data are available in patients with renal or hepatic impairment. The renal 

elimination of intact secukinumab, an IgG monoclonal antibody, is expected to be low and of minor 

importance. IgGs are mainly eliminated via catabolism and hepatic impairment is not expected to 

influence clearance of secukinumab. 

 

Effect of weight on pharmacokinetics 

Secukinumab clearance and volume of distribution increase as body weight increases. 

 



 

58 

Paediatric population 

In a pool of the two paediatric studies, patients with moderate to severe plaque psoriasis (6 to less than 

18 years of age) were administered secukinumab at the recommended paediatric dosing regimen. At 

week 24, patients weighing ≥25 and <50 kg had a mean ± SD steady-state trough concentration of 

19.8 ± 6.96 µg/ml (n=24) after 75 mg of secukinumab and patients weighing ≥50 kg had mean ±SD 

trough concentration of 27.3 ± 10.1 µg/ml (n=36) after 150 mg of secukinumab. The mean ± SD 

steady-state trough concentration in patients weighing <25 kg (n=8) was 32.6 ± 10.8 µg/ml at week 24 

after 75 mg dose. 

 

5.3 Preclinical safety data 

 

Non-clinical data revealed no special hazard for humans (adult or paediatric) based on conventional 

studies of safety pharmacology, repeated dose and reproductive toxicity, or tissue cross-reactivity. 

 

Animal studies have not been conducted to evaluate the carcinogenic potential of secukinumab. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 
 

Trehalose dihydrate 

Histidine 

Histidine hydrochloride monohydrate 

Methionine 

Polysorbate 80 

Water for injections 

 

6.2 Incompatibilities 
 

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 

products. 

 

 

6.3 Shelf life 
 

18 months 

If necessary, Cosentyx may be stored unrefrigerated for a single period of up to 4 days at room 

temperature, not above 30°C. 

 

6.4 Special precautions for storage 

 

Store in a refrigerator (2°C - 8°C). Do not freeze. 

Store in the original package in order to protect from light. 

 

6.5 Nature and contents of container 

 

Cosentyx 150 mg solution for injection in pre-filled syringe 

 

Cosentyx 150 mg solution for injection in pre-filled syringe is supplied in a pre-filled 1 ml glass 

syringe with a silicone-coated bromobutyl rubber plunger stopper, staked 27G x ½″ needle and rigid 

needle shield of styrene butadiene rubber assembled in an automatic needle guard of polycarbonate. 

 

Cosentyx 150 mg solution for injection in pre-filled syringe is available in unit packs containing 1 or 

2 pre-filled syringes and in multipacks containing 6 (3 packs of 2) pre-filled syringes. 

 



 

59 

Cosentyx 300 mg solution for injection in pre-filled syringe 

 

Cosentyx 300 mg solution for injection in pre-filled syringe is supplied in a pre-filled 2.25 ml glass 

syringe with a silicone-coated bromobutyl rubber plunger stopper, staked 27G x ½″ needle and rigid 

needle shield of synthetic polyisoprene rubber assembled in an automatic needle guard of 

polycarbonate. 

 

Cosentyx 300 mg solution for injection in pre-filled syringe is available in unit packs containing 

1 pre-filled syringe and in multipacks containing 3 (3 packs of 1) pre-filled syringes. 

 

Cosentyx 150 mg solution for injection in pre-filled pen 

 

Cosentyx 150 mg solution for injection in pre-filled pen is supplied in a single-use pre-filled syringe 

assembled into a triangular-shaped pen with transparent window and label. The pre-filled syringe 

inside the pen is a 1 ml glass syringe with a silicone-coated bromobutyl rubber plunger stopper, staked 

27G x ½″ needle and rigid needle shield of styrene butadiene rubber. 

 

Cosentyx 150 mg solution for injection in pre-filled pen is available in unit packs containing 1 or 

2 pre-filled pens and in multipacks containing 6 (3 packs of 2) pre-filled pens. 

 

Cosentyx 300 mg solution for injection in pre-filled pen 

 

Cosentyx 300 mg solution for injection in pre-filled pen is supplied in a single-use pre-filled syringe 

assembled into a squared-shaped pen with transparent window and label. The pre-filled syringe inside 

the pen is a 2.25 ml glass syringe with a silicone-coated bromobutyl rubber plunger stopper, staked 

27G x ½″ needle and rigid needle shield of synthetic polyisoprene rubber. 

 

Cosentyx 300 mg solution for injection in pre-filled pen is available in unit packs containing 

1 pre-filled pen and in multipacks containing 3 (3 packs of 1) pre-filled pens. 

 

Not all pack sizes may be marketed. 

 

6.6 Special precautions for disposal and other handling 

 

Cosentyx 150 mg solution for injection in pre-filled syringe 

 

Cosentyx 150 mg solution for injection is supplied in a single-use pre-filled syringe for individual use. 

The syringe should be taken out of the refrigerator 20 minutes before injecting to allow it to reach 

room temperature. 

 

Cosentyx 300 mg solution for injection in pre-filled syringe 

 

Cosentyx 300 mg solution for injection is supplied in a single-use pre-filled syringe for individual use. 

The syringe should be taken out of the refrigerator 30-45 minutes before injecting to allow it to reach 

room temperature. 

 

Cosentyx 150 mg solution for injection in pre-filled pen 

 

Cosentyx 150 mg solution for injection is supplied in a single-use pre-filled pen for individual use. 

The pen should be taken out of the refrigerator 20 minutes before injecting to allow it to reach room 

temperature. 

 

Cosentyx 300 mg solution for injection in pre-filled pen 

 

Cosentyx 300 mg solution for injection is supplied in a single-use pre-filled pen for individual use. 

The pen should be taken out of the refrigerator 30-45 minutes before injecting to allow it to reach 

room temperature. 



 

60 

 

Prior to use, a visual inspection of the pre-filled syringe or pre-filled pen is recommended. The liquid 

should be clear. Its colour may vary from colourless to slightly yellow. You may see a small air 

bubble, which is normal. Do not use if the liquid contains easily visible particles, is cloudy or is 

distinctly brown. 

Detailed instructions for use are provided in the package leaflet. 

 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements. 

 

 

7. MARKETING AUTHORISATION HOLDER 
 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

8. MARKETING AUTHORISATION NUMBER(S) 

 

Cosentyx 150 mg solution for injection in pre-filled syringe 

 

EU/1/14/980/002 

EU/1/14/980/003 

EU/1/14/980/006 

 

Cosentyx 300 mg solution for injection in pre-filled syringe 

 

EU/1/14/980/008-009 

 

Cosentyx150 mg solution for injection in pre-filled pen 

 

EU/1/14/980/004 

EU/1/14/980/005 

EU/1/14/980/007 

 

Cosentyx 300 mg solution for injection in pre-filled pen 

 

EU/1/14/980/010-011 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 

Date of first authorisation: 15 January 2015 

Date of latest renewal: 03 September 2019 

 

 

10. DATE OF REVISION OF THE TEXT 

 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency http://www.ema.europa.eu. 

  



 

61 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX II 

 

A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 



 

62 

A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 

MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 

Name and address of the manufacturers of the biological active substance 

 

Novartis Pharma S.A.S. 

Centre de Biotechnologie 

8, rue de l’Industrie 

F-68330 Huningue 

France 

 

Sandoz GmbH 

Business Unit Biologics Technical Development and Manufacturing Drug Substance Schaftenau 

(BTDM DSS) 

Biochemiestrasse 10 

6336 Langkampfen 

Austria 

 

Name and address of the manufacturer responsible for batch release 

 

Powder for solution for injection 

Novartis Pharma GmbH 

Roonstraße 25 

90429 Nuremberg 

Germany 

 

Solution for injection in pre-filled syringe / Solution for injection in pre-filled pen 

Novartis Pharma GmbH 

Roonstraße 25 

90429 Nuremberg 

Germany 

 

Sandoz GmbH 

Biochemiestrasse 10 

6336 Langkampfen 

Austria 

 

The printed package leaflet of the medicinal product must state the name and address of the 

manufacturer responsible for the release of the concerned batch. 

 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 

Characteristics, section 4.2). 

 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 

 

 Periodic safety update reports (PSURs) 
 

The requirements for submission of PSURs for this medicinal product are set out in the list of Union 

reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any 

subsequent updates published on the European medicines web-portal. 

 

 



 

63 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 

 Risk management plan (RMP) 
 

The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 

and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation 

and any agreed subsequent updates of the RMP. 

 

An updated RMP should be submitted: 

 At the request of the European Medicines Agency; 

 Whenever the risk management system is modified, especially as the result of new information 
being received that may lead to a significant change to the benefit/risk profile or as the result of 

an important (pharmacovigilance or risk minimisation) milestone being reached. 

  



 

64 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 

  



 

65 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 
  



 

66 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON – vial 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Cosentyx 150 mg powder for solution for injection 

secukinumab 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One vial contains 150 mg secukinumab. After reconstitution, 1 ml of solution contains 150 mg 

secukinumab. 

 

 

3. LIST OF EXCIPIENTS 

 

Also contains: Sucrose, histidine, histidine hydrochloride monohydrate, polysorbate 80. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Powder for solution for injection 

 

1 vial 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Subcutaneous use 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store in a refrigerator. 

 

 



 

67 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/14/980/001 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Cosentyx 150 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC 

SN 

NN 
  



 

68 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

VIAL LABEL 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Cosentyx 150 mg powder for solution for injection 

secukinumab 

SC 

 

 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

 

6. OTHER 

 

  



 

69 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON OF UNIT PACK – pre-filled syringe 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Cosentyx 150 mg solution for injection in pre-filled syringe 

secukinumab 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled syringe contains 150 mg secukinumab in 1 ml of solution. 

 

 

3. LIST OF EXCIPIENTS 

 

Also contains: Trehalose dihydrate, histidine, histidine hydrochloride monohydrate, methionine, 

polysorbate 80, water for injections. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection 

 

1 pre-filled syringe 

2 pre-filled syringes 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Subcutaneous use 

Single use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 



 

70 

9. SPECIAL STORAGE CONDITIONS 

 

Store in a refrigerator. Do not freeze. 

Keep the pre-filled syringe in the outer carton in order to protect from light. 

Keep the pre-filled syringes in the outer carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/14/980/002 Pack containing 1 pre-filled syringe 

EU/1/14/980/003 Pack containing 2 pre-filled syringes 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Cosentyx 150 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC 

SN 

NN 
  



 

71 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) – pre-filled syringe 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Cosentyx 150 mg solution for injection in pre-filled syringe 

secukinumab 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled syringe contains 150 mg secukinumab in 1 ml of solution. 

 

 

3. LIST OF EXCIPIENTS 

 

Also contains: Trehalose dihydrate, histidine, histidine hydrochloride monohydrate, methionine, 

polysorbate 80, water for injections. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection 

 

Multipack: 6 (3 packs of 2) pre-filled syringes 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Subcutaneous use 

Single use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 



 

72 

9. SPECIAL STORAGE CONDITIONS 

 

Store in a refrigerator. Do not freeze. 

Keep the pre-filled syringes in the outer carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/14/980/006 Multipack containing 6 (3 x 2) pre-filled syringes 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Cosentyx 150 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC 

SN 

NN 
  



 

73 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) – pre-filled syringe 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Cosentyx 150 mg solution for injection in pre-filled syringe 

secukinumab 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled syringe contains 150 mg secukinumab in 1 ml of solution. 

 

 

3. LIST OF EXCIPIENTS 

 

Also contains: Trehalose dihydrate, histidine, histidine hydrochloride monohydrate, methionine, 

polysorbate 80, water for injections. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection 

 

2 pre-filled syringes. Component of a multipack. Not to be sold separately. 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Subcutaneous use 

Single use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 



 

74 

9. SPECIAL STORAGE CONDITIONS 

 

Store in a refrigerator. Do not freeze. 

Keep the pre-filled syringes in the outer carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/14/980/006 Multipack containing 6 (3 x 2) pre-filled syringes 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Cosentyx 150 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

  



 

75 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER OF PRE-FILLED SYRINGE 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Cosentyx 150 mg solution for injection in pre-filled syringe 

secukinumab 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

  



 

76 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

SYRINGE LABEL 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Cosentyx 150 mg injection 

secukinumab 

SC 

 

 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

 

6. OTHER 

 

 

  



 

77 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON OF UNIT PACK – pre-filled pen 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Cosentyx 150 mg solution for injection in pre-filled pen 

secukinumab 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled pen contains 150 mg secukinumab in 1 ml of solution. 

 

 

3. LIST OF EXCIPIENTS 

 

Also contains: Trehalose dihydrate, histidine, histidine hydrochloride monohydrate, methionine, 

polysorbate 80, water for injections. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection 

 

1 pre-filled SensoReady pen 

2 pre-filled SensoReady pens 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Subcutaneous use 

Single use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 



 

78 

9. SPECIAL STORAGE CONDITIONS 

 

Store in a refrigerator. Do not freeze. 

Keep the pre-filled pen in the outer carton in order to protect from light. 

Keep the pre-filled pens in the outer carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/14/980/004 Pack containing 1 pre-filled pen 

EU/1/14/980/005 Pack containing 2 pre-filled pens 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Cosentyx 150 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC 

SN 

NN 
  



 

79 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) – pre-filled pen 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Cosentyx 150 mg solution for injection in pre-filled pen 

secukinumab 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled pen contains 150 mg secukinumab in 1 ml of solution. 

 

 

3. LIST OF EXCIPIENTS 

 

Also contains: Trehalose dihydrate, histidine, histidine hydrochloride monohydrate, methionine, 

polysorbate 80, water for injections. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection 

 

Multipack: 6 (3 packs of 2) pre-filled pens 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Subcutaneous use 

Single use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 



 

80 

9. SPECIAL STORAGE CONDITIONS 

 

Store in a refrigerator. Do not freeze. 

Keep the pre-filled pens in the outer carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/14/980/007 Multipack containing 6 (3 x 2) pre-filled pens 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Cosentyx 150 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC 

SN 

NN 
  



 

81 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) – pre-filled pen 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Cosentyx 150 mg solution for injection in pre-filled pen 

secukinumab 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled pen contains 150 mg secukinumab in 1 ml of solution. 

 

 

3. LIST OF EXCIPIENTS 

 

Also contains: Trehalose dihydrate, histidine, histidine hydrochloride monohydrate, methionine, 

polysorbate 80, water for injections. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection 

 

2 pre-filled pens. Component of a multipack. Not to be sold separately. 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Subcutaneous use 

Single use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 



 

82 

9. SPECIAL STORAGE CONDITIONS 

 

Store in a refrigerator. Do not freeze. 

Keep the pre-filled pens in the outer carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/14/980/007 Multipack containing 6 (3 x 2) pre-filled pens 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Cosentyx 150 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

  



 

83 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

PEN LABEL 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Cosentyx 150 mg solution for injection in pre-filled pen 

secukinumab 

SC 

 

 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

 

6. OTHER 

 

SensoReady pen 

  



 

84 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON OF UNIT PACK – pre-filled syringe 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Cosentyx 300 mg solution for injection in pre-filled syringe 

secukinumab 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled syringe contains 300 mg secukinumab in 2 ml of solution. 

 

 

3. LIST OF EXCIPIENTS 

 

Also contains: Trehalose dihydrate, histidine, histidine hydrochloride monohydrate, methionine, 

polysorbate 80, water for injections. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection 

 

1 pre-filled syringe 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Subcutaneous use 

Single use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 



 

85 

9. SPECIAL STORAGE CONDITIONS 

 

Store in a refrigerator. Do not freeze. 

Keep the pre-filled syringe in the outer carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/14/980/008 Pack containing 1 pre-filled syringe 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Cosentyx 300 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC 

SN 

NN 
  



 

86 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) – pre-filled syringe 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Cosentyx 300 mg solution for injection in pre-filled syringe 

secukinumab 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled syringe contains 300 mg secukinumab in 2 ml of solution. 

 

 

3. LIST OF EXCIPIENTS 

 

Also contains: Trehalose dihydrate, histidine, histidine hydrochloride monohydrate, methionine, 

polysorbate 80, water for injections. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection 

 

Multipack: 3 (3 packs of 1) pre-filled syringes 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Subcutaneous use 

Single use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 



 

87 

9. SPECIAL STORAGE CONDITIONS 

 

Store in a refrigerator. Do not freeze. 

Keep the pre-filled syringes in the outer carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/14/980/009 Multipack containing 3 (3 x 1) pre-filled syringes 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Cosentyx 300 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC 

SN 

NN 
  



 

88 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) – pre-filled syringe 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Cosentyx 300 mg solution for injection in pre-filled syringe 

secukinumab 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled syringe contains 300 mg secukinumab in 2 ml of solution. 

 

 

3. LIST OF EXCIPIENTS 

 

Also contains: Trehalose dihydrate, histidine, histidine hydrochloride monohydrate, methionine, 

polysorbate 80, water for injections. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection 

 

1 pre-filled syringe. Component of a multipack. Not to be sold separately. 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Subcutaneous use 

Single use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 



 

89 

9. SPECIAL STORAGE CONDITIONS 

 

Store in a refrigerator. Do not freeze. 

Keep the pre-filled syringe in the outer carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/14/980/009 Multipack containing 3 (3 x 1) pre-filled syringes 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Cosentyx 300 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

  



 

90 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER OF PRE-FILLED SYRINGE 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Cosentyx 300 mg solution for injection in pre-filled syringe 

secukinumab 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

  



 

91 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

SYRINGE LABEL 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Cosentyx 300 mg injection 

secukinumab 

SC 

 

 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

 

6. OTHER 

  



 

92 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON OF UNIT PACK – pre-filled pen 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Cosentyx 300 mg solution for injection in pre-filled pen 

secukinumab 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled pen contains 300 mg secukinumab in 2 ml of solution. 

 

 

3. LIST OF EXCIPIENTS 

 

Also contains: Trehalose dihydrate, histidine, histidine hydrochloride monohydrate, methionine, 

polysorbate 80, water for injections. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection 

 

1 pre-filled UnoReady pen 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Subcutaneous use 

Single use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 



 

93 

9. SPECIAL STORAGE CONDITIONS 

 

Store in a refrigerator. Do not freeze. 

Keep the pre-filled pen in the outer carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/14/980/010 Pack containing 1 pre-filled pen 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Cosentyx 300 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC 

SN 

NN 
  



 

94 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) – pre-filled pen 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Cosentyx 300 mg solution for injection in pre-filled pen 

secukinumab 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled pen contains 300 mg secukinumab in 2 ml of solution. 

 

 

3. LIST OF EXCIPIENTS 

 

Also contains: Trehalose dihydrate, histidine, histidine hydrochloride monohydrate, methionine, 

polysorbate 80, water for injections. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection 

 

Multipack: 3 (3 packs of 1) pre-filled pens 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Subcutaneous use 

Single use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 



 

95 

9. SPECIAL STORAGE CONDITIONS 

 

Store in a refrigerator. Do not freeze. 

Keep the pre-filled pens in the outer carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/14/980/011 Multipack containing 3 (3 x 1) pre-filled pens 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Cosentyx 300 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC 

SN 

NN 
  



 

96 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) – pre-filled pen 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Cosentyx 300 mg solution for injection in pre-filled pen 

secukinumab 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled pen contains 300 mg secukinumab in 2 ml of solution. 

 

 

3. LIST OF EXCIPIENTS 

 

Also contains: Trehalose dihydrate, histidine, histidine hydrochloride monohydrate, methionine, 

polysorbate 80, water for injections. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection 

 

1 pre-filled pen. Component of a multipack. Not to be sold separately. 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Subcutaneous use 

Single use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 



 

97 

9. SPECIAL STORAGE CONDITIONS 

 

Store in a refrigerator. Do not freeze. 

Keep the pre-filled pen in the outer carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/14/980/011 Multipack containing 3 (3 x 1) pre-filled pens 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Cosentyx 300 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

  



 

98 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

PEN LABEL 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Cosentyx 300 mg injection 

secukinumab 

SC 

 

 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

 

6. OTHER 

 

UnoReady pen 

  



 

99 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 



 

100 

Package leaflet: Information for the patient 
 

Cosentyx 150 mg powder for solution for injection 

 

secukinumab 

 

Read all of this leaflet carefully before you start using this medicine because it contains 

important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 
side effects not listed in this leaflet. See section 4. 

 

What is in this leaflet 

1. What Cosentyx is and what it is used for 

2. What you need to know before you use Cosentyx 

3. How to use Cosentyx 

4. Possible side effects 

5. How to store Cosentyx 

6. Contents of the pack and other information 

 

 

1. What Cosentyx is and what it is used for 

 

Cosentyx contains the active substance secukinumab. Secukinumab is a monoclonal antibody which 

belongs to a group of medicines called interleukin (IL) inhibitors. This medicine works by neutralising 

the activity of a protein called IL-17A, which is present at increased levels in diseases such as 

psoriasis, psoriatic arthritis and axial spondyloarthritis. 

 

Cosentyx is used for the treatment of the following inflammatory diseases: 

 Plaque psoriasis 

 Psoriatic arthritis 

 Axial spondyloarthritis, including ankylosing spondylitis (radiographic axial spondyloarthritis) 
and non-radiographic axial spondyloarthritis 

 

Plaque psoriasis 
Cosentyx is used to treat a skin condition called “plaque psoriasis”, which causes inflammation 

affecting the skin. Cosentyx reduces the inflammation and other symptoms of the disease. Cosentyx is 

used in adults, adolescents and children (6 years of age and older) with moderate to severe plaque 

psoriasis. 

 

Using Cosentyx in plaque psoriasis will benefit you by leading to improvements of skin clearance and 

reducing your symptoms such as scaling, itching and pain. 

 

Psoriatic arthritis 

Cosentyx is used to treat a condition called “psoriatic arthritis”. The condition is an inflammatory 

disease of the joints, often accompanied by psoriasis. If you have active psoriatic arthritis you will first 

be given other medicines. If you do not respond well enough to these medicines, you will be given 

Cosentyx to reduce the signs and symptoms of active psoriatic arthritis, improve physical function and 

slow down the damage to the cartilage and bone of the joints involved in the disease. 

 

Cosentyx is used in adults with active psoriatic arthritis and can be used alone or with another 

medicine called methotrexate. 

  



 

101 

 

Using Cosentyx in psoriatic arthritis will benefit you by reducing the signs and symptoms of the 

disease, slowing down the damage to the cartilage and bone of the joints and improving your ability to 

do normal daily activities. 

 

Axial spondyloarthritis, including ankylosing spondylitis (radiographic axial spondyloarthritis) 

and non-radiographic axial spondyloarthritis 

Cosentyx is used to treat conditions called “ankylosing spondylitis” and “non-radiographic axial 

spondyloarthritis”. These conditions are inflammatory diseases primarily affecting the spine which 

cause inflammation of the spinal joints. If you have ankylosing spondylitis or non-radiographic axial 

spondyloarthritis you will first be given other medicines. If you do not respond well enough to these 

medicines, you will be given Cosentyx to reduce the signs and symptoms of the disease, reduce 

inflammation and improve your physical function. 

 

Cosentyx is used in adults with active ankylosing spondylitis and active non-radiographic axial 

spondyloarthritis. 

 

Using Cosentyx in ankylosing spondylitis and non-radiographic axial spondyloarthritis will benefit 

you by reducing the signs and symptoms of your disease and improving your physical function. 

 

 

2. What you need to know before you use Cosentyx 

 

Do not use Cosentyx: 

 if you are allergic to secukinumab or any of the other ingredients of this medicine (listed in 
section 6). 

If you think you may be allergic, ask your doctor for advice before using Cosentyx. 

 if you have an active infection which your doctor thinks is important. 
 

Warnings and precautions 

Talk to your doctor, nurse or pharmacist before using Cosentyx: 

 if you currently have an infection 

 if you have long-term or repeated infections. 

 if you have tuberculosis. 

 if you have an inflammatory disease affecting your gut called Crohn’s disease. 

 if you have an inflammation of your large intestine called ulcerative colitis. 

 if you have recently had a vaccination or if you are due to have a vaccination during treatment 
with Cosentyx. 

 if you are receiving any other treatment for psoriasis, such as another immunosuppressant or 
phototherapy with ultraviolet (UV) light. 

 

Inflammatory bowel disease (Crohn’s disease or ulcerative colitis) 

Stop using Cosentyx and tell your doctor or seek medical help immediately if you notice abdominal 

cramps and pain, diarrhoea, weight loss, blood in the stool or any other signs of bowel problems. 

 

Look out for infections and allergic reactions 

Cosentyx can potentially cause serious side effects, including infections and allergic reactions. You 

must look out for signs of these conditions while you are taking Cosentyx. 

 

Stop using Cosentyx and tell your doctor or seek medical help immediately if you notice any signs 

indicating a possible serious infection or an allergic reaction. Such signs are listed under “Serious side 

effects” in section 4. 

  



 

102 

 

Children and adolescents 

Cosentyx is not recommended for children younger than 6 years of age with plaque psoriasis because 

it has not been studied in this age group. 

 

Cosentyx is not recommended for children and adolescents (under 18 years of age) in other indications 

because it has not been studied in this age group. 

 

Other medicines and Cosentyx 
Tell your doctor or pharmacist: 

 if you are taking, have recently taken or might take any other medicines. 

 if you have recently had or are due to have a vaccination. You should not be given certain types 
of vaccines (live vaccines) while using Cosentyx. 

 

Pregnancy, breast-feeding and fertility 

 It is preferable to avoid the use of Cosentyx in pregnancy. The effects of this medicine in 
pregnant women are not known. If you are a woman of childbearing potential, you are advised 

to avoid becoming pregnant and must use adequate contraception while using Cosentyx and for 

at least 20 weeks after the last Cosentyx dose. 

Talk to your doctor if you are pregnant, think you may be pregnant or are planning to have a 

baby. 

 Talk to your doctor if you are breast-feeding or are planning to breast-feed. You and your doctor 
should decide if you will breast-feed or use Cosentyx. You should not do both. After using 

Cosentyx you should not breast-feed for at least 20 weeks after the last dose. 

 

Driving and using machines 

Cosentyx is unlikely to influence your ability to drive and use machines. 

 

 

3. How to use Cosentyx 

 

Cosentyx is given via injection under your skin (known as a subcutaneous injection) by a healthcare 

professional. 

 

Make sure you discuss with your doctor when you will have your injections and your follow-up 

appointments. 

 

How much Cosentyx is given and for how long 

Your doctor will decide how much Cosentyx you need and for how long. 

 

Plaque psoriasis 

Adult 

 The recommended dose is 300 mg by subcutaneous injection. 

 Each 300 mg dose is given as two injections of 150 mg. 
 

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by 

monthly injections. At each timepoint you will receive a 300 mg dose given as two injections of 

150 mg. 

  



 

103 

 

Children aged 6 years and older 

 The recommended dose given by subcutaneous injection is based on body weight as follows: 
o Weight below 25 kg: 75 mg using the powder for solution for injection. 
o Weight 25 kg or above and below 50 kg: 75 mg using the powder for solution for 

injection. 

o Weight 50 kg or above: 150 mg using the powder for solution for injection, the pre-filled 
syringe or the pre-filled pen. 

Your doctor may increase the dose to 300 mg using the powder for solution for injection, 

the pre-filled syringe or the pre-filled pen. 

 Each 75 mg dose is given as one injection of 75 mg. Each 150 mg dose is given as one 
injection of 150 mg. Each 300 mg dose is given as two injections of 150 mg. 

 

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by 

monthly injections. 

 

Psoriatic arthritis 

For psoriatic arthritis patients who also have moderate to severe plaque psoriasis or patients who did 

not respond well to medicines called tumour necrosis factor (TNF) blockers: 

 The recommended dose is 300 mg by subcutaneous injection. 

 Each 300 mg dose is given as two injections of 150 mg. 
 

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by 

monthly injections. At each timepoint you will receive a 300 mg dose given as two injections of 

150 mg. 

 

For other psoriatic arthritis patients: 

 The recommended dose is 150 mg by subcutaneous injection. 
 

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by 

monthly injections. 

 

Based on your response, your doctor may increase your dose to 300 mg. 

 

Ankylosing spondylitis (Radiographic axial spondyloarthritis) 

 The recommended dose is 150 mg by subcutaneous injection. 
 

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by 

monthly injections. 

 

Based on your response, your doctor may increase your dose to 300 mg. Each 300 mg dose is given as 

two injections of 150 mg. 

 

Non-radiographic axial spondyloarthritis 

 The recommended dose is 150 mg by subcutaneous injection. 
 

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by 

monthly injections. 

 

Cosentyx is for long-term treatment. Your doctor will regularly monitor your condition to check that 

the treatment is having the desired effect. 

  



 

104 

 

If you use more Cosentyx than you should 
If you have received more Cosentyx than you should or the dose has been administered sooner than 

according to your doctor’s prescription, inform your doctor. 

 

If you forget to use Cosentyx 

If you have missed a Cosentyx injection, talk to your doctor. 

 

If you stop using Cosentyx 

It is not dangerous to stop using Cosentyx. However, if you stop, your psoriasis, psoriatic arthritis or 

axial spondyloarthritis symptoms may come back. 

 

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 

 

 

4. Possible side effects 
 

Like all medicines, this medicine can cause side effects, although not everybody gets them. 

 

Serious side effects 

Stop using Cosentyx and tell your doctor or seek medical help immediately if you get any of the 

following side effects: 

 

Possible serious infection - the signs may include: 

 fever, flu-like symptoms, night sweats 

 feeling tired or short of breath, cough which will not go away 

 warm, red and painful skin, or a painful skin rash with blisters 

 burning sensation when passing urine. 
 

Serious allergic reaction - the signs may include: 

 difficulty breathing or swallowing 

 low blood pressure, which can cause dizziness or light-headedness 

 swelling of the face, lips, tongue or throat 

 severe itching of the skin, with a red rash or raised bumps. 
Your doctor will decide if and when you may restart the treatment. 

 

Other side effects 

Most of the following side effects are mild to moderate. If any of these side effects becomes severe, 

tell your doctor, pharmacist or nurse. 

 

Very common (may affect more than 1 in 10 people): 

 upper respiratory tract infections with symptoms such as sore throat and stuffy nose 
(nasopharyngitis, rhinitis) 

 

Common (may affect up to 1 in 10 people): 

 cold sores (oral herpes) 

 diarrhoea 

 runny nose (rhinorrhoea) 

 athlete’s foot (tinea pedis) 

 headache 

 nausea 

 fatigue 
  



 

105 

 

Uncommon (may affect up to 1 in 100 people): 

 oral thrush (oral candidiasis) 

 signs of low levels of white blood cells, such as fever, sore throat or mouth ulcers due to 
infections (neutropenia) 

 infection of the external ear (otitis externa) 

 discharge from the eye with itching, redness and swelling (conjunctivitis) 

 itchy rash (urticaria) 

 lower respiratory tract infections 

 abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel 
problems) 

 

Rare (may affect up to 1 in 1,000 people): 

 severe allergic reaction with shock (anaphylactic reaction) 

 redness and shedding of skin over a larger area of the body, which may be itchy or 
painful (exfoliative dermatitis) 

 

Not known (frequency cannot be estimated from the available data): 

 fungal infections of the skin and mucous membranes (including oesophageal candidiasis) 
 

Reporting of side effects 

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 

effects not listed in this leaflet. You can also report side effects directly via the national reporting 

system listed in Appendix V. By reporting side effects you can help provide more information on the 

safety of this medicine. 

 

 

5. How to store Cosentyx 

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine after the expiry date which is stated on the outer box or vial after “EXP”. 

 

Before reconstitution: Store the vial in the refrigerator between 2°C and 8°C. 

 

After reconstitution: The solution can be used immediately or can be stored at 2°C to 8°C for up to 

24 hours. Do not freeze. The solution should be administered within one hour after removal from 2°C 

to 8°C storage. 

 

Do not use this medicine if you notice that the powder has not fully dissolved or if the liquid contains 

easily visible particles, is cloudy or is distinctly brown. 

 

This medicine is for single use only. 

 

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines 

you no longer use. These measures will help protect the environment. 

 

  

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

106 

 

6. Contents of the pack and other information 

 

What Cosentyx contains 

- The active substance is secukinumab. Each vial of powder for solution for injection contains 
150 mg secukinumab. After reconstitution, 1 ml of solution contains 150 mg secukinumab. 

- The other ingredients are sucrose, histidine, histidine hydrochloride monohydrate and 
polysorbate 80. 

 

What Cosentyx looks like and contents of the pack 

Cosentyx powder for solution for injection is a white solid powder in a glass vial. 

Cosentyx is supplied in a pack containing one vial. 

 

Marketing Authorisation Holder 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

Manufacturer 

Novartis Pharma GmbH 

Roonstraße 25 

90429 Nuremberg 

Germany 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

 

België/Belgique/Belgien 

Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Lietuva 

SIA Novartis Baltics Lietuvos filialas 

Tel: +370 5 269 16 50 

 

България 

Novartis Bulgaria EOOD 

Тел: +359 2 489 98 28 

 

Luxembourg/Luxemburg 

Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Česká republika 

Novartis s.r.o. 

Tel: +420 225 775 111 

 

Magyarország 

Novartis Hungária Kft. 

Tel.: +36 1 457 65 00 

Danmark 

Novartis Healthcare A/S 

Tlf: +45 39 16 84 00 

 

Malta 

Novartis Pharma Services Inc. 

Tel: +356 2122 2872 

Deutschland 

Novartis Pharma GmbH 

Tel: +49 911 273 0 

 

Nederland 

Novartis Pharma B.V. 

Tel: +31 88 04 52 111 

Eesti 

SIA Novartis Baltics Eesti filiaal 

Tel: +372 66 30 810 

 

Norge 

Novartis Norge AS 

Tlf: +47 23 05 20 00 

Ελλάδα 

Novartis (Hellas) A.E.B.E. 

Τηλ: +30 210 281 17 12 

 

Österreich 

Novartis Pharma GmbH 

Tel: +43 1 86 6570 



 

107 

España 

Novartis Farmacéutica, S.A. 

Tel: +34 93 306 42 00 

 

Polska 

Novartis Poland Sp. z o.o. 

Tel.: +48 22 375 4888 

France 

Novartis Pharma S.A.S. 

Tél: +33 1 55 47 66 00 

 

Portugal 

Novartis Farma - Produtos Farmacêuticos, S.A. 

Tel: +351 21 000 8600 

Hrvatska 

Novartis Hrvatska d.o.o. 

Tel. +385 1 6274 220 

 

România 

Novartis Pharma Services Romania SRL 

Tel: +40 21 31299 01 

Ireland 

Novartis Ireland Limited 

Tel: +353 1 260 12 55 

 

Slovenija 

Novartis Pharma Services Inc. 

Tel: +386 1 300 75 50 

Ísland 

Vistor hf. 

Sími: +354 535 7000 

 

Slovenská republika 

Novartis Slovakia s.r.o. 

Tel: +421 2 5542 5439 

 

Italia 

Novartis Farma S.p.A. 

Tel: +39 02 96 54 1 

Suomi/Finland 

Novartis Finland Oy 

Puh/Tel: +358 (0)10 6133 200 

 

Κύπρος 

Novartis Pharma Services Inc. 

Τηλ: +357 22 690 690 

 

Sverige 

Novartis Sverige AB 

Tel: +46 8 732 32 00 

 

Latvija 

SIA Novartis Baltics 

Tel: +371 67 887 070 

 

United Kingdom 

Novartis Pharmaceuticals UK Ltd. 

Tel: +44 1276 698370 

 

 

 

This leaflet was last revised in 
 

 

Other sources of information 
Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu 

 

http://www.ema.europa.eu/


 

108 

Instructions for use of Cosentyx powder for solution for injection 

 

The following information is intended for medical or healthcare professionals only. 

 

The preparation of the solution for subcutaneous injection must be done without interruption and 

ensuring that aseptic technique is used. The preparation time from piercing the stopper until end of 

reconstitution takes 20 minutes on average and should not exceed 90 minutes. 

 

To prepare Cosentyx 150 mg powder for solution for injection, please adhere to the following 

instructions: 

 

Instructions for reconstitution of Cosentyx 150 mg powder for solution for injection: 

1. Bring the vial of powder to room temperature and ensure that the sterile water for injections is at 

room temperature. 

2. Withdraw slightly more than 1.0 ml sterile water for injections into a 1 ml graduated disposable 

syringe and adjust to 1.0 ml. 

3. Remove the plastic cap from the vial. 

4. Insert the syringe needle into the vial containing the powder through the centre of the rubber 

stopper and reconstitute the powder by slowly injecting 1.0 ml of sterile water for injections into 

the vial. The stream of sterile water for injections should be directed onto the powder. 

 
5. Tilt the vial to an angle of approx. 45° and gently rotate between the fingertips for approx. 

1 minute. Do not shake or invert the vial. 

 
6. Keep the vial standing at room temperature for a minimum of 10 minutes to allow for 

dissolution. Note that foaming of the solution may occur. 

7. Tilt the vial to an angle of approx. 45° and gently rotate between the fingertips for approx. 

1 minute. Do not shake or invert the vial. 

 
8. Allow the vial to stand undisturbed at room temperature for approximately 5 minutes. The 

resulting solution should be clear. Its colour may vary from colourless to slightly yellow. Do not 

use if the lyophilised powder has not fully dissolved or if the liquid contains easily visible 

particles, is cloudy or is distinctly brown. 

  



 

109 

9. Prepare the required number of vials (1 vial for the 75 mg dose, 1 vial for the 150 mg dose, 

2 vials for the 300 mg dose). 

 

After storage at 2°C to 8°C, the solution should be allowed to come to room temperature for 

approximately 20 minutes before administration. 

 

Instructions for administration of Cosentyx solution 

1. Tilt the vial to an angle of approximately 45° and position the needle tip at the very bottom of 

the solution in the vial when drawing the solution into the syringe. DO NOT invert the vial. 

 
2. For the 150 mg and 300 mg doses, carefully withdraw slightly more than 1.0 ml of the solution 

for subcutaneous injection from the vial into a 1 ml graduated disposable syringe using a 

suitable needle (e.g. 21G x 2″). This needle will only be used for withdrawing Cosentyx into the 

disposable syringe. Prepare the required number of syringes (2 syringes for the 300 mg dose). 

For a child receiving the 75 mg dose, carefully withdraw slightly more than 0.5 ml of the 

solution for subcutaneous injection and discard the rest immediately. 

3. With the needle pointing upward, gently tap the syringe to move any air bubbles to the top. 

 
4. Replace the attached needle with a 27G x ½″ needle. 

 
5. Expel the air bubbles and advance the plunger to the 1.0 ml mark for the 150 mg dose. 

Expel the air bubbles and advance the plunger to the 0.5 ml mark for the 75 mg dose. 

6. Clean the injection site with an alcohol swab. 



 

110 

7. Inject the Cosentyx solution subcutaneously into the front of thighs, lower abdomen (but not the 

area 5 centimetres around the navel) or outer upper arms. Choose a different site each time an 

injection is administered. Do not inject into areas where the skin is tender, bruised, red, scaly or 

hard. Avoid areas with scars or stretch marks. 

 
8. Any remaining solution in the vial must not be used and should be discarded in accordance with 

local requirements. Vials are for single use only. Dispose of the used syringe in a sharps 

container (closable, puncture-resistant container). For the safety and health of you and others, 

needles and used syringes must never be re-used. 



 

111 

Package leaflet: Information for the patient 
 

Cosentyx 150 mg solution for injection in pre-filled syringe 

 

secukinumab 

 

Read all of this leaflet carefully before you start using this medicine because it contains 

important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 
side effects not listed in this leaflet. See section 4. 

 

What is in this leaflet 

1. What Cosentyx is and what it is used for 

2. What you need to know before you use Cosentyx 

3. How to use Cosentyx 

4. Possible side effects 

5. How to store Cosentyx 

6. Contents of the pack and other information 

 

 

1. What Cosentyx is and what it is used for 

 

Cosentyx contains the active substance secukinumab. Secukinumab is a monoclonal antibody which 

belongs to a group of medicines called interleukin (IL) inhibitors. This medicine works by neutralising 

the activity of a protein called IL-17A, which is present at increased levels in diseases such as 

psoriasis, psoriatic arthritis and axial spondyloarthritis. 

 

Cosentyx is used for the treatment of the following inflammatory diseases: 

 Plaque psoriasis 

 Psoriatic arthritis 

 Axial spondyloarthritis, including ankylosing spondylitis (radiographic axial spondyloarthritis) 
and non-radiographic axial spondyloarthritis 

 

Plaque psoriasis 
Cosentyx is used to treat a skin condition called “plaque psoriasis”, which causes inflammation 

affecting the skin. Cosentyx reduces the inflammation and other symptoms of the disease. Cosentyx is 

used in adults, adolescents and children (6 years of age and older) with moderate to severe plaque 

psoriasis. 

 

Using Cosentyx in plaque psoriasis will benefit you by leading to improvements of skin clearance and 

reducing your symptoms such as scaling, itching and pain. 

 

Psoriatic arthritis 

Cosentyx is used to treat a condition called “psoriatic arthritis”. The condition is an inflammatory 

disease of the joints, often accompanied by psoriasis. If you have active psoriatic arthritis you will first 

be given other medicines. If you do not respond well enough to these medicines, you will be given 

Cosentyx to reduce the signs and symptoms of active psoriatic arthritis, improve physical function and 

slow down the damage to the cartilage and bone of the joints involved in the disease. 

 

Cosentyx is used in adults with active psoriatic arthritis and can be used alone or with another 

medicine called methotrexate. 

  



 

112 

 

Using Cosentyx in psoriatic arthritis will benefit you by reducing the signs and symptoms of the 

disease, slowing down the damage to the cartilage and bone of the joints and improving your ability to 

do normal daily activities. 

 

Axial spondyloarthritis, including ankylosing spondylitis (radiographic axial spondyloarthritis) 

and non-radiographic axial spondyloarthritis 

Cosentyx is used to treat conditions called “ankylosing spondylitis” and “non-radiographic axial 

spondyloarthritis”. These conditions are inflammatory diseases primarily affecting the spine which 

cause inflammation of the spinal joints. If you have ankylosing spondylitis or non-radiographic axial 

spondyloarthritis you will first be given other medicines. If you do not respond well enough to these 

medicines, you will be given Cosentyx to reduce the signs and symptoms of the disease, reduce 

inflammation and improve your physical function. 

 

Cosentyx is used in adults with active ankylosing spondylitis and active non-radiographic axial 

spondyloarthritis. 

 

Using Cosentyx in ankylosing spondylitis and non-radiographic axial spondyloarthritis will benefit 

you by reducing the signs and symptoms of your disease and improving your physical function. 

 

 

2. What you need to know before you use Cosentyx 

 

Do not use Cosentyx: 

 if you are allergic to secukinumab or any of the other ingredients of this medicine (listed in 
section 6). 

If you think you may be allergic, ask your doctor for advice before using Cosentyx. 

 if you have an active infection which your doctor thinks is important. 
 

Warnings and precautions 

Talk to your doctor, nurse or pharmacist before using Cosentyx: 

 if you currently have an infection 

 if you have long-term or repeated infections. 

 if you have tuberculosis. 

 if you have ever had an allergic reaction to latex. 

 if you have an inflammatory disease affecting your gut called Crohn’s disease. 

 if you have an inflammation of your large intestine called ulcerative colitis. 

 if you have recently had a vaccination or if you are due to have a vaccination during treatment 
with Cosentyx. 

 if you are receiving any other treatment for psoriasis, such as another immunosuppressant or 
phototherapy with ultraviolet (UV) light. 

 

Inflammatory bowel disease (Crohn’s disease or ulcerative colitis) 

Stop using Cosentyx and tell your doctor or seek medical help immediately if you notice abdominal 

cramps and pain, diarrhoea, weight loss, blood in the stool or any other signs of bowel problems. 

 

Look out for infections and allergic reactions 

Cosentyx can potentially cause serious side effects, including infections and allergic reactions. You 

must look out for signs of these conditions while you are taking Cosentyx. 

 

Stop using Cosentyx and tell your doctor or seek medical help immediately if you notice any signs 

indicating a possible serious infection or an allergic reaction. Such signs are listed under “Serious side 

effects” in section 4. 

 



 

113 

Children and adolescents 

Cosentyx is not recommended for children younger than 6 years of age with plaque psoriasis because 

it has not been studied in this age group. 

 

Cosentyx is not recommended for children and adolescents (under 18 years of age) in other indications 

because it has not been studied in this age group. 

 

Other medicines and Cosentyx 
Tell your doctor or pharmacist: 

 if you are taking, have recently taken or might take any other medicines. 

 if you have recently had or are due to have a vaccination. You should not be given certain types 
of vaccines (live vaccines) while using Cosentyx. 

 

Pregnancy, breast-feeding and fertility 

 It is preferable to avoid the use of Cosentyx in pregnancy. The effects of this medicine in 
pregnant women are not known. If you are a woman of childbearing potential, you are advised 

to avoid becoming pregnant and must use adequate contraception while using Cosentyx and for 

at least 20 weeks after the last Cosentyx dose. 

Talk to your doctor if you are pregnant, think you may be pregnant or are planning to have a 

baby. 

 Talk to your doctor if you are breast-feeding or are planning to breast-feed. You and your doctor 
should decide if you will breast-feed or use Cosentyx. You should not do both. After using 

Cosentyx you should not breast-feed for at least 20 weeks after the last dose. 

 

Driving and using machines 

Cosentyx is unlikely to influence your ability to drive and use machines. 

 

 

3. How to use Cosentyx 

 

Always use this medicine exactly as your doctor has told you. Check with your doctor, nurse or 

pharmacist if you are not sure. 

 

Cosentyx is given via injection under your skin (known as a subcutaneous injection). You and your 

doctor should decide if you should inject Cosentyx yourself. 

 

It is important not to try to inject yourself until you have been trained by your doctor, nurse or 

pharmacist. A caregiver may also give you your Cosentyx injection after proper training. 

 

For detailed instructions on how to inject Cosentyx, see “Instructions for use of Cosentyx 150 mg 

pre-filled syringe” at the end of this leaflet. 

 

How much Cosentyx is given and for how long 

Your doctor will decide how much Cosentyx you need and for how long. 

 

Plaque psoriasis 

Adult 

 The recommended dose is 300 mg by subcutaneous injection. 

 Each 300 mg dose is given as two injections of 150 mg. 
 

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by 

monthly injections. At each timepoint you will receive a 300 mg dose given as two injections of 

150 mg. 

  



 

114 

 

Children aged 6 years and older 

 The recommended dose given by subcutaneous injection is based on body weight as follows: 
o Weight below 25 kg: 75 mg using the powder for solution for injection. 
o Weight 25 kg or above and below 50 kg: 75 mg using the powder for solution for 

injection. 

o Weight 50 kg or above: 150 mg using the powder for solution for injection, the pre-filled 
syringe or the pre-filled pen. 

Your doctor may increase the dose to 300 mg using the powder for solution for injection, 

the pre-filled syringe or the pre-filled pen. 

 Each 75 mg dose is given as one injection of 75 mg. Each 150 mg dose is given as one 
injection of 150 mg. Each 300 mg dose is given as two injections of 150 mg. 

 

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by 

monthly injections. 

 

Psoriatic arthritis 

For psoriatic arthritis patients who also have moderate to severe plaque psoriasis or patients who did 

not respond well to medicines called tumour necrosis factor (TNF) blockers: 

 The recommended dose is 300 mg by subcutaneous injection. 

 Each 300 mg dose is given as two injections of 150 mg. 
 

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by 

monthly injections. At each timepoint you will receive a 300 mg dose given as two injections of 

150 mg. 

 

For other psoriatic arthritis patients: 

 The recommended dose is 150 mg by subcutaneous injection. 
 

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by 

monthly injections. 

 

Based on your response, your doctor may increase your dose to 300 mg. 

 

Ankylosing spondylitis (Radiographic axial spondyloarthritis) 

 The recommended dose is 150 mg by subcutaneous injection. 
 

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by 

monthly injections. 

 

Based on your response, your doctor may increase your dose to 300 mg. Each 300 mg dose is given as 

two injections of 150 mg. 

 

Non-radiographic axial spondyloarthritis 

 The recommended dose is 150 mg by subcutaneous injection. 
 

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by 

monthly injections. 

 

Cosentyx is for long-term treatment. Your doctor will regularly monitor your condition to check that 

the treatment is having the desired effect. 

  



 

115 

 

If you use more Cosentyx than you should 
If you have received more Cosentyx than you should or the dose has been administered sooner than 

according to your doctor’s prescription, inform your doctor. 

 

If you forget to use Cosentyx 

If you have forgotten to inject a dose of Cosentyx, inject the next dose as soon as you remember. Then 

talk to your doctor to discuss when you should inject the next dose. 

 

If you stop using Cosentyx 

It is not dangerous to stop using Cosentyx. However, if you stop, your psoriasis, psoriatic arthritis or 

axial spondyloarthritis symptoms may come back. 

 

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 

 

 

4. Possible side effects 
 

Like all medicines, this medicine can cause side effects, although not everybody gets them. 

 

Serious side effects 

Stop using Cosentyx and tell your doctor or seek medical help immediately if you get any of the 

following side effects: 

 

Possible serious infection - the signs may include: 

 fever, flu-like symptoms, night sweats 

 feeling tired or short of breath, cough which will not go away 

 warm, red and painful skin, or a painful skin rash with blisters 

 burning sensation when passing urine. 
 

Serious allergic reaction - the signs may include: 

 difficulty breathing or swallowing 

 low blood pressure, which can cause dizziness or light-headedness 

 swelling of the face, lips, tongue or throat 

 severe itching of the skin, with a red rash or raised bumps. 
Your doctor will decide if and when you may restart the treatment. 

 

Other side effects 

Most of the following side effects are mild to moderate. If any of these side effects becomes severe, 

tell your doctor, pharmacist or nurse. 

 

Very common (may affect more than 1 in 10 people): 

 upper respiratory tract infections with symptoms such as sore throat and stuffy nose 
(nasopharyngitis, rhinitis) 

 

Common (may affect up to 1 in 10 people): 

 cold sores (oral herpes) 

 diarrhoea 

 runny nose (rhinorrhoea) 

 athlete’s foot (tinea pedis) 

 headache 

 nausea 

 fatigue 
  



 

116 

 

Uncommon (may affect up to 1 in 100 people): 

 oral thrush (oral candidiasis) 

 signs of low levels of white blood cells, such as fever, sore throat or mouth ulcers due to 
infections (neutropenia) 

 infection of the external ear (otitis externa) 

 discharge from the eye with itching, redness and swelling (conjunctivitis) 

 itchy rash (urticaria) 

 lower respiratory tract infections 

 abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel 
problems) 

 

Rare (may affect up to 1 in 1,000 people): 

 severe allergic reaction with shock (anaphylactic reaction) 

 redness and shedding of skin over a larger area of the body, which may be itchy or 
painful (exfoliative dermatitis) 

 

Not known (frequency cannot be estimated from the available data): 

 fungal infections of the skin and mucous membranes (including oesophageal candidiasis) 
 

Reporting of side effects 

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 

effects not listed in this leaflet. You can also report side effects directly via the national reporting 

system listed in Appendix V. By reporting side effects you can help provide more information on the 

safety of this medicine. 

 

 

5. How to store Cosentyx 

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine: 

 after the expiry date which is stated on the outer box or the label on the syringe after “EXP”. 

 if the liquid contains easily visible particles, is cloudy or is distinctly brown. 
 

Store the syringe sealed in its box to protect from light. Store in the refrigerator between 2°C and 8°C. 

Do not freeze. Do not shake. 

If necessary, Cosentyx can be left out of the refrigerator for a single period of up to 4 days at room 

temperature, not above 30°C. 

 

This medicine is for single use only. 

 

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines 

you no longer use. These measures will help protect the environment. 

 

  

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

117 

 

6. Contents of the pack and other information 

 

What Cosentyx contains 

- The active substance is secukinumab. Each pre-filled syringe contains 150 mg secukinumab. 
- The other ingredients are trehalose dihydrate, histidine, histidine hydrochloride monohydrate, 

methionine, polysorbate 80 and water for injections. 

 

What Cosentyx looks like and contents of the pack 

Cosentyx solution for injection is a clear liquid. Its colour may vary from colourless to slightly yellow. 

Cosentyx 150 mg solution for injection in pre-filled syringe is available in unit packs containing 1 or 

2 pre-filled syringe(s) and in multipacks containing 6 (3 packs of 2) pre-filled syringes. 

Not all pack sizes may be marketed. 

 

Marketing Authorisation Holder 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

Manufacturer 

Novartis Pharma GmbH 

Roonstraße 25 

90429 Nuremberg 

Germany 

 

Sandoz GmbH 

Biochemiestrasse 10 

6336 Langkampfen 

Austria 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

 

België/Belgique/Belgien 

Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Lietuva 

SIA Novartis Baltics Lietuvos filialas 

Tel: +370 5 269 16 50 

 

България 

Novartis Bulgaria EOOD 

Тел: +359 2 489 98 28 

 

Luxembourg/Luxemburg 

Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Česká republika 

Novartis s.r.o. 

Tel: +420 225 775 111 

 

Magyarország 

Novartis Hungária Kft. 

Tel.: +36 1 457 65 00 

Danmark 

Novartis Healthcare A/S 

Tlf: +45 39 16 84 00 

 

Malta 

Novartis Pharma Services Inc. 

Tel: +356 2122 2872 

Deutschland 

Novartis Pharma GmbH 

Tel: +49 911 273 0 

 

Nederland 

Novartis Pharma B.V. 

Tel: +31 88 04 52 111 



 

118 

Eesti 

SIA Novartis Baltics Eesti filiaal 

Tel: +372 66 30 810 

 

Norge 

Novartis Norge AS 

Tlf: +47 23 05 20 00 

Ελλάδα 

Novartis (Hellas) A.E.B.E. 

Τηλ: +30 210 281 17 12 

 

Österreich 

Novartis Pharma GmbH 

Tel: +43 1 86 6570 

España 

Novartis Farmacéutica, S.A. 

Tel: +34 93 306 42 00 

 

Polska 

Novartis Poland Sp. z o.o. 

Tel.: +48 22 375 4888 

France 

Novartis Pharma S.A.S. 

Tél: +33 1 55 47 66 00 

 

Portugal 

Novartis Farma - Produtos Farmacêuticos, S.A. 

Tel: +351 21 000 8600 

Hrvatska 

Novartis Hrvatska d.o.o. 

Tel. +385 1 6274 220 

 

România 

Novartis Pharma Services Romania SRL 

Tel: +40 21 31299 01 

Ireland 

Novartis Ireland Limited 

Tel: +353 1 260 12 55 

 

Slovenija 

Novartis Pharma Services Inc. 

Tel: +386 1 300 75 50 

Ísland 

Vistor hf. 

Sími: +354 535 7000 

 

Slovenská republika 

Novartis Slovakia s.r.o. 

Tel: +421 2 5542 5439 

 

Italia 

Novartis Farma S.p.A. 

Tel: +39 02 96 54 1 

Suomi/Finland 

Novartis Finland Oy 

Puh/Tel: +358 (0)10 6133 200 

 

Κύπρος 

Novartis Pharma Services Inc. 

Τηλ: +357 22 690 690 

 

Sverige 

Novartis Sverige AB 

Tel: +46 8 732 32 00 

 

Latvija 

SIA Novartis Baltics 

Tel: +371 67 887 070 

 

United Kingdom 

Novartis Pharmaceuticals UK Ltd. 

Tel: +44 1276 698370 

 

 

 

This leaflet was last revised in 
 

 

Other sources of information 
Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu 

 

http://www.ema.europa.eu/


 

119 

Instructions for use of Cosentyx 150 mg pre-filled syringe 

 

Read ALL the way through these instructions before injecting. It is important not to try to inject 

yourself or a person in your care until you have been trained by your doctor, nurse or pharmacist. The 

box contains Cosentyx 150 mg pre-filled syringe(s) individually sealed in a plastic blister. 

 

Your Cosentyx 150 mg pre-filled syringe 

 

 

 
 

After the medicine has been injected the syringe guard will be activated to cover the needle. This is 

intended to aid in the protection of healthcare professionals, patients who self-inject doctor-prescribed 

medicines, and individuals who assist self-injecting patients from accidental needlestick injuries. 

 

What you additionally need for 

your injection: 

 Alcohol swab. 

 Cotton ball or gauze. 

 Sharps disposal container. 
 

 
 

Important safety information 

Caution: Keep the syringe out of the sight and reach of children. 

1. The needle cap of the syringe may contain dry rubber (latex), which should not be handled by 

persons sensitive to this substance. 

2. Do not open the sealed outer box until you are ready to use this medicine. 

3. Do not use this medicine if either the seal on the outer box or the seal of the blister is broken, as 

it may not be safe for you to use. 

4. Never leave the syringe lying around where others might tamper with it. 

5. Do not shake the syringe. 

6. Be careful not to touch the syringe guard wings before use. By touching them, the syringe guard 

may be activated too early. 

7. Do not remove the needle cap until just before you give the injection. 

8. The syringe cannot be re-used. Dispose of the used syringe immediately after use in a sharps 

container. 

 

Storage of the Cosentyx 150 mg pre-filled syringe 

1. Store this medicine sealed in its outer box to protect it from light. Store in the refrigerator 

between 2°C and 8°C. DO NOT FREEZE. 

2. Remember to take the syringe out of the refrigerator and allow it to reach room temperature 

before preparing it for injection (15-30 minutes). 

Needle cap 

Syringe guard 

Viewing window, label & 

expiry date 

Finger grips 

Syringe guard 

wings 

Plunger 

Plunger 

head 



 

120 

3. Do not use the syringe after the expiry date which is stated on the outer box or syringe label 

after “EXP”. If it has expired, return the entire pack to the pharmacy. 

 

The injection site 

 

 

The injection site is the place on the body where you are 

going to use the syringe. 

 The recommended site is the front of your thighs. You 
may also use the lower abdomen, but not the area 

5 centimetres around the navel (belly button).  

 Choose a different site each time you give yourself an 
injection. 

 Do not inject into areas where the skin is tender, 
bruised, red, scaly or hard. Avoid areas with scars or 

stretch marks. 

 

If a caregiver is giving you the injection, the outer upper 

arms may also be used. 

 

Preparing the Cosentyx 150 mg pre-filled syringe ready for use 

Note: For a 150 mg dose, prepare 1 pre-filled syringe and inject the content. For a 300 mg dose, 

prepare 2 pre-filled syringes and inject the contents of both. 

1. Take the box containing the syringe out of the refrigerator and leave it unopened for about 

15-30 minutes so that it reaches room temperature. 

2. When you are ready to use the syringe, wash your hands thoroughly with soap and water. 

3. Clean the injection site with an alcohol swab. 

4. Remove the syringe from the outer box and take it out of the blister by holding the syringe 

guard body. 

5. Inspect the syringe. The liquid should be clear. Its colour may vary from colourless to slightly 

yellow. You may see a small air bubble, which is normal. DO NOT USE if the liquid contains 

easily visible particles, is cloudy or is distinctly brown. DO NOT USE if the syringe is broken. 

In all these cases, return the entire product pack to the pharmacy. 

 

How to use the Cosentyx 150 mg pre-filled syringe 

 

 

Carefully remove the needle cap from the 

syringe by holding the syringe guard body. 

Discard the needle cap. You may see a drop of 

liquid at the end of the needle. This is normal. 



 

121 

 

Gently pinch the skin at the injection site and 

insert the needle as shown. Push the needle all 

the way in to ensure that the medicine can be 

fully administered. 

 

Hold the syringe as shown. Slowly depress the 

plunger as far as it will go so that the plunger 

head is completely between the syringe guard 

wings. 

Keep the plunger pressed fully down while you 

hold the syringe in place for 5 seconds. 

 

Keep the plunger fully depressed while you 

carefully lift the needle straight out from the 

injection site. 

 

Slowly release the plunger and allow the syringe 

guard to automatically cover the exposed needle. 

 

There may be a small amount of blood at the 

injection site. You can press a cotton ball or 

gauze over the injection site and hold it for 

10 seconds. Do not rub the injection site. You 

may cover the injection site with a small 

adhesive bandage, if needed. 

 

Disposal instructions 

 

 

Dispose of the used syringe in a sharps container 

(closable, puncture resistant container). For the 

safety and health of you and others, needles and 

used syringes must never be re-used. 



 

122 

Package leaflet: Information for the patient 
 

Cosentyx 150 mg solution for injection in pre-filled pen 

 

secukinumab 

 

Read all of this leaflet carefully before you start using this medicine because it contains 

important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 
side effects not listed in this leaflet. See section 4. 

 

What is in this leaflet 

1. What Cosentyx is and what it is used for 

2. What you need to know before you use Cosentyx 

3. How to use Cosentyx 

4. Possible side effects 

5. How to store Cosentyx 

6. Contents of the pack and other information 

 

 

1. What Cosentyx is and what it is used for 

 

Cosentyx contains the active substance secukinumab. Secukinumab is a monoclonal antibody which 

belongs to a group of medicines called interleukin (IL) inhibitors. This medicine works by neutralising 

the activity of a protein called IL-17A, which is present at increased levels in diseases such as 

psoriasis, psoriatic arthritis and axial spondyloarthritis. 

 

Cosentyx is used for the treatment of the following inflammatory diseases: 

 Plaque psoriasis 

 Psoriatic arthritis 

 Axial spondyloarthritis, including ankylosing spondylitis (radiographic axial spondyloarthritis) 
and non-radiographic axial spondyloarthritis 

 

Plaque psoriasis 
Cosentyx is used to treat a skin condition called “plaque psoriasis”, which causes inflammation 

affecting the skin. Cosentyx reduces the inflammation and other symptoms of the disease. Cosentyx is 

used in adults, adolescents and children (6 years of age and older) with moderate to severe plaque 

psoriasis. 

 

Using Cosentyx in plaque psoriasis will benefit you by leading to improvements of skin clearance and 

reducing your symptoms such as scaling, itching and pain. 

 

Psoriatic arthritis 

Cosentyx is used to treat a condition called “psoriatic arthritis”. The condition is an inflammatory 

disease of the joints, often accompanied by psoriasis. If you have active psoriatic arthritis you will first 

be given other medicines. If you do not respond well enough to these medicines, you will be given 

Cosentyx to reduce the signs and symptoms of active psoriatic arthritis, improve physical function and 

slow down the damage to the cartilage and bone of the joints involved in the disease. 

 

Cosentyx is used in adults with active psoriatic arthritis and can be used alone or with another 

medicine called methotrexate. 

  



 

123 

 

Using Cosentyx in psoriatic arthritis will benefit you by reducing the signs and symptoms of the 

disease, slowing down the damage to the cartilage and bone of the joints and improving your ability to 

do normal daily activities. 

 

Axial spondyloarthritis, including ankylosing spondylitis (radiographic axial spondyloarthritis) 

and non-radiographic axial spondyloarthritis 

Cosentyx is used to treat conditions called “ankylosing spondylitis” and “non-radiographic axial 

spondyloarthritis”. These conditions are inflammatory diseases primarily affecting the spine which 

cause inflammation of the spinal joints. If you have ankylosing spondylitis or non-radiographic axial 

spondyloarthritis you will first be given other medicines. If you do not respond well enough to these 

medicines, you will be given Cosentyx to reduce the signs and symptoms of the disease, reduce 

inflammation and improve your physical function. 

 

Cosentyx is used in adults with active ankylosing spondylitis and active non-radiographic axial 

spondyloarthritis. 

 

Using Cosentyx in ankylosing spondylitis and non-radiographic axial spondyloarthritis will benefit 

you by reducing the signs and symptoms of your disease and improving your physical function. 

 

 

2. What you need to know before you use Cosentyx 

 

Do not use Cosentyx: 

 if you are allergic to secukinumab or any of the other ingredients of this medicine (listed in 
section 6). 

If you think you may be allergic, ask your doctor for advice before using Cosentyx. 

 if you have an active infection which your doctor thinks is important. 
 

Warnings and precautions 

Talk to your doctor, nurse or pharmacist before using Cosentyx: 

 if you currently have an infection 

 if you have long-term or repeated infections. 

 if you have tuberculosis. 

 if you have ever had an allergic reaction to latex. 

 if you have an inflammatory disease affecting your gut called Crohn’s disease. 

 if you have an inflammation of your large intestine called ulcerative colitis. 

 if you have recently had a vaccination or if you are due to have a vaccination during treatment 
with Cosentyx. 

 if you are receiving any other treatment for psoriasis, such as another immunosuppressant or 
phototherapy with ultraviolet (UV) light. 

 

Inflammatory bowel disease (Crohn’s disease or ulcerative colitis) 

Stop using Cosentyx and tell your doctor or seek medical help immediately if you notice abdominal 

cramps and pain, diarrhoea, weight loss, blood in the stool or any other signs of bowel problems. 

 

Look out for infections and allergic reactions 

Cosentyx can potentially cause serious side effects, including infections and allergic reactions. You 

must look out for signs of these conditions while you are taking Cosentyx. 

 

Stop using Cosentyx and tell your doctor or seek medical help immediately if you notice any signs 

indicating a possible serious infection or an allergic reaction. Such signs are listed under “Serious side 

effects” in section 4. 

 



 

124 

Children and adolescents 

Cosentyx is not recommended for children younger than 6 years of age with plaque psoriasis because 

it has not been studied in this age group. 

 

Cosentyx is not recommended for children and adolescents (under 18 years of age) in other indications 

because it has not been studied in this age group. 

 

Other medicines and Cosentyx 
Tell your doctor or pharmacist: 

 if you are taking, have recently taken or might take any other medicines. 

 if you have recently had or are due to have a vaccination. You should not be given certain types 
of vaccines (live vaccines) while using Cosentyx. 

 

Pregnancy, breast-feeding and fertility 

 It is preferable to avoid the use of Cosentyx in pregnancy. The effects of this medicine in 
pregnant women are not known. If you are a woman of childbearing potential, you are advised 

to avoid becoming pregnant and must use adequate contraception while using Cosentyx and for 

at least 20 weeks after the last Cosentyx dose. 

Talk to your doctor if you are pregnant, think you may be pregnant or are planning to have a 

baby. 

 Talk to your doctor if you are breast-feeding or are planning to breast-feed. You and your doctor 
should decide if you will breast-feed or use Cosentyx. You should not do both. After using 

Cosentyx you should not breast-feed for at least 20 weeks after the last dose. 

 

Driving and using machines 

Cosentyx is unlikely to influence your ability to drive and use machines. 

 

 

3. How to use Cosentyx 

 

Always use this medicine exactly as your doctor has told you. Check with your doctor, nurse or 

pharmacist if you are not sure. 

 

Cosentyx is given via injection under your skin (known as a subcutaneous injection). You and your 

doctor should decide if you should inject Cosentyx yourself. 

 

It is important not to try to inject yourself until you have been trained by your doctor, nurse or 

pharmacist. A caregiver may also give you your Cosentyx injection after proper training. 

 

For detailed instructions on how to inject Cosentyx, see “Instructions for use of the Cosentyx 

SensoReady pen 150 mg” at the end of this leaflet. 

 

How much Cosentyx is given and for how long 

Your doctor will decide how much Cosentyx you need and for how long. 

 

Plaque psoriasis 

Adult 

 The recommended dose is 300 mg by subcutaneous injection. 

 Each 300 mg dose is given as two injections of 150 mg. 
 

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by 

monthly injections. At each timepoint you will receive a 300 mg dose given as two injections of 

150 mg. 

  



 

125 

 

Children aged 6 years and older 

 The recommended dose given by subcutaneous injection is based on body weight as follows: 
o Weight below 25 kg: 75 mg using the powder for solution for injection. 
o Weight 25 kg or above and below 50 kg: 75 mg using the powder for solution for 

injection. 

o Weight 50 kg or above: 150 mg using the powder for solution for injection, the pre-filled 
syringe or the pre-filled pen. 

Your doctor may increase the dose to 300 mg using the powder for solution for injection, 

the pre-filled syringe or the pre-filled pen. 

 Each 75 mg dose is given as one injection of 75 mg. Each 150 mg dose is given as one 
injection of 150 mg. Each 300 mg dose is given as two injections of 150 mg. 

 

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by 

monthly injections. 

 

Psoriatic arthritis 

For psoriatic arthritis patients who also have moderate to severe plaque psoriasis or patients who did 

not respond well to medicines called tumour necrosis factor (TNF) blockers: 

 The recommended dose is 300 mg by subcutaneous injection. 

 Each 300 mg dose is given as two injections of 150 mg. 
 

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by 

monthly injections. At each timepoint you will receive a 300 mg dose given as two injections of 

150 mg. 

 

For other psoriatic arthritis patients: 

 The recommended dose is 150 mg by subcutaneous injection. 
 

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by 

monthly injections. 

 

Based on your response, your doctor may increase your dose to 300 mg. 

 

Ankylosing spondylitis (Radiographic axial spondyloarthritis) 

 The recommended dose is 150 mg by subcutaneous injection. 
 

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by 

monthly injections. 

 

Based on your response, your doctor may increase your dose to 300 mg. Each 300 mg dose is given as 

two injections of 150 mg. 

 

Non-radiographic axial spondyloarthritis 

 The recommended dose is 150 mg by subcutaneous injection. 
 

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by 

monthly injections. 

 

Cosentyx is for long-term treatment. Your doctor will regularly monitor your condition to check that 

the treatment is having the desired effect. 

  



 

126 

 

If you use more Cosentyx than you should 
If you have received more Cosentyx than you should or the dose has been administered sooner than 

according to your doctor’s prescription, inform your doctor. 

 

If you forget to use Cosentyx 

If you have forgotten to inject a dose of Cosentyx, inject the next dose as soon as you remember. Then 

talk to your doctor to discuss when you should inject the next dose. 

 

If you stop using Cosentyx 

It is not dangerous to stop using Cosentyx. However, if you stop, your psoriasis, psoriatic arthritis or 

axial spondyloarthritis symptoms may come back. 

 

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 

 

 

4. Possible side effects 
 

Like all medicines, this medicine can cause side effects, although not everybody gets them. 

 

Serious side effects 

Stop using Cosentyx and tell your doctor or seek medical help immediately if you get any of the 

following side effects: 

 

Possible serious infection - the signs may include: 

 fever, flu-like symptoms, night sweats 

 feeling tired or short of breath, cough which will not go away 

 warm, red and painful skin, or a painful skin rash with blisters 

 burning sensation when passing urine. 
 

Serious allergic reaction - the signs may include: 

 difficulty breathing or swallowing 

 low blood pressure, which can cause dizziness or light-headedness 

 swelling of the face, lips, tongue or throat 

 severe itching of the skin, with a red rash or raised bumps. 
Your doctor will decide if and when you may restart the treatment. 

 

Other side effects 

Most of the following side effects are mild to moderate. If any of these side effects becomes severe, 

tell your doctor, pharmacist or nurse. 

 

Very common (may affect more than 1 in 10 people): 

 upper respiratory tract infections with symptoms such as sore throat and stuffy nose 
(nasopharyngitis, rhinitis) 

 

Common (may affect up to 1 in 10 people): 

 cold sores (oral herpes) 

 diarrhoea 

 runny nose (rhinorrhoea) 

 athlete’s foot (tinea pedis) 

 headache 

 nausea 

 fatigue 
  



 

127 

 

Uncommon (may affect up to 1 in 100 people): 

 oral thrush (oral candidiasis) 

 signs of low levels of white blood cells, such as fever, sore throat or mouth ulcers due to 
infections (neutropenia) 

 infection of the external ear (otitis externa) 

 discharge from the eye with itching, redness and swelling (conjunctivitis) 

 itchy rash (urticaria) 

 lower respiratory tract infections 

 abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel 
problems) 

 

Rare (may affect up to 1 in 1,000 people): 

 severe allergic reaction with shock (anaphylactic reaction) 

 redness and shedding of skin over a larger area of the body, which may be itchy or 
painful (exfoliative dermatitis) 

 

Not known (frequency cannot be estimated from the available data): 

 fungal infections of the skin and mucous membranes (including oesophageal candidiasis) 
 

Reporting of side effects 

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 

effects not listed in this leaflet. You can also report side effects directly via the national reporting 

system listed in Appendix V. By reporting side effects you can help provide more information on the 

safety of this medicine. 

 

 

5. How to store Cosentyx 

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine: 

 after the expiry date which is stated on the outer box or the label on the pen after “EXP”. 

 if the liquid contains easily visible particles, is cloudy or is distinctly brown. 
 

Store the pen sealed in its box to protect from light. Store in the refrigerator between 2°C and 8°C. Do 

not freeze. Do not shake. 

If necessary, Cosentyx can be left out of the refrigerator for a single period of up to 4 days at room 

temperature, not above 30°C. 

 

This medicine is for single use only. 

 

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines 

you no longer use. These measures will help protect the environment. 

 

  

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

128 

 

6. Contents of the pack and other information 

 

What Cosentyx contains 

- The active substance is secukinumab. Each pre-filled pen contains 150 mg secukinumab. 
- The other ingredients are trehalose dihydrate, histidine, histidine hydrochloride monohydrate, 

methionine, polysorbate 80 and water for injections. 

 

What Cosentyx looks like and contents of the pack 

Cosentyx solution for injection is a clear liquid. Its colour may vary from colourless to slightly yellow. 

Cosentyx 150 mg solution for injection in pre-filled pen is available in unit packs containing 1 or 

2 pre-filled pen(s) and in multipacks containing 6 (3 packs of 2) pre-filled pens. 

Not all pack sizes may be marketed. 

 

Marketing Authorisation Holder 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

Manufacturer 

Novartis Pharma GmbH 

Roonstraße 25 

90429 Nuremberg 

Germany 

 

Sandoz GmbH 

Biochemiestrasse 10 

6336 Langkampfen 

Austria 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

 

België/Belgique/Belgien 

Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Lietuva 

SIA Novartis Baltics Lietuvos filialas 

Tel: +370 5 269 16 50 

 

България 

Novartis Bulgaria EOOD 

Тел: +359 2 489 98 28 

 

Luxembourg/Luxemburg 

Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Česká republika 

Novartis s.r.o. 

Tel: +420 225 775 111 

 

Magyarország 

Novartis Hungária Kft. 

Tel.: +36 1 457 65 00 

Danmark 

Novartis Healthcare A/S 

Tlf: +45 39 16 84 00 

 

Malta 

Novartis Pharma Services Inc. 

Tel: +356 2122 2872 

Deutschland 

Novartis Pharma GmbH 

Tel: +49 911 273 0 

 

Nederland 

Novartis Pharma B.V. 

Tel: +31 88 04 52 111 



 

129 

Eesti 

SIA Novartis Baltics Eesti filiaal 

Tel: +372 66 30 810 

 

Norge 

Novartis Norge AS 

Tlf: +47 23 05 20 00 

Ελλάδα 

Novartis (Hellas) A.E.B.E. 

Τηλ: +30 210 281 17 12 

 

Österreich 

Novartis Pharma GmbH 

Tel: +43 1 86 6570 

España 

Novartis Farmacéutica, S.A. 

Tel: +34 93 306 42 00 

 

Polska 

Novartis Poland Sp. z o.o. 

Tel.: +48 22 375 4888 

France 

Novartis Pharma S.A.S. 

Tél: +33 1 55 47 66 00 

 

Portugal 

Novartis Farma - Produtos Farmacêuticos, S.A. 

Tel: +351 21 000 8600 

Hrvatska 

Novartis Hrvatska d.o.o. 

Tel. +385 1 6274 220 

 

România 

Novartis Pharma Services Romania SRL 

Tel: +40 21 31299 01 

Ireland 

Novartis Ireland Limited 

Tel: +353 1 260 12 55 

 

Slovenija 

Novartis Pharma Services Inc. 

Tel: +386 1 300 75 50 

Ísland 

Vistor hf. 

Sími: +354 535 7000 

 

Slovenská republika 

Novartis Slovakia s.r.o. 

Tel: +421 2 5542 5439 

 

Italia 

Novartis Farma S.p.A. 

Tel: +39 02 96 54 1 

Suomi/Finland 

Novartis Finland Oy 

Puh/Tel: +358 (0)10 6133 200 

 

Κύπρος 

Novartis Pharma Services Inc. 

Τηλ: +357 22 690 690 

 

Sverige 

Novartis Sverige AB 

Tel: +46 8 732 32 00 

 

Latvija 

SIA Novartis Baltics 

Tel: +371 67 887 070 

 

United Kingdom 

Novartis Pharmaceuticals UK Ltd. 

Tel: +44 1276 698370 

 

 

 

This leaflet was last revised in 
 

 

Other sources of information 
Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu 

 

http://www.ema.europa.eu/


 

130 

Instructions for use of the Cosentyx SensoReady pen 150 mg 

 

 

 

Cosentyx SensoReady pen 150 mg 

 

Solution for injection in a pre-filled pen 

 

Secukinumab 

 

Patient Instructions for Use 

 

 

 

 

Read ALL the way through these instructions before injecting. 

 

These instructions are to help you to inject correctly using the Cosentyx 

SensoReady pen. 

 

It is important not to try to inject yourself or the person in your care until 

you have been trained by your doctor, nurse or pharmacist. 

 
 

Your Cosentyx SensoReady pen 150 mg: 

 

 

 

 

 

 

 
 

 

Cosentyx SensoReady pen 150 mg shown 

with the cap removed. Do not remove the 

cap until you are ready to inject. 

 

Store your boxed pen in a refrigerator between 2°C 

and 8°C and out of the reach of children. 

 

 Do not freeze the pen. 

 Do not shake the pen. 

 Do not use the pen if it has been dropped with the 
cap removed. 

 

For a more comfortable injection, take the pen out of 

the refrigerator 15-30 minutes before injecting to 

allow it to reach room temperature. 
 

What you need for your injection: 

 
Included in the carton: 

 

A new and unused Cosentyx 

SensoReady pen 150 mg (1 pen is 

needed for a 150 mg dose and 
2 pens are needed for a 300 mg 

dose). 

 

Not included in the carton: 

 

 Alcohol swab. 

 Cotton ball or gauze. 

 Sharps disposal 
container. 

 

 

 

 

 

 

 
 

 

Needle 

Needle guard 

Cap Inspection 

window 

Internal needle 

cover 



 

131 

Before your injection: 

 

 

 

 

 
 

1. Important safety checks before you inject: 
The liquid should be clear. Its colour may vary from colourless to 

slightly yellow. 
Do not use if the liquid contains easily visible particles, is cloudy or is 

distinctly brown. You may see a small air bubble, which is normal. 

Do not use the pen if the expiry date has passed. 

Do not use if the safety seal has been broken. 

 

Contact your pharmacist if the pen fails any of these checks. 

 

 

2a. Choose your injection site: 

 The recommended site is the front of the thighs. You may also use 
the lower abdomen, but not the area 5 centimetres around the navel 

(belly button). 

 Choose a different site each time you give yourself an injection. 

 Do not inject into areas where the skin is tender, bruised, red, scaly 
or hard. Avoid areas with scars or stretch marks. 

 
 

2b. Caregivers and healthcare professionals only: 
 If a caregiver or healthcare professional is giving you your 

injection, they may also inject into your outer upper arm. 

 

3. Cleaning your injection site: 

 Wash your hands with soap and hot water. 

 Using a circular motion, clean the injection site with the alcohol 
swab. Leave it to dry before injecting. 

 Do not touch the cleaned area again before injecting. 

 

  



 

132 

 

Your injection: 

 

 

4. Removing the cap: 

 Only remove the cap when you are ready to use the pen. 

 Twist off the cap in the direction of the arrows. 

 Once removed, throw away the cap. Do not try to re-attach the 
cap. 

 Use the pen within 5 minutes of removing the cap. 

 

5. Holding your pen: 

 Hold the pen at 90 degrees to the cleaned injection site. 

 
 Correct Incorrect 

 

 

YOU MUST READ THIS BEFORE INJECTING. 
 

During the injection you will hear 2 loud clicks. 

 

The 1st click indicates that the injection has started. Several seconds 

later a 2nd click will indicate that the injection is almost finished. 

 

You must keep holding the pen firmly against your skin until you see a 

green indicator fill the window and stop moving. 

 

 

6. Starting your injection: 

 Press the pen firmly against the skin to start the injection. 

 The 1st click indicates the injection has started. 

 Keep holding the pen firmly against your skin. 

 The green indicator shows the progress of the injection. 
 

 

7. Completing your injection: 

 Listen for the 2nd click. This indicates the injection is almost 
complete. 

 Check the green indicator fills the window and has stopped 
moving. 

 The pen can now be removed. 

 



 

133 

After your injection: 

 

 

8. Check the green indicator fills the window: 

 This means the medicine has been delivered. Contact your doctor 
if the green indicator is not visible. 

 There may be a small amount of blood at the injection site. You 
can press a cotton ball or gauze over the injection site and hold it 

for 10 seconds. Do not rub the injection site. You may cover the 

injection site with a small adhesive bandage, if needed. 

 

9. Disposing of your Cosentyx SensoReady pen: 

 Dispose of the used pen in a sharps disposal container (i.e. a 
puncture-resistant closable container, or similar). 

 Never try to reuse your pen. 

 



 

134 

Package leaflet: Information for the patient 
 

Cosentyx 300 mg solution for injection in pre-filled syringe 

 

secukinumab 

 

Read all of this leaflet carefully before you start using this medicine because it contains 

important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 
side effects not listed in this leaflet. See section 4. 

 

What is in this leaflet 

1. What Cosentyx is and what it is used for 

2. What you need to know before you use Cosentyx 

3. How to use Cosentyx 

4. Possible side effects 

5. How to store Cosentyx 

6. Contents of the pack and other information 

 

 

1. What Cosentyx is and what it is used for 

 

Cosentyx contains the active substance secukinumab. Secukinumab is a monoclonal antibody which 

belongs to a group of medicines called interleukin (IL) inhibitors. This medicine works by neutralising 

the activity of a protein called IL-17A, which is present at increased levels in diseases such as 

psoriasis, psoriatic arthritis and axial spondyloarthritis. 

 

Cosentyx is used for the treatment of the following inflammatory diseases: 

 Plaque psoriasis 

 Psoriatic arthritis 

 Axial spondyloarthritis, including ankylosing spondylitis (radiographic axial spondyloarthritis) 
and non-radiographic axial spondyloarthritis 

 

Plaque psoriasis 
Cosentyx is used to treat a skin condition called “plaque psoriasis”, which causes inflammation 

affecting the skin. Cosentyx reduces the inflammation and other symptoms of the disease. Cosentyx is 

used in adults, adolescents and children (6 years of age and older) with moderate to severe plaque 

psoriasis. 

 

Using Cosentyx in plaque psoriasis will benefit you by leading to improvements of skin clearance and 

reducing your symptoms such as scaling, itching and pain. 

 

Psoriatic arthritis 

Cosentyx is used to treat a condition called “psoriatic arthritis”. The condition is an inflammatory 

disease of the joints, often accompanied by psoriasis. If you have active psoriatic arthritis you will first 

be given other medicines. If you do not respond well enough to these medicines, you will be given 

Cosentyx to reduce the signs and symptoms of active psoriatic arthritis, improve physical function and 

slow down the damage to the cartilage and bone of the joints involved in the disease. 

 

Cosentyx is used in adults with active psoriatic arthritis and can be used alone or with another 

medicine called methotrexate. 

  



 

135 

 

Using Cosentyx in psoriatic arthritis will benefit you by reducing the signs and symptoms of the 

disease, slowing down the damage to the cartilage and bone of the joints and improving your ability to 

do normal daily activities. 

 

Axial spondyloarthritis, including ankylosing spondylitis (radiographic axial spondyloarthritis) 

and non-radiographic axial spondyloarthritis 

Cosentyx is used to treat conditions called “ankylosing spondylitis” and “non-radiographic axial 

spondyloarthritis”. These conditions are inflammatory diseases primarily affecting the spine which 

cause inflammation of the spinal joints. If you have ankylosing spondylitis or non-radiographic axial 

spondyloarthritis you will first be given other medicines. If you do not respond well enough to these 

medicines, you will be given Cosentyx to reduce the signs and symptoms of the disease, reduce 

inflammation and improve your physical function. 

 

Cosentyx is used in adults with active ankylosing spondylitis and active non-radiographic axial 

spondyloarthritis. 

 

Using Cosentyx in ankylosing spondylitis and non-radiographic axial spondyloarthritis will benefit 

you by reducing the signs and symptoms of your disease and improving your physical function. 

 

 

2. What you need to know before you use Cosentyx 

 

Do not use Cosentyx: 

 if you are allergic to secukinumab or any of the other ingredients of this medicine (listed in 
section 6). 

If you think you may be allergic, ask your doctor for advice before using Cosentyx. 

 if you have an active infection which your doctor thinks is important. 
 

Warnings and precautions 

Talk to your doctor, nurse or pharmacist before using Cosentyx: 

 if you currently have an infection 

 if you have long-term or repeated infections. 

 if you have tuberculosis. 

 if you have an inflammatory disease affecting your gut called Crohn’s disease. 

 if you have an inflammation of your large intestine called ulcerative colitis. 

 if you have recently had a vaccination or if you are due to have a vaccination during treatment 
with Cosentyx. 

 if you are receiving any other treatment for psoriasis, such as another immunosuppressant or 
phototherapy with ultraviolet (UV) light. 

 

Inflammatory bowel disease (Crohn’s disease or ulcerative colitis) 

Stop using Cosentyx and tell your doctor or seek medical help immediately if you notice abdominal 

cramps and pain, diarrhoea, weight loss, blood in the stool or any other signs of bowel problems. 

 

Look out for infections and allergic reactions 

Cosentyx can potentially cause serious side effects, including infections and allergic reactions. You 

must look out for signs of these conditions while you are taking Cosentyx. 

 

Stop using Cosentyx and tell your doctor or seek medical help immediately if you notice any signs 

indicating a possible serious infection or an allergic reaction. Such signs are listed under “Serious side 

effects” in section 4. 

  



 

136 

 

Children and adolescents 

Cosentyx is not recommended for children younger than 6 years of age with plaque psoriasis because 

it has not been studied in this age group. 

 

Cosentyx is not recommended for children and adolescents (under 18 years of age) in other indications 

because it has not been studied in this age group. 

 

Other medicines and Cosentyx 
Tell your doctor or pharmacist: 

 if you are taking, have recently taken or might take any other medicines. 

 if you have recently had or are due to have a vaccination. You should not be given certain types 
of vaccines (live vaccines) while using Cosentyx. 

 

Pregnancy, breast-feeding and fertility 

 It is preferable to avoid the use of Cosentyx in pregnancy. The effects of this medicine in 
pregnant women are not known. If you are a woman of childbearing potential, you are advised 

to avoid becoming pregnant and must use adequate contraception while using Cosentyx and for 

at least 20 weeks after the last Cosentyx dose. 

Talk to your doctor if you are pregnant, think you may be pregnant or are planning to have a 

baby. 

 Talk to your doctor if you are breast-feeding or are planning to breast-feed. You and your doctor 
should decide if you will breast-feed or use Cosentyx. You should not do both. After using 

Cosentyx you should not breast-feed for at least 20 weeks after the last dose. 

 

Driving and using machines 

Cosentyx is unlikely to influence your ability to drive and use machines. 

 

 

3. How to use Cosentyx 

 

Always use this medicine exactly as your doctor has told you. Check with your doctor, nurse or 

pharmacist if you are not sure. 

 

Cosentyx is given via injection under your skin (known as a subcutaneous injection). You and your 

doctor should decide if you should inject Cosentyx yourself. 

 

It is important not to try to inject yourself until you have been trained by your doctor, nurse or 

pharmacist. A caregiver may also give you your Cosentyx injection after proper training. 

 

For detailed instructions on how to inject Cosentyx, see “Instructions for use of Cosentyx 300 mg 

pre-filled syringe” at the end of this leaflet. 

 

How much Cosentyx is given and for how long 

Your doctor will decide how much Cosentyx you need and for how long. 

 

Plaque psoriasis 

Adult 

 The recommended dose is 300 mg by subcutaneous injection. 

 Each 300 mg dose is given as one injection of 300 mg. 
 

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by 

monthly injections. At each timepoint you will receive a 300 mg dose given as one injection of 

300 mg. 

 



 

137 

Children aged 6 years and older 

 The recommended dose given by subcutaneous injection is based on body weight as follows: 
o Weight below 25 kg: 75 mg using the powder for solution for injection. 
o Weight 25 kg or above and below 50 kg: 75 mg using the powder for solution for 

injection. 

o Weight 50 kg or above: 150 mg using the powder for solution for injection, the pre-filled 
syringe or the pre-filled pen. 

Your doctor may increase the dose to 300 mg using the powder for solution for injection, 

the pre-filled syringe or the pre-filled pen. 

 Each 75 mg dose is given as one injection of 75 mg. Each 150 mg dose is given as one 
injection of 150 mg. Each 300 mg dose is given as one injection of 300 mg. 

 

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by 

monthly injections. 

 

Psoriatic arthritis 

For psoriatic arthritis patients who also have moderate to severe plaque psoriasis or patients who did 

not respond well to medicines called tumour necrosis factor (TNF) blockers: 

 The recommended dose is 300 mg by subcutaneous injection. 

 Each 300 mg dose is given as one injection of 300 mg. 
 

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by 

monthly injections. At each timepoint you will receive a 300 mg dose given as one injection of 

300 mg. 

 

For other psoriatic arthritis patients: 

 The recommended dose is 150 mg by subcutaneous injection. 
 

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by 

monthly injections. 

 

Based on your response, your doctor may increase your dose to 300 mg. 

 

Ankylosing spondylitis (Radiographic axial spondyloarthritis) 

 The recommended dose is 150 mg by subcutaneous injection. 
 

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by 

monthly injections. 

 

Based on your response, your doctor may increase your dose to 300 mg. Each 300 mg dose is given as 

one injection of 300 mg. 

 

Non-radiographic axial spondyloarthritis 

 The recommended dose is 150 mg by subcutaneous injection. 
 

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by 

monthly injections. 

 

Cosentyx is for long-term treatment. Your doctor will regularly monitor your condition to check that 

the treatment is having the desired effect. 

 

If you use more Cosentyx than you should 
If you have received more Cosentyx than you should or the dose has been administered sooner than 

according to your doctor’s prescription, inform your doctor. 

  



 

138 

 

If you forget to use Cosentyx 

If you have forgotten to inject a dose of Cosentyx, inject the next dose as soon as you remember. Then 

talk to your doctor to discuss when you should inject the next dose. 

 

If you stop using Cosentyx 

It is not dangerous to stop using Cosentyx. However, if you stop, your psoriasis, psoriatic arthritis or 

axial spondyloarthritis symptoms may come back. 

 

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 

 

 

4. Possible side effects 
 

Like all medicines, this medicine can cause side effects, although not everybody gets them. 

 

Serious side effects 

Stop using Cosentyx and tell your doctor or seek medical help immediately if you get any of the 

following side effects: 

 

Possible serious infection - the signs may include: 

 fever, flu-like symptoms, night sweats 

 feeling tired or short of breath, cough which will not go away 

 warm, red and painful skin, or a painful skin rash with blisters 

 burning sensation when passing urine. 
 

Serious allergic reaction - the signs may include: 

 difficulty breathing or swallowing 

 low blood pressure, which can cause dizziness or light-headedness 

 swelling of the face, lips, tongue or throat 

 severe itching of the skin, with a red rash or raised bumps. 
Your doctor will decide if and when you may restart the treatment. 

 

Other side effects 

Most of the following side effects are mild to moderate. If any of these side effects becomes severe, 

tell your doctor, pharmacist or nurse. 

 

Very common (may affect more than 1 in 10 people): 

 upper respiratory tract infections with symptoms such as sore throat and stuffy nose 
(nasopharyngitis, rhinitis) 

 

Common (may affect up to 1 in 10 people): 

 cold sores (oral herpes) 

 diarrhoea 

 runny nose (rhinorrhoea) 

 athlete’s foot (tinea pedis) 

 headache 

 nausea 

 fatigue 
  



 

139 

 

Uncommon (may affect up to 1 in 100 people): 

 oral thrush (oral candidiasis) 

 signs of low levels of white blood cells, such as fever, sore throat or mouth ulcers due to 
infections (neutropenia) 

 infection of the external ear (otitis externa) 

 discharge from the eye with itching, redness and swelling (conjunctivitis) 

 itchy rash (urticaria) 

 lower respiratory tract infections 

 abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel 
problems) 

 

Rare (may affect up to 1 in 1,000 people): 

 severe allergic reaction with shock (anaphylactic reaction) 

 redness and shedding of skin over a larger area of the body, which may be itchy or 
painful (exfoliative dermatitis) 

 

Not known (frequency cannot be estimated from the available data): 

 fungal infections of the skin and mucous membranes (including oesophageal candidiasis) 
 

Reporting of side effects 

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 

effects not listed in this leaflet. You can also report side effects directly via the national reporting 

system listed in Appendix V. By reporting side effects you can help provide more information on the 

safety of this medicine. 

 

 

5. How to store Cosentyx 

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine: 

 after the expiry date which is stated on the outer box or the label on the syringe after “EXP”. 

 if the liquid contains easily visible particles, is cloudy or is distinctly brown. 
 

Store the syringe sealed in its box to protect from light. Store in the refrigerator between 2°C and 8°C. 

Do not freeze. Do not shake. 

If necessary, Cosentyx can be left out of the refrigerator for a single period of up to 4 days at room 

temperature, not above 30°C. 

 

This medicine is for single use only. 

 

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines 

you no longer use. These measures will help protect the environment. 

 

  

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

140 

 

6. Contents of the pack and other information 

 

What Cosentyx contains 

- The active substance is secukinumab. Each pre-filled syringe contains 300 mg secukinumab. 
- The other ingredients are trehalose dihydrate, histidine, histidine hydrochloride monohydrate, 

methionine, polysorbate 80 and water for injections. 

 

What Cosentyx looks like and contents of the pack 

Cosentyx solution for injection is a clear liquid. Its colour may vary from colourless to slightly yellow. 

Cosentyx 300 mg solution for injection in pre-filled syringe is available in a pack containing 

1 pre-filled syringe and in multipacks containing 3 (3 packs of 1) pre-filled syringes. 

Not all pack sizes may be marketed. 

 

Marketing Authorisation Holder 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

Manufacturer 

Novartis Pharma GmbH 

Roonstraße 25 

90429 Nuremberg 

Germany 

 

Sandoz GmbH 

Biochemiestrasse 10 

6336 Langkampfen 

Austria 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

 

België/Belgique/Belgien 

Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Lietuva 

SIA Novartis Baltics Lietuvos filialas 

Tel: +370 5 269 16 50 

 

България 

Novartis Bulgaria EOOD 

Тел: +359 2 489 98 28 

 

Luxembourg/Luxemburg 

Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Česká republika 

Novartis s.r.o. 

Tel: +420 225 775 111 

 

Magyarország 

Novartis Hungária Kft. 

Tel.: +36 1 457 65 00 

Danmark 

Novartis Healthcare A/S 

Tlf: +45 39 16 84 00 

 

Malta 

Novartis Pharma Services Inc. 

Tel: +356 2122 2872 

Deutschland 

Novartis Pharma GmbH 

Tel: +49 911 273 0 

 

Nederland 

Novartis Pharma B.V. 

Tel: +31 88 04 52 111 



 

141 

Eesti 

SIA Novartis Baltics Eesti filiaal 

Tel: +372 66 30 810 

 

Norge 

Novartis Norge AS 

Tlf: +47 23 05 20 00 

Ελλάδα 

Novartis (Hellas) A.E.B.E. 

Τηλ: +30 210 281 17 12 

 

Österreich 

Novartis Pharma GmbH 

Tel: +43 1 86 6570 

España 

Novartis Farmacéutica, S.A. 

Tel: +34 93 306 42 00 

 

Polska 

Novartis Poland Sp. z o.o. 

Tel.: +48 22 375 4888 

France 

Novartis Pharma S.A.S. 

Tél: +33 1 55 47 66 00 

 

Portugal 

Novartis Farma - Produtos Farmacêuticos, S.A. 

Tel: +351 21 000 8600 

Hrvatska 

Novartis Hrvatska d.o.o. 

Tel. +385 1 6274 220 

 

România 

Novartis Pharma Services Romania SRL 

Tel: +40 21 31299 01 

Ireland 

Novartis Ireland Limited 

Tel: +353 1 260 12 55 

 

Slovenija 

Novartis Pharma Services Inc. 

Tel: +386 1 300 75 50 

Ísland 

Vistor hf. 

Sími: +354 535 7000 

 

Slovenská republika 

Novartis Slovakia s.r.o. 

Tel: +421 2 5542 5439 

 

Italia 

Novartis Farma S.p.A. 

Tel: +39 02 96 54 1 

Suomi/Finland 

Novartis Finland Oy 

Puh/Tel: +358 (0)10 6133 200 

 

Κύπρος 

Novartis Pharma Services Inc. 

Τηλ: +357 22 690 690 

 

Sverige 

Novartis Sverige AB 

Tel: +46 8 732 32 00 

 

Latvija 

SIA Novartis Baltics 

Tel: +371 67 887 070 

 

United Kingdom 

Novartis Pharmaceuticals UK Ltd. 

Tel: +44 1276 698370 

 

 

 

This leaflet was last revised in 
 

 

Other sources of information 
Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu 

 

http://www.ema.europa.eu/


 

142 

Instructions for use of Cosentyx 300 mg pre-filled syringe 

 

Read ALL the way through these instructions before injecting. It is important not to try to inject 

yourself until you have been trained by your doctor, nurse or pharmacist. The box contains the 

Cosentyx 300 mg pre-filled syringe individually sealed in a plastic blister. 

 

Your Cosentyx 300 mg pre-filled syringe 

 

 

 
 

 

After the medicine has been injected the syringe guard will be activated to cover the needle. This is 

intended to aid in the protection of healthcare professionals, patients who self-inject doctor-prescribed 

medicines, and individuals who assist self-injecting patients from accidental needlestick injuries. 

 

What you additionally need for 

your injection: 

 Alcohol swab. 

 Cotton ball or gauze. 

 Sharps disposal container. 
 

 
 

Important safety information 

Caution: Keep the syringe out of the sight and reach of children. 

1. Do not open the sealed outer box until you are ready to use this medicine. 

2. Do not use this medicine if either the seal on the outer box or the seal of the blister is broken, as 

it may not be safe for you to use. 

3. Never leave the syringe lying around where others might tamper with it. 

4. Do not shake the syringe. 

5. Be careful not to touch the syringe guard wings before use. By touching them, the syringe guard 

may be activated too early. 

6. Do not remove the needle cap until just before you give the injection. 

7. The syringe cannot be re-used. Dispose of the used syringe immediately after use in a sharps 

container. 

 

Storage of the Cosentyx 300 mg pre-filled syringe 

1. Store this medicine sealed in its outer box to protect it from light. Store in the refrigerator 

between 2°C and 8°C. DO NOT FREEZE. 

2. Remember to take the syringe out of the refrigerator and allow it to reach room temperature 

before preparing it for injection (30-45 minutes). 

3. Do not use the syringe after the expiry date which is stated on the outer box or syringe label 

after “EXP”. If it has expired, return the entire pack to the pharmacy. 

 

Needle cap 

Syringe guard 

Viewing window label 

& expiry date 

Finger grips 

Syringe guard 

wings 

Plunger 

Plunger head 



 

143 

The injection site 

 

 

The injection site is the place on the body where you are 

going to use the syringe. 

 The recommended site is the front of your thighs. You 
may also use the lower abdomen, but not the area 

5 centimetres around the navel (belly button). 

 Choose a different site each time you give yourself an 
injection. 

 Do not inject into areas where the skin is tender, 
bruised, red, scaly or hard. Avoid areas with scars or 

stretch marks. 

 

If a caregiver is giving you the injection, the outer upper 

arms may also be used. 

 

Preparing the Cosentyx 300 mg pre-filled syringe ready for use 

1. Take the box containing the syringe out of the refrigerator and leave it unopened for about 

30-45 minutes so that it reaches room temperature. 

2. When you are ready to use the syringe, wash your hands thoroughly with soap and water. 

3. Clean the injection site with an alcohol swab. 

4. Remove the syringe from the outer box and take it out of the blister by holding the syringe 

guard body. 

5. Inspect the syringe. The liquid should be clear. Its colour may vary from colourless to slightly 

yellow. You may see a small air bubble, which is normal. DO NOT USE if the liquid contains 

easily visible particles, is cloudy or is distinctly brown. DO NOT USE if the syringe is broken. 

In all these cases, return the entire product pack to the pharmacy. 

 

How to use the Cosentyx 300 mg pre-filled syringe 

 

 

Carefully remove the needle cap from the 

syringe by holding the syringe guard body. 

Discard the needle cap. You may see a drop of 

liquid at the end of the needle. This is normal. 

 

Gently pinch the skin at the injection site and 

insert the needle as shown. Push the needle all 

the way in to ensure that the medicine can be 

fully administered. 



 

144 

 

Hold the syringe as shown. Slowly depress the 

plunger as far as it will go so that the plunger 

head is completely between the syringe guard 

wings. 

Keep the plunger pressed fully down while you 

hold the syringe in place for 5 seconds. 

 

Keep the plunger fully depressed while you 

carefully lift the needle straight out from the 

injection site. 

 

Slowly release the plunger and allow the syringe 

guard to automatically cover the exposed needle. 

 

There may be a small amount of blood at the 

injection site. You can press a cotton ball or 

gauze over the injection site and hold it for 

10 seconds. Do not rub the injection site. You 

may cover the injection site with a small 

adhesive bandage, if needed. 

 

Disposal instructions 

 

 

Dispose of the used syringe in a sharps container 

(closable, puncture resistant container). For the 

safety and health of you and others, needles and 

used syringes must never be re-used. 



 

145 

Package leaflet: Information for the patient 
 

Cosentyx 300 mg solution for injection in pre-filled pen 
secukinumab 

 

Read all of this leaflet carefully before you start using this medicine because it contains 

important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 
side effects not listed in this leaflet. See section 4. 

 

What is in this leaflet 

1. What Cosentyx is and what it is used for 

2. What you need to know before you use Cosentyx 

3. How to use Cosentyx 

4. Possible side effects 

5. How to store Cosentyx 

6. Contents of the pack and other information 

 

 

1. What Cosentyx is and what it is used for 

 

Cosentyx contains the active substance secukinumab. Secukinumab is a monoclonal antibody which 

belongs to a group of medicines called interleukin (IL) inhibitors. This medicine works by neutralising 

the activity of a protein called IL-17A, which is present at increased levels in diseases such as 

psoriasis, psoriatic arthritis and axial spondyloarthritis. 

 

Cosentyx is used for the treatment of the following inflammatory diseases: 

 Plaque psoriasis 

 Psoriatic arthritis 

 Axial spondyloarthritis, including ankylosing spondylitis (radiographic axial spondyloarthritis) 
and non-radiographic axial spondyloarthritis 

 

Plaque psoriasis 
Cosentyx is used to treat a skin condition called “plaque psoriasis”, which causes inflammation 

affecting the skin. Cosentyx reduces the inflammation and other symptoms of the disease. Cosentyx is 

used in adults, adolescents and children (6 years of age and older) with moderate to severe plaque 

psoriasis. 

 

Using Cosentyx in plaque psoriasis will benefit you by leading to improvements of skin clearance and 

reducing your symptoms such as scaling, itching and pain. 

 

Psoriatic arthritis 

Cosentyx is used to treat a condition called “psoriatic arthritis”. The condition is an inflammatory 

disease of the joints, often accompanied by psoriasis. If you have active psoriatic arthritis you will first 

be given other medicines. If you do not respond well enough to these medicines, you will be given 

Cosentyx to reduce the signs and symptoms of active psoriatic arthritis, improve physical function and 

slow down the damage to the cartilage and bone of the joints involved in the disease. 

 

Cosentyx is used in adults with active psoriatic arthritis and can be used alone or with another 

medicine called methotrexate. 

  



 

146 

 

Using Cosentyx in psoriatic arthritis will benefit you by reducing the signs and symptoms of the 

disease, slowing down the damage to the cartilage and bone of the joints and improving your ability to 

do normal daily activities. 

 

Axial spondyloarthritis, including ankylosing spondylitis (radiographic axial spondyloarthritis) 

and non-radiographic axial spondyloarthritis 

Cosentyx is used to treat conditions called “ankylosing spondylitis” and “non-radiographic axial 

spondyloarthritis”. These conditions are inflammatory diseases primarily affecting the spine which 

cause inflammation of the spinal joints. If you have ankylosing spondylitis or non-radiographic axial 

spondyloarthritis you will first be given other medicines. If you do not respond well enough to these 

medicines, you will be given Cosentyx to reduce the signs and symptoms of the disease, reduce 

inflammation and improve your physical function. 

 

Cosentyx is used in adults with active ankylosing spondylitis and active non-radiographic axial 

spondyloarthritis. 

 

Using Cosentyx in ankylosing spondylitis and non-radiographic axial spondyloarthritis will benefit 

you by reducing the signs and symptoms of your disease and improving your physical function. 

 

 

2. What you need to know before you use Cosentyx 

 

Do not use Cosentyx: 

 if you are allergic to secukinumab or any of the other ingredients of this medicine (listed in 
section 6). 

If you think you may be allergic, ask your doctor for advice before using Cosentyx. 

 if you have an active infection which your doctor thinks is important. 
 

Warnings and precautions 

Talk to your doctor, nurse or pharmacist before using Cosentyx: 

 if you currently have an infection 

 if you have long-term or repeated infections. 

 if you have tuberculosis. 

 if you have an inflammatory disease affecting your gut called Crohn’s disease. 

 if you have an inflammation of your large intestine called ulcerative colitis. 

 if you have recently had a vaccination or if you are due to have a vaccination during treatment 
with Cosentyx. 

 if you are receiving any other treatment for psoriasis, such as another immunosuppressant or 
phototherapy with ultraviolet (UV) light. 

 

Inflammatory bowel disease (Crohn’s disease or ulcerative colitis) 

Stop using Cosentyx and tell your doctor or seek medical help immediately if you notice abdominal 

cramps and pain, diarrhoea, weight loss, blood in the stool or any other signs of bowel problems. 

 

Look out for infections and allergic reactions 

Cosentyx can potentially cause serious side effects, including infections and allergic reactions. You 

must look out for signs of these conditions while you are taking Cosentyx. 

 

Stop using Cosentyx and tell your doctor or seek medical help immediately if you notice any signs 

indicating a possible serious infection or an allergic reaction. Such signs are listed under “Serious side 

effects” in section 4. 

  



 

147 

 

Children and adolescents 

Cosentyx is not recommended for children younger than 6 years of age with plaque psoriasis because 

it has not been studied in this age group. 

 

Cosentyx is not recommended for children and adolescents (under 18 years of age) in other indications 

because it has not been studied in this age group. 

 

Other medicines and Cosentyx 
Tell your doctor or pharmacist: 

 if you are taking, have recently taken or might take any other medicines. 

 if you have recently had or are due to have a vaccination. You should not be given certain types 
of vaccines (live vaccines) while using Cosentyx. 

 

Pregnancy, breast-feeding and fertility 

 It is preferable to avoid the use of Cosentyx in pregnancy. The effects of this medicine in 
pregnant women are not known. If you are a woman of childbearing potential, you are advised 

to avoid becoming pregnant and must use adequate contraception while using Cosentyx and for 

at least 20 weeks after the last Cosentyx dose. 

Talk to your doctor if you are pregnant, think you may be pregnant or are planning to have a 

baby. 

 Talk to your doctor if you are breast-feeding or are planning to breast-feed. You and your doctor 
should decide if you will breast-feed or use Cosentyx. You should not do both. After using 

Cosentyx you should not breast-feed for at least 20 weeks after the last dose. 

 

Driving and using machines 

Cosentyx is unlikely to influence your ability to drive and use machines. 

 

 

3. How to use Cosentyx 

 

Always use this medicine exactly as your doctor has told you. Check with your doctor, nurse or 

pharmacist if you are not sure. 

 

Cosentyx is given via injection under your skin (known as a subcutaneous injection). You and your 

doctor should decide if you should inject Cosentyx yourself. 

 

It is important not to try to inject yourself until you have been trained by your doctor, nurse or 

pharmacist. A caregiver may also give you your Cosentyx injection after proper training. 

 

For detailed instructions on how to inject Cosentyx, see “Instructions for use of the Cosentyx 

UnoReady pen 300 mg” at the end of this leaflet. 

 

How much Cosentyx is given and for how long 

Your doctor will decide how much Cosentyx you need and for how long. 

 

Plaque psoriasis 

Adult 

 The recommended dose is 300 mg by subcutaneous injection. 

 Each 300 mg dose is given as one injection of 300 mg. 
 

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by 

monthly injections. At each timepoint you will receive a 300 mg dose given as one injection of 

300 mg. 

 



 

148 

Children aged 6 years and older 

 The recommended dose given by subcutaneous injection is based on body weight as follows: 
o Weight below 25 kg: 75 mg using the powder for solution for injection. 
o Weight 25 kg or above and below 50 kg: 75 mg using the powder for solution for 

injection. 

o Weight 50 kg or above: 150 mg using the powder for solution for injection, the pre-filled 
syringe or the pre-filled pen. 

Your doctor may increase the dose to 300 mg using the powder for solution for injection, 

the pre-filled syringe or the pre-filled pen. 

 Each 75 mg dose is given as one injection of 75 mg. Each 150 mg dose is given as one 
injection of 150 mg. Each 300 mg dose is given as one injection of 300 mg. 

 

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by 

monthly injections. 

 

Psoriatic arthritis 

For psoriatic arthritis patients who also have moderate to severe plaque psoriasis or patients who did 

not respond well to medicines called tumour necrosis factor (TNF) blockers: 

 The recommended dose is 300 mg by subcutaneous injection. 

 Each 300 mg dose is given as one injection of 300 mg. 
 

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by 

monthly injections. At each timepoint you will receive a 300 mg dose given as one injection of 

300 mg. 

 

For other psoriatic arthritis patients: 

 The recommended dose is 150 mg by subcutaneous injection. 
 

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by 

monthly injections. 

 

Based on your response, your doctor may increase your dose to 300 mg. 

 

Ankylosing spondylitis (Radiographic axial spondyloarthritis) 

 The recommended dose is 150 mg by subcutaneous injection. 
 

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by 

monthly injections. 

 

Based on your response, your doctor may increase your dose to 300 mg. Each 300 mg dose is given as 

one injection of 300 mg. 

 

Non-radiographic axial spondyloarthritis 

 The recommended dose is 150 mg by subcutaneous injection. 
 

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by 

monthly injections. 

 

Cosentyx is for long-term treatment. Your doctor will regularly monitor your condition to check that 

the treatment is having the desired effect. 

 

If you use more Cosentyx than you should 
If you have received more Cosentyx than you should or the dose has been administered sooner than 

according to your doctor’s prescription, inform your doctor. 

  



 

149 

 

If you forget to use Cosentyx 

If you have forgotten to inject a dose of Cosentyx, inject the next dose as soon as you remember. Then 

talk to your doctor to discuss when you should inject the next dose. 

 

If you stop using Cosentyx 

It is not dangerous to stop using Cosentyx. However, if you stop, your psoriasis, psoriatic arthritis or 

axial spondyloarthritis symptoms may come back. 

 

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 

 

 

4. Possible side effects 
 

Like all medicines, this medicine can cause side effects, although not everybody gets them. 

 

Serious side effects 

Stop using Cosentyx and tell your doctor or seek medical help immediately if you get any of the 

following side effects: 

 

Possible serious infection - the signs may include: 

 fever, flu-like symptoms, night sweats 

 feeling tired or short of breath, cough which will not go away 

 warm, red and painful skin, or a painful skin rash with blisters 

 burning sensation when passing urine. 
 

Serious allergic reaction - the signs may include: 

 difficulty breathing or swallowing 

 low blood pressure, which can cause dizziness or light-headedness 

 swelling of the face, lips, tongue or throat 

 severe itching of the skin, with a red rash or raised bumps. 
Your doctor will decide if and when you may restart the treatment. 

 

Other side effects 

Most of the following side effects are mild to moderate. If any of these side effects becomes severe, 

tell your doctor, pharmacist or nurse. 

 

Very common (may affect more than 1 in 10 people): 

 upper respiratory tract infections with symptoms such as sore throat and stuffy nose 
(nasopharyngitis, rhinitis) 

 

Common (may affect up to 1 in 10 people): 

 cold sores (oral herpes) 

 diarrhoea 

 runny nose (rhinorrhoea) 

 athlete’s foot (tinea pedis) 

 headache 

 nausea 

 fatigue 
  



 

150 

 

Uncommon (may affect up to 1 in 100 people): 

 oral thrush (oral candidiasis) 

 signs of low levels of white blood cells, such as fever, sore throat or mouth ulcers due to 
infections (neutropenia) 

 infection of the external ear (otitis externa) 

 discharge from the eye with itching, redness and swelling (conjunctivitis) 

 itchy rash (urticaria) 

 lower respiratory tract infections 

 abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel 
problems) 

 

Rare (may affect up to 1 in 1,000 people): 

 severe allergic reaction with shock (anaphylactic reaction) 

 redness and shedding of skin over a larger area of the body, which may be itchy or 
painful (exfoliative dermatitis) 

 

Not known (frequency cannot be estimated from the available data): 

 fungal infections of the skin and mucous membranes (including oesophageal candidiasis) 
 

Reporting of side effects 

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 

effects not listed in this leaflet. You can also report side effects directly via the national reporting 

system listed in Appendix V. By reporting side effects you can help provide more information on the 

safety of this medicine. 

 

 

5. How to store Cosentyx 

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine: 

 after the expiry date which is stated on the outer box or the label on the pen after “EXP”. 

 if the liquid contains easily visible particles, is cloudy or is distinctly brown. 
 

Store the pen sealed in its box to protect from light. Store in the refrigerator between 2°C and 8°C. Do 

not freeze. Do not shake. 

If necessary, Cosentyx can be left out of the refrigerator for a single period of up to 4 days at room 

temperature, not above 30°C. 

 

This medicine is for single use only. 

 

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines 

you no longer use. These measures will help protect the environment. 

 

  

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

151 

 

6. Contents of the pack and other information 

 

What Cosentyx contains 

- The active substance is secukinumab. Each pre-filled pen contains 300 mg secukinumab. 
- The other ingredients are trehalose dihydrate, histidine, histidine hydrochloride monohydrate, 

methionine, polysorbate 80 and water for injections. 

 

What Cosentyx looks like and contents of the pack 

Cosentyx solution for injection is a clear liquid. Its colour may vary from colourless to slightly yellow. 

Cosentyx 300 mg solution for injection in pre-filled pen is available in a pack containing 1 pre-filled 

pen and in multipacks containing 3 (3 packs of 1) pre-filled pens. 

Not all pack sizes may be marketed. 

 

Marketing Authorisation Holder 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

Manufacturer 

Novartis Pharma GmbH 

Roonstraße 25 

90429 Nuremberg 

Germany 

 

Sandoz GmbH 

Biochemiestrasse 10 

6336 Langkampfen 

Austria 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

 

België/Belgique/Belgien 

Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Lietuva 

SIA Novartis Baltics Lietuvos filialas 

Tel: +370 5 269 16 50 

 

България 

Novartis Bulgaria EOOD 

Тел: +359 2 489 98 28 

 

Luxembourg/Luxemburg 

Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Česká republika 

Novartis s.r.o. 

Tel: +420 225 775 111 

 

Magyarország 

Novartis Hungária Kft. 

Tel.: +36 1 457 65 00 

Danmark 

Novartis Healthcare A/S 

Tlf: +45 39 16 84 00 

 

Malta 

Novartis Pharma Services Inc. 

Tel: +356 2122 2872 

Deutschland 

Novartis Pharma GmbH 

Tel: +49 911 273 0 

 

Nederland 

Novartis Pharma B.V. 

Tel: +31 88 04 52 111 



 

152 

Eesti 

SIA Novartis Baltics Eesti filiaal 

Tel: +372 66 30 810 

 

Norge 

Novartis Norge AS 

Tlf: +47 23 05 20 00 

Ελλάδα 

Novartis (Hellas) A.E.B.E. 

Τηλ: +30 210 281 17 12 

 

Österreich 

Novartis Pharma GmbH 

Tel: +43 1 86 6570 

España 

Novartis Farmacéutica, S.A. 

Tel: +34 93 306 42 00 

 

Polska 

Novartis Poland Sp. z o.o. 

Tel.: +48 22 375 4888 

France 

Novartis Pharma S.A.S. 

Tél: +33 1 55 47 66 00 

 

Portugal 

Novartis Farma - Produtos Farmacêuticos, S.A. 

Tel: +351 21 000 8600 

Hrvatska 

Novartis Hrvatska d.o.o. 

Tel. +385 1 6274 220 

 

România 

Novartis Pharma Services Romania SRL 

Tel: +40 21 31299 01 

Ireland 

Novartis Ireland Limited 

Tel: +353 1 260 12 55 

 

Slovenija 

Novartis Pharma Services Inc. 

Tel: +386 1 300 75 50 

Ísland 

Vistor hf. 

Sími: +354 535 7000 

 

Slovenská republika 

Novartis Slovakia s.r.o. 

Tel: +421 2 5542 5439 

 

Italia 

Novartis Farma S.p.A. 

Tel: +39 02 96 54 1 

Suomi/Finland 

Novartis Finland Oy 

Puh/Tel: +358 (0)10 6133 200 

 

Κύπρος 

Novartis Pharma Services Inc. 

Τηλ: +357 22 690 690 

 

Sverige 

Novartis Sverige AB 

Tel: +46 8 732 32 00 

 

Latvija 

SIA Novartis Baltics 

Tel: +371 67 887 070 

 

United Kingdom 

Novartis Pharmaceuticals UK Ltd. 

Tel: +44 1276 698370 

 

 

 

This leaflet was last revised in 
 

 

Other sources of information 
Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu 

 

http://www.ema.europa.eu/


 

153 

Instructions for use of Cosentyx UnoReady pen 300 mg 

 

secukinumab 

 

 

 

Read ALL the way through these instructions before injecting. 

 

These instructions are to help you to inject correctly using the Cosentyx 

UnoReady pen. 

 

It is important not to try to inject yourself until you have been trained by 

your doctor, nurse or pharmacist. 

 
 

Your Cosentyx UnoReady pen 300 mg: 

 

 

 
 

Cosentyx UnoReady pen 300 mg is shown 

above with the cap removed. Do not remove 

the cap until you are ready to inject. 

Do not use the Cosentyx UnoReady pen if the seal on 

the outer carton is broken. 

 

Keep the Cosentyx UnoReady pen in the sealed outer 

carton until you are ready to use it to protect it from 

light. 

 

Store your Cosentyx UnoReady pen in a refrigerator 

between 2°C and 8°C and out of the reach of 

children. 

 

 Do not freeze the pen. 

 Do not shake the pen. 

 Do not use the pen if it has been dropped with the 
cap removed. 

 

The needle is covered by the needle guard and the 

needle will not be seen. Do not touch or push the 

needle guard because you could get a needle stick 

injury. 
 

What you need for your injection: 

 
Included in the carton: 

 

A new and unused Cosentyx 

UnoReady pen 300 mg. 

 

Not included in the carton: 

 

 Alcohol swab. 

 Cotton ball or gauze. 

 Sharps disposal 
container. 

 

 

 
 

 

  

Cap 

Needle guard 

Internal needle cover 

Viewing 

window 



 

154 

 

Before your injection: 

 

Take the Cosentyx UnoReady pen 300 mg out of the refrigerator 30 to 45 minutes before injecting to 

allow it to reach room temperature. 

 

 

 
 

 

1. Important safety checks before you inject: 
 

For the “Viewing window”: 

The liquid should be clear. Its colour may vary from 

colourless to slightly yellow. 
Do not use if the liquid contains easily visible particles, is 

cloudy or is distinctly brown. You may see a small air 

bubble, which is normal. 

 

For the “Expiry date”: 

Look at the expiry date (EXP) on your Cosentyx UnoReady 

pen. Do not use the pen if the expiry date has passed. 

 

Check that your pen contains the correct medicine and 

dose. 

 

Contact your pharmacist if the pen fails any of these 

checks. 

 

 

2a. Choose your injection site: 

 The recommended site is the front of the thighs. You 
may also use the lower abdomen, but not the area 

5 centimetres around the navel (belly button). 

 Choose a different site each time you give yourself an 
injection. 

 Do not inject into areas where the skin is tender, 
bruised, red, scaly or hard. Avoid areas with scars or 

stretch marks. 

 
 

2b. Caregivers and healthcare professionals only: 
 If a caregiver or healthcare professional is giving you 

your injection, they may also inject into your outer 

upper arm. 

 

3. Cleaning your injection site: 

 Wash your hands with soap and hot water. 

 Using a circular motion, clean the injection site with 
the alcohol swab. Leave it to dry before injecting. 

 Do not touch the cleaned area again before injecting. 

 

Viewing window Expiry date (EXP) 



 

155 

Your injection: 

 

 

4. Removing the cap: 

 Only remove the cap when you are ready to use the pen. 

 Pull the cap straight off in the direction of the arrow that is 
shown in the figure on the left. 

 Once removed, throw away the cap. Do not try to re-attach 
the cap. 

 Use the pen within 5 minutes of removing the cap. 

 

5. Holding your pen: 

 Hold the pen at 90 degrees to the cleaned injection site. 

 
 Correct Incorrect 

 

 

YOU MUST READ THIS BEFORE INJECTING. 
 

During the injection you will hear 2 clicks. 

 

The 1st click indicates that the injection has started. Several seconds 

later a 2nd click will indicate that the injection is almost finished. 

 

You must keep holding the pen firmly against your skin until you see a 

green indicator with a grey tip fill the window and stop moving. 

 

 

6. Starting your injection: 

 Press the pen firmly against the skin to start the injection. 

 The 1st click indicates the injection has started. 

 Keep holding the pen firmly against your skin. 
The green indicator with the grey tip shows the 

progress of the injection. 

1st CLICK 



 

156 

 

7. Completing your injection: 

 Listen for the 2nd click. This indicates the injection is 
almost complete. 

 Check the green indicator with the grey tip fills the 
window and has stopped moving. 

 The pen can now be removed. 

 

After your injection: 

 

 

8. Check the green indicator fills the window: 

 This means the medicine has been delivered. Contact 
your doctor if the green indicator is not visible. 

 There may be a small amount of blood at the injection 
site. You can press a cotton ball or gauze over the 

injection site and hold it for 10 seconds. Do not rub the 

injection site. You may cover the injection site with a 

small adhesive bandage, if needed. 

 

9. Disposing of your Cosentyx UnoReady pen 300 mg: 

 Dispose of the used pen in a sharps disposal container 
(i.e. a puncture-resistant closable container, or similar). 

 Never try to reuse your pen. 

 

 

2nd CLICK 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET