Stelara

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ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS



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1. NAME OF THE MEDICINAL PRODUCT

STELARA 130 mg concentrate for solution for infusion

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each vial contains 130 mg ustekinumab in 26 mL (5 mg/mL).

Ustekinumab is a fully human IgG1κ monoclonal antibody to interleukin (IL)-12/23 produced in a 
murine myeloma cell line using recombinant DNA technology.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Concentrate for solution for infusion.

The solution is clear, colourless to light yellow.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Crohn’s Disease
STELARA is indicated for the treatment of adult patients with moderately to severely active Crohn’s 
disease who have had an inadequate response with, lost response to, or were intolerant to either 
conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.

Ulcerative colitis
STELARA is indicated for the treatment of adult patients with moderately to severely active ulcerative 
colitis who have had an inadequate response with, lost response to, or were intolerant to either 
conventional therapy or a biologic or have medical contraindications to such therapies (see 
section 5.1).

4.2 Posology and method of administration

STELARA concentrate for solution for infusion is intended for use under the guidance and supervision 
of physicians experienced in the diagnosis and treatment of Crohn's disease or ulcerative colitis. 
STELARA concentrate for solution for infusion should only be used for the intravenous induction 
dose.

Posology

Crohn’s Disease and Ulcerative Colitis
STELARA treatment is to be initiated with a single intravenous dose based on body weight. The 
infusion solution is to be composed of the number of vials of STELARA 130 mg as specified in 
Table 1 (see section 6.6 for preparation).



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Table 1 Initial intravenous dosing of STELARA
Body weight of patient at the time of 
dosing

Recommended dosea Number of 130 mg 
STELARA Vials

≤ 55 kg 260 mg 2
> 55 kg to ≤ 85 kg 390 mg 3
> 85 kg 520 mg 4
a Approximately 6 mg/kg

The first subcutaneous dose should be given at week 8 following the intravenous dose. For the 
posology of the subsequent subcutaneous dosing regimen, see section 4.2 of the STELARA solution 
for injection (vial) and solution for injection in pre-filled syringe SmPC.

Elderly (≥ 65 years)
No dose adjustment is needed for elderly patients (see section 4.4).

Renal and hepatic impairment
STELARA has not been studied in these patient populations. No dose recommendations can be made.

Paediatric population
The safety and efficacy of STELARA for the treatment of Crohn’s disease or ulcerative colitis in 
children less than 18 years have not yet been established. No data are available.

Method of administration
STELARA 130 mg is for intravenous use only. It should be administered over at least one hour.
For instructions on dilution of the medicinal product before administration, see section 6.6.

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 tradename and the batch 
number of the administered product should be clearly recorded.

Infections
Ustekinumab may have the potential to increase the risk of infections and reactivate latent infections. 
In clinical studies, serious bacterial, fungal, and viral infections have been observed in patients 
receiving STELARA (see section 4.8).

Caution should be exercised when considering the use of STELARA in patients with a chronic 
infection or a history of recurrent infection (see section 4.3).

Prior to initiating treatment with STELARA, patients should be evaluated for tuberculosis infection. 
STELARA must not be given to patients with active tuberculosis (see section 4.3). Treatment of latent 
tuberculosis infection should be initiated prior to administering STELARA. Anti-tuberculosis therapy 
should also be considered prior to initiation of STELARA in patients with a history of latent or active 
tuberculosis in whom an adequate course of treatment cannot be confirmed. Patients receiving 
STELARA should be monitored closely for signs and symptoms of active tuberculosis during and 
after treatment.

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 STELARA 
should not be administered until the infection resolves.



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Malignancies
Immunosuppressants like ustekinumab have the potential to increase the risk of malignancy. Some 
patients who received STELARA in clinical studies developed cutaneous and non-cutaneous 
malignancies (see section 4.8).

No studies have been conducted that include patients with a history of malignancy or that continue 
treatment in patients who develop malignancy while receiving STELARA. Thus, caution should be 
exercised when considering the use of STELARA in these patients.

All patients, in particular those greater than 60 years of age, patients with a medical history of 
prolonged immunosuppressant therapy or those with a history of PUVA treatment, should be 
monitored for the appearance of non-melanoma skin cancer (see section 4.8).

Systemic and respiratory hypersensitivity reactions
Systemic
Serious hypersensitivity reactions have been reported in the postmarketing setting, in some cases 
several days after treatment. Anaphylaxis and angioedema have occurred. If an anaphylactic or other 
serious hypersensitivity reaction occurs, appropriate therapy should be instituted and administration of 
STELARA should be discontinued (see section 4.8).

Respiratory
Cases of allergic alveolitis, eosinophilic pneumonia, and non-infectious organising pneumonia have 
been reported during post-approval use of ustekinumab. Clinical presentations included cough, 
dyspnoea, and interstitial infiltrates following one to three doses. Serious outcomes have included 
respiratory failure and prolonged hospitalisation. Improvement has been reported after discontinuation 
of ustekinumab and also, in some cases, administration of corticosteroids. If infection has been 
excluded and diagnosis is confirmed, discontinue ustekinumab and institute appropriate treatment (see 
section 4.8).

Vaccinations
It is recommended that live viral or live bacterial vaccines (such as Bacillus of Calmette and Guérin 
(BCG)) should not be given concurrently with STELARA. Specific studies have not been conducted 
in patients who had recently received live viral or live bacterial vaccines. No data are available on the 
secondary transmission of infection by live vaccines in patients receiving STELARA. Before live viral 
or live bacterial vaccination, treatment with STELARA should be withheld for at least 15 weeks after 
the last dose and can be resumed at least 2 weeks after vaccination. Prescribers should consult the 
Summary of Product Characteristics for the specific vaccine for additional information and guidance 
on concomitant use of immunosuppressive agents post-vaccination.

Patients receiving STELARA may receive concurrent inactivated or non-live vaccinations.

Long term treatment with STELARA does not suppress the humoral immune response to 
pneumococcal polysaccharide or tetanus vaccines (see section 5.1).

Concomitant immunosuppressive therapy
In psoriasis studies, the safety and efficacy of STELARA in combination with immunosuppressants, 
including biologics, or phototherapy have not been evaluated. In psoriatic arthritis studies, 
concomitant MTX use did not appear to influence the safety or efficacy of STELARA. In Crohn’s 
disease and ulcerative colitis studies, concomitant use of immunosuppressants or corticosteroids did 
not appear to influence the safety or efficacy of STELARA. Caution should be exercised when 
considering concomitant use of other immunosuppressants and STELARA or when transitioning from 
other immunosuppressive biologics (see section 4.5).

Immunotherapy
STELARA has not been evaluated in patients who have undergone allergy immunotherapy. It is not 
known whether STELARA may affect allergy immunotherapy.



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Serious skin conditions
In patients with psoriasis, exfoliative dermatitis has been reported following ustekinumab treatment 
(see section 4.8). Patients with plaque psoriasis may develop erythrodermic psoriasis, with symptoms 
that may be clinically indistinguishable from exfoliative dermatitis, as part of the natural course of 
their disease. As part of the monitoring of the patient’s psoriasis, physicians should be alert for 
symptoms of erythrodermic psoriasis or exfoliative dermatitis. If these symptoms occur, appropriate 
therapy should be instituted. STELARA should be discontinued if a drug reaction is suspected.

Special populations
Elderly (≥ 65 years)
No overall differences in efficacy or safety in patients age 65 and older who received STELARA were 
observed compared to younger patients in clinical studies in approved indications, however the 
number of patients aged 65 and older is not sufficient to determine whether they respond differently 
from younger patients. Because there is a higher incidence of infections in the elderly population in 
general, caution should be used in treating the elderly.

Sodium content
STELARA contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’. 
STELARA is however, diluted in sodium chloride 9 mg/mL (0.9%) solution for infusion. This should 
be taken into consideration for patients on a controlled sodium diet (see section 6.6).

4.5 Interaction with other medicinal products and other forms of interaction

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

No interaction studies have been performed in humans. In the population pharmacokinetic analyses of 
the phase 3 studies, the effect of the most frequently used concomitant medicinal products in patients 
with psoriasis (including paracetamol, ibuprofen, acetylsalicylic acid, metformin, atorvastatin, 
levothyroxine) on pharmacokinetics of ustekinumab was explored. There were no indications of an 
interaction with these concomitantly administered medicinal products. The basis for this analysis was 
that at least 100 patients (> 5% of the studied population) were treated concomitantly with these 
medicinal products for at least 90% of the study period. The pharmacokinetics of ustekinumab was not 
impacted by concomitant use of MTX, NSAIDs, 6-mercaptopurine, azathioprine and oral 
corticosteroids in patients with psoriatic arthritis, Crohn’s disease or ulcerative colitis, or prior 
exposure to anti-TNFα agents, in patients with psoriatic arthritis or Crohn’s disease or by prior 
exposure to biologics (i.e. anti-TNFα agents and/or vedolizumab) in patients with ulcerative colitis.

The results of an in vitro study do not suggest the need for dose adjustments in patients who are 
receiving concomitant CYP450 substrates (see section 5.2).

In psoriasis studies, the safety and efficacy of STELARA in combination with immunosuppressants, 
including biologics, or phototherapy have not been evaluated. In psoriatic arthritis studies, 
concomitant MTX use did not appear to influence the safety or efficacy of STELARA. In Crohn’s 
disease and ulcerative colitis studies, concomitant use of immunosuppressants or corticosteroids did 
not appear to influence the safety or efficacy of STELARA. (see section 4.4).

4.6 Fertility, pregnancy and lactation

Women of childbearing potential
Women of childbearing potential should use effective methods of contraception during treatment and 
for at least 15 weeks after treatment.

Pregnancy
There are no adequate data from the use of ustekinumab in pregnant women. Animal studies do not 
indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, 
parturition or postnatal development (see section 5.3). As a precautionary measure, it is preferable to 



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avoid the use of STELARA in pregnancy.

Breast-feeding
It is unknown whether ustekinumab is excreted in human breast milk. Animal studies have shown 
excretion of ustekinumab at low levels in breast milk. It is not known if ustekinumab is absorbed 
systemically after ingestion. Because of the potential for adverse reactions in nursing infants from 
ustekinumab, a decision on whether to discontinue breast-feeding during treatment and up to 15 weeks 
after treatment or to discontinue therapy with STELARA must be made taking into account the benefit 
of breast-feeding to the child and the benefit of STELARA therapy to the woman.

Fertility
The effect of ustekinumab on human fertility has not been evaluated (see section 5.3).

4.7 Effects on ability to drive and use machines

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

4.8 Undesirable effects

Summary of the safety profile
The most common adverse reactions (> 5%) in controlled periods of the adult psoriasis, psoriatic 
arthritis, Crohn’s disease and ulcerative colitis clinical studies with ustekinumab were nasopharyngitis
and headache. Most were considered to be mild and did not necessitate discontinuation of study 
treatment. The most serious adverse reaction that has been reported for STELARA is serious 
hypersensitivity reactions including anaphylaxis (see section 4.4). The overall safety profile was 
similar for patients with psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.

Tabulated list of adverse reactions
The safety data described below reflect exposure in adults to ustekinumab in 14 phase 2 and 
phase 3 studies in 6,709 patients (4,135 with psoriasis and/or psoriatic arthritis, 1,749 with Crohn’s 
disease and 825 patients with ulcerative colitis). This includes exposure to STELARA in the 
controlled and non-controlled periods of the clinical studies for at least 6 months or 1 year (4,577 and
3,253 patients respectively with psoriasis, psoriatic arthritis, Crohn’s disease or ulcerative colitis) and 
exposure for at least 4 or 5 years (1,482 and 838 patients with psoriasis respectively).

Table 2 provides a list of adverse reactions from adult psoriasis, psoriatic arthritis, Crohn’s disease and 
ulcerative colitis clinical studies as well as adverse reactions reported from post-marketing experience. 
The adverse reactions are classified by System Organ Class and frequency, using 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), not known (cannot be estimated from the 
available data). Within each frequency grouping, adverse reactions are presented in order of 
decreasing seriousness.

Table 2 List of adverse reactions
System Organ Class Frequency: Adverse reaction

Infections and infestations Common: Upper respiratory tract infection, nasopharyngitis, 
sinusitis
Uncommon: Cellulitis, dental infections, herpes zoster, lower 
respiratory tract infection, viral upper respiratory tract infection, 
vulvovaginal mycotic infection

Immune system disorders Uncommon: Hypersensitivity reactions (including rash, urticaria)
Rare: Serious hypersensitivity reactions (including anaphylaxis, 
angioedema)



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Psychiatric disorders Uncommon: Depression

Nervous system disorders Common: Dizziness, headache
Uncommon: Facial palsy

Respiratory, thoracic and 
mediastinal disorders

Common: Oropharyngeal pain
Uncommon: Nasal congestion
Rare: Allergic alveolitis, eosinophilic pneumonia
Very rare: Organising pneumonia*

Gastrointestinal disorders Common: Diarrhoea, nausea, vomiting

Skin and subcutaneous tissue 
disorders

Common: Pruritus
Uncommon: Pustular psoriasis, skin exfoliation, acne
Rare: Exfoliative dermatitis, hypersensitivity vasculitis

Musculoskeletal and connective 
tissue disorders

Common: Back pain, myalgia, arthralgia

General disorders and 
administration site conditions

Common: Fatigue, injection site erythema, injection site pain
Uncommon: Injection site reactions (including haemorrhage, 
haematoma, induration, swelling and pruritus), asthenia

* See section 4.4, Systemic and respiratory hypersensitivity reactions.

Description of selected adverse reactions
Infections
In the placebo-controlled studies of patients with psoriasis, psoriatic arthritis, Crohn’s disease and 
ulcerative colitis, the rates of infection or serious infection were similar between ustekinumab-treated 
patients and those treated with placebo. In the placebo-controlled period of these clinical studies, the 
rate of infection was 1.36 per patient-year of follow-up in ustekinumab-treated patients, and 1.34 in 
placebo-treated patients. Serious infections occurred at the rate of 0.03 per patient-year of follow-up in 
ustekinumab-treated patients (30 serious infections in 930 patient-years of follow-up) and 0.03 in 
placebo-treated patients (15 serious infections in 434 patient-years of follow-up) (see section 4.4).

In the controlled and non-controlled periods of psoriasis, psoriatic arthritis, Crohn’s disease and 
ulcerative colitis clinical studies, representing 11,581 patient-years of exposure in 6,709 patients, the 
median follow up was 1.0 years; 1.1 years for psoriatic disease studies, 0.6 year for Crohn’s disease
studies and 1.0 years for ulcerative colitis studies. The rate of infection was 0.91 per patient-year of 
follow-up in ustekinumab-treated patients, and the rate of serious infections was 0.02 per patient-year 
of follow-up in ustekinumab-treated patients (199 serious infections in 11,581 patient-years of 
follow-up) and serious infections reported included pneumonia, anal abscess, cellulitis, diverticulitis, 
gastroenteritis and viral infections.

In clinical studies, patients with latent tuberculosis who were concurrently treated with isoniazid did 
not develop tuberculosis.

Malignancies
In the placebo-controlled period of the psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative 
colitis clinical studies, the incidence of malignancies excluding non-melanoma skin cancer was 0.11
per 100 patient-years of follow-up for ustekinumab-treated patients (1 patient in 929 patient-years of 
follow-up) compared with 0.23 for placebo-treated patients (1 patient in 434 patient-years of 
follow-up). The incidence of non-melanoma skin cancer was 0.43 per 100 patient-years of follow-up 
for ustekinumab-treated patients (4 patients in 929 patient-years of follow-up) compared to 0.46 for 
placebo-treated patients (2 patients in 433 patient-years of follow-up).

In the controlled and non-controlled periods of psoriasis, psoriatic arthritis, Crohn’s disease and 
ulcerative colitis clinical studies, representing 11,561 patient-years of exposure in 6,709 patients, the 



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median follow-up was 1.0 years; 1.1 years for psoriatic disease studies, 0.6 year for Crohn’s disease
studies and 1.0 years for ulcerative colitis studies. Malignancies excluding non-melanoma skin cancers 
were reported in 62 patients in 11,561 patient-years of follow-up (incidence of 0.54 per 100 patient-
years of follow-up for ustekinumab-treated patients). The incidence of malignancies reported in 
ustekinumab-treated patients was comparable to the incidence expected in the general population 
(standardised incidence ratio = 0.93 [95% confidence interval: 0.71, 1.20], adjusted for age, gender 
and race). The most frequently observed malignancies, other than non-melanoma skin cancer, were 
prostate, colorectal, melanoma and breast cancers. The incidence of non-melanoma skin cancer was 
0.49 per 100 patient-years of follow-up for ustekinumab-treated patients (56 patients in 
11,545 patient-years of follow-up). The ratio of patients with basal versus squamous cell skin cancers 
(3:1) is comparable with the ratio expected in the general population (see section 4.4).

Hypersensitivity and infusion reactions
In Crohn’s disease and ulcerative colitis intravenous induction studies, no events of anaphylaxis or 
other serious infusion reactions were reported following the single intravenous dose. In these studies,
2.2% of 785 placebo treated patients and 1.9% of 790 patients treated with the recommended dose of 
ustekinumab reported adverse events occurring during or within an hour of the infusion.

Paediatric population
Paediatric patients 6 years and older with plaque psoriasis
The safety of ustekinumab has been studied in two phase 3 studies of paediatric patients with moderate 
to severe plaque psoriasis. The first study was in 110 patients from 12 to 17 years of age treated for up 
to 60 weeks and the second study was in 44 patients from 6 to 11 years of age treated for up to 
56 weeks. In general, the adverse events reported in these two studies with safety data up to 1 year
were similar to those seen in previous studies in adults with plaque psoriasis.

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

Single doses up to 6 mg/kg have been administered intravenously in clinical studies without 
dose-limiting toxicity. In case 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.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC05.

Mechanism of action
Ustekinumab is a fully human IgG1κ monoclonal antibody that binds with specificity to the shared 
p40 protein subunit of human cytokines interleukin (IL)-12 and IL-23. Ustekinumab inhibits the 
bioactivity of human IL-12 and IL-23 by preventing p40 from binding to the IL-12R1 receptor 
protein expressed on the surface of immune cells. Ustekinumab cannot bind to IL-12 or IL-23 that is 
already bound to IL-12R1 cell surface receptors. Thus, ustekinumab is not likely to contribute to 
complement- or antibody-mediated cytotoxicity of cells with IL-12 and/or IL-23 receptors. IL-12 and 
IL-23 are heterodimeric cytokines secreted by activated antigen presenting cells, such as macrophages 
and dendritic cells, and both cytokines participate in immune functions; IL-12 stimulates natural killer 
(NK) cells and drives the differentiation of CD4+ T cells toward the T helper 1 (Th1) phenotype, 
IL-23 induces the T helper 17 (Th17) pathway. However, abnormal regulation of IL 12 and IL 23 has 

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000134.jsp&mid=WC0b01ac0580022c59


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been associated with immune mediated diseases, such as psoriasis, psoriatic arthritis, Crohn’s disease
and ulcerative colitis.

By binding the shared p40 subunit of IL-12 and IL-23, ustekinumab may exert its clinical effects in 
psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis through interruption of the Th1 and 
Th17 cytokine pathways, which are central to the pathology of these diseases.

In patients with Crohn’s disease and ulcerative colitis, treatment with ustekinumab resulted in a 
decrease in inflammatory markers including C-Reactive Protein (CRP) and fecal calprotectin during 
the induction phase, which were then maintained throughout the maintenance phase.

Immunisation
During the long term extension of Psoriasis Study 2 (PHOENIX 2), adult patients treated with 
STELARA for at least 3.5 years mounted similar antibody responses to both pneumococcal 
polysaccharide and tetanus vaccines as a non-systemically treated psoriasis control group. Similar 
proportions of adult patients developed protective levels of anti-pneumococcal and anti-tetanus 
antibodies and antibody titers were similar among STELARA-treated and control patients.

Clinical efficacy

Crohn’s Disease
The safety and efficacy of ustekinumab was assessed in three randomized, double-blind, 
placebo-controlled, multicenter studies in adult patients with moderately to severely active Crohn’s 
disease (Crohn’s Disease Activity Index [CDAI] score of ≥ 220 and ≤ 450). The clinical development 
program consisted of two 8-week intravenous induction studies (UNITI-1 and UNITI-2) followed by a 
44 week subcutaneous randomized withdrawal maintenance study (IM-UNITI) representing 52 weeks 
of therapy.

The induction studies included 1409 (UNITI-1, n = 769; UNITI-2 n = 640) patients. The primary 
endpoint for both induction studies was the proportion of subjects in clinical response (defined as a 
reduction in CDAI score of ≥ 100 points) at week 6. Efficacy data were collected and analyzed 
through week 8 for both studies. Concomitant doses of oral corticosteroids, immunomodulators, 
aminosalicylates and antibiotics were permitted and 75% of patients continued to receive at least one 
of these medications. In both studies, patients were randomised to receive a single intravenous 
administration of either the recommended tiered dose of approximately 6 mg/kg (see Table 1, 
section 4.2), a fixed dose of 130 mg ustekinumab, or placebo at week 0.

Patients in UNITI-1 had failed or were intolerant to prior anti-TNFα therapy. Approximately 48% of 
the patients had failed 1 prior anti-TNF therapy and 52% had failed 2 or 3 prior anti-TNFα therapies.
In this study, 29.1% of the patients had an inadequate initial response (primary non-responders), 
69.4% responded but lost response (secondary non-responders), and 36.4% were intolerant to 
anti-TNFα therapies.

Patients in UNITI-2 had failed at least one conventional therapy, including corticosteroids or 
immunomodulators, and were either anti-TNF-α naïve (68.6%) or had previously received but not 
failed anti-TNFα therapy (31.4%).

In both UNITI-1 and UNITI-2, a significantly greater proportion of patients were in clinical response 
and remission in the ustekinumab treated group compared to placebo (Table 3). Clinical response and 
remission were significant as early as week 3 in ustekinumab treated patients and continued to 
improve through week 8. In these induction studies, efficacy was higher and better sustained in the 
tiered dose group compared to the 130 mg dose group, and tiered dosing is therefore the recommended 
intravenous induction dose.



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Table 3: Induction of Clinical Response and Remission in UNITI-1 and UNITI 2
UNITI-1* UNITI-2**

Placebo
N = 247

Recommended 
dose of 

ustekinumab
N = 249

Placebo
N = 209

Recommended 
dose of 

ustekinumab
N = 209

Clinical Remission, week 8 18 (7.3%) 52 (20.9%)a 41 (19.6%) 84 (40.2%)a

Clinical Response (100 point), week 6 53 (21.5%) 84 (33.7%)b 60 (28.7%) 116 (55.5%)a

Clinical Response (100 point), week 8 50 (20.2%) 94 (37.8%)a 67 (32.1%) 121 (57.9%)a

70 Point Response, week 3 67 (27.1%) 101 (40.6%)b 66 (31.6%) 106 (50.7%)a

70 Point Response, week 6 75 (30.4%) 109 (43.8%)b 81 (38.8%) 135 (64.6%)a

Clinical remission is defined as CDAI score < 150; Clinical response is defined as reduction in CDAI score by at least 
100 points or being in clinical remission
70 point response is defined as reduction in CDAI score by at least 70 points
* Anti-TNFα failures
** Conventional therapy failures
a p < 0.001
b p < 0.01

The maintenance study (IM-UNITI), evaluated 388 patients who achieved 100 point clinical response 
at week 8 of induction with ustekinumab in studies UNITI-1 and UNITI-2. Patients were randomized 
to receive a subcutaneous maintenance regimen of either 90 mg ustekinumab every 8 weeks, 90 mg 
ustekinumab every 12 weeks or placebo for 44 weeks (for recommended maintenance posology, see 
section 4.2 of the STELARA Solution for injection (vial) and Solution for injection in pre-filled 
syringe SmPC).

Significantly higher proportions of patients maintained clinical remission and response in the 
ustekinumab treated groups compared to the placebo group at week 44 (see Table 4).

Table 4: Maintenance of Clinical Response and Remission in IM-UNITI (week 44; 52 weeks from 
initiation of the induction dose)

Placebo*

N = 131†

90 mg 
ustekinumab 
every 8 weeks

N = 128†

90 mg 
ustekinumab 

every 
12 weeks
N = 129†

Clinical Remission 36% 53%a 49%b

Clinical Response 44% 59%b 58%b

Corticosteroid-Free Clinical Remission 30% 47%a 43%c

Clinical Remission in patients:
in remission at the start of maintenance 
therapy

46% (36/79) 67% (52/78)a 56% (44/78)

who entered from study CRD3002‡ 44% (31/70) 63% (45/72)c 57% (41/72)
who are Anti-TNFα naïve 49% (25/51) 65% (34/52)c 57% (30/53)
who entered from study CRD3001§ 26% (16/61) 41% (23/56) 39% (22/57)

Clinical remission is defined as CDAI score < 150; Clinical response is defined as reduction in CDAI of at least 100 points 
or being in clinical remission
* The placebo group consisted of patients who were in response to ustekinumab and were randomized to receive 

placebo at the start of maintenance therapy.
† Patients who were in 100 point clinical response to ustekinumab at start of maintenance therapy
‡ Patients who failed conventional therapy but not anti-TNFα therapy
§ Patients who are anti-TNFα refractory/intolerant
a p < 0.01
b p < 0.05
c nominally significant (p < 0.05)

In IM-UNITI, 29 of 129 patients did not maintain response to ustekinumab when treated every 
12 weeks and were allowed to dose adjust to receive ustekinumab every 8 weeks. Loss of response 



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was defined as a CDAI score ≥ 220 points and a ≥ 100 point increase from the CDAI score at baseline.
In these patients, clinical remission was achieved in 41.4% of patients 16 weeks after dose adjustment.

Patients who were not in clinical response to ustekinumab induction at week 8 of the UNITI-1 and 
UNITI-2 induction studies (476 patients) entered into the non-randomized portion of the maintenance 
study (IM-UNITI) and received a 90 mg subcutaneous injection of ustekinumab at that time. 
Eight weeks later, 50.5% of the patients achieved clinical response and continued to receive 
maintenance dosing every 8 weeks; among these patients with continued maintenance dosing, a 
majority maintained response (68.1%) and achieved remission (50.2%) at week 44, at proportions that
were similar to the patients who initially responded to ustekinumab induction.

Of 131 patients who responded to ustekinumab induction, and were randomized to the placebo group 
at the start of the maintenance study, 51 subsequently lost response and received 90 mg ustekinumab 
subcutaneously every 8 weeks. The majority of patients who lost response and resumed ustekinumab 
did so within 24 weeks of the induction infusion. Of these 51 patients, 70.6% achieved clinical 
response and 39.2% percent achieved clinical remission 16 weeks after receiving the first 
subcutaneous dose of ustekinumab.

In IM-UNITI, patients who completed the study through week 44 were eligible to continue treatment 
in a study extension. Among patients who entered the study extension, clinical remission and response 
were generally maintained through week 92 for both patients who failed TNF-therapies and those who 
failed conventional therapies.

No new safety concerns were identified in this study extension with up to 2 years of treatment in 
patients with Crohn’s Disease.

Endoscopy
Endoscopic appearance of the mucosa was evaluated in 252 patients with eligible baseline endoscopic 
disease activity in a substudy. The primary endpoint was change from baseline in Simplified 
Endoscopic Disease Severity Score for Crohn’s Disease (SES-CD), a composite score across 5 ileo-
colonic segments of presence/size of ulcers, proportion of mucosal surface covered by ulcers, 
proportion of mucosal surface affected by any other lesions and presence/type of narrowing/strictures.
At week 8, after a single intravenous induction dose, the change in SES-CD score was greater in the 
ustekinumab group (n = 155, mean change = -2.8) than in the placebo group (n = 97, mean 
change = -0.7, p = 0.012).

Fistula Response
In a subgroup of patients with draining fistulas at baseline (8.8%; n = 26), 12/15 (80%) of 
ustekinumab-treated patients achieved a fistula response over 44 weeks (defined as ≥ 50% reduction 
from baseline of the induction study in the number of draining fistulas) compared to 5/11 (45.5%) 
exposed to placebo.

Health-related quality of life
Health-related quality of life was assessed by Inflammatory Bowel Disease Questionnaire (IBDQ) and 
SF-36 questionnaires. At week 8, patients receiving ustekinumab showed statistically significantly 
greater and clinically meaningful improvements on IBDQ total score and SF-36 Mental Component 
Summary Score in both UNITI-1 and UNITI-2, and SF-36 Physical Component Summary Score in 
UNITI-2, when compared to placebo. These improvements were generally better maintained in 
ustekinumab-treated patients in the IM-UNITI study through week 44 when compared to placebo.
Improvement in health-related quality of life was generally maintained during the extension through 
week 92.

Ulcerative colitis
The safety and efficacy of ustekinumab was assessed in two randomized, double-blind, placebo-
controlled, multicenter studies in adult patients with moderately to severely active ulcerative colitis 
(Mayo score 6 to 12; Endoscopy subscore ≥ 2). The clinical development program consisted of one 
intravenous induction study (referred to as UNIFI-I) with treatment of up to 16 weeks followed by a 



12

44 week subcutaneous randomized withdrawal maintenance study (referred to as UNIFI-M)
representing at least 52 weeks of therapy.

Efficacy results presented for UNIFI-I and UNIFI-M were based on central review of endoscopies.

UNIFI-I included 961 patients. The primary endpoint for the induction study was the proportion of 
subjects in clinical remission at week 8. Patients were randomised to receive a single intravenous 
administration of either the recommended tiered dose of approximately 6 mg/kg (see Table 1, 
section 4.2), a fixed dose of 130 mg ustekinumab, or placebo at week 0.

Concomitant doses of oral corticosteroids, immunomodulators, and aminosalicylates were permitted 
and 90% of patients continued to receive at least one of these medications. Enrolled patients had to 
have failed conventional therapy (corticosteroids or immunomodulators) or at least one biologic (a 
TNFα antagonist and/or vedolizumab). 49% of patients had failed conventional therapy, but not a 
biologic (of which 94% where biological-naïve). 51% of patients had failed or were intolerant to a 
biologic. Approximately 50% of the patients had failed at least 1 prior anti-TNF therapy (of which 
48% were primary non-responders) and 17% had failed at least 1 anti-TNFα therapy and vedolizumab.

In UNIFI-I a significantly greater proportion of patients were in clinical remission in the ustekinumab 
treated group compared to placebo at week 8 (Table 5). As early as Week 2, the earliest scheduled 
study visit, and at each visit thereafter, a higher proportion of ustekinumab patients had no rectal 
bleeding or achieved normal stool frequency as compared with placebo patients. Significant 
differences in partial Mayo score and symptomatic remission were observed between ustekinumab and 
placebo as early as Week 2.

Efficacy was higher in the tiered dose group (6 mg/kg) compared to the 130 mg dose group in select 
endpoints, and tiered dosing is therefore the recommended intravenous induction dose.

Table 5: Summary of Key Efficacy Outcomes in UNIFI-I (Week 8)
Placebo
N = 319

Recommended dose 
of ustekinumab£

N = 322
Clinical Remission* 5% 16%a

In patients who failed conventional therapy, but not a 
biologic

9% (15/158) 19% (29/156)c

In patients who failed biological therapy¥ 1% (2/161) 13% (21/166)b

In patients who failed both a TNF and vedolizumab 0% (0/47) 10% (6/58)c

Clinical Response§ 31% 62%a

In patients who failed conventional therapy, but not a 
biologic

35% (56/158) 67% (104/156)b

In patients who failed biological therapy¥ 27% (44/161) 57% (95/166)b

In patients who failed both a TNF and vedolizumab 28% (13/47) 52% (30/58)c

Mucosal Healing† 14% 27%a

In patients who failed conventional therapy, but not a 
biologic

21% (33/158) 33% (52/156)c

In patients who failed biological therapy 7% (11/161) 21% (35/166)b

Symptomatic Remission‡ 23% 45%b

Combined Symptomatic Remission and Mucosal 
Healing⸸

8% 21%b



13

£ Infusion dose of ustekinumab using the weight-based dosage regimen specified in Table 1.
* Clinical remission is defined as Mayo score ≤2 points, with no individual subscore > 1.
§ Clinical response is defined as a decrease from baseline in the Mayo score by ≥30% and ≥3 points, with either a decrease 

from baseline in the rectal bleeding subscore ≥1 or a rectal bleeding subscore of 0 or 1.
¥ A TNFα antagonist and/or vedolizumab.
† Mucosal healing is defined as a Mayo endoscopic subscore of 0 or 1.
‡ Symptomatic remission is defined as a Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.
⸸ Combined symptomatic remission and mucosal healing is defined as a stool frequency subscore of 0 or 1, a rectal 

bleeding subscore of 0, and an endoscopy subscore of 0 or 1.
a p < 0.001
b Nominally significant (p < 0.001)
c Nominally significant (p < 0.05)

UNIFI-M, evaluated 523 patients who achieved clinical response with single IV administration of 
ustekinumab in UNIFI-I. Patients were randomized to receive a subcutaneous maintenance regimen of 
either 90 mg ustekinumab every 8 weeks, 90 mg ustekinumab every 12 weeks or placebo for 44 weeks 
(for recommended maintenance posology, see section 4.2 of the STELARA Solution for injection 
(vial) and Solution for injection in pre-filled syringe SmPC).

Significantly greater proportions of patients were in clinical remission in both ustekinumab treated 
groups compared to the placebo group at week 44 (see Table 6).

Table 6: Summary of Key Efficacy Measures in UNIFI-M (week 44; 52 weeks from initiation of the 
induction dose)

Placebo*
N = 175

90 mg 
ustekinumab

every 8 Weeks
N = 176

90 mg 
ustekinumab 

every 
12 Weeks
N = 172

Clinical Remission** 24% 44% a 38% b

In patients who failed conventional 
therapy, but not a biologic

31% (27/87) 48% (41/85)d 49% (50/102) d

In patients who failed biological therapy¥ 17% (15/88) 40% (36/91) c 23% (16/70) d

In patients who failed both a TNF and 
vedolizumab

15% (4/27) 33% (7/21)e 23% (5/22)e

Maintenance of Clinical Response through 
week 44§

45% 71% a 68% a

In patients who failed conventional 
therapy, but not a biologic

51% (44/87) 78% (66/85) c 77% (78/102) c

In patients who failed biological therapy¥ 39% (34/88) 65% (59/91) c 56% (39/70) d

In patients who failed both a TNF and 
vedolizumab

41% (11/27) 67% (14/21)e 50% (11/22)e

Mucosal Healing† 29% 51% a 44% b

Maintenance of Clinical Remission through 
week 44£

38% (17/45) 58% (22/38) 65% (26/40) c

Corticosteroid Free Clinical Remission€ 23% 42% a 38% b

Durable Remissionǁ 35% 57% c 48% d

Symptomatic Remission‡ 45% 68% c 62% d

Combined Symptomatic Remission and 
Mucosal Healing⸸

28% 48% c 41% d



14

* Following response to IV ustekinumab.
** Clinical remission is defined as Mayo score ≤2 points, with no individual subscore > 1.
§ Clinical response is defined as a decrease from baseline in the Mayo score by ≥30% and ≥3 points, with either a

decrease from baseline in the rectal bleeding subscore ≥1 or a rectal bleeding subscore of 0 or 1.
¥ A TNFα antagonist and/or vedolizumab.
† Mucosal healing is defined as a Mayo endoscopic sub-score of 0 or 1.
£ Maintenance of clinical remission through Week 44 is defined as patients in clinical remission through Week 44 

among patients in clinical remission at maintenance baseline.
€ Corticosteroid-free clinical remission is defined as patients in clinical remission and not receiving corticosteroids at 

Week 44.
ǁ Durable Remission is defined as partial Mayo remission at ≥80% of all visits prior to Week 44 and in partial Mayo 

remission at last visit (Week 44).
‡ Symptomatic remission is defined as a Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.
⸸ Combined symptomatic remission and mucosal healing is defined as a stool frequency subscore of 0 or 1, a rectal 

bleeding subscore of 0, and an endoscopy subscore of 0 or 1.
a p < 0.001
b p < 0.05
c Nominally significant (p < 0.001)
d Nominally significant (p < 0.05)
e Not statistically significant

The beneficial effect of ustekinumab on clinical response, mucosal healing and clinical remission was 
observed in induction and in maintenance both in patients who failed conventional therapy but not a 
biologic therapy, as well as in those who had failed at least one prior TNFα antagonist therapy 
including in patients with a primary non-response to TNFα antagonist therapy. A beneficial effect was 
also observed in induction in patients who failed at least one prior TNFα antagonist therapy and 
vedolizumab, however the number of patients in this subgroup was too small to draw definitive 
conclusions about the beneficial effect in this group during maintenance.

Week 16 Responders to Ustekinumab Induction
Ustekinumab treated patients who were not in response at week 8 of UNIFI-I received an 
administration of 90 mg SC ustekinumab at week 8 (36% of patients). Of those patients, 9% of 
patients who were initially randomized to the recommended induction dose achieved clinical 
remission and 58% achieved clinical response at Week 16.

Patients who were not in clinical response to ustekinumab induction at week 8 of the UNFI-I study but 
were in response at week 16 (157 patients) entered into the non-randomized portion of UNIFI-M and 
continued to receive maintenance dosing every 8 weeks; among these patients, a majority (62%) 
maintained response and 30% achieved remission at week 44.

Endoscopic Normalization
Endoscopic normalization was defined as a Mayo endoscopic subscore of 0 and was observed as early 
as week 8 of UNIFI-I. At week 44 of UNIFI-M, it was achieved in 24% and 29% of patients treated 
with ustekinumab every 12 or 8 weeks, respectively, as compared to 18% of patients in the placebo 
group.

Histologic & Histo-Endoscopic Mucosal Healing
Histologic healing (defined as neutrophil infiltration in < 5% of crypts, no crypt destruction, and no 
erosions, ulcerations, or granulation tissue) was assessed at week 8 of UNIFI-I and Week 44 of 
UNIFI-M. At week 8, after a single intravenous induction dose, significantly greater proportions of 
patients in the recommended dose group achieved histologic healing (36%) compared with patients in 
the placebo group (22%). At Week 44 maintenance of this effect was observed with significantly more 
patients in histologic healing in the every 12 week (54%) and every 8 week (59%) ustekinumab groups 
as compared to placebo (33%).

A combined endpoint of histo-endoscopic mucosal healing defined as subjects having both mucosal 
healing and histologic healing was evaluated at week 8 of UNIFI-I and week 44 of UNIFI-M. Patients 
receiving ustekinumab at the recommended dose showed significant improvements on the histo-



15

endoscopic mucosal healing endpoint at week 8 in the ustekinumab group (18%) as compared to the 
placebo group (9%). At week 44, maintenance of this effect was observed with significantly more 
patients in histo-endoscopic mucosal healing in the every 12 week (39%) and every 8 week (46%) 
ustekinumab groups compared to placebo (24%).

Health-related quality of life
Health-related quality of life was assessed by Inflammatory Bowel Disease Questionnaire (IBDQ), 
SF-36 and EuroQoL-5D (EQ-5D) questionnaires.

At week 8 of UNIFI-I, patients receiving ustekinumab showed significantly greater and clinically 
meaningful improvements on IBDQ total score, EQ-5D and EQ-5D VAS, and SF-36 Mental 
Component Summary Score and SF-36 Physical Component Summary Score when compared to 
placebo. These improvements were maintained in ustekinumab-treated patients in UNIFI-M through 
week 44.

Patients receiving ustekinumab experienced significantly more improvements in work productivity as 
assessed by greater reductions in overall work impairment and in activity impairment as assessed by 
the WPAI-GH questionnaire than patients receiving placebo.

Hospitalizations and ulcerative colits (UC) related surgeries
Through week 8 of UNIFI-I, the proportions of subjects with UC disease related hospitalizations were 
significantly lower for subjects in the ustekinumab recommended dose group (1.6%, 5/322) compared 
with subjects in the placebo group (4.4%, 14/319) and no subjects underwent UC disease related 
surgeries in subjects receiving ustekinumab at the recommended induction dose compared to 0.6% 
(2/319) subjects in the placebo group.

Through week 44 of UNIFI-M, a significantly lower number of UC-related hospitalizations was 
observed in subjects in the combined ustekinumab group (2.0%, 7/348) as compared with subjects in 
the placebo group (5.7%, 10/175). A numerically lower number of subjects in the ustekinumab group 
(0.6%, 2/348) underwent UC disease related surgeries compared with subjects in the placebo group 
(1.7%, 3/175) through week 44.

Immunogenicity
Antibodies to ustekinumab may develop during ustekinumab treatment and most are neutralising. The 
formation of anti-ustekinumab antibodies is associated with increased clearance of ustekinumab in 
patients with Crohn’s disease or ulcerative colitis. No reduced efficacy was observed. There is no 
apparent correlation between the presence of anti-ustekinumab antibodies and the occurrence of 
injection site reactions.

Paediatric population
The European Medicines Agency has deferred the obligation to submit the results of studies with 
ustekinumab in one or more subsets of the paediatric population in Crohn’s Disease and ulcerative 
colitis (see section 4.2 for information on paediatric use).

5.2 Pharmacokinetic properties

Following the recommended intravenous induction dose, median peak serum ustekinumab 
concentration, observed 1 hour after the infusion, was 126.1 μg/mL in patients with Crohn’s disease 
and 127.0 µg/mL in patients with ulcerative colitis.

Distribution
Median volume of distribution during the terminal phase (Vz) following a single intravenous 
administration to patients with psoriasis ranged from 57 to 83 mL/kg.

Biotransformation
The exact metabolic pathway for ustekinumab is unknown.



16

Elimination
Median systemic clearance (CL) following a single intravenous administration to patients with 
psoriasis ranged from 1.99 to 2.34 mL/day/kg. Median half-life (t1/2) of ustekinumab was 
approximately 3 weeks in patients with ulcerative colitis, Crohn’s disease, psoriasis and/or psoriatic 
arthritis, ranging from 15 to 32 days across all psoriasis and psoriatic arthritis studies.

Dose linearity
The systemic exposure of ustekinumab (Cmax and AUC) increased in an approximately 
dose-proportional manner after a single intravenous administration at doses ranging from 0.09 mg/kg 
to 4.5 mg/kg.

Special populations
No pharmacokinetic data are available in patients with impaired renal or hepatic function.
No specific studies have been conducted with intravenous ustekinumab in elderly or paediatric 
patients.

In patients with Crohn’s disease and ulcerative colitis, variability in ustekinumab clearance was 
affected by body weight, serum albumin level, sex, and antibody to ustekinumab status while body 
weight was the main covariate affecting the volume of distribution. Additionally in Crohn’s disease, 
clearance was affected by C-reactive protein, TNF antagonist failure status and race (Asian versus 
non-Asian). The impact of these covariates was within ±20% of the typical or reference value of the 
respective PK parameter, thus dose adjustment is not warranted for these covariates. Concomitant use 
of immunomodulators did not have a significant impact on ustekinumab disposition.

Regulation of CYP450 enzymes
The effects of IL-12 or IL-23 on the regulation of CYP450 enzymes were evaluated in an in vitro
study using human hepatocytes, which showed that IL-12 and/or IL-23 at levels of 10 ng/mL did not 
alter human CYP450 enzyme activities (CYP1A2, 2B6, 2C9, 2C19, 2D6, or 3A4; see section 4.5).

5.3 Preclinical safety data

Non-clinical data reveal no special hazard (e.g. organ toxicity) for humans based on studies of 
repeated-dose toxicity and developmental and reproductive toxicity, including safety pharmacology 
evaluations. In developmental and reproductive toxicity studies in cynomolgus monkeys, neither 
adverse effects on male fertility indices nor birth defects or developmental toxicity were observed. No 
adverse effects on female fertility indices were observed using an analogous antibody to IL-12/23 in 
mice.

Dose levels in animal studies were up to approximately 45-fold higher than the highest equivalent 
dose intended to be administered to psoriasis patients and resulted in peak serum concentrations in 
monkeys that were more than 100-fold higher than observed in humans.

Carcinogenicity studies were not performed with ustekinumab due to the lack of appropriate models 
for an antibody with no cross-reactivity to rodent IL-12/23 p40.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

EDTA disodium salt dihydrate
L-histidine
L-histidine monohydrochloride monohydrate
L-methionine
Polysorbate 80
Sucrose
Water for injection



17

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. STELARA should only be diluted with sodium chloride 9 mg/mL (0.9%) solution.
STELARA should not be administered concomitantly in the same intravenous line with other 
medicinal products.

6.3 Shelf life

3 years.
Do not freeze.

Chemical and physical in-use stability has been demonstrated for 8 hours at 15-25°C.

From a microbiological point of view, unless the method of dilution precludes the risk of microbial 
contamination, the product should be used immediately. If not used immediately, in-use storage times 
and conditions are the responsibility of user.

6.4 Special precautions for storage

Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the vial in the outer carton in order to protect from light.

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

6.5 Nature and contents of container

26 mL solution in a type I glass 30 mL vial closed with a coated butyl rubber stopper. STELARA is 
available in a 1 vial pack.

6.6 Special precautions for disposal and other handling

The solution in the STELARA vial should not be shaken. The solution should be visually inspected for 
particulate matter or discoloration prior to administration. The solution is clear, colourless to light 
yellow. The medicinal product should not be used if the solution is discoloured or cloudy, or if foreign 
particulate matter is present.

Dilution
STELARA concentrate for solution for infusion must be diluted and prepared by a healthcare 
professional using aseptic technique.

1. Calculate the dose and the number of STELARA vials needed based on patient weight (see 
section 4.2, Table 1). Each 26 mL vial of STELARA contains 130 mg of ustekinumab. Only use 
complete vials of STELARA.

2. Withdraw and discard a volume of the sodium chloride 9 mg/mL (0.9%) solution from the 
250 mL infusion bag equal to the volume of STELARA to be added. (discard 26 mL sodium 
chloride for each vial of STELARA needed, for 2 vials-discard 52 mL, for 3 vials- discard 
78 mL, for 4 vials- discard 104 mL)

3. Withdraw 26 mL of STELARA from each vial needed and add it to the 250 mL infusion bag. 
The final volume in the infusion bag should be 250 mL. Gently mix.

4. Visually inspect the diluted solution before administration. Do not use if visibly opaque 
particles, discoloration or foreign particles are observed.

5. Administer the diluted solution over a period of at least one hour. Once diluted, the infusion 
should be completed within eight hours of the dilution in the infusion bag.

6. Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore 
size 0.2 micrometer).



18

7. Each vial is for single use only and any unused medicinal product should be disposed of in 
accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

8. MARKETING AUTHORISATION NUMBER(S)

EU/1/08/494/005

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 16 January 2009
Date of latest renewal: 19 September 2013

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/


19

1. NAME OF THE MEDICINAL PRODUCT

STELARA 45 mg solution for injection
STELARA 45 mg solution for injection in pre-filled syringe
STELARA 90 mg solution for injection in pre-filled syringe

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

STELARA 45 mg solution for injection
Each vial contains 45 mg ustekinumab in 0.5 mL.

STELARA 45 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 45 mg ustekinumab in 0.5 mL.

STELARA 90 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 90 mg ustekinumab in 1 mL.

Ustekinumab is a fully human IgG1κ monoclonal antibody to interleukin (IL)-12/23 produced in a 
murine myeloma cell line using recombinant DNA technology.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

STELARA 45 mg solution for injection
Solution for injection.

STELARA 45 mg solution for injection in pre-filled syringe
Solution for injection.

STELARA 90 mg solution for injection in pre-filled syringe
Solution for injection.

The solution is clear to slightly opalescent, colourless to light yellow.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Plaque psoriasis
STELARA is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to
respond to, or who have a contraindication to, or are intolerant to other systemic therapies including 
ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A) (see section 5.1).

Paediatric plaque psoriasis
STELARA is indicated for the treatment of moderate to severe plaque psoriasis in children and 
adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are 
intolerant to, other systemic therapies or phototherapies (see section 5.1).

Psoriatic arthritis (PsA)
STELARA, alone or in combination with MTX, is indicated for the treatment of active psoriatic 
arthritis in adult patients when the response to previous non-biological disease-modifying 
anti-rheumatic drug (DMARD) therapy has been inadequate (see section 5.1).



20

Crohn’s Disease
STELARA is indicated for the treatment of adult patients with moderately to severely active Crohn’s 
disease who have had an inadequate response with, lost response to, or were intolerant to either 
conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.

Ulcerative colitis
STELARA is indicated for the treatment of adult patients with moderately to severely active ulcerative 
colitis who have had an inadequate response with, lost response to, or were intolerant to either 
conventional therapy or a biologic or have medical contraindications to such therapies (see 
section 5.1).

4.2 Posology and method of administration

STELARA is intended for use under the guidance and supervision of physicians experienced in the 
diagnosis and treatment of conditions for which STELARA is indicated.

Posology

Plaque psoriasis
The recommended posology of STELARA is an initial dose of 45 mg administered subcutaneously, 
followed by a 45 mg dose 4 weeks later, and then every 12 weeks thereafter.

Consideration should be given to discontinuing treatment in patients who have shown no response up 
to 28 weeks of treatment.

Patients with body weight > 100 kg
For patients with a body weight > 100 kg the initial dose is 90 mg administered subcutaneously, 
followed by a 90 mg dose 4 weeks later, and then every 12 weeks thereafter. In these patients, 45 mg 
was also shown to be efficacious. However, 90 mg resulted in greater efficacy. (see section 5.1, 
Table 4)

Psoriatic arthritis (PsA)
The recommended posology of STELARA is an initial dose of 45 mg administered subcutaneously, 
followed by a 45 mg dose 4 weeks later, and then every 12 weeks thereafter. Alternatively, 90 mg may 
be used in patients with a body weight > 100 kg.

Consideration should be given to discontinuing treatment in patients who have shown no response up 
to 28 weeks of treatment.

Elderly (≥ 65 years)
No dose adjustment is needed for elderly patients (see section 4.4).

Renal and hepatic impairment
STELARA has not been studied in these patient populations. No dose recommendations can be made.

Paediatric population
The safety and efficacy of STELARA in children with psoriasis less than 6 years of age or in children 
with psoriatic arthritis less than 18 years of age have not yet been established.

Paediatric plaque psoriasis (6 years and older)
The recommended dose of STELARA based on body weight is shown below (Tables 1 and 2). 
STELARA should be administered at Weeks 0 and 4, then every 12 weeks thereafter.

Table 1 Recommended dose of STELARA for paediatric psoriasis
Body weight at the time of dosing Recommended Dose

< 60 kg 0.75 mg/kg
≥ 60-≤ 100 kg 45 mg



21

> 100 kg 90 mg

To calculate the volume of injection (mL) for patients < 60 kg, use the following formula: body 
weight (kg) x 0.0083 (mL/kg) or see Table 2. The calculated volume should be rounded to the nearest 
0.01 mL and administered using a 1 mL graduated syringe. A 45 mg vial is available for paediatric 
patients who need to receive less than the full 45 mg dose.

Table 2 Injection volumes of STELARA for paediatric psoriasis patients < 60 kg
Body weight at time of dosing 

(kg)
Dose (mg) Volume of injection (mL)

15 11.3 0.12
16 12.0 0.13
17 12.8 0.14
18 13.5 0.15
19 14.3 0.16
20 15.0 0.17
21 15.8 0.17
22 16.5 0.18
23 17.3 0.19
24 18.0 0.20
25 18.8 0.21
26 19.5 0.22
27 20.3 0.22
28 21.0 0.23
29 21.8 0.24
30 22.5 0.25
31 23.3 0.26
32 24.0 0.27
33 24.8 0.27
34 25.5 0.28
35 26.3 0.29
36 27.0 0.30
37 27.8 0.31
38 28.5 0.32
39 29.3 0.32
40 30.0 0.33
41 30.8 0.34
42 31.5 0.35
43 32.3 0.36
44 33.0 0.37
45 33.8 0.37
46 34.5 0.38
47 35.3 0.39
48 36.0 0.40
49 36.8 0.41
50 37.5 0.42
51 38.3 0.42
52 39.0 0.43
53 39.8 0.44
54 40.5 0.45
55 41.3 0.46
56 42.0 0.46
57 42.8 0.47
58 43.5 0.48
59 44.3 0.49



22

Consideration should be given to discontinuing treatment in patients who have shown no response up 
to 28 weeks of treatment.

Crohn’s Disease and Ulcerative Colitis
In the treatment regimen, the first dose of STELARA is administered intravenously. For the posology 
of the intravenous dosing regimen, see section 4.2 of the STELARA 130 mg Concentrate for solution 
for infusion SmPC.

The first subcutaneous administration of 90 mg STELARA should take place at week 8 after the 
intravenous dose. After this, dosing every 12 weeks is recommended.

Patients who have not shown adequate response at 8 weeks after the first subcutaneous dose, may 
receive a second subcutaneous dose at this time (see section 5.1).

Patients who lose response on dosing every 12 weeks may benefit from an increase in dosing 
frequency to every 8 weeks (see section 5.1, section 5.2).

Patients may subsequently be dosed every 8 weeks or every 12 weeks according to clinical judgment 
(see section 5.1).

Consideration should be given to discontinuing treatment in patients who show no evidence of 
therapeutic benefit 16 weeks after the IV induction dose or 16 weeks after switching to the 8-weekly 
maintenance dose.

Immunomodulators and/or corticosteroids may be continued during treatment with STELARA. In 
patients who have responded to treatment with STELARA, corticosteroids may be reduced or 
discontinued in accordance with standard of care.

In Crohn’s disease, if therapy is interrupted, resumption of treatment with subcutaneous dosing every 
8 weeks is safe and effective.

Elderly (≥ 65 years)
No dose adjustment is needed for elderly patients (see section 4.4).

Renal and hepatic impairment
STELARA has not been studied in these patient populations. No dose recommendations can be made.

Paediatric population
The safety and efficacy of STELARA in treatment of Crohn’s disease or ulcerative colitis in children 
less than 18 years have not yet been established. No data are available.

Method of administration
STELARA 45 mg vials or 45 mg and 90 mg pre-filled syringes are for subcutaneous injection only. If 
possible, areas of the skin that show psoriasis should be avoided as injection sites.

After proper training in subcutaneous injection technique, patients or their caregivers may inject 
STELARA if a physician determines that it is appropriate. However, the physician should ensure 
appropriate follow-up of patients. Patients or their caregivers should be instructed to inject the 
prescribed amount of STELARA according to the directions provided in the package leaflet. 
Comprehensive instructions for administration are given in the package leaflet.

For further instructions on preparation and special precautions for handling, see section 6.6.

4.3 Contraindications

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



23

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 tradename and the batch 
number of the administered product should be clearly recorded.

Infections
Ustekinumab may have the potential to increase the risk of infections and reactivate latent infections. 
In clinical studies, serious bacterial, fungal, and viral infections have been observed in patients 
receiving STELARA (see section 4.8).

Caution should be exercised when considering the use of STELARA in patients with a chronic 
infection or a history of recurrent infection (see section 4.3).

Prior to initiating treatment with STELARA, patients should be evaluated for tuberculosis infection. 
STELARA must not be given to patients with active tuberculosis (see section 4.3). Treatment of latent 
tuberculosis infection should be initiated prior to administering STELARA. Anti-tuberculosis therapy 
should also be considered prior to initiation of STELARA in patients with a history of latent or active 
tuberculosis in whom an adequate course of treatment cannot be confirmed. Patients receiving 
STELARA should be monitored closely for signs and symptoms of active tuberculosis during and 
after treatment.

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 STELARA 
should not be administered until the infection resolves.

Malignancies
Immunosuppressants like ustekinumab have the potential to increase the risk of malignancy. Some 
patients who received STELARA in clinical studies developed cutaneous and non-cutaneous 
malignancies (see section 4.8).

No studies have been conducted that include patients with a history of malignancy or that continue 
treatment in patients who develop malignancy while receiving STELARA. Thus, caution should be 
exercised when considering the use of STELARA in these patients.

All patients, in particular those greater than 60 years of age, patients with a medical history of 
prolonged immunosuppressant therapy or those with a history of PUVA treatment, should be 
monitored for the appearance of non-melanoma skin cancer (see section 4.8).

Systemic and respiratory hypersensitivity reactions
Systemic
Serious hypersensitivity reactions have been reported in the postmarketing setting, in some cases 
several days after treatment. Anaphylaxis and angioedema have occurred. If an anaphylactic or other 
serious hypersensitivity reaction occurs, appropriate therapy should be instituted and administration of 
STELARA should be discontinued (see section 4.8).

Respiratory
Cases of allergic alveolitis, eosinophilic pneumonia, and non-infectious organising pneumonia have 
been reported during post-approval use of ustekinumab. Clinical presentations included cough, 
dyspnoea, and interstitial infiltrates following one to three doses. Serious outcomes have included 
respiratory failure and prolonged hospitalisation. Improvement has been reported after discontinuation 
of ustekinumab and also, in some cases, administration of corticosteroids. If infection has been 
excluded and diagnosis is confirmed, discontinue ustekinumab and institute appropriate treatment (see 
section 4.8).



24

Latex sensitivity
The needle cover on the syringe in the STELARA pre-filled syringe is manufactured from dry natural 
rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex.

Vaccinations
It is recommended that live viral or live bacterial vaccines (such as Bacillus of Calmette and Guérin 
(BCG)) should not be given concurrently with STELARA. Specific studies have not been conducted 
in patients who had recently received live viral or live bacterial vaccines. No data are available on the 
secondary transmission of infection by live vaccines in patients receiving STELARA. Before live viral 
or live bacterial vaccination, treatment with STELARA should be withheld for at least 15 weeks after 
the last dose and can be resumed at least 2 weeks after vaccination. Prescribers should consult the 
Summary of Product Characteristics for the specific vaccine for additional information and guidance 
on concomitant use of immunosuppressive agents post-vaccination.

Patients receiving STELARA may receive concurrent inactivated or non-live vaccinations.

Long term treatment with STELARA does not suppress the humoral immune response to 
pneumococcal polysaccharide or tetanus vaccines (see section 5.1).

Concomitant immunosuppressive therapy
In psoriasis studies, the safety and efficacy of STELARA in combination with immunosuppressants, 
including biologics, or phototherapy have not been evaluated. In psoriatic arthritis studies, 
concomitant MTX use did not appear to influence the safety or efficacy of STELARA. In Crohn’s 
disease and ulcerative colitis studies, concomitant use of immunosuppressants or corticosteroids did 
not appear to influence the safety or efficacy of STELARA. Caution should be exercised when 
considering concomitant use of other immunosuppressants and STELARA or when transitioning from 
other immunosuppressive biologics (see section 4.5).

Immunotherapy
STELARA has not been evaluated in patients who have undergone allergy immunotherapy. It is not 
known whether STELARA may affect allergy immunotherapy.

Serious skin conditions
In patients with psoriasis, exfoliative dermatitis has been reported following ustekinumab treatment 
(see section 4.8). Patients with plaque psoriasis may develop erythrodermic psoriasis, with symptoms 
that may be clinically indistinguishable from exfoliative dermatitis, as part of the natural course of 
their disease. As part of the monitoring of the patient’s psoriasis, physicians should be alert for 
symptoms of erythrodermic psoriasis or exfoliative dermatitis. If these symptoms occur, appropriate 
therapy should be instituted. STELARA should be discontinued if a drug reaction is suspected.

Special populations
Elderly (≥ 65 years)
No overall differences in efficacy or safety in patients age 65 and older who received STELARA were 
observed compared to younger patients in clinical studies in approved indications, however the 
number of patients aged 65 and older is not sufficient to determine whether they respond differently 
from younger patients. Because there is a higher incidence of infections in the elderly population in 
general, caution should be used in treating the elderly.

4.5 Interaction with other medicinal products and other forms of interaction

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

No interaction studies have been performed in humans. In the population pharmacokinetic analyses of 
the phase 3 studies, the effect of the most frequently used concomitant medicinal products in patients 
with psoriasis (including paracetamol, ibuprofen, acetylsalicylic acid, metformin, atorvastatin, 
levothyroxine) on pharmacokinetics of ustekinumab was explored. There were no indications of an 



25

interaction with these concomitantly administered medicinal products. The basis for this analysis was 
that at least 100 patients (> 5% of the studied population) were treated concomitantly with these 
medicinal products for at least 90% of the study period. The pharmacokinetics of ustekinumab was not 
impacted by concomitant use of MTX, NSAIDs, 6-mercaptopurine, azathioprine and oral 
corticosteroids in patients with psoriatic arthritis, Crohn’s disease or ulcerative colitis, or prior 
exposure to anti-TNFα agents, in patients with psoriatic arthritis or Crohn’s disease or by prior 
exposure to biologics (i.e. anti-TNFα agents and/or vedolizumab) in patients with ulcerative colitis.

The results of an in vitro study do not suggest the need for dose adjustments in patients who are 
receiving concomitant CYP450 substrates (see section 5.2).

In psoriasis studies, the safety and efficacy of STELARA in combination with immunosuppressants, 
including biologics, or phototherapy have not been evaluated. In psoriatic arthritis studies, 
concomitant MTX use did not appear to influence the safety or efficacy of STELARA. In Crohn’s 
disease and ulcerative colitis studies, concomitant use of immunosuppressants or corticosteroids did 
not appear to influence the safety or efficacy of STELARA. (see section 4.4).

4.6 Fertility, pregnancy and lactation

Women of childbearing potential
Women of childbearing potential should use effective methods of contraception during treatment and 
for at least 15 weeks after treatment.

Pregnancy
There are no adequate data from the use of ustekinumab in pregnant women. Animal studies do not 
indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, 
parturition or postnatal development (see section 5.3). As a precautionary measure, it is preferable to 
avoid the use of STELARA in pregnancy.

Breast-feeding
It is unknown whether ustekinumab is excreted in human breast milk. Animal studies have shown 
excretion of ustekinumab at low levels in breast milk. It is not known if ustekinumab is absorbed 
systemically after ingestion. Because of the potential for adverse reactions in nursing infants from 
ustekinumab, a decision on whether to discontinue breast-feeding during treatment and up to 15 weeks 
after treatment or to discontinue therapy with STELARA must be made taking into account the benefit 
of breast-feeding to the child and the benefit of STELARA therapy to the woman.

Fertility
The effect of ustekinumab on human fertility has not been evaluated (see section 5.3).

4.7 Effects on ability to drive and use machines

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

4.8 Undesirable effects

Summary of the safety profile
The most common adverse reactions (> 5%) in controlled periods of the adult psoriasis, psoriatic 
arthritis, Crohn’s disease and ulcerative colitis clinical studies with ustekinumab were nasopharyngitis
and headache. Most were considered to be mild and did not necessitate discontinuation of study 
treatment. The most serious adverse reaction that has been reported for STELARA is serious 
hypersensitivity reactions including anaphylaxis (see section 4.4). The overall safety profile was 
similar for patients with psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.

Tabulated list of adverse reactions
The safety data described below reflect exposure in adults to ustekinumab in 14 phase 2 and 
phase 3 studies in 6,709 patients (4,135 with psoriasis and/or psoriatic arthritis, 1,749 with Crohn’s 



26

disease and 825 patients with ulcerative colitis). This includes exposure to STELARA in the 
controlled and non-controlled periods of the clinical studies for at least 6 months or 1 year (4,577 and 
3,253 patients respectively with psoriasis, psoriatic arthritis, Crohn’s disease or ulcerative colitis) and 
exposure for at least 4 or 5 years (1,482 and 838 patients with psoriasis respectively).

Table 3 provides a list of adverse reactions from adult psoriasis, psoriatic arthritis, Crohn’s disease and 
ulcerative colitis clinical studies as well as adverse reactions reported from post-marketing experience. 
The adverse reactions are classified by System Organ Class and frequency, using 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), not known (cannot be estimated from the 
available data). Within each frequency grouping, adverse reactions are presented in order of 
decreasing seriousness.

Table 3 List of adverse reactions
System Organ Class Frequency: Adverse reaction

Infections and infestations Common: Upper respiratory tract infection, nasopharyngitis, 
sinusitis
Uncommon: Cellulitis, dental infections, herpes zoster, lower 
respiratory tract infection, viral upper respiratory tract infection, 
vulvovaginal mycotic infection

Immune system disorders Uncommon: Hypersensitivity reactions (including rash, urticaria)
Rare: Serious hypersensitivity reactions (including anaphylaxis, 
angioedema)

Psychiatric disorders Uncommon: Depression

Nervous system disorders Common: Dizziness, headache
Uncommon: Facial palsy

Respiratory, thoracic and 
mediastinal disorders

Common: Oropharyngeal pain
Uncommon: Nasal congestion
Rare: Allergic alveolitis, eosinophilic pneumonia
Very rare: Organising pneumonia*

Gastrointestinal disorders Common: Diarrhoea, nausea, vomiting

Skin and subcutaneous tissue 
disorders

Common: Pruritus
Uncommon: Pustular psoriasis, skin exfoliation, acne
Rare: Exfoliative dermatitis, hypersensitivity vasculitis

Musculoskeletal and connective 
tissue disorders

Common: Back pain, myalgia, arthralgia

General disorders and 
administration site conditions

Common: Fatigue, injection site erythema, injection site pain
Uncommon: Injection site reactions (including haemorrhage, 
haematoma, induration, swelling and pruritus), asthenia

* See section 4.4, Systemic and respiratory hypersensitivity reactions.

Description of selected adverse reactions
Infections
In the placebo-controlled studies of patients with psoriasis, psoriatic arthritis, Crohn’s disease and 
ulcerative colitis, the rates of infection or serious infection were similar between ustekinumab-treated 
patients and those treated with placebo. In the placebo-controlled period of these clinical studies, the 
rate of infection was 1.36 per patient-year of follow-up in ustekinumab-treated patients, and 1.34 in 
placebo-treated patients. Serious infections occurred at the rate of 0.03 per patient-year of follow-up in 



27

ustekinumab-treated patients (30 serious infections in 930 patient-years of follow-up) and 0.03 in 
placebo-treated patients (15 serious infections in 434 patient-years of follow-up) (see section 4.4).

In the controlled and non-controlled periods of psoriasis, psoriatic arthritis, Crohn’s disease and 
ulcerative colitis clinical studies, representing 11,581 patient-years of exposure in 6,709 patients, the 
median follow up was 1.0 years; 1.1 years for psoriatic disease studies, 0.6 year for Crohn’s disease
studies, and 1.0 years for ulcerative colitis studies. The rate of infection was 0.91 per patient-year of 
follow-up in ustekinumab-treated patients, and the rate of serious infections was 0.02 per patient-year 
of follow-up in ustekinumab-treated patients (199 serious infections in 11,581 patient-years of 
follow-up) and serious infections reported included pneumonia, anal abscess, cellulitis, diverticulitis, 
gastroenteritis and viral infections.

In clinical studies, patients with latent tuberculosis who were concurrently treated with isoniazid did 
not develop tuberculosis.

Malignancies
In the placebo-controlled period of the psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative 
colitis clinical studies, the incidence of malignancies excluding non-melanoma skin cancer was 
0.11 per 100 patient-years of follow-up for ustekinumab-treated patients (1 patient in 929 patient-years 
of follow-up) compared with 0.23 for placebo-treated patients (1 patient in 434 patient-years of 
follow-up). The incidence of non-melanoma skin cancer was 0.43 per 100 patient-years of follow-up 
for ustekinumab-treated patients (4 patients in 929 patient-years of follow-up) compared to 0.46 for 
placebo-treated patients (2 patients in 433 patient-years of follow-up).

In the controlled and non-controlled periods of psoriasis, psoriatic arthritis, Crohn’s disease and 
ulcerative colitis clinical studies, representing 11,561 patient-years of exposure in 6,709 patients, the 
median follow-up was 1.0 years; 1.1 years for psoriatic disease studies, 0.6 year for Crohn’s disease 
studies and 1.0 years for ulcerative colitis studies. Malignancies excluding non-melanoma skin cancers 
were reported in 62 patients in 11,561 patient-years of follow-up (incidence of 0.54 per 100 patient-
years of follow-up for ustekinumab-treated patients). The incidence of malignancies reported in 
ustekinumab-treated patients was comparable to the incidence expected in the general population 
(standardised incidence ratio = 0.93 [95% confidence interval: 0.71, 1.20], adjusted for age, gender 
and race). The most frequently observed malignancies, other than non-melanoma skin cancer, were 
prostate, colorectal, melanoma and breast cancers. The incidence of non-melanoma skin cancer was
0.49 per 100 patient-years of follow-up for ustekinumab-treated patients (56 patients in 
11,545 patient-years of follow-up). The ratio of patients with basal versus squamous cell skin cancers 
(3:1) is comparable with the ratio expected in the general population (see section 4.4).

Hypersensitivity reactions
During the controlled periods of the psoriasis and psoriatic arthritis clinical studies of ustekinumab, 
rash and urticaria have each been observed in < 1% of patients (see section 4.4).

Paediatric population
Paediatric patients 6 years and older with plaque psoriasis
The safety of ustekinumab has been studied in two phase 3 studies of paediatric patients with moderate 
to severe plaque psoriasis. The first study was in 110 patients from 12 to 17 years of age treated for up 
to 60 weeks and the second study was in 44 patients from 6 to 11 years of age treated for up to 
56 weeks. In general, the adverse events reported in these two studies with safety data up to 1 year
were similar to those seen in previous studies in adults with plaque psoriasis.

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.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000134.jsp&mid=WC0b01ac0580022c59


28

4.9 Overdose

Single doses up to 6 mg/kg have been administered intravenously in clinical studies without 
dose-limiting toxicity. In case 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.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC05.

Mechanism of action
Ustekinumab is a fully human IgG1κ monoclonal antibody that binds with specificity to the shared 
p40 protein subunit of human cytokines interleukin (IL)-12 and IL-23. Ustekinumab inhibits the 
bioactivity of human IL-12 and IL-23 by preventing p40 from binding to the IL-12R1 receptor 
protein expressed on the surface of immune cells. Ustekinumab cannot bind to IL-12 or IL-23 that is 
already bound to IL-12R1 cell surface receptors. Thus, ustekinumab is not likely to contribute to 
complement- or antibody-mediated cytotoxicity of cells with IL-12 and/or IL-23 receptors. IL-12 and 
IL-23 are heterodimeric cytokines secreted by activated antigen presenting cells, such as macrophages 
and dendritic cells, and both cytokines participate in immune functions; IL-12 stimulates natural killer 
(NK) cells and drives the differentiation of CD4+ T cells toward the T helper 1 (Th1) phenotype,
IL-23 induces the T helper 17 (Th17) pathway. However, abnormal regulation of IL 12 and IL 23 has 
been associated with immune mediated diseases, such as psoriasis, psoriatic arthritis, Crohn’s disease
and ulcerative colitis.

By binding the shared p40 subunit of IL-12 and IL-23, ustekinumab may exert its clinical effects in 
psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis through interruption of the Th1 and 
Th17 cytokine pathways, which are central to the pathology of these diseases.

In patients with Crohn’s disease and ulcerative colitis, treatment with ustekinumab resulted in a 
decrease in inflammatory markers including C-Reactive Protein (CRP) and fecal calprotectin during 
the induction phase, which were then maintained throughout the maintenance phase.

Immunisation
During the long term extension of Psoriasis Study 2 (PHOENIX 2), adult patients treated with 
STELARA for at least 3.5 years mounted similar antibody responses to both pneumococcal 
polysaccharide and tetanus vaccines as a non-systemically treated psoriasis control group. Similar 
proportions of adult patients developed protective levels of anti-pneumococcal and anti-tetanus 
antibodies and antibody titers were similar among STELARA-treated and control patients.

Clinical efficacy

Plaque psoriasis (Adults)
The safety and efficacy of ustekinumab was assessed in 1,996 patients in two randomised, 
double-blind, placebo-controlled studies in patients with moderate to severe plaque psoriasis and who 
were candidates for phototherapy or systemic therapy. In addition, a randomised, blinded assessor, 
active-controlled study compared ustekinumab and etanercept in patients with moderate to severe 
plaque psoriasis who had had an inadequate response to, intolerance to, or contraindication to 
ciclosporin, MTX, or PUVA.

Psoriasis Study 1 (PHOENIX 1) evaluated 766 patients. 53% of these patients were either 
non-responsive, intolerant, or had a contraindication to other systemic therapy. Patients randomised to 
ustekinumab received 45 mg or 90 mg doses at Weeks 0 and 4 and followed by the same dose every 
12 weeks. Patients randomised to receive placebo at Weeks 0 and 4 crossed over to receive 



29

ustekinumab (either 45 mg or 90 mg) at Weeks 12 and 16 followed by dosing every 12 weeks. Patients 
originally randomised to ustekinumab who achieved Psoriasis Area and Severity Index 75 response 
(PASI improvement of at least 75% relative to baseline) at both Weeks 28 and 40 were re-randomised 
to receive ustekinumab every 12 weeks or to placebo (i.e., withdrawal of therapy). Patients who were 
re-randomised to placebo at week 40 reinitiated ustekinumab at their original dosing regimen when 
they experienced at least a 50% loss of their PASI improvement obtained at week 40. All patients were 
followed for up to 76 weeks following first administration of study treatment.

Psoriasis Study 2 (PHOENIX 2) evaluated 1,230 patients. 61% of these patients were either 
non-responsive, intolerant, or had a contraindication to other systemic therapy. Patients randomised to 
ustekinumab received 45 mg or 90 mg doses at Weeks 0 and 4 followed by an additional dose at 
16 weeks. Patients randomised to receive placebo at Weeks 0 and 4 crossed over to receive 
ustekinumab (either 45 mg or 90 mg) at Weeks 12 and 16. All patients were followed for up to 
52 weeks following first administration of study treatment.

Psoriasis Study 3 (ACCEPT) evaluated 903 patients with moderate to severe psoriasis who 
inadequately responded to, were intolerant to, or had a contraindication to other systemic therapy and 
compared the efficacy of ustekinumab to etanercept and evaluated the safety of ustekinumab and 
etanercept. During the 12-week active-controlled portion of the study, patients were randomised to 
receive etanercept (50 mg twice a week), ustekinumab 45 mg at Weeks 0 and 4, or ustekinumab 90 mg 
at Weeks 0 and 4.

Baseline disease characteristics were generally consistent across all treatment groups in Psoriasis 
Studies 1 and 2 with a median baseline PASI score from 17 to 18, median baseline Body Surface Area 
(BSA) ≥ 20, and median Dermatology Life Quality Index (DLQI) range from 10 to 12. Approximately 
one third (Psoriasis Study 1) and one quarter (Psoriasis Study 2) of subjects had Psoriatic Arthritis 
(PsA). Similar disease severity was also seen in Psoriasis Study 3.

The primary endpoint in these studies was the proportion of patients who achieved PASI 75 response 
from baseline at week 12 (see Tables 4 and 5).

Table 4 Summary of clinical response in Psoriasis Study 1 (PHOENIX 1) and Psoriasis Study 2 
(PHOENIX 2)

Week 12
2 doses (week 0 and week 4)

Week 28
3 doses (week 0, week 4 

and week 16)
PBO 45 mg 90 mg 45 mg 90 mg

Psoriasis Study 1
Number of patients 
randomised

255 255 256 250 243

PASI 50 response N (%) 26 (10%) 213 (84%)a 220 (86%)a 228 (91%) 234 (96%)
PASI 75 response N (%) 8 (3%) 171 (67%)a 170 (66%)a 178 (71%) 191 (79%)
PASI 90 response N (%) 5 (2%) 106 (42%)a 94 (37%)a 123 (49%) 135 (56%)
PGAb of cleared or minimal N 
(%)

10 (4%) 151 (59%)a 156 (61%)a 146 (58%) 160 (66%)

Number of patients ≤ 100 kg 166 168 164 164 153
PASI 75 response N (%) 6 (4%) 124 (74%) 107 (65%) 130 (79%) 124 (81%)

Number of patients > 100 kg 89 87 92 86 90
PASI 75 response N (%) 2 (2%) 47 (54%) 63 (68%) 48 (56%) 67 (74%)

Psoriasis Study 2
Number of patients 
randomised

410 409 411 397 400

PASI 50 response N (%) 41 (10%) 342 (84%)a 367 (89%)a 369 (93%) 380 (95%)
PASI 75 response N (%) 15 (4%) 273 (67%)a 311 (76%)a 276 (70%) 314 (79%)
PASI 90 response N (%) 3 (1%) 173 (42%)a 209 (51%)a 178 (45%) 217 (54%)



30

PGAb of cleared or minimal N 
(%)

18 (4%) 277 (68%)a 300 (73%)a 241 (61%) 279 (70%)

Number of patients ≤ 100 kg 290 297 289 287 280
PASI 75 response N (%) 12 (4%) 218 (73%) 225 (78%) 217 (76%) 226 (81%)

Number of patients > 100 kg 120 112 121 110 119
PASI 75 response N (%) 3 (3%) 55 (49%) 86 (71%) 59 (54%) 88 (74%)

a p < 0.001 for ustekinumab 45 mg or 90 mg in comparison with placebo (PBO).
b PGA = Physician Global Assessment

Table 5 Summary of clinical response at week 12 in Psoriasis Study 3 (ACCEPT)
Psoriasis Study 3

Etanercept
24 doses

(50 mg twice a 
week)

Ustekinumab
2 doses (week 0 and week 4)

45 mg 90 mg

Number of patients randomised 347 209 347
PASI 50 response N (%) 286 (82%) 181 (87%) 320 (92%)a

PASI 75 response N (%) 197 (57%) 141 (67%)b 256 (74%)a

PASI 90 response N (%) 80 (23%) 76 (36%)a 155 (45%)a

PGA of cleared or minimal N (%) 170 (49%) 136 (65%)a 245 (71%)a

Number of patients ≤ 100 kg 251 151 244
PASI 75 response N (%) 154 (61%) 109 (72%) 189 (77%)

Number of patients > 100 kg 96 58 103
PASI 75 response N (%) 43 (45%) 32 (55%) 67 (65%)

a p < 0.001 for ustekinumab 45 mg or 90 mg in comparison with etanercept.
b p = 0.012 for ustekinumab 45 mg in comparison with etanercept.

In Psoriasis Study 1 maintenance of PASI 75 was significantly superior with continuous treatment 
compared with treatment withdrawal (p < 0.001). Similar results were seen with each dose of 
ustekinumab. At 1 year (week 52), 89% of patients re-randomised to maintenance treatment were 
PASI 75 responders compared with 63% of patients re-randomised to placebo (treatment withdrawal) 
(p < 0.001). At 18 months (week 76), 84% of patients re-randomised to maintenance treatment were 
PASI 75 responders compared with 19% of patients re-randomised to placebo (treatment withdrawal).
At 3 years (week 148), 82% of patients re-randomised to maintenance treatment were PASI 75 
responders. At 5 years (week 244), 80% of patients re-randomised to maintenance treatment were 
PASI 75 responders.

In patients re-randomised to placebo, and who reinitiated their original ustekinumab treatment regimen 
after loss of ≥ 50% of PASI improvement 85% regained PASI 75 response within 12 weeks after 
re-initiating therapy.

In Psoriasis Study 1, at week 2 and week 12, significantly greater improvements from baseline were 
demonstrated in the DLQI in each ustekinumab treatment group compared with placebo. The 
improvement was sustained through week 28. Similarly, significant improvements were seen in 
Psoriasis Study 2 at week 4 and 12, which were sustained through week 24. In Psoriasis Study 1, 
improvements in nail psoriasis (Nail Psoriasis Severity Index), in the physical and mental component 
summary scores of the SF-36 and in the Itch Visual Analogue Scale (VAS) were also significant in 
each ustekinumab treatment group compared with placebo. In Psoriasis Study 2, the Hospital Anxiety 
and Depression Scale (HADS) and Work Limitations Questionnaire (WLQ) were also significantly 
improved in each ustekinumab treatment group compared with placebo.

Psoriatic arthritis (PsA) (Adults)
Ustekinumab has been shown to improve signs and symptoms, physical function and health-related 
quality of life, and reduce the rate of progression of peripheral joint damage in adult patients with 
active PsA.



31

The safety and efficacy of ustekinumab was assessed in 927 patients in two randomised, double-blind, 
placebo-controlled studies in patients with active PsA (≥ 5 swollen joints and ≥ 5 tender joints) despite 
non-steroidal anti-inflammatory (NSAID) or disease modifying antirheumatic (DMARD) therapy. 
Patients in these studies had a diagnosis of PsA for at least 6 months. Patients with each subtype of 
PsA were enrolled, including polyarticular arthritis with no evidence of rheumatoid nodules (39%), 
spondylitis with peripheral arthritis (28%), asymmetric peripheral arthritis (21%), distal 
interphalangeal involvement (12%) and arthritis mutilans (0.5%). Over 70% and 40% of the patients in 
both studies had enthesitis and dactylitis at baseline, respectively. Patients were randomised to receive 
treatment with ustekinumab 45 mg, 90 mg, or placebo subcutaneously at Weeks 0 and 4 followed by 
every 12 weeks (q12w) dosing. Approximately 50% of patients continued on stable doses of MTX 
(≤ 25 mg/week).

In PsA Study 1 (PSUMMIT I) and PsA Study 2 (PSUMMIT II), 80% and 86% of the patients, 
respectively, had been previously treated with DMARDs. In Study 1 previous treatment with 
anti-tumour necrosis factor (TNF)α agent was not allowed. In Study 2, the majority of patients (58%, 
n = 180) had been previously treated with one or more anti-TNFα agent(s), of whom over 70% had 
discontinued their anti-TNFα treatment for lack of efficacy or intolerance at any time.

Signs and symptoms
Treatment with ustekinumab resulted in significant improvements in the measures of disease activity 
compared to placebo at week 24. The primary endpoint was the percentage of patients who achieved 
American College of Rheumatology (ACR) 20 response at week 24. The key efficacy results are 
shown in Table 6 below.

Table 6 Number of patients who achieved clinical response in Psoriatic arthritis Study 1 
(PSUMMIT I) and Study 2 (PSUMMIT II) at week 24

Psoriatic arthritis Study 1 Psoriatic arthritis Study 2
PBO 45 mg 90 mg PBO 45 mg 90 mg

Number of 
patients 
randomised

206 205 204 104 103 105

ACR 20 
response, N (%)

47 (23%) 87 (42%)a 101 (50%)a 21 (20%) 45 (44%)a 46 (44%)a

ACR 50 
response, N (%)

18 (9%) 51 (25%)a 57 (28%)a 7 (7%) 18 (17%)b 24 (23%)a

ACR 70
response, N (%)

5 (2%) 25 (12%)a 29 (14%)a 3 (3%) 7 (7%)c 9 (9%)c

Number of patients 
with ≥ 3% BSAd 146 145 149 80 80 81

PASI 75 
response, N (%)

16 (11%) 83 (57%)a 93 (62%)a 4 (5%) 41 (51%)a 45 (56%)a

PASI 90 
response, N (%) 4 (3%) 60 (41%)a 65 (44%)a 3 (4%) 24 (30%)a 36 (44%)a

Combined 
PASI 75 and 
ACR 20 
response, N (%)

8 (5%) 40 (28%)a 62 (42%)a 2 (3%) 24 (30%)a 31 (38%)a

Number of 
patients ≤ 100 kg

154 153 154 74 74 73

ACR 20 
response, N (%)

39 (25%) 67 (44%) 78 (51%) 17 (23%) 32 (43%) 34 (47%)

Number of patients 
with ≥ 3% BSAd 105 105 111 54 58 57

PASI 75 
response, N (%)

14 (13%) 64 (61%) 73 (66%) 4 (7%) 31 (53%) 32 (56%)

Number of 
patients > 100 kg

52 52 50 30 29 31



32

ACR 20 
response, N (%)

8 (15%) 20 (38%) 23 (46%) 4 (13%) 13 (45%) 12 (39%)

Number of patients 
with ≥ 3% BSAd 41 40 38 26 22 24

PASI 75 
response, N (%)

2 (5%) 19 (48%) 20 (53%) 0 10 (45%) 13 (54%)

a p < 0.001
b p < 0.05
c p = NS
d Number of patients with ≥ 3% BSA psoriasis skin involvement at baseline

ACR 20, 50 and 70 responses continued to improve or were maintained through week 52 (PsA Study 1 
and 2) and week 100 (PsA Study 1). In PsA Study 1, ACR 20 responses at week 100 were achieved by 
57% and 64%, for 45 mg and 90 mg, respectively. In PsA Study 2, ACR 20 responses at week 52 were 
achieved by 47% and 48%, for 45 mg and 90 mg, respectively.

The proportion of patients achieving a modified PsA response criteria (PsARC) response was also 
significantly greater in the ustekinumab groups compared to placebo at week 24. PsARC responses 
were maintained through weeks 52 and 100. A higher proportion of patients treated with ustekinumab 
who had spondylitis with peripheral arthritis as their primary presentation, demonstrated 50 and 
70 percent improvement in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores 
compared with placebo at week 24.

Responses observed in the ustekinumab treated groups were similar in patients receiving and not 
receiving concomitant MTX, and were maintained through weeks 52 and 100. Patients previously 
treated with anti-TNFα agents who received ustekinumab achieved a greater response at week 24 than 
patients receiving placebo (ACR 20 response at week 24 for 45 mg and 90 mg was 37% and 34%, 
respectively, compared with placebo 15%; p < 0.05), and responses were maintained through week 52.

For patients with enthesitis and/or dactylitis at baseline, in PsA Study 1 significant improvement in 
enthesitis and dactylitis score was observed in the ustekinumab groups compared with placebo at 
week 24. In PsA Study 2 significant improvement in enthesitis score and numerical improvement (not 
statistically significant) in dactylitis score was observed in the ustekinumab 90 mg group compared 
with placebo at week 24. Improvements in enthesitis score and dactylitis score were maintained 
through weeks 52 and 100.

Radiographic Response
Structural damage in both hands and feet was expressed as change in total van der Heijde-Sharp score 
(vdH-S score), modified for PsA by addition of hand distal interphalangeal joints, compared to 
baseline. A pre-specified integrated analysis combining data from 927 subjects in both PsA Study 1 
and 2 was performed. Ustekinumab demonstrated a statistically significant decrease in the rate of 
progression of structural damage compared to placebo, as measured by change from baseline to 
week 24 in the total modified vdH-S score (mean ± SD score was 0.97 ± 3.85 in the placebo group 
compared with 0.40 ± 2.11 and 0.39 ± 2.40 in the ustekinumab 45 mg (p < 0.05) and 90 mg 
(p < 0.001) groups, respectively). This effect was driven by PsA Study 1. The effect is considered 
demonstrated irrespective of concomitant MTX use, and was maintained through Weeks 52 
(integrated analysis) and 100 (PsA Study 1).

Physical function and health-related quality of life
Ustekinumab-treated patients showed significant improvement in physical function as assessed by the 
Disability Index of the Health Assessment Questionnaire (HAQ-DI) at week 24. The proportion of 
patients achieving a clinically meaningful ≥ 0.3 improvement in HAQ-DI score from baseline was also 
significantly greater in the ustekinumab groups when compared with placebo. Improvement in 
HAQ-DI score from baseline was maintained through Weeks 52 and 100.

There was significant improvement in DLQI scores in the ustekinumab groups as compared with 
placebo at week 24, which was maintained through weeks 52 and 100. In PsA Study 2 there was a 
significant improvement in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) 



33

scores in the ustekinumab groups when compared with placebo at week 24. The proportion of patients 
achieving a clinically significant improvement in fatigue (4 points in FACIT-F) was also significantly 
greater in the ustekinumab groups compared with placebo. Improvements in FACIT scores were 
maintained through week 52.

Paediatric population
The European Medicines Agency has deferred the obligation to submit the results of studies with 
ustekinumab in one or more subsets of the paediatric population with juvenile idiopathic arthritis (see 
section 4.2 for information on paediatric use).

Paediatric plaque psoriasis
Ustekinumab has been shown to improve signs and symptoms, and health-related quality of life in 
paediatric patients 6 years and older with plaque psoriasis.

Adolescent patients (12-17 years)
The efficacy of ustekinumab was studied in 110 paediatric patients aged 12 to 17 years with moderate 
to severe plaque psoriasis in a multicenter, phase 3, randomised, double blind, placebo controlled 
study (CADMUS). Patients were randomised to receive either placebo (n = 37), or the recommended 
dose of ustekinumab (see section 4.2; n = 36) or half of the recommended dose of ustekinumab 
(n = 37) by subcutaneous injection at Weeks 0 and 4 followed by every 12 week (q12w) dosing. At 
week 12, placebo treated patients crossed over to receive ustekinumab.

Patients with PASI ≥ 12, PGA ≥ 3 and BSA involvement of at least 10%, who were candidates for 
systemic therapy or phototherapy, were eligible for the study. Approximately 60% of the patients had 
prior exposure to conventional systemic therapy or phototherapy. Approximately 11% of the patients 
had prior exposure to biologics.

The primary endpoint was the proportion of patients who achieved a PGA score of cleared (0) or 
minimal (1) at week 12. Secondary endpoints included PASI 75, PASI 90, change from baseline in 
Children’s Dermatology Life Quality Index (CDLQI), change from baseline in the total scale score of 
PedsQL (Paediatric Quality of Life Inventory) at week 12. At week 12, subjects treated with 
ustekinumab showed significantly greater improvement in their psoriasis and health-related quality of 
life compared with placebo (Table 7).

All patients were followed for efficacy for up to 52 weeks following first administration of study 
agent. The proportion of patients with a PGA score of cleared (0) or minimal (1) and the proportion 
achieving PASI 75 showed separation between the ustekinumab treated group and placebo at the first 
post-baseline visit at week 4, reaching a maximum by week 12. Improvements in PGA, PASI, CDLQI 
and PedsQL were maintained through week 52 (Table 7).

Table 7 Summary of primary and secondary endpoints at week 12 and week 52
Paediatric psoriasis study (CADMUS) (Age 12-17)

Week 12 Week 52

Placebo
Recommended dose 

of Ustekinumab
Recommended dose 

of Ustekinumab
N (%) N (%) N (%)

Patients randomised 37 36 35
PGA
PGA of cleared (0) or 
minimal (1)

2 (5.4%) 25 (69.4%)a 20 (57.1%)

PGA of Cleared (0) 1 (2.7%) 17 (47.2%)a 13 (37.1%)
PASI
PASI 75 responders 4 (10.8%) 29 (80.6%)a 28 (80.0%)
PASI 90 responders 2 (5.4%) 22 (61.1%)a 23 (65.7%)
PASI 100 responders 1 (2.7%) 14 (38.9%)a 13 (37.1%)



34

CDLQI
CDLQI of 0 or 1b 6 (16.2%) 18 (50.0%)c 20 (57.1%)
PedsQL
Change from baseline
Mean (SD)d 3.35 (10.04) 8.03 (10.44)e 7.26 (10.92)

a p < 0.001
b CDLQI: The CDLQI is a dermatology instrument to assess the effect of a skin problem on the health-related quality of 

life in the paediatric population. CDLQI of 0 or 1 indicates no effect on child’s quality of life.
c p = 0.002
d PedsQL: The PedsQL Total Scale Score is a general health-related quality of life measure developed for use in 

children and adolescent populations. For the placebo group at week 12, N = 36
e p = 0.028

During the placebo controlled period through week 12, the efficacy of both the recommended and half 
of the recommended dose groups were generally comparable at the primary endpoint (69.4% and 
67.6% respectively) although there was evidence of a dose response for higher level efficacy criteria 
(e.g. PGA of cleared (0), PASI 90). Beyond week 12, efficacy was generally higher and better 
sustained in the recommended dose group compared with half of the recommended dosage group in 
which a modest loss of efficacy was more frequently observed toward the end of each 12 week dosing 
interval. The safety profiles of the recommended dose and half of the recommended dose were 
comparable.

Children (6-11 years)
The efficacy of ustekinumab was studied in 44 paediatric patients aged 6 to 11 years with moderate to 
severe plaque psoriasis in an open label, single-arm, multicenter, phase 3, study (CADMUS Jr.). 
Patients were treated with the recommended dose of ustekinumab (see section 4.2; n = 44) by 
subcutaneous injection at weeks 0 and 4 followed by every 12 week (q12w) dosing.

Patients with PASI ≥ 12, PGA ≥ 3 and BSA involvement of at least 10%, who were candidates for 
systemic therapy or phototherapy, were eligible for the study. Approximately 43% of the patients had 
prior exposure to conventional systemic therapy or phototherapy. Approximately 5% of the patients 
had prior exposure to biologics.

The primary endpoint was the proportion of patients who achieved a PGA score of cleared (0) or 
minimal (1) at week 12. Secondary endpoints included PASI 75, PASI 90, and change from baseline 
in Children’s Dermatology Life Quality Index (CDLQI) at week 12. At week 12, subjects treated with 
ustekinumab showed clinically meaningful improvements in their psoriasis and health-related quality 
of life (Table 8).

All patients were followed for efficacy for up to 52 weeks following first administration of study 
agent. The proportion of patients with a PGA score of cleared (0) or minimal (1) at week 12 was 
77.3%. Efficacy (defined as PGA 0 or 1) was observed as early as the first post-baseline visit at 
week 4 and the proportion of subjects who achieved a PGA score of 0 or 1 increased through week 16 
and then remained relatively stable through week 52. Improvements in PGA, PASI, and CDLQI were 
maintained through week 52 (Table 8).

Table 8 Summary of primary and secondary endpoints at week 12 and week 52
Paediatric psoriasis study (CADMUS Jr.) (Age 6-11)

Week 12 Week 52

Recommended dose of 
Ustekinumab

Recommended dose of 
Ustekinumab

N (%) N (%)
Patients enrolled 44 41
PGA
PGA of cleared (0) or minimal 
(1)

34 (77.3%) 31 (75.6%)



35

PGA of cleared (0) 17 (38.6%) 23 (56.1%)
PASI
PASI 75 responders 37 (84.1%) 36 (87.8%)
PASI 90 responders 28 (63.6%) 29 (70.7%)
PASI 100 responders 15 (34.1%) 22 (53.7%)
CDLQIa

Patients with a CDLQI > 1 at 
baseline

(N=39) (N=36)

CDLQI of 0 or 1 24 (61.5%) 21 (58.3%)
a CDLQI: The CDLQI is a dermatology instrument to assess the effect of a skin problem on the health-related quality 

of life in the paediatric population. CDLQI of 0 or 1 indicates no effect on child’s quality of life.

Crohn’s Disease
The safety and efficacy of ustekinumab was assessed in three randomized, double-blind, placebo-
controlled, multicenter studies in adult patients with moderately to severely active Crohn’s disease 
(Crohn’s Disease Activity Index [CDAI] score of ≥ 220 and ≤ 450). The clinical development program 
consisted of two 8-week intravenous induction studies (UNITI-1 and UNITI-2) followed by a 44 week 
subcutaneous randomized withdrawal maintenance study (IM-UNITI) representing 52 weeks of 
therapy.

The induction studies included 1409 (UNITI-1, n = 769; UNITI-2 n = 640) patients. The primary 
endpoint for both induction studies was the proportion of subjects in clinical response (defined as a 
reduction in CDAI score of ≥ 100 points) at week 6. Efficacy data were collected and analyzed 
through week 8 for both studies. Concomitant doses of oral corticosteroids, immunomodulators, 
aminosalicylates and antibiotics were permitted and 75% of patients continued to receive at least one 
of these medications. In both studies, patients were randomised to receive a single intravenous 
administration of either the recommended tiered dose of approximately 6 mg/kg (see section 4.2 of the 
STELARA 130 mg Concentrate for solution for infusion SmPC), a fixed dose of 130 mg ustekinumab, 
or placebo at week 0.

Patients in UNITI-1 had failed or were intolerant to prior anti-TNFα therapy. Approximately 48% of 
the patients had failed 1 prior anti-TNF therapy and 52% had failed 2 or 3 prior anti-TNFα therapies. 
In this study, 29.1% of the patients had an inadequate initial response (primary non-responders), 
69.4% responded but lost response (secondary non-responders), and 36.4% were intolerant to anti-
TNFα therapies.

Patients in UNITI-2 had failed at least one conventional therapy, including corticosteroids or 
immunomodulators, and were either anti-TNF-α naïve (68.6%) or had previously received but not 
failed anti-TNFα therapy (31.4%).

In both UNITI-1 and UNITI-2, a significantly greater proportion of patients were in clinical response 
and remission in the ustekinumab treated group compared to placebo (Table 9). Clinical response and 
remission were significant as early as week 3 in ustekinumab treated patients and continued to 
improve through week 8. In these induction studies, efficacy was higher and better sustained in the 
tiered dose group compared to the 130 mg dose group, and tiered dosing is therefore the recommended 
intravenous induction dose.

Table 9: Induction of Clinical Response and Remission in UNITI-1 and UNITI 2
UNITI-1* UNITI-2**

Placebo
N = 247

Recommende
d dose of 

ustekinumab
N = 249

Placebo
N = 209

Recommende
d dose of 

ustekinumab
N = 209

Clinical Remission, week 8 18 (7.3%) 52 (20.9%)a 41 (19.6%) 84 (40.2%)a

Clinical Response (100 point), week 6 53 (21.5%) 84 (33.7%)b 60 (28.7%) 116 (55.5%)a

Clinical Response (100 point), week 8 50 (20.2%) 94 (37.8%)a 67 (32.1%) 121 (57.9%)a

70 Point Response, week 3 67 (27.1%) 101 (40.6%)b 66 (31.6%) 106 (50.7%)a



36

70 Point Response, week 6 75 (30.4%) 109 (43.8%)b 81 (38.8%) 135 (64.6%)a

Clinical remission is defined as CDAI score < 150; Clinical response is defined as reduction in CDAI score by at least 
100 points or being in clinical remission
70 point response is defined as reduction in CDAI score by at least 70 points
* Anti-TNFα failures
** Conventional therapy failures
a p < 0.001
b p < 0.01

The maintenance study (IM-UNITI), evaluated 388 patients who achieved 100 point clinical response 
at week 8 of induction with ustekinumab in studies UNITI-1 and UNITI-2. Patients were randomized 
to receive a subcutaneous maintenance regimen of either 90 mg ustekinumab every 8 weeks, 90 mg 
ustekinumab every 12 weeks or placebo for 44 weeks (for recommended maintenance posology, see 
section 4.2).

Significantly higher proportions of patients maintained clinical remission and response in the 
ustekinumab treated groups compared to the placebo group at week 44 (see Table 10).

Table 10: Maintenance of Clinical Response and Remission in IM-UNITI (week 44; 52 weeks from 
initiation of the induction dose)

Placebo*

N = 131†

90 mg 
ustekinumab 
every 8 weeks

N = 128†

90 mg 
ustekinumab 

every 12 weeks

N = 129†

Clinical Remission 36% 53%a 49%b

Clinical Response 44% 59%b 58%b

Corticosteroid-Free Clinical Remission 30% 47%a 43%c

Clinical Remission in patients:
in remission at the start of maintenance 
therapy

46% (36/79) 67% (52/78)a 56% (44/78)

who entered from study CRD3002‡ 44% (31/70) 63% (45/72)c 57% (41/72)
who are Anti-TNFα naïve 49% (25/51) 65% (34/52)c 57% (30/53)
who entered from study CRD3001§ 26% (16/61) 41% (23/56) 39% (22/57)

Clinical remission is defined as CDAI score < 150; Clinical response is defined as reduction in CDAI of at least 100 points 
or being in clinical remission
* The placebo group consisted of patients who were in response to ustekinumab and were randomized to receive 

placebo at the start of maintenance therapy.
† Patients who were in 100 point clinical response to ustekinumab at start of maintenance therapy
‡ Patients who failed conventional therapy but not anti-TNFα therapy
§ Patients who are anti-TNFα refractory/intolerant
a p < 0.01
b p < 0.05
c nominally significant (p < 0.05)

In IM-UNITI, 29 of 129 patients did not maintain response to ustekinumab when treated every 
12 weeks and were allowed to dose adjust to receive ustekinumab every 8 weeks. Loss of response 
was defined as a CDAI score ≥ 220 points and a ≥ 100 point increase from the CDAI score at baseline.
In these patients, clinical remission was achieved in 41.4% of patients 16 weeks after dose adjustment.

Patients who were not in clinical response to ustekinumab induction at week 8 of the UNITI-1 and 
UNITI-2 induction studies (476 patients) entered into the non-randomized portion of the maintenance 
study (IM-UNITI) and received a 90 mg subcutaneous injection of ustekinumab at that time. 
Eight weeks later, 50.5% of the patients achieved clinical response and continued to receive 
maintenance dosing every 8 weeks; among these patients with continued maintenance dosing, a 
majority maintained response (68.1%) and achieved remission (50.2%) at week 44, at proportions that 
were similar to the patients who initially responded to ustekinumab induction.



37

Of 131 patients who responded to ustekinumab induction, and were randomized to the placebo group 
at the start of the maintenance study, 51 subsequently lost response and received 90 mg ustekinumab 
subcutaneously every 8 weeks. The majority of patients who lost response and resumed ustekinumab 
did so within 24 weeks of the induction infusion. Of these 51 patients, 70.6% achieved clinical 
response and 39.2% percent achieved clinical remission 16 weeks after receiving the first 
subcutaneous dose of ustekinumab.

In IM-UNITI, patients who completed the study through week 44 were eligible to continue treatment 
in a study extension. Among patients who entered the study extension, clinical remission and response 
were generally maintained through week 92 for both patients who failed TNF-therapies and those who 
failed conventional therapies.

No new safety concerns were identified in this study extension with up to 2 years of treatment in 
patients with Crohn’s Disease.

Endoscopy
Endoscopic appearance of the mucosa was evaluated in 252 patients with eligible baseline endoscopic 
disease activity in a substudy. The primary endpoint was change from baseline in Simplified 
Endoscopic Disease Severity Score for Crohn’s Disease (SES-CD), a composite score across 5 ileo-
colonic segments of presence/size of ulcers, proportion of mucosal surface covered by ulcers, 
proportion of mucosal surface affected by any other lesions and presence/type of narrowing/strictures.
At week 8, after a single intravenous induction dose, the change in SES-CD score was greater in the 
ustekinumab group (n = 155, mean change = -2.8) than in the placebo group (n = 97, mean 
change = -0.7, p = 0.012).

Fistula Response
In a subgroup of patients with draining fistulas at baseline (8.8%; n = 26), 12/15 (80%) of 
ustekinumab-treated patients achieved a fistula response over 44 weeks (defined as ≥ 50% reduction 
from baseline of the induction study in the number of draining fistulas) compared to 5/11 (45.5%) 
exposed to placebo.

Health-related quality of life
Health-related quality of life was assessed by Inflammatory Bowel Disease Questionnaire (IBDQ) and 
SF-36 questionnaires. At week 8, patients receiving ustekinumab showed statistically significantly 
greater and clinically meaningful improvements on IBDQ total score and SF-36 Mental Component 
Summary Score in both UNITI-1 and UNITI-2, and SF-36 Physical Component Summary Score in 
UNITI-2, when compared to placebo. These improvements were generally better maintained in 
ustekinumab-treated patients in the IM-UNITI study through week 44 when compared to placebo.
Improvement in health-related quality of life was generally maintained during the extension through 
week 92.

Ulcerative colitis
The safety and efficacy of ustekinumab was assessed in two randomized, double-blind, placebo-
controlled, multicenter studies in adult patients with moderately to severely active ulcerative colitis 
(Mayo score 6 to 12; Endoscopy subscore ≥ 2). The clinical development program consisted of one 
intravenous induction study (referred to as UNIFI-I) with treatment of up to 16 weeks followed by a 
44 week subcutaneous randomized withdrawal maintenance study (referred to as UNIFI-M)
representing at least 52 weeks of therapy.

Efficacy results presented for UNIFI-I and UNIFI-M were based on central review of endoscopies.

UNIFI-I included 961 patients. The primary endpoint for the induction study was the proportion of 
subjects in clinical remission at week 8. Patients were randomised to receive a single intravenous 
administration of either the recommended tiered dose of approximately 6 mg/kg (see Table 1, 
section 4.2), a fixed dose of 130 mg ustekinumab, or placebo at week 0.



38

Concomitant doses of oral corticosteroids, immunomodulators, and aminosalicylates were permitted 
and 90% of patients continued to receive at least one of these medications. Enrolled patients had to 
have failed conventional therapy (corticosteroids or immunomodulators) or at least one biologic (a 
TNFα antagonist and/or vedolizumab). 49% of patients had failed conventional therapy, but not a 
biologic (of which 94% where biological-naïve). 51% of patients had failed or were intolerant to a 
biologic. Approximately 50% of the patients had failed at least 1 prior anti-TNF therapy (of which 
48% were primary non-responders) and 17% had failed at least 1 anti-TNFα therapy and vedolizumab.

In UNIFI-I a significantly greater proportion of patients were in clinical remission in the ustekinumab 
treated group compared to placebo at week 8 (Table 11). As early as Week 2, the earliest scheduled 
study visit, and at each visit thereafter, a higher proportion of ustekinumab patients had no rectal 
bleeding or achieved normal stool frequency as compared with placebo patients. Significant 
differences in partial Mayo score and symptomatic remission were observed between ustekinumab and 
placebo as early as Week 2.

Efficacy was higher in the tiered dose group (6 mg/kg) compared to the 130 mg dose group in select 
endpoints, and tiered dosing is therefore the recommended intravenous induction dose.

Table 11: Summary of Key Efficacy Outcomes in UNIFI-I (Week 8)
Placebo
N = 319

Recommended dose 
of ustekinumab£

N = 322
Clinical Remission* 5% 16%a

In patients who failed conventional therapy, but not a 
biologic

9% (15/158) 19% (29/156)c

In patients who failed biological therapy¥ 1% (2/161) 13% (21/166)b

In patients who failed both a TNF and vedolizumab 0% (0/47) 10% (6/58%)c

Clinical Response§ 31% 62%a

In patients who failed conventional therapy, but not a 
biologic

35% (56/158) 67% (104/156)b

In patients who failed biological therapy¥ 27% (44/161) 57% (95/166)b

In patients who failed both a TNF and vedolizumab 28% (13/47) 52% (30/58)c

Mucosal Healing† 14% 27%a

In patients who failed conventional therapy, but not a 
biologic

21% (33/158) 33% (52/156)c

In patients who failed biological therapy 7% (11/161) 21% (35/166)b

Symptomatic Remission‡ 23% 45%b

Combined Symptomatic Remission and Mucosal 
Healing⸸

8% 21%b

£ Infusion dose of ustekinumab using the weight-based dosage regimen specified in Table 1.
* Clinical remission is defined as Mayo score ≤2 points, with no individual subscore > 1.
§ Clinical response is defined as a decrease from baseline in the Mayo score by ≥30% and ≥3 points, with either a decrease 

from baseline in the rectal bleeding subscore ≥1 or a rectal bleeding subscore of 0 or 1.
¥ A TNFα antagonist and/or vedolizumab.
† Mucosal healing is defined as a Mayo endoscopic subscore of 0 or 1.
‡ Symptomatic remission is defined as a Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.
⸸ Combined symptomatic remission and mucosal healing is defined as a stool frequency subscore of 0 or 1, a rectal 

bleeding subscore of 0, and an endoscopy subscore of 0 or 1.
a p < 0.001
b Nominally significant (p < 0.001)
c Nominally significant (p < 0.05)

UNIFI-M, evaluated 523 patients who achieved clinical response with single IV administration of 
ustekinumab in UNIFI-I. Patients were randomized to receive a subcutaneous maintenance regimen of 
either 90 mg ustekinumab every 8 weeks, 90 mg ustekinumab every 12 weeks or placebo for 44 weeks 
(for recommended maintenance posology, see section 4.2 of the STELARA Solution for injection 
(vial) and Solution for injection in pre-filled syringe SmPC).



39

Significantly greater proportions of patients were in clinical remission in both ustekinumab treated 
groups compared to the placebo group at week 44 (see Table 12).

Table 12: Summary of Key Efficacy Measures in UNIFI-M (week 44; 52 weeks from initiation of the 
induction dose)

Placebo*
N = 175

90 mg 
ustekinumab

every 8 Weeks
N = 176

90 mg 
ustekinumab 

every 
12 Weeks
N = 172

Clinical Remission** 24% 44% a 38% b

In patients who failed conventional 
therapy, but not a biologic

31% (27/87) 48% (41/85)d 49% (50/102) d

In patients who failed biological therapy¥ 17% (15/88) 40% (36/91) c 23% (16/70) d

In patients who failed both a TNF and 
vedolizumab

15% (4/27) 33% (7/21)e 23% (5/22)e

Maintenance of Clinical Response through 
week 44§

45% 71% a 68% a

In patients who failed conventional 
therapy, but not a biologic

51% (44/87) 78% (66/85) c 77% (78/102) c

In patients who failed biological therapy¥ 39% (34/88) 65% (59/91) c 56% (39/70) d

In patients who failed both a TNF and 
vedolizumab

41% (11/27) 67% (14/21)e 50% (11/22)e

Mucosal Healing† 29% 51% a 44% b

Maintenance of Clinical Remission through 
week 44£

38% (17/45) 58% (22/38) 65% (26/40) c

Corticosteroid Free Clinical Remission€ 23% 42% a 38% b

Durable Remissionǁ 35% 57% c 48% d

Symptomatic Remission‡ 45% 68% c 62% d

Combined Symptomatic Remission and 
Mucosal Healing⸸

28% 48% c 41% d

* Following response to IV ustekinumab.
** Clinical remission is defined as Mayo score ≤2 points, with no individual subscore > 1.
§ Clinical response is defined as a decrease from baseline in the Mayo score by ≥30% and ≥3 points, with either a

decrease from baseline in the rectal bleeding subscore ≥1 or a rectal bleeding subscore of 0 or 1.
¥ A TNFα antagonist and/or vedolizumab.
† Mucosal healing is defined as a Mayo endoscopic sub-score of 0 or 1.
£ Maintenance of clinical remission through Week 44 is defined as patients in clinical remission through Week 44 

among patients in clinical remission at maintenance baseline.
€ Corticosteroid-free clinical remission is defined as patients in clinical remission and not receiving corticosteroids at 

Week 44.
ǁ Durable Remission is defined as partial Mayo remission at ≥80% of all visits prior to Week 44 and in partial Mayo 

remission at last visit (Week 44).
‡ Symptomatic remission is defined as a Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.
⸸ Combined symptomatic remission and mucosal healing is defined as a stool frequency subscore of 0 or 1, a rectal 

bleeding subscore of 0, and an endoscopy subscore of 0 or 1.
a p < 0.001
b p < 0.05
c Nominally significant (p < 0.001)
d Nominally significant (p < 0.05)
e Not statistically significant

The beneficial effect of ustekinumab on clinical response, mucosal healing and clinical remission was 
observed in induction and in maintenance both in patients who failed conventional therapy but not a 
biologic therapy, as well as in those who had failed at least one prior TNFα antagonist therapy 
including in patients with a primary non-response to TNFα antagonist therapy. A beneficial effect was 
also observed in induction in patients who failed at least one prior TNFα antagonist therapy and 



40

vedolizumab, however the number of patients in this subgroup was too small to draw definitive 
conclusions about the beneficial effect in this group during maintenance.

Week 16 Responders to Ustekinumab Induction
Ustekinumab treated patients who were not in response at week 8 of UNIFI-I received an 
administration of 90 mg SC ustekinumab at week 8 (36% of patients). Of those patients, 9% of 
patients who were initially randomized to the recommended induction dose achieved clinical 
remission and 58% achieved clinical response at Week 16.

Patients who were not in clinical response to ustekinumab induction at week 8 of the UNFI-I study but 
were in response at week 16 (157 patients) entered into the non-randomized portion of UNIFI-M and 
continued to receive maintenance dosing every 8 weeks; among these patients, a majority (62%) 
maintained response and 30% achieved remission at week 44.

Endoscopic Normalization
Endoscopic normalization was defined as a Mayo endoscopic subscore of 0 and was observed as early 
as week 8 of UNIFI-I. At week 44 of UNIFI-M, it was achieved in 24% and 29% of patients treated 
with ustekinumab every 12 or 8 weeks, respectively, as compared to 18% of patients in the placebo 
group.

Histologic & Histo-Endoscopic Mucosal Healing
Histologic healing (defined as neutrophil infiltration in < 5% of crypts, no crypt destruction, and no 
erosions, ulcerations, or granulation tissue) was assessed at week 8 of UNIFI-I and Week 44 of 
UNIFI-M. At week 8, after a single intravenous induction dose, significantly greater proportions of 
patients in the recommended dose group achieved histologic healing (36%) compared with patients in 
the placebo group (22%). At Week 44 maintenance of this effect was observed with significantly more 
patients in histologic healing in the every 12 week (54%) and every 8 week (59%) ustekinumab groups 
as compared to placebo (33%).

A combined endpoint of histo-endoscopic mucosal healing defined as subjects having both mucosal 
healing and histologic healing was evaluated at week 8 of UNIFI-I and week 44 of UNIFI-M. Patients 
receiving ustekinumab at the recommended dose showed significant improvements on the histo-
endoscopic mucosal healing endpoint at week 8 in the ustekinumab group (18%) as compared to the 
placebo group (9%). At week 44, maintenance of this effect was observed with significantly more 
patients in histo-endoscopic mucosal healing in the every 12 week (39%) and every 8 week (46%) 
ustekinumab groups as compared to placebo (24%).

Health-related quality of life
Health-related quality of life was assessed by Inflammatory Bowel Disease Questionnaire (IBDQ), 
SF-36 and EuroQoL-5D (EQ-5D) questionnaires.

At week 8 of UNIFI-I, patients receiving ustekinumab showed significantly greater and clinically 
meaningful improvements on IBDQ total score, EQ-5D and EQ-5D VAS, and SF-36 Mental 
Component Summary Score and SF-36 Physical Component Summary Score when compared to 
placebo. These improvements were maintained in ustekinumab-treated patients in UNIFI-M through 
week 44.

Patients receiving ustekinumab experienced significantly more improvements in work productivity as 
assessed by greater reductions in overall work impairment and in activity impairment as assessed by 
the WPAI-GH questionnaire than patients receiving placebo.

Hospitalizations and ulcerative colitis (UC) related surgeries
Through week 8 of UNIFI-I, the proportions of subjects with UC disease related hospitalizations were 
significantly lower for subjects in the ustekinumab recommended dose group (1.6%, 5/322) compared 
with subjects in the placebo group (4.4%, 14/319) and no subjects underwent UC disease related 
surgeries in subjects receiving ustekinumab at the recommended induction dose compared to 0.6% 
(2/319) subjects in the placebo group.



41

Through week 44 of UNIFI-M, a significantly lower number of UC-related hospitalizations was 
observed in subjects in the combined ustekinumab group (2.0%, 7/348) as compared with subjects in 
the placebo group (5.7%, 10/175). A numerically lower number of subjects in the ustekinumab group 
(0.6%, 2/348) underwent UC disease related surgeries compared with subjects in the placebo group 
(1.7%, 3/175) through week 44.

Immunogenicity
Antibodies to ustekinumab may develop during ustekinumab treatment and most are neutralising. The 
formation of anti-ustekinumab antibodies is associated with both increased clearance and reduced 
efficacy of ustekinumab, except in patients with Crohn’s disease or ulcerative colitis where no reduced 
efficacy was observed. There is no apparent correlation between the presence of anti-ustekinumab 
antibodies and the occurrence of injection site reactions.

Paediatric population
The European Medicines Agency has deferred the obligation to submit the results of studies with 
ustekinumab in one or more subsets of the paediatric population in Crohn’s Disease and ulcerative 
colitis (see section 4.2 for information on paediatric use).

5.2 Pharmacokinetic properties

Absorption
The median time to reach the maximum serum concentration (tmax) was 8.5 days after a single 90 mg 
subcutaneous administration in healthy subjects. The median tmax values of ustekinumab following a 
single subcutaneous administration of either 45 mg or 90 mg in patients with psoriasis were 
comparable to those observed in healthy subjects.

The absolute bioavailability of ustekinumab following a single subcutaneous administration was 
estimated to be 57.2% in patients with psoriasis.

Distribution
Median volume of distribution during the terminal phase (Vz) following a single intravenous 
administration to patients with psoriasis ranged from 57 to 83 mL/kg.

Biotransformation
The exact metabolic pathway for ustekinumab is unknown.

Elimination
Median systemic clearance (CL) following a single intravenous administration to patients with 
psoriasis ranged from 1.99 to 2.34 mL/day/kg. Median half-life (t1/2) of ustekinumab was 
approximately 3 weeks in patients with psoriasis, psoriatic arthritis, Crohn’s disease or ulcerative 
colitis, ranging from 15 to 32 days across all psoriasis and psoriatic arthritis studies. In a population 
pharmacokinetic analysis, the apparent clearance (CL/F) and apparent volume of distribution (V/F) 
were 0.465 l/day and 15.7 l, respectively, in patients with psoriasis. The CL/F of ustekinumab was not 
impacted by gender. Population pharmacokinetic analysis showed that there was a trend towards a 
higher clearance of ustekinumab in patients who tested positive for antibodies to ustekinumab.

Dose linearity
The systemic exposure of ustekinumab (Cmax and AUC) increased in an approximately 
dose-proportional manner after a single intravenous administration at doses ranging from 0.09 mg/kg 
to 4.5 mg/kg or following a single subcutaneous administration at doses ranging from approximately 
24 mg to 240 mg in patients with psoriasis.

Single dose versus multiple doses
Serum concentration-time profiles of ustekinumab were generally predictable after single or multiple 
subcutaneous dose administrations. In patients with psoriasis, steady-state serum concentrations of 
ustekinumab were achieved by week 28 after initial subcutaneous doses at Weeks 0 and 4 followed by 



42

doses every 12 weeks. The median steady-state trough concentration ranged from 0.21 μg/mL to 
0.26 μg/mL (45 mg) and from 0.47 μg/mL to 0.49 μg/mL (90 mg). There was no apparent 
accumulation in serum ustekinumab concentration over time when given subcutaneously every 
12 weeks.

In patients with Crohn’s disease and ulcerative colitis, following an intravenous dose of ~6 mg/kg, 
starting at week 8, subcutaneous maintenance dosing of 90 mg ustekinumab was administered every 8 
or 12 weeks. Steady state ustekinumab concentration was achieved by the start of the second 
maintenance dose. In patients with Crohn’s disease, median steady-state trough concentrations ranged 
from 1.97 μg/mL to 2.24 μg/mL and from 0.61 μg/mL to 0.76 μg/mL for 90 mg ustekinumab every 
8 weeks or every 12 weeks respectively. In patients with ulcerative colitis, median steady-state trough 
concentrations ranged from 2.69 μg/mL to 3.09 μg/mL and from 0.92 μg/mL to 1.19 μg/mL for 90 mg 
ustekinumab every 8 weeks or every 12 weeks. The steady-state trough ustekinumab levels resulting 
from 90 mg ustekinumab every 8 weeks were associated with higher clinical remission rates as 
compared to the steady-state trough levels following 90 mg every 12 weeks.

Impact of weight on pharmacokinetics
In a population pharmacokinetic analysis using data from patients with psoriasis, body weight was 
found to be the most significant covariate affecting the clearance of ustekinumab. The median CL/F in 
patients with weight > 100 kg was approximately 55% higher compared to patients with weight 
≤ 100 kg. The median V/F in patients with weight > 100 kg was approximately 37% higher as 
compared to patients with weight ≤ 100 kg. The median trough serum concentrations of ustekinumab 
in patients with higher weight (> 100 kg) in the 90 mg group were comparable to those in patients with 
lower weight (≤ 100 kg) in the 45 mg group. Similar results were obtained from a confirmatory 
population pharmacokinetic analysis using data from patients with psoriatic arthritis.

Dosing frequency adjustment
In patients with Crohn’s disease and ulcerative colitis, based on observed data and population PK 
analyses, randomized subjects who lost response to treatment had lower serum ustekinumab 
concentrations over time compared with subjects who did not lose response. In Crohn’s disease, dose 
adjustment from 90 mg every 12 weeks to 90 mg every 8 weeks was associated with an increase in 
trough serum ustekinumab concentrations and an accompanying increase in efficacy. In ulcerative 
colitis, population PK model based simulations demonstrated that adjusting dosing from 90 mg every 
12 weeks to every 8 weeks would be expected to result in a 3-fold increase in steady-state trough 
ustekinumab concentrations. Additionally on the basis of clinical trial data in patients with ulcerative 
colitis, a positive exposure-response relationship was established between trough concentrations, and 
clinical remission and mucosal healing.

Special populations
No pharmacokinetic data are available in patients with impaired renal or hepatic function.
No specific studies have been conducted in elderly patients.

The pharmacokinetics of ustekinumab were generally comparable between Asian and non-Asian 
patients with psoriasis and ulcerative colitis.

In patients with Crohn’s disease and ulcerative colitis, variability in ustekinumab clearance was 
affected by body weight, serum albumin level, sex, and antibody to ustekinumab status while body 
weight was the main covariate affecting the volume of distribution. Additionally in Crohn’s disease, 
clearance was affected by C-reactive protein, TNF antagonist failure status and race (Asian versus 
non-Asian). The impact of these covariates was within ± 20% of the typical or reference value of the 
respective PK parameter, thus dose adjustment is not warranted for these covariates. Concomitant use 
of immunomodulators did not have a significant impact on ustekinumab disposition.

In the population pharmacokinetic analysis, there were no indications of an effect of tobacco or 
alcohol on the pharmacokinetics of ustekinumab.

Serum ustekinumab concentrations in paediatric psoriasis patients 6 to 17 years of age, treated with the 



43

recommended weight-based dose were generally comparable to those in the adult psoriasis population
treated with the adult dose. Serum ustekinumab concentrations in paediatric psoriasis patients 
12-17 years of age (CADMUS) treated with half of the recommended weight-based dose were 
generally lower than those in adults.

Regulation of CYP450 enzymes
The effects of IL-12 or IL-23 on the regulation of CYP450 enzymes were evaluated in an in vitro
study using human hepatocytes, which showed that IL-12 and/or IL-23 at levels of 10 ng/mL did not 
alter human CYP450 enzyme activities (CYP1A2, 2B6, 2C9, 2C19, 2D6, or 3A4; see section 4.5).

5.3 Preclinical safety data

Non-clinical data reveal no special hazard (e.g. organ toxicity) for humans based on studies of 
repeated-dose toxicity and developmental and reproductive toxicity, including safety pharmacology 
evaluations. In developmental and reproductive toxicity studies in cynomolgus monkeys, neither 
adverse effects on male fertility indices nor birth defects or developmental toxicity were observed. No 
adverse effects on female fertility indices were observed using an analogous antibody to IL-12/23 in 
mice.

Dose levels in animal studies were up to approximately 45-fold higher than the highest equivalent 
dose intended to be administered to psoriasis patients and resulted in peak serum concentrations in 
monkeys that were more than 100-fold higher than observed in humans.

Carcinogenicity studies were not performed with ustekinumab due to the lack of appropriate models 
for an antibody with no cross-reactivity to rodent IL-12/23 p40.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

L-histidine
L-histidine monohydrochloride monohydrate
Polysorbate 80
Sucrose
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

STELARA 45 mg solution for injection
2 years

STELARA 45 mg solution for injection in pre-filled syringe
3 years

STELARA 90 mg solution for injection in pre-filled syringe
3 years

Individual pre-filled syringes may be stored at room temperature up to 30°C for a maximum single 
period of up to 30 days in the original carton in order to protect from light. Record the date when the 
pre-filled syringe is first removed from the refrigerator and the discard date in the spaces provided on 
the outer carton. The discard date must not exceed the original expiry date printed on the carton. Once 



44

a syringe has been stored at room temperature (up to 30°C), it should not be returned to the 
refrigerator. Discard the syringe if not used within 30 days at room temperature storage or by the 
original expiry date, whichever is earlier.

6.4 Special precautions for storage

Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the vial or pre-filled syringe in the outer carton in order to protect from light.
If needed, individual pre-filled syringes may be stored at room temperature up to 30°C (see 
section 6.3).

6.5 Nature and contents of container

STELARA 45 mg solution for injection
0.5 mL solution in a type I glass 2 mL vial closed with a coated butyl rubber stopper.

STELARA 45 mg solution for injection in pre-filled syringe
0.5 mL solution in a type I glass 1 mL syringe with a fixed stainless steel needle and a needle cover 
containing dry natural rubber (a derivative of latex). The syringe is fitted with a passive safety guard.

STELARA 90 mg solution for injection in pre-filled syringe
1 mL solution in a type I glass 1 mL syringe with a fixed stainless steel needle and a needle cover 
containing dry natural rubber (a derivative of latex). The syringe is fitted with a passive safety guard.

STELARA is available in a 1 vial pack or a pack of 1 pre-filled syringe.

6.6 Special precautions for disposal and other handling

The solution in the STELARA vial or pre-filled syringe should not be shaken. The solution should be 
visually inspected for particulate matter or discoloration prior to subcutaneous administration. The
solution is clear to slightly opalescent, colourless to light yellow and may contain a few small 
translucent or white particles of protein. This appearance is not unusual for proteinaceous solutions. 
The medicinal product should not be used if the solution is discoloured or cloudy, or if foreign 
particulate matter is present. Before administration, STELARA should be allowed to reach room
temperature (approximately half an hour). Detailed instructions for use are provided in the package 
leaflet.

STELARA does not contain preservatives; therefore any unused medicinal product remaining in the 
vial and the syringe should not be used. STELARA is supplied as a sterile, single-use vial or single-
use pre-filled syringe. The syringe, needle and vial must never be re-used. Any unused medicinal 
product or waste material should be disposed of in accordance with local requirements.

When using the single-dose vial, a 1 mL syringe with a 27 gauge, ½ inch (13 mm) needle is 
recommended.

7. MARKETING AUTHORISATION HOLDER

Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium



45

8. MARKETING AUTHORISATION NUMBER(S)

STELARA 45 mg solution for injection
EU/1/08/494/001

STELARA 45 mg solution for injection in pre-filled syringe
EU/1/08/494/003

STELARA 90 mg solution for injection in pre-filled syringe
EU/1/08/494/004

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 16 January 2009
Date of latest renewal: 19 September 2013

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/


46

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



47

A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturers of the biological active substance

Janssen Biologics B.V.
Einsteinweg 101
NL-2333 CB Leiden
The Netherlands

Janssen Sciences Ireland UC
Barnahely
Ringaskiddy
Co. Cork
Ireland

Name and address of the manufacturer responsible for batch release

Janssen Biologics B.V.
Einsteinweg 101
NL-2333 CB Leiden
The Netherlands

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.

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.



48

ANNEX III

LABELLING AND PACKAGE LEAFLET



49

A. LABELLING



50

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (130 mg)

1. NAME OF THE MEDICINAL PRODUCT

STELARA 130 mg concentrate for solution for infusion
ustekinumab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 130 mg of ustekinumab in 26 mL.

3. LIST OF EXCIPIENTS

Excipients: EDTA disodium salt dihydrate, L-histidine, L-histidine monohydrochloride monohydrate, 
L-methionine, polysorbate 80, sucrose, water for injection.

4. PHARMACEUTICAL FORM AND CONTENTS

Concentrate for Solution for infusion
130 mg/26 mL
1 vial

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Do not shake.
Read the package leaflet before use.
For single use only.
Intravenous use after dilution.

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.



51

Do not freeze.
Keep the vial 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

Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/08/494/005

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including in Braille accepted.

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC
SN
NN



52

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL TEXT (130 mg)

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

STELARA 130 mg concentrate for solution for infusion
ustekinumab

2. METHOD OF ADMINISTRATION

For IV use after dilution.
Do not shake.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

130 mg/26 mL

6. OTHER



53

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

VIAL CARTON TEXT (45 mg)

1. NAME OF THE MEDICINAL PRODUCT

STELARA 45 mg solution for injection
ustekinumab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 45 mg of ustekinumab in 0.5 mL.

3. LIST OF EXCIPIENTS

Excipients: Sucrose, L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, water 
for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection
45 mg/0.5 mL
1 vial

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Do not shake.
Subcutaneous use
Read the package leaflet before 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.
Do not freeze.



54

Keep the vial 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

Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/08/494/001

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

STELARA 45 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC
SN
NN



55

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL TEXT (45 mg)

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

STELARA 45 mg solution for injection
ustekinumab
SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

45 mg/0.5 mL

6. OTHER



56

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED SYRINGE CARTON TEXT (45 mg)

1. NAME OF THE MEDICINAL PRODUCT

STELARA 45 mg solution for injection in pre-filled syringe
ustekinumab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled syringe contains 45 mg of ustekinumab in 0.5 mL.

3. LIST OF EXCIPIENTS

Excipients: Sucrose, L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, water 
for injections. The container of this medicinal product contains latex rubber. See the package leaflet 
for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection in pre-filled syringe
45 mg/0.5 mL
1 pre-filled syringe

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Do not shake.
Subcutaneous use
Read the package leaflet before 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
Discard date, if stored at room temperature:___________________



57

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.
Can be stored at room temperature (up to 30°C) for a single period up to 30 days, but not exceeding 
the original expiry date.

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

Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/08/494/003

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

STELARA 45 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.



58

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC
SN
NN



59

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE LABEL TEXT (45 mg)

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

STELARA 45 mg injection
ustekinumab
SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

45 mg/0.5 mL

6. OTHER



60

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED SYRINGE CARTON TEXT (90 mg)

1. NAME OF THE MEDICINAL PRODUCT

STELARA 90 mg solution for injection in pre-filled syringe
ustekinumab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled syringe contains 90 mg of ustekinumab in 1 mL.

3. LIST OF EXCIPIENTS

Excipients: Sucrose, L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, water 
for injections. The container of this medicinal product contains latex rubber. See the package leaflet 
for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection in pre-filled syringe
90 mg/1 mL
1 pre-filled syringe

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Do not shake.
Subcutaneous use
Read the package leaflet before 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
Discard date, if stored at room temperature:___________________



61

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.
Can be stored at room temperature (up to 30°C) for a single period up to 30 days, but not exceeding 
the original expiry date.

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

Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/08/494/004

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

STELARA 90 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.



62

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC
SN
NN



63

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE LABEL TEXT (90 mg)

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

STELARA 90 mg injection
ustekinumab
SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

90 mg/1 mL

6. OTHER



64

B. PACKAGE LEAFLET



65

Package leaflet: Information for the user

STELARA 130 mg concentrate for solution for infusion
ustekinumab

Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you.

This leaflet has been written for the person taking the medicine.

- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4.

What is in this leaflet
1. What Stelara is and what it is used for
2. What you need to know before you use Stelara
3. How Stelara will be given
4. Possible side effects
5. How to store Stelara
6. Contents of the pack and other information

1. What Stelara is and what it is used for

What Stelara is
Stelara contains the active substance ‘ustekinumab’, a monoclonal antibody. Monoclonal antibodies 
are proteins that recognise and bind specifically to certain proteins in the body.

Stelara belongs to a group of medicines called ‘immunosuppressants’. These medicines work by 
weakening part of the immune system.

What Stelara is used for
Stelara is used to treat the following inflammatory diseases:
 Moderate to severe Crohn’s disease - in adults
 Moderate to severe ulcerative colitis - in adults

Crohn’s disease
Crohn’s disease is an inflammatory disease of the bowel. If you have Crohn’s disease you will first be 
given other medicines. If you do not respond well enough or are intolerant to these medicines, you 
may be given Stelara to reduce the signs and symptoms of your disease.

Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the bowel. If you have ulcerative colitis you will first 
be given other medicines. If you do not respond well enough or are intolerant to these medicines, you 
may be given Stelara to reduce the signs and symptoms of your disease.

2. What you need to know before you use Stelara

Do not use Stelara:
 If you are allergic to ustekinumab or any of the other ingredients of this medicine (listed in 

section 6).
 If you have an active infection which your doctor thinks is important.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using 



66

Stelara.

Warnings and precautions
Talk to your doctor or pharmacist before using Stelara. Your doctor will check how well you are 
before treatment. Make sure you tell your doctor about any illness you have before treatment. Also tell 
your doctor if you have recently been near anyone who might have tuberculosis. Your doctor will 
examine you and do a test for tuberculosis, before you have Stelara. If your doctor thinks you are at 
risk of tuberculosis, you may be given medicines to treat it.

Look out for serious side effects
Stelara can cause serious side effects, including allergic reactions and infections. You must look out 
for certain signs of illness while you are taking Stelara. See ‘Serious side effects’ in section 4 for a full 
list of these side effects.

Before you use Stelara tell your doctor:
 If you ever had an allergic reaction to Stelara. Ask your doctor if you are not sure.
 If you have ever had any type of cancer – this is because immunosuppressants like Stelara 

weaken part of the immune system. This may increase the risk of cancer.
 If you have or have had a recent infection or if you have any abnormal skin openings 

(fistulae).
 If you have any new or changing lesions within psoriasis areas or on normal skin.
 If you are having any other treatment for psoriasis and/or psoriatic arthritis – such as 

another immunosuppressant or phototherapy (when your body is treated with a type of 
ultraviolet (UV) light). These treatments may also weaken part of the immune system. Using 
these therapies together with Stelara has not been studied. However it is possible it may increase 
the chance of diseases related to a weaker immune system.

 If you are having or have ever had injections to treat allergies – it is not known if Stelara 
may affect these.

 If you are 65 years of age or over – you may be more likely to get infections.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using 
Stelara.

Children and adolescents
Stelara is not recommended for use in children under 18 years of age with Crohn’s disease or 
ulcerative colitis because it has not been studied in this age group.

Other medicines, vaccines and Stelara
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 going to have a vaccination. Some types of vaccines (live 

vaccines) should not be given while using Stelara.

Pregnancy and breast-feeding
 It is preferable to avoid the use of Stelara in pregnancy. The effects of Stelara 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 Stelara and for at least 
15 weeks after the last Stelara treatment.

 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 should breast-feed or use Stelara - do not do both.

Driving and using machines
Stelara has no or negligible influence on the ability to drive and use machines.



67

Stelara contains sodium
Stelara contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’. 
However, before Stelara is given to you, it is mixed with a solution that contains sodium. Talk to your 
doctor if you are on a low salt diet.

3. How Stelara will be given

Stelara is intended for use under the guidance and supervision of a doctor experienced in the diagnosis 
and treatment of Crohn’s disease or ulcerative colitis.

Stelara 130 mg concentrate for solution for infusion will be given to you by your doctor, through a 
drip in the vein of your arm (intravenous infusion) over at least one hour. Talk to your doctor about 
when you will have your injections and follow-up appointments.

How much Stelara is given
Your doctor will decide how much Stelara you need to receive and for how long.

Adults aged 18 years or older
 The doctor will work out the recommended intravenous infusion dose for you based on your 

body weight.

Your body weight Dose
≤ 55 kg 260 mg
> 55 kg to ≤ 85 kg 390 mg
> 85 kg 520 mg

 After the starting intravenous dose, you will have the next dose of 90 mg Stelara by an injection 
under your skin (subcutaneous injection) 8 weeks later, and then every 12 weeks therafter.

How Stelara is given
 The first dose of Stelara for treatment of Crohn’s disease or ulcerative colitis is given by a 

doctor as a drip in the vein of an arm (intravenous infusion).
Talk to your doctor if you have any questions about receiving Stelara.

If you forget to use Stelara
If you forget or miss the appointment for receiving the dose, contact your doctor to reschedule your 
appointment.

If you stop using Stelara
It is not dangerous to stop using Stelara. However, if you stop, your symptoms may come back.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
Some patients may have serious side effects that may need urgent treatment.

Allergic reactions – these may need urgent treatment. Tell your doctor or get emergency 
medical help straight away if you notice any of the following signs.
 Serious allergic reactions (‘anaphylaxis’) are rare in people taking Stelara (may affect up 

to 1 in 1,000 people). Signs include:
o difficulty breathing or swallowing



68

o low blood pressure, which can cause dizziness or light-headedness
o swelling of the face, lips, mouth or throat.

 Common signs of an allergic reaction include skin rash and hives (these may affect up to 
1 in 100 people).

In rare cases, allergic lung reactions and lung inflammation have been reported in patients 
who receive ustekinumab. Tell your doctor right away if you develop symptoms such as 
cough, shortness of breath, and fever.

If you have a serious allergic reaction, your doctor may decide that you should not use Stelara 
again.

Infections – these may need urgent treatment. Tell your doctor straight away if you notice 
any of the following signs.
 Infections of the nose or throat and common cold are common (may affect up to 1 in 

10 people)
 Infections of the chest are uncommon (may affect up to 1 in 100 people)
 Inflammation of tissue under the skin (‘cellulitis’) is uncommon (may affect up to 1 in 

100 people)
 Shingles (a type of painful rash with blisters) are uncommon (may affect up to 1 in 

100 people)

Stelara may make you less able to fight infections, and some infections could become serious.
You must look out for signs of infection while you are using Stelara. These 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 when passing water
 diarrhoea.

Tell your doctor straight away if you notice any of these signs of infection. These may be signs 
of infections such as chest infections, or skin infections or shingles that could have serious 
complications. Tell your doctor if you have any kind of infection that will not go away or keeps 
coming back. Your doctor may decide that you should not use Stelara until the infection goes 
away. Also tell your doctor if you have any open cuts or sores as they might get infected.

Shedding of skin – increase in redness and shedding of skin over a larger area of the body 
may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious 
skin conditions. You should tell your doctor straight away if you notice any of these signs.

Other side effects

Common side effects (may affect up to 1 in 10 people):
 Diarrhoea
 Nausea
 Vomiting
 Feeling tired
 Feeling dizzy
 Headache
 Itching (‘pruritus’)
 Back, muscle or joint pain
 Sore throat
 Redness and pain where the injection is given
 Sinus infection



69

Uncommon side effects (may affect up to 1 in 100 people):
 Tooth infections
 Vaginal yeast infection
 Depression
 Blocked or stuffy nose
 Bleeding, bruising, hardness, swelling and itching where the injection is given
 Feeling weak
 Drooping eyelid and sagging muscles on one side of the face (‘facial palsy’ or ‘Bell’s 

palsy’), which is usually temporary
 A change in psoriasis with redness and new tiny, yellow or white skin blisters, sometimes 

accompanied by fever (pustular psoriasis)
 Peeling of the skin (skin exfoliation)
 Acne

Rare side effects (may affect up to 1 in 1000 people)
 Redness and shedding of skin over a larger area of the body, which may be itchy or 

painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural change 
in the type of psoriasis symptoms (erythrodermic psoriasis)

 Inflammation of small blood vessels, which can lead to a skin rash with small red or 
purple bumps, fever or joint pain (vasculitis)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 Stelara

 Stelara 130 mg concentrate for solution for infusion is given in a hospital or clinic and patients 
should not need to store or handle it.

 Keep this medicine out of the sight and reach of children.
 Store in a refrigerator (2°C–8°C). Do not freeze.
 Keep the vial in the outer carton in order to protect from light.
 Do not shake the Stelara vials. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine:
 After the expiry date which is stated on the label and the carton after ‘EXP’. The expiry date 

refers to the last day of that month.
 If the liquid is discoloured, cloudy or you can see other foreign particles floating in it (see 

section 6 ‘What Stelara looks like and contents of the pack’).
 If you know, or think that it may have been exposed to extreme temperatures (such as 

accidentally frozen or heated).
 If the product has been shaken vigorously.
 If the seal is broken.

Stelara is for single use only. Any diluted infusion solution or unused product remaining in the vial 
and the syringe should be thrown away in accordance with local requirements.

6. Contents of the pack and other information

What Stelara contains
 The active substance is ustekinumab. Each vial contains130 mg ustekinumab in 26 mL.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000134.jsp&mid=WC0b01ac0580022c59


70

 The other ingredients are EDTA disodium salt dihydrate, L-histidine, L-histidine 
monohydrochloride monohydrate, L-methionine, polysorbate 80, sucrose and water for 
injection.

What Stelara looks like and contents of the pack
Stelara is a clear, colourless to light yellow concentrate for solution for infusion. It is supplied as a 
carton pack containing 1 single-dose, glass 30 mL vial. Each vial contains 130 mg ustekinumab in 
26 mL of concentrate for solution for infusion.

Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer
Janssen Biologics B.V.
Einsteinweg 101
2333 CB Leiden
The Netherlands

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder:

België/Belgique/Belgien
Janssen-Cilag NV
Tel/Tél: + 32 14 64 94 11
janssen@jacbe.jnj.com

Lietuva
UAB "JOHNSON & JOHNSON"
Tel: +370 5 278 68 88
lt@its.jnj.com

България
„Джонсън & Джонсън България” ЕООД
Тел.: +359 2 489 94 00
jjsafety@its.jnj.com

Luxembourg/Luxemburg
Janssen-Cilag NV
Tél/Tel: +32 14 64 94 11
janssen@jacbe.jnj.com

Česká republika
Janssen-Cilag s.r.o.
Tel: +420 227 012 227

Magyarország
Janssen-Cilag Kft.
Tel.: +36 1 884 2858
janssenhu@its.jnj.com

Danmark
Janssen-Cilag A/S
Tlf: +45 4594 8282
jacdk@its.jnj.com

Malta
AM MANGION LTD
Tel: +356 2397 6000

Deutschland
Janssen-Cilag GmbH
Tel: +49 2137 955 955
jancil@its.jnj.com

Nederland
Janssen-Cilag B.V.
Tel: +31 76 711 1111
janssen@jacnl.jnj.com

Eesti
UAB "JOHNSON & JOHNSON" Eesti filiaal
Tel: +372 617 7410
ee@its.jnj.com

Norge
Janssen-Cilag AS
Tlf: + 47 24 12 65 00
jacno@its.jnj.com



71

Ελλάδα
Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε.
Tηλ: +30 210 80 90 000

Österreich
Janssen-Cilag Pharma GmbH
Tel: +43 1 610 300 

España
Janssen-Cilag, S.A.
Tel: +34 91 722 81 00
contacto@its.jnj.com

Polska
Janssen-Cilag Polska Sp. z o.o.
Tel.: + 48 22 237 60 00

France
Janssen-Cilag
Tél: 0 800 25 50 75 / +33 1 55 00 40 03
medisource@its.jnj.com

Portugal
Janssen-Cilag Farmacêutica, Lda.
Tel: +351 214 368 600

Hrvatska
Johnson & Johnson S.E. d.o.o.
Tel: +385 1 6610 700
jjsafety@JNJCR.JNJ.com

România
Johnson & Johnson România SRL
Tel: +40 21 207 1800

Ireland
Janssen Sciences Ireland UC
Tel: +353 1 800 709 122

Slovenija
Johnson & Johnson d.o.o.
Tel. +386 1 401 18 00
Janssen_safety_slo@its.jnj.com

Ísland
Janssen-Cilag AB
c/o Vistor hf.
Sími: +354 535 7000
janssen@vistor.is

Slovenská republika
Johnson & Johnson, s.r.o.
Tel: +421 232 408 400

Italia
Janssen-Cilag SpA
Tel: 800.688.777 / +39 02 2510 1
janssenita@its.jnj.com

Suomi/Finland
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300
jacfi@its.jnj.com

Κύπρος
Βαρνάβας Χατζηπαναγής Λτδ
Tηλ: +357 22 207 700

Sverige
Janssen-Cilag AB
Tfn: +46 8 626 50 00
jacse@its.jnj.com

Latvija
UAB "JOHNSON & JOHNSON" filiāle 
Latvijā
Tel: +371 678 93561
lv@its.jnj.com

United Kingdom
Janssen-Cilag Ltd.
Tel: +44 1 494 567 444

This leaflet was last revised in {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/.

---------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

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


72

Traceability:

In order to improve the traceability of biological medicinal products, the tradename and the batch 
number of the administered product should be clearly recorded.

Instructions for dilution:

STELARA concentrate for solution for infusion must be diluted, prepared and infused by a healthcare 
professional using aseptic technique.

1. Calculate the dose and the number of STELARA vials needed based on patient weight (see 
section 3, Table 1). Each 26 mL vial of STELARA contains 130 mg of ustekinumab.

2. Withdraw and then discard a volume of the sodium chloride 9 mg/mL (0.9%) solution from the 
250 mL infusion bag equal to the volume of STELARA to be added (discard 26 mL sodium 
chloride for each vial of STELARA needed, for 2 vials- discard 52 mL, for 3 vials discard 
78 mL, for 4 vials- discard 104 mL).

3. Withdraw 26 mL of STELARA from each vial needed and add it to the 250 mL infusion bag. 
The final volume in the infusion bag should be 250 mL. Gently mix.

4. Visually inspect the diluted solution before infusion. Do not use if visibly opaque particles, 
discoloration or foreign particles are observed.

5. Infuse the diluted solution over a period of at least one hour. Once diluted, the infusion should 
be completed within eight hours of the dilution in the infusion bag.

6. Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore 
size 0.2 micrometer).

7. Each vial is for single use only and any unused medicinal product should be disposed of in 
accordance with local requirements.

Storage
If necessary, the diluted infusion solution may be stored at room temperature. The infusion should be 
completed within 8 hours of the dilution in the infusion bag. Do not freeze.



73

Package leaflet: Information for the user

STELARA 45 mg solution for injection
ustekinumab

Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you.

This leaflet has been written for the person taking the medicine. If you are the parent or 
caregiver who will give Stelara to a child, please read this information carefully.

- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- 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 or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4.

What is in this leaflet
1. What Stelara is and what it is used for
2. What you need to know before you use Stelara
3. How to use Stelara
4. Possible side effects
5. How to store Stelara
6. Contents of the pack and other information

1. What Stelara is and what it is used for

What Stelara is
Stelara contains the active substance ‘ustekinumab’, a monoclonal antibody. Monoclonal antibodies 
are proteins that recognise and bind specifically to certain proteins in the body.

Stelara belongs to a group of medicines called ‘immunosuppressants’. These medicines work by 
weakening part of the immune system.

What Stelara is used for
Stelara is used to treat the following inflammatory diseases:
 Plaque psoriasis - in adults and children aged 6 years and older
 Psoriatic arthritis - in adults
 Moderate to severe Crohn’s disease - in adults
 Moderate to severe ulcerative colitis – in adults

Plaque psoriasis
Plaque psoriasis is a skin condition that causes inflammation affecting the skin and nails. Stelara will 
reduce the inflammation and other signs of the disease.

Stelara is used in adults with moderate to severe plaque psoriasis, who cannot use ciclosporin,
methotrexate or phototherapy, or where these treatments did not work.

Stelara is used in children and adolescents aged 6 years and older with moderate to severe plaque 
psoriasis who are unable to tolerate phototherapy or other systemic therapies or where these treatments 
did not work.



74

Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints, usually 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 may be given Stelara to:
 Reduce the signs and symptoms of your disease.
 Improve your physical function.
 Slow down the damage to your joints.

Crohn’s disease
Crohn’s disease is an inflammatory disease of the bowel. If you have Crohn’s disease you will first be 
given other medicines. If you do not respond well enough or are intolerant to these medicines, you 
may be given Stelara to reduce the signs and symptoms of your disease.

Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the bowel. If you have ulcerative colitis you will first 
be given other medicines. If you do not respond well enough or are intolerant to these medicines, you 
may be given Stelara to reduce the signs and symptoms of your disease.

2. What you need to know before you use Stelara

Do not use Stelara:
 If you are allergic to ustekinumab or any of the other ingredients of this medicine (listed in 

section 6).
 If you have an active infection which your doctor thinks is important.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using
Stelara.

Warnings and precautions
Talk to your doctor or pharmacist before using Stelara. Your doctor will check how well you are 
before each treatment. Make sure you tell your doctor about any illness you have before each 
treatment. Also tell your doctor if you have recently been near anyone who might have tuberculosis. 
Your doctor will examine you and do a test for tuberculosis, before you have Stelara. If your doctor 
thinks you are at risk of tuberculosis, you may be given medicines to treat it.

Look out for serious side effects
Stelara can cause serious side effects, including allergic reactions and infections. You must look out 
for certain signs of illness while you are taking Stelara. See ‘Serious side effects’ in section 4 for a full 
list of these side effects.

Before you use Stelara tell your doctor:
 If you ever had an allergic reaction to Stelara. Ask your doctor if you are not sure.
 If you have ever had any type of cancer – this is because immunosuppressants like Stelara 

weaken part of the immune system. This may increase the risk of cancer.
 If you have or have had a recent infection.
 If you have any new or changing lesions within psoriasis areas or on normal skin.
 If you are having any other treatment for psoriasis and/or psoriatic arthritis – such as 

another immunosuppressant or phototherapy (when your body is treated with a type of 
ultraviolet (UV) light). These treatments may also weaken part of the immune system. Using 
these therapies together with Stelara has not been studied. However it is possible it may increase 
the chance of diseases related to a weaker immune system.

 If you are having or have ever had injections to treat allergies – it is not known if Stelara 
may affect these.

 If you are 65 years of age or over – you may be more likely to get infections.



75

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using
Stelara.

Children and adolescents
Stelara is not recommended for use in children with psoriasis under 6 years of age, or for use in 
children under 18 years of age with psoriatic arthritis, Crohn’s disease, or ulcerative colitis because it 
has not been studied in this age group.

Other medicines, vaccines and Stelara
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 going to have a vaccination. Some types of vaccines (live 

vaccines) should not be given while using Stelara.

Pregnancy and breast-feeding
 It is preferable to avoid the use of Stelara in pregnancy. The effects of Stelara 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 Stelara and for at least 
15 weeks after the last Stelara treatment.

 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 should breast-feed or use Stelara - do not do both.

Driving and using machines
Stelara has no or negligible influence on the ability to drive and use machines.

3. How to use Stelara

Stelara is intended for use under the guidance and supervision of a doctor experienced in treating 
conditions for which STELARA is intended.

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not 
sure. Talk to your doctor about when you will have your injections and follow-up appointments.

How much Stelara is given
Your doctor will decide how much Stelara you need to use and for how long.

Adults aged 18 years or older
Psoriasis or Psoriatic Arthritis
 The recommended starting dose is 45 mg Stelara. Patients who weigh more than 100 kilograms 

(kg) may start on a dose of 90 mg instead of 45 mg.
 After the starting dose, you will have the next dose 4 weeks later, and then every 12 weeks. The 

following doses are usually the same as the starting dose.

Crohn’s disease or Ulcerative Colitis
 During treatment, the first dose of approximately 6 mg/kg Stelara will be given by your doctor 

through a drip in a vein in your arm (intravenous infusion). After the starting dose, you will 
receive the next dose of 90 mg Stelara after 8 weeks, then every 12 weeks thereafter by an 
injection under the skin (‘subcutaneously’).

 In some patients, after the first injection under the skin, 90 mg Stelara may be given every 
8 weeks. Your doctor will decide when you should receive your next dose.



76

Children and adolescents aged 6 years or older
Psoriasis
 The doctor will work out the right dose for you, including the amount (volume) of Stelara to be 

injected to give the right dose. The right dose for you will depend on your body weight at the 
time each dose is given.

 If you weigh less than 60 kg, the recommended dose is 0.75 mg of Stelara per kg body weight.
 If you weigh 60 kg to 100 kg, the recommended dose is 45 mg Stelara.
 If you weigh more than 100 kg, the recommended dose is 90 mg Stelara.
 After the starting dose, you will have the next dose 4 weeks later, and then every 12 weeks.

How Stelara is given
 Stelara is given as an injection under the skin (‘subcutaneously’). At the start of your treatment, 

medical or nursing staff may inject Stelara.
 However, you and your doctor may decide that you may inject Stelara yourself. In this case you 

will get training on how to inject Stelara yourself.
 For instructions on how to inject Stelara, see ‘Instructions for administration’ at the end of this 

leaflet.
Talk to your doctor if you have any questions about giving yourself an injection.

If you use more Stelara than you should
If you have used or been given too much Stelara, talk to a doctor or pharmacist straight away. Always 
have the outer carton of the medicine with you, even if it is empty.

If you forget to use Stelara
If you forget a dose, contact your doctor or pharmacist. Do not take a double dose to make up for a 
forgotten dose.

If you stop using Stelara
It is not dangerous to stop using Stelara. However, if you stop, your symptoms may come back.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
Some patients may have serious side effects that may need urgent treatment.

Allergic reactions – these may need urgent treatment. Tell your doctor or get emergency 
medical help straight away if you notice any of the following signs.
 Serious allergic reactions (‘anaphylaxis’) are rare in people taking Stelara (may affect up 

to 1 in 1,000 people). Signs include:
o difficulty breathing or swallowing
o low blood pressure, which can cause dizziness or light-headedness
o swelling of the face, lips, mouth or throat.

 Common signs of an allergic reaction include skin rash and hives (these may affect up to 
1 in 100 people).

In rare cases, allergic lung reactions and lung inflammation have been reported in patients 
who receive ustekinumab. Tell your doctor right away if you develop symptoms such as 
cough, shortness of breath, and fever.

If you have a serious allergic reaction, your doctor may decide that you should not use Stelara 
again.



77

Infections – these may need urgent treatment. Tell your doctor straight away if you notice 
any of the following signs.
 Infections of the nose or throat and common cold are common (may affect up to 1 in 

10 people)
 Infections of the chest are uncommon (may affect up to 1 in 100 people)
 Inflammation of tissue under the skin (‘cellulitis’) is uncommon (may affect up to 1 in 

100 people)
 Shingles (a type of painful rash with blisters) are uncommon (may affect up to 1 in 

100 people)

Stelara may make you less able to fight infections, and some infections could become serious.
You must look out for signs of infection while you are using Stelara. These 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 when passing water
 diarrhoea.

Tell your doctor straight away if you notice any of these signs of infection. These may be signs 
of infections such as chest infections, or skin infections or shingles that could have serious 
complications. Tell your doctor if you have any kind of infection that will not go away or keeps 
coming back. Your doctor may decide that you should not use Stelara until the infection goes 
away. Also tell your doctor if you have any open cuts or sores as they might get infected.

Shedding of skin – increase in redness and shedding of skin over a larger area of the body 
may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious 
skin conditions. You should tell your doctor straight away if you notice any of these signs.

Other side effects

Common side effects (may affect up to 1 in 10 people):
 Diarrhoea
 Nausea
 Vomiting
 Feeling tired
 Feeling dizzy
 Headache
 Itching (‘pruritus’)
 Back, muscle or joint pain
 Sore throat
 Redness and pain where the injection is given
 Sinus infection

Uncommon side effects (may affect up to 1 in 100 people):
 Tooth infections
 Vaginal yeast infection
 Depression
 Blocked or stuffy nose
 Bleeding, bruising, hardness, swelling and itching where the injection is given
 Feeling weak
 Drooping eyelid and sagging muscles on one side of the face (‘facial palsy’ or ‘Bell’s 

palsy’), which is usually temporary
 A change in psoriasis with redness and new tiny, yellow or white skin blisters, sometimes 

accompanied by fever (pustular psoriasis)



78

 Peeling of the skin (skin exfoliation)
 Acne

Rare side effects (may affect up to 1 in 1000 people)
 Redness and shedding of skin over a larger area of the body, which may be itchy or 

painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural change 
in the type of psoriasis symptoms (erythrodermic psoriasis)

 Inflammation of small blood vessels, which can lead to a skin rash with small red or 
purple bumps, fever or joint pain (vasculitis)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 Stelara

 Keep this medicine out of the sight and reach of children.
 Store in a refrigerator (2°C–8°C). Do not freeze.
 Keep the vial in the outer carton in order to protect from light.
 Do not shake the Stelara vials. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine:
 After the expiry date which is stated on the label and the carton after ‘EXP’. The expiry date 

refers to the last day of that month.
 If the liquid is discoloured, cloudy or you can see other foreign particles floating in it (see 

section 6 ‘What Stelara looks like and contents of the pack’).
 If you know, or think that it may have been exposed to extreme temperatures (such as 

accidentally frozen or heated).
 If the product has been shaken vigorously.
 If the seal is broken.

Stelara is for single use only. Any unused product remaining in the vial and the syringe should be
thrown away. Do not throw away any medicines via wastewater or household waste. Ask your 
pharmacist how to throw away medicines you no longer use. These measures will help protect the 
environment.

6. Contents of the pack and other information

What Stelara contains
 The active substance is ustekinumab. Each vial contains 45 mg ustekinumab in 0.5 mL.
 The other ingredients are L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 

80, sucrose and water for injections.

What Stelara looks like and contents of the pack
Stelara is a clear to slightly opalescent (having a pearl-like shine), colourless to light yellow solution 
for injection. The solution may contain a few small translucent or white particles of protein. It is 
supplied as a carton pack containing 1 single-dose, glass 2 mL vial. Each vial contains 45 mg 
ustekinumab in 0.5 mL of solution for injection.

Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000134.jsp&mid=WC0b01ac0580022c59


79

B-2340 Beerse
Belgium

Manufacturer
Janssen Biologics B.V.
Einsteinweg 101
2333 CB Leiden
The Netherlands

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder:

België/Belgique/Belgien
Janssen-Cilag NV
Tel/Tél: + 32 14 64 94 11
janssen@jacbe.jnj.com

Lietuva
UAB "JOHNSON & JOHNSON"
Tel: +370 5 278 68 88
lt@its.jnj.com

България
„Джонсън & Джонсън България” ЕООД
Тел.: +359 2 489 94 00
jjsafety@its.jnj.com

Luxembourg/Luxemburg
Janssen-Cilag NV
Tél/Tel: +32 14 64 94 11
janssen@jacbe.jnj.com

Česká republika
Janssen-Cilag s.r.o.
Tel: +420 227 012 227

Magyarország
Janssen-Cilag Kft.
Tel.: +36 1 884 2858
janssenhu@its.jnj.com

Danmark
Janssen-Cilag A/S
Tlf: +45 4594 8282
jacdk@its.jnj.com

Malta
AM MANGION LTD
Tel: +356 2397 6000

Deutschland
Janssen-Cilag GmbH
Tel: +49 2137 955 955
jancil@its.jnj.com

Nederland
Janssen-Cilag B.V.
Tel: +31 76 711 1111
janssen@jacnl.jnj.com

Eesti
UAB "JOHNSON & JOHNSON" Eesti filiaal
Tel: +372 617 7410
ee@its.jnj.com

Norge
Janssen-Cilag AS
Tlf: + 47 24 12 65 00
jacno@its.jnj.com

Ελλάδα
Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε.
Tηλ: +30 210 80 90 000

Österreich
Janssen-Cilag Pharma GmbH
Tel: +43 1 610 300 

España
Janssen-Cilag, S.A.
Tel: +34 91 722 81 00
contacto@its.jnj.com

Polska
Janssen-Cilag Polska Sp. z o.o.
Tel.: + 48 22 237 60 00

France
Janssen-Cilag
Tél: 0 800 25 50 75 / +33 1 55 00 40 03
medisource@its.jnj.com

Portugal
Janssen-Cilag Farmacêutica, Lda.
Tel: +351 214 368 600



80

Hrvatska
Johnson & Johnson S.E. d.o.o.
Tel: +385 1 6610 700
jjsafety@JNJCR.JNJ.com

România
Johnson & Johnson România SRL
Tel: +40 21 207 1800

Ireland
Janssen Sciences Ireland UC
Tel: +353 1 800 709 122

Slovenija
Johnson & Johnson d.o.o.
Tel. +386 1 401 18 00
Janssen_safety_slo@its.jnj.com

Ísland
Janssen-Cilag AB
c/o Vistor hf.
Sími: +354 535 7000
janssen@vistor.is

Slovenská republika
Johnson & Johnson, s.r.o.
Tel: +421 232 408 400

Italia
Janssen-Cilag SpA
Tel: 800.688.777 / +39 02 2510 1
janssenita@its.jnj.com

Suomi/Finland
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300
jacfi@its.jnj.com

Κύπρος
Βαρνάβας Χατζηπαναγής Λτδ
Tηλ: +357 22 207 700

Sverige
Janssen-Cilag AB
Tfn: +46 8 626 50 00
jacse@its.jnj.com

Latvija
UAB "JOHNSON & JOHNSON" filiāle 
Latvijā
Tel: +371 678 93561
lv@its.jnj.com

United Kingdom
Janssen-Cilag Ltd.
Tel: +44 1 494 567 444

This leaflet was last revised in {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/.

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


81

Instructions for administration

At the start of treatment, your healthcare provider will assist you with your first injection. However, 
you and your doctor may decide that you may inject Stelara yourself. If this happens, you will get 
training on how to inject Stelara. Talk to your doctor if you have any questions about giving yourself
an injection.
 Do not mix Stelara with other liquids for injection
 Do not shake Stelara vials. This is because strong shaking may damage the medicine. Do not 

use the medicine if it has been shaken strongly.

1. Check the number of vials and prepare the materials:
Take the vial(s) out of the refrigerator. Let the vial stand for about half an hour. This will let the liquid 
come to a comfortable temperature for injection (room temperature).

Check the vial(s) to make sure:
 the number of vials and strength is correct

o If your dose is 45 mg or less, you will get one 45 mg vial of Stelara
o If your dose is 90 mg you will get two 45 mg vials of Stelara and you will need to give 

yourself two injections. Choose two different sites for these injections (for example one 
injection in the right thigh and the other injection in the left thigh), and give the injections 
one right after the other. Use a new needle and syringe for each injection.

 it is the right medicine
 it has not passed its expiry date
 the vial is not damaged and the seal is not broken
 the solution in the vial is clear to slightly opalescent (having a pearl-like shine) and colourless to 

light yellow
 the solution is not discoloured or cloudy and does not contain any foreign particles
 the solution is not frozen.

Children weighing less than 60 kg need a dose lower than 45 mg. Make sure you know the proper 
amount (volume) to remove from the vial and type of syringe needed for dosing. If you don’t know the 
amount or type of syringe needed, contact your healthcare provider for further instruction.

Get everything together that you need and lay out on a clean surface. This includes a syringe, needle, 
antiseptic wipes, a cotton ball or gauze, and a sharps container (see Figure 1).

Figure 1

2. Choose and prepare the injection site:
Choose an injection site (see Figure 2)
 Stelara is given by injection under the skin (subcutaneously)
 Good places for the injection are the upper thigh or around the belly (abdomen) at least 5 cm 

away from the navel (belly button)



82

 If possible, do not use areas of skin that show signs of psoriasis
 If someone will assist in giving you the injection, then he or she may also choose the upper arms 

as an injection site

Figure 2

Prepare the injection site
 Wash your hands very well with soap and warm water
 Wipe the injection site on the skin with an antiseptic wipe
 Do not touch this area again before giving the injection

3. Prepare the dose:
 Take the cap off the top of the vial (see Figure 3)

Figure 3

 Do not remove the stopper
 Clean the stopper with an antiseptic swab
 Put the vial on a flat surface.
 Pick up the syringe and remove the needle cover
 Do not touch the needle or let the needle touch anything
 Push the needle through the rubber stopper
 Turn the vial and the syringe upside down
 Pull on the syringe plunger to fill the syringe with the amount of liquid prescribed by your 

doctor
 It is important that the needle is always in the liquid. This stops air bubbles forming in the 

syringe (see Figure 4)

Figure 4

*Areas in gray are recommended injection sites.



83

 Remove the needle from the vial
 Hold the syringe with the needle pointing up to see if it has any air bubbles inside
 If there are air bubbles, tap the side gently until the air bubbles go to the top of the syringe (see 

Figure 5)

Figure 5

 Then press the plunger until all of the air (but none of the liquid) has been removed
 Do not lay the syringe down or allow the needle to touch anything.

4. Inject the dose:
 Gently pinch the cleaned skin between your thumb and index finger. Do not squeeze it tightly
 Push the needle into the pinched skin
 Push the plunger with your thumb as far as it will go to inject all of the liquid. Push it slowly 

and evenly, keeping the skin gently pinched
 When the plunger is pushed as far as it will go, take out the needle and let go of the skin

5. After the injection:
 Press an antiseptic wipe over the injection site for a few seconds after the injection
 There may be a small amount of blood or liquid at the injection site. This is normal
 You can press a cotton ball or gauze over the injection site and hold for 10 seconds
 Do not rub the skin at the injection site. You may cover the injection site with a small adhesive 

bandage, if necessary.

6. Disposal:
 Used syringes and needles should be placed in a puncture-resistant container, like a sharps 

container. Never re-use needles and syringes, for your safety and health, and for the safety of 
others. Dispose of your sharps container according to your local regulations

 Empty vials, antiseptic wipes, and other supplies can be disposed of in your garbage.



84

Package leaflet: Information for the user

STELARA 45 mg solution for injection in pre-filled syringe
ustekinumab

Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you.

This leaflet has been written for the person taking the medicine. If you are the parent or 
caregiver who will give Stelara to a child, please read this information carefully.

- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- 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 or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4.

What is in this leaflet
1. What Stelara is and what it is used for
2. What you need to know before you use Stelara
3. How to use Stelara
4. Possible side effects
5. How to store Stelara
6. Contents of the pack and other information

1. What Stelara is and what it is used for

What Stelara is
Stelara contains the active substance ‘ustekinumab’, a monoclonal antibody. Monoclonal antibodies 
are proteins that recognise and bind specifically to certain proteins in the body.

Stelara belongs to a group of medicines called ‘immunosuppressants’. These medicines work by 
weakening part of the immune system.

What Stelara is used for
Stelara is used to treat the following inflammatory diseases:
 Plaque psoriasis - in adults and children aged 6 years and older
 Psoriatic arthritis - in adults
 Moderate to severe Crohn’s disease - in adults
 Moderate to severe ulcerative colitis – in adults

Plaque psoriasis
Plaque psoriasis is a skin condition that causes inflammation affecting the skin and nails. Stelara will 
reduce the inflammation and other signs of the disease.

Stelara is used in adults with moderate to severe plaque psoriasis, who cannot use ciclosporin,
methotrexate or phototherapy, or where these treatments did not work.

Stelara is used in children and adolescents aged 6 years and older with moderate to severe plaque 
psoriasis who are unable to tolerate phototherapy or other systemic therapies or where these treatments 
did not work.



85

Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints, usually 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 may be given Stelara to:
 Reduce the signs and symptoms of your disease.
 Improve your physical function.
 Slow down the damage to your joints.

Crohn’s disease
Crohn’s disease is an inflammatory disease of the bowel. If you have Crohn’s disease you will first be 
given other medicines. If you do not respond well enough or are intolerant to these medicines, you 
may be given Stelara to reduce the signs and symptoms of your disease.

Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the bowel. If you have ulcerative colitis you will first 
be given other medicines. If you do not respond well enough or are intolerant to these medicines, you 
may be given Stelara to reduce the signs and symptoms of your disease.

2. What you need to know before you use Stelara

Do not use Stelara:
 If you are allergic to ustekinumab or any of the other ingredients of this medicine (listed in 

section 6).
 If you have an active infection which your doctor thinks is important.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using
Stelara.

Warnings and precautions
Talk to your doctor or pharmacist before using Stelara. Your doctor will check how well you are 
before each treatment. Make sure you tell your doctor about any illness you have before each 
treatment. Also tell your doctor if you have recently been near anyone who might have tuberculosis. 
Your doctor will examine you and do a test for tuberculosis, before you have Stelara. If your doctor 
thinks you are at risk of tuberculosis, you may be given medicines to treat it.

Look out for serious side effects
Stelara can cause serious side effects, including allergic reactions and infections. You must look out 
for certain signs of illness while you are taking Stelara. See ‘Serious side effects’ in section 4 for a full 
list of these side effects.

Before you use Stelara tell your doctor:
 If you ever had an allergic reaction to Stelara. Ask your doctor if you are not sure.
 If you have ever had any type of cancer – this is because immunosuppressants like Stelara 

weaken part of the immune system. This may increase the risk of cancer.
 If you have or have had a recent infection.
 If you have any new or changing lesions within psoriasis areas or on normal skin.
 If you have ever had an allergic reaction to latex or Stelara injection – the container of this 

medicinal product contains latex rubber, which may cause severe allergic reactions in people 
who are sensitive to latex. See ‘Look out for serious side effects’ in section 4 for the signs of an 
allergic reaction.

 If you are having any other treatment for psoriasis and/or psoriatic arthritis – such as 
another immunosuppressant or phototherapy (when your body is treated with a type of 
ultraviolet (UV) light). These treatments may also weaken part of the immune system. Using 
these therapies together with Stelara has not been studied. However it is possible it may increase 
the chance of diseases related to a weaker immune system.



86

 If you are having or have ever had injections to treat allergies – it is not known if Stelara 
may affect these.

 If you are 65 years of age or over – you may be more likely to get infections.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using
Stelara.

Children and adolescents
Stelara is not recommended for use in children with psoriasis under 6 years of age, or for use in 
children under 18 years of age with psoriatic arthritis, Crohn’s disease, or ulcerative colitis because it 
has not been studied in this age group.

Other medicines, vaccines and Stelara
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 going to have a vaccination. Some types of vaccines (live 

vaccines) should not be given while using Stelara.

Pregnancy and breast-feeding
 It is preferable to avoid the use of Stelara in pregnancy. The effects of Stelara 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 Stelara and for at least 
15 weeks after the last Stelara treatment.

 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 should breast-feed or use Stelara - do not do both.

Driving and using machines
Stelara has no or negligible influence on the ability to drive and use machines.

3. How to use Stelara

Stelara is intended for use under the guidance and supervision of a doctor experienced in treating 
conditions for which STELARA is intended.

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not 
sure. Talk to your doctor about when you will have your injections and follow-up appointments.

How much Stelara is given
Your doctor will decide how much Stelara you need to use and for how long.

Adults aged 18 years or older
Psoriasis or Psoriatic Arthritis
 The recommended starting dose is 45 mg Stelara. Patients who weigh more than 100 kilograms 

(kg) may start on a dose of 90 mg instead of 45 mg.
 After the starting dose, you will have the next dose 4 weeks later, and then every 12 weeks. The 

following doses are usually the same as the starting dose.

Crohn’s disease or Ulcerative Colitis
 During treatment, the first dose of approximately 6 mg/kg Stelara will be given by your doctor 

through a drip in a vein in your arm (intravenous infusion). After the starting dose, you will 
receive the next dose of 90 mg Stelara after 8 weeks, then every 12 weeks thereafter by an 
injection under the skin (‘subcutaneously’).



87

 In some patients, after the first injection under the skin, 90 mg Stelara may be given every 
8 weeks. Your doctor will decide when you should receive your next dose.

Children and adolescents aged 6 years or older
Psoriasis
 The doctor will work out the right dose for you, including the amount (volume) of Stelara to be 

injected to give the right dose. The right dose for you will depend on your body weight at the 
time each dose is given.

 A 45 mg vial is available for children who need to receive less than the full 45 mg dose.
 If you weigh less than 60 kg, the recommended dose is 0.75 mg of Stelara per kg body weight.
 If you weigh 60 kg to 100 kg, the recommended dose is 45 mg Stelara.
 If you weigh more than 100 kg, the recommended dose is 90 mg Stelara.
 After the starting dose, you will have the next dose 4 weeks later, and then every 12 weeks.

How Stelara is given
 Stelara is given as an injection under the skin (‘subcutaneously’). At the start of your treatment, 

medical or nursing staff may inject Stelara.
 However, you and your doctor may decide that you may inject Stelara yourself. In this case you 

will get training on how to inject Stelara yourself.
 For instructions on how to inject Stelara, see ‘Instructions for administration’ at the end of this 

leaflet.
Talk to your doctor if you have any questions about giving yourself an injection.

If you use more Stelara than you should
If you have used or been given too much Stelara, talk to a doctor or pharmacist straight away. Always 
have the outer carton of the medicine with you, even if it is empty.

If you forget to use Stelara
If you forget a dose, contact your doctor or pharmacist. Do not take a double dose to make up for a 
forgotten dose.

If you stop using Stelara
It is not dangerous to stop using Stelara. However, if you stop, your symptoms may come back.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
Some patients may have serious side effects that may need urgent treatment.

Allergic reactions – these may need urgent treatment. Tell your doctor or get emergency 
medical help straight away if you notice any of the following signs.
 Serious allergic reactions (‘anaphylaxis’) are rare in people taking Stelara (may affect up 

to 1 in 1,000 people). Signs include:
o difficulty breathing or swallowing
o low blood pressure, which can cause dizziness or light-headedness
o swelling of the face, lips, mouth or throat.

 Common signs of an allergic reaction include skin rash and hives (these may affect up to 
1 in 100 people).

In rare cases, allergic lung reactions and lung inflammation have been reported in patients 
who receive ustekinumab. Tell your doctor right away if you develop symptoms such as 



88

cough, shortness of breath, and fever.

If you have a serious allergic reaction, your doctor may decide that you should not use Stelara 
again.

Infections – these may need urgent treatment. Tell your doctor straight away if you notice 
any of the following signs.

 Infections of the nose or throat and common cold are common (may affect up to 1 in 
10 people)

 Infections of the chest are uncommon (may affect up to 1 in 100 people)
 Inflammation of tissue under the skin (‘cellulitis’) is uncommon (may affect up to 1 in 

100 people)
 Shingles (a type of painful rash with blisters) are uncommon (may affect up to 1 in 

100 people)

Stelara may make you less able to fight infections, and some infections could become serious.
You must look out for signs of infection while you are using Stelara. These 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 when passing water
 diarrhoea.

Tell your doctor straight away if you notice any of these signs of infection. These may be signs 
of infections such as chest infections, or skin infections or shingles that could have serious 
complications. Tell your doctor if you have any kind of infection that will not go away or keeps 
coming back. Your doctor may decide that you should not use Stelara until the infection goes 
away. Also tell your doctor if you have any open cuts or sores as they might get infected.

Shedding of skin – increase in redness and shedding of skin over a larger area of the body 
may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious 
skin conditions. You should tell your doctor straight away if you notice any of these signs.

Other side effects

Common side effects (may affect up to 1 in 10 people):
 Diarrhoea
 Nausea
 Vomiting
 Feeling tired
 Feeling dizzy
 Headache
 Itching (‘pruritus’)
 Back, muscle or joint pain
 Sore throat
 Redness and pain where the injection is given
 Sinus infection

Uncommon side effects (may affect up to 1 in 100 people):
 Tooth infections
 Vaginal yeast infection
 Depression
 Blocked or stuffy nose
 Bleeding, bruising, hardness, swelling and itching where the injection is given



89

 Feeling weak
 Drooping eyelid and sagging muscles on one side of the face (‘facial palsy’ or ‘Bell’s 

palsy’), which is usually temporary
 A change in psoriasis with redness and new tiny, yellow or white skin blisters, sometimes 

accompanied by fever (pustular psoriasis)
 Peeling of the skin (skin exfoliation)
 Acne

Rare side effects (may affect up to 1 in 1000 people)
 Redness and shedding of skin over a larger area of the body, which may be itchy or 

painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural change 
in the type of psoriasis symptoms (erythrodermic psoriasis)

 Inflammation of small blood vessels, which can lead to a skin rash with small red or 
purple bumps, fever or joint pain (vasculitis)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 Stelara

 Keep this medicine out of the sight and reach of children.
 Store in a refrigerator (2°C–8°C). Do not freeze.
 Keep the pre-filled syringe in the outer carton in order to protect from light.
 If needed, individual Stelara pre-filled syringes may also be stored at room temperature up to 

30°C for a maximum single period of up to 30 days in the original carton in order to protect
from light. Record the date when the pre-filled syringe is first removed from the refrigerator and 
the discard date in the spaces provided on the outer carton. The discard date must not exceed the 
original expiry date printed on the carton. Once a syringe has been stored at room temperature
(up to 30°C), it should not be returned to the refrigerator. Discard the syringe if not used within 
30 days at room temperature storage or by the original expiry date, whichever is earlier.

 Do not shake Stelara pre-filled syringes. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine:
 After the expiry date which is stated on the label and the carton after ‘EXP’. The expiry date 

refers to the last day of that month.
 If the liquid is discoloured, cloudy or you can see other foreign particles floating in it (see 

section 6 ‘What Stelara looks like and contents of the pack’).
 If you know, or think that it may have been exposed to extreme temperatures (such as 

accidentally frozen or heated).
 If the product has been shaken vigorously.

Stelara is for single use only. Any unused product remaining in the syringe should be thrown away.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Stelara contains
 The active substance is ustekinumab. Each pre-filled syringe contains 45 mg ustekinumab in 

0.5 mL.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000134.jsp&mid=WC0b01ac0580022c59


90

 The other ingredients are L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 
80, sucrose and water for injections.

What Stelara looks like and contents of the pack
Stelara is a clear to slightly opalescent (having a pearl-like shine), colourless to light yellow solution 
for injection. The solution may contain a few small translucent or white particles of protein. It is 
supplied as a carton pack containing 1 single-dose, glass 1 mL pre-filled syringe. Each pre-filled 
syringe contains 45 mg ustekinumab in 0.5 mL of solution for injection.

Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer
Janssen Biologics B.V.
Einsteinweg 101
2333 CB Leiden
The Netherlands

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder:

België/Belgique/Belgien
Janssen-Cilag NV
Tel/Tél: + 32 14 64 94 11
janssen@jacbe.jnj.com

Lietuva
UAB "JOHNSON & JOHNSON"
Tel: +370 5 278 68 88
lt@its.jnj.com

България
„Джонсън & Джонсън България” ЕООД
Тел.: +359 2 489 94 00
jjsafety@its.jnj.com

Luxembourg/Luxemburg
Janssen-Cilag NV
Tél/Tel: +32 14 64 94 11
janssen@jacbe.jnj.com

Česká republika
Janssen-Cilag s.r.o.
Tel: +420 227 012 227

Magyarország
Janssen-Cilag Kft.
Tel.: +36 1 884 2858
janssenhu@its.jnj.com

Danmark
Janssen-Cilag A/S
Tlf: +45 4594 8282
jacdk@its.jnj.com

Malta
AM MANGION LTD
Tel: +356 2397 6000

Deutschland
Janssen-Cilag GmbH
Tel: +49 2137 955 955
jancil@its.jnj.com

Nederland
Janssen-Cilag B.V.
Tel: +31 76 711 1111
janssen@jacnl.jnj.com

Eesti
UAB "JOHNSON & JOHNSON" Eesti filiaal
Tel: +372 617 7410
ee@its.jnj.com

Norge
Janssen-Cilag AS
Tlf: + 47 24 12 65 00
jacno@its.jnj.com



91

Ελλάδα
Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε.
Tηλ: +30 210 80 90 000

Österreich
Janssen-Cilag Pharma GmbH
Tel: +43 1 610 300 

España
Janssen-Cilag, S.A.
Tel: +34 91 722 81 00
contacto@its.jnj.com

Polska
Janssen-Cilag Polska Sp. z o.o.
Tel.: + 48 22 237 60 00

France
Janssen-Cilag
Tél: 0 800 25 50 75 / +33 1 55 00 40 03
medisource@its.jnj.com

Portugal
Janssen-Cilag Farmacêutica, Lda.
Tel: +351 214 368 600

Hrvatska
Johnson & Johnson S.E. d.o.o.
Tel: +385 1 6610 700
jjsafety@JNJCR.JNJ.com

România
Johnson & Johnson România SRL
Tel: +40 21 207 1800

Ireland
Janssen Sciences Ireland UC
Tel: +353 1 800 709 122

Slovenija
Johnson & Johnson d.o.o.
Tel. +386 1 401 18 00
Janssen_safety_slo@its.jnj.com

Ísland
Janssen-Cilag AB
c/o Vistor hf.
Sími: +354 535 7000
janssen@vistor.is

Slovenská republika
Johnson & Johnson, s.r.o.
Tel: +421 232 408 400

Italia
Janssen-Cilag SpA
Tel: 800.688.777 / +39 02 2510 1
janssenita@its.jnj.com

Suomi/Finland
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300
jacfi@its.jnj.com

Κύπρος
Βαρνάβας Χατζηπαναγής Λτδ
Tηλ: +357 22 207 700

Sverige
Janssen-Cilag AB
Tfn: +46 8 626 50 00
jacse@its.jnj.com

Latvija
UAB "JOHNSON & JOHNSON" filiāle 
Latvijā
Tel: +371 678 93561
lv@its.jnj.com

United Kingdom
Janssen-Cilag Ltd.
Tel: +44 1 494 567 444

This leaflet was last revised in {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/.

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


92

Instructions for administration

At the start of treatment, your healthcare provider will assist you with your first injection. However, 
you and your doctor may decide that you may inject Stelara yourself. If this happens, you will get 
training on how to inject Stelara. Talk to your doctor if you have any questions about giving yourself 
an injection.
 Do not mix Stelara with other liquids for injection
 Do not shake Stelara pre-filled syringes. This is because strong shaking may damage the 

medicine. Do not use the medicine if it has been shaken strongly.

Figure 1 shows what the pre-filled syringe looks like.

Figure 1

1. Check the number of pre-filled syringes and prepare the materials:
Preparing for use of the pre-filled syringe
 Take the pre-filled syringe(s) out of the refrigerator. Let the pre-filled syringe stand outside the 

box for about half an hour. This will let the liquid come to a comfortable temperature for 
injection (room temperature). Do not remove the syringe’s needle cover while allowing it to 
reach room temperature

 Hold the pre-filled syringe by the body of the syringe with the covered needle pointing upward
 Do not hold by the plunger head, plunger, needle guard wings, or needle cover
 Do not pull back on the plunger at any time
 Do not remove the needle cover from the pre-filled syringe until instructed to do so
 Do not touch the needle guard activation clips (as indicated by asterisks * in Figure 1) to 

prevent prematurely covering the needle with the needle guard.

Check the pre-filled syringe(s) to make sure
 the number of pre-filled syringes and strength is correct

o If your dose is 45 mg you will get one 45 mg pre-filled syringe of Stelara
o If your dose is 90 mg you will get two 45 mg pre-filled syringes of Stelara and you will 

need to give yourself two injections. Choose two different sites for these injections (e.g. 
one injection in the right thigh and the other injection in the left thigh), and give the 
injections one right after the other.

 it is the right medicine
 it has not passed its expiry date
 the pre-filled syringe is not damaged
 the solution in the pre-filled syringe is clear to slightly opalescent (having a pearl-like shine) 

and colourless to light yellow
 the solution in the pre-filled syringe is not discoloured or cloudy and does not contain any 

foreign particles
 the solution in the pre-filled syringe is not frozen.



93

Get everything together that you need and lay out on a clean surface. This includes antiseptic wipes, a 
cotton ball or gauze, and a sharps container.

2. Choose and prepare the injection site:
Choose an injection site (see Figure 2)
 Stelara is given by injection under the skin (subcutaneously)
 Good places for the injection are the upper thigh or around the belly (abdomen) at least 5 cm 

away from the navel (belly button)
 If possible, do not use areas of skin that show signs of psoriasis
 If someone will assist in giving you the injection, then he or she may also choose the upper arms 

as an injection site

Figure 2

Prepare the injection site
 Wash your hands very well with soap and warm water
 Wipe the injection site on the skin with an antiseptic wipe
 Do not touch this area again before giving the injection

3. Remove the needle cover (see Figure 3):
 The needle cover should not be removed until you are ready to inject the dose
 Pick up the pre-filled syringe, hold the body of the syringe with one hand
 Pull the needle cover straight off and throw it away. Do not touch the plunger while you do this

Figure 3

 You may notice an air bubble in the pre-filled syringe or a drop of liquid at the end of the 
needle. These are both normal and do not need to be removed

 Do not touch the needle or allow it to touch any surface
 Do not use the pre-filled syringe if it is dropped without the needle cover in place. If this 

happens, please contact your doctor or pharmacist
 Inject the dose promptly after removing the needle cover.

*Areas in gray are recommended injection sites.



94

4. Inject the dose:
 Hold the pre-filled syringe with one hand between the middle and index fingers and place the 

thumb on top of the plunger head and use the other hand to gently pinch the cleaned skin 
between your thumb and index finger. Do not squeeze it tightly

 Do not pull back on the plunger at any time
 In a single and swift motion, insert the needle through the skin as far as it will go (see Figure 4)

Figure 4

 Inject all of the medication by pushing in the plunger until the plunger head is completely 
between the needle guard wings (see Figure 5)

Figure 5

 When the plunger is pushed as far as it will go, continue to keep the pressure on the plunger 
head, take out the needle and let go of the skin (see Figure 6)

Figure 6

 Slowly take your thumb off the plunger head to allow the empty syringe to move up until the 
entire needle is covered by the needle guard, as shown by Figure 7:



95

Figure 7

5. After the injection:
 Press an antiseptic wipe over the injection site for a few seconds after the injection.
 There may be a small amount of blood or liquid at the injection site. This is normal.
 You can press a cotton ball or gauze over the injection site and hold for 10 seconds.
 Do not rub the skin at the injection site. You may cover the injection site with a small adhesive 

bandage, if necessary.

6. Disposal:
 Used syringes should be placed in a puncture-resistant container, like a sharps container (see 

Figure 8). Never re-use a syringe, for your safety and health and for the safety of others.
Dispose of your sharps container according to your local regulations

 Antiseptic wipes and other supplies can be disposed of in your garbage.

Figure 8



96

Package leaflet: Information for the user

STELARA 90 mg solution for injection in pre-filled syringe
ustekinumab

Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you.

This leaflet has been written for the person taking the medicine. If you are the parent or 
caregiver who will give Stelara to a child, please read this information carefully.

- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- 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 or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4.

What is in this leaflet
1. What Stelara is and what it is used for
2. What you need to know before you use Stelara
3. How to use Stelara
4. Possible side effects
5. How to store Stelara
6. Contents of the pack and other information

1. What Stelara is and what it is used for

What Stelara is
Stelara contains the active substance ‘ustekinumab’, a monoclonal antibody. Monoclonal antibodies 
are proteins that recognise and bind specifically to certain proteins in the body.

Stelara belongs to a group of medicines called ‘immunosuppressants’. These medicines work by 
weakening part of the immune system.

What Stelara is used for
Stelara is used to treat the following inflammatory diseases:
 Plaque psoriasis - in adults and children aged 6 years and older
 Psoriatic arthritis - in adults
 Moderate to severe Crohn’s disease - in adults
 Moderate to severe ulcerative colitis – in adults

Plaque psoriasis
Plaque psoriasis is a skin condition that causes inflammation affecting the skin and nails. Stelara will 
reduce the inflammation and other signs of the disease.

Stelara is used in adults with moderate to severe plaque psoriasis, who cannot use ciclosporin,
methotrexate or phototherapy, or where these treatments did not work.

Stelara is used in children and adolescents aged 6 years and older with moderate to severe plaque 
psoriasis who are unable to tolerate phototherapy or other systemic therapies or where these treatments 
did not work.



97

Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints, usually 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 may be given Stelara to:
 Reduce the signs and symptoms of your disease.
 Improve your physical function.
 Slow down the damage to your joints.

Crohn’s disease
Crohn’s disease is an inflammatory disease of the bowel. If you have Crohn’s disease you will first be 
given other medicines. If you do not respond well enough or are intolerant to these medicines, you 
may be given Stelara to reduce the signs and symptoms of your disease.

Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the bowel. If you have ulcerative colitis you will first 
be given other medicines. If you do not respond well enough or are intolerant to these medicines, you 
may be given Stelara to reduce the signs and symptoms of your disease.

2. What you need to know before you use Stelara

Do not use Stelara:
 If you are allergic to ustekinumab or any of the other ingredients of this medicine (listed in 

section 6).
 If you have an active infection which your doctor thinks is important.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using
Stelara.

Warnings and precautions
Talk to your doctor or pharmacist before using Stelara. Your doctor will check how well you are 
before each treatment. Make sure you tell your doctor about any illness you have before each 
treatment. Also tell your doctor if you have recently been near anyone who might have tuberculosis. 
Your doctor will examine you and do a test for tuberculosis, before you have Stelara. If your doctor 
thinks you are at risk of tuberculosis, you may be given medicines to treat it.

Look out for serious side effects
Stelara can cause serious side effects, including allergic reactions and infections. You must look out 
for certain signs of illness while you are taking Stelara. See ‘Serious side effects’ in section 4 for a full 
list of these side effects.

Before you use Stelara tell your doctor:
 If you ever had an allergic reaction to Stelara. Ask your doctor if you are not sure.
 If you have ever had any type of cancer – this is because immunosuppressants like Stelara 

weaken part of the immune system. This may increase the risk of cancer.
 If you have or have had a recent infection.
 If you have any new or changing lesions within psoriasis areas or on normal skin.
 If you have ever had an allergic reaction to latex or Stelara injection – the container of this 

medicinal product contains latex rubber, which may cause severe allergic reactions in people 
who are sensitive to latex. See ‘Look out for serious side effects’ in section 4 for the signs of an 
allergic reaction.

 If you are having any other treatment for psoriasis and/or psoriatic arthritis – such as 
another immunosuppressant or phototherapy (when your body is treated with a type of 
ultraviolet (UV) light). These treatments may also weaken part of the immune system. Using 
these therapies together with Stelara has not been studied. However it is possible it may increase 
the chance of diseases related to a weaker immune system.



98

 If you are having or have ever had injections to treat allergies – it is not known if Stelara 
may affect these.

 If you are 65 years of age or over – you may be more likely to get infections.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using
Stelara.

Children and adolescents
Stelara is not recommended for use in children with psoriasis under 6 years of age, or for use in 
children under 18 years of age with psoriatic arthritis, Crohn’s disease, or ulcerative colitis because it 
has not been studied in this age group.

Other medicines, vaccines and Stelara
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 going to have a vaccination. Some types of vaccines (live 

vaccines) should not be given while using Stelara.

Pregnancy and breast-feeding
 It is preferable to avoid the use of Stelara in pregnancy. The effects of Stelara 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 Stelara and for at least 
15 weeks after the last Stelara treatment.

 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 should breast-feed or use Stelara -do not do both.

Driving and using machines
Stelara has no or negligible influence on the ability to drive and use machines.

3. How to use Stelara

Stelara is intended for use under the guidance and supervision of a doctor experienced in treating 
conditions for which STELARA is intended.

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not 
sure. Talk to your doctor about when you will have your injections and follow-up appointments.

How much Stelara is given
Your doctor will decide how much Stelara you need to use and for how long.

Adults aged 18 years or older
Psoriasis or Psoriatic Arthritis
 The recommended starting dose is 45 mg Stelara. Patients who weigh more than 100 kilograms 

(kg) may start on a dose of 90 mg instead of 45 mg.
 After the starting dose, you will have the next dose 4 weeks later, and then every 12 weeks. The 

following doses are usually the same as the starting dose.

Crohn’s disease or Ulcerative Colitis
 During treatment, the first dose of approximately 6 mg/kg Stelara will be given by your doctor 

through a drip in a vein in your arm (intravenous infusion). After the starting dose, you will 
receive the next dose of 90 mg Stelara after 8 weeks, then every 12 weeks thereafter by an 
injection under the skin (‘subcutaneously’).



99

 In some patients, after the first injection under the skin, 90 mg Stelara may be given every 
8 weeks. Your doctor will decide when you should receive your next dose.

Children and adolescents aged 6 years or older
Psoriasis
 The doctor will work out the right dose for you, including the amount (volume) of Stelara to be 

injected to give the right dose. The right dose for you will depend on your body weight at the 
time each dose is given.

 A 45 mg vial is available for children who need to receive less than the full 45 mg dose.
 If you weigh less than 60 kg, the recommended dose is 0.75 mg of Stelara per kg body weight.
 If you weigh 60 kg to 100 kg, the recommended dose is 45 mg Stelara.
 If you weigh more than 100 kg, the recommended dose is 90 mg Stelara.
 After the starting dose, you will have the next dose 4 weeks later, and then every 12 weeks.

How Stelara is given
 Stelara is given as an injection under the skin (‘subcutaneously’). At the start of your treatment, 

medical or nursing staff may inject Stelara.
 However, you and your doctor may decide that you may inject Stelara yourself. In this case you 

will get training on how to inject Stelara yourself.
 For instructions on how to inject Stelara, see ‘Instructions for administration’ at the end of this 

leaflet.
Talk to your doctor if you have any questions about giving yourself an injection.

If you use more Stelara than you should
If you have used or been given too much Stelara, talk to a doctor or pharmacist straight away. Always 
have the outer carton of the medicine with you, even if it is empty.

If you forget to use Stelara
If you forget a dose, contact your doctor or pharmacist. Do not take a double dose to make up for a 
forgotten dose.

If you stop using Stelara
It is not dangerous to stop using Stelara. However, if you stop, your symptoms may come back.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
Some patients may have serious side effects that may need urgent treatment.

Allergic reactions – these may need urgent treatment. Tell your doctor or get emergency 
medical help straight away if you notice any of the following signs.
 Serious allergic reactions (‘anaphylaxis’) are rare in people taking Stelara (may affect up 

to 1 in 1,000 people). Signs include:
o difficulty breathing or swallowing
o low blood pressure, which can cause dizziness or light-headedness
o swelling of the face, lips, mouth or throat.

 Common signs of an allergic reaction include skin rash and hives (these may affect up to 
1 in 100 people).

In rare cases, allergic lung reactions and lung inflammation have been reported in patients 
who receive ustekinumab. Tell your doctor right away if you develop symptoms such as 



100

cough, shortness of breath, and fever.

If you have a serious allergic reaction, your doctor may decide that you should not use Stelara 
again.

Infections – these may need urgent treatment. Tell your doctor straight away if you notice 
any of the following signs.
 Infections of the nose or throat and common cold are common (may affect up to 1 in 

10 people)
 Infections of the chest are uncommon (may affect up to 1 in 100 people)
 Inflammation of tissue under the skin (‘cellulitis’) is uncommon (may affect up to 1 in 

100 people)
 Shingles (a type of painful rash with blisters) are uncommon (may affect up to 1 in 

100 people)

Stelara may make you less able to fight infections, and some infections could become serious.
You must look out for signs of infection while you are using Stelara. These 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 when passing water
 diarrhoea.

Tell your doctor straight away if you notice any of these signs of infection. These may be signs 
of infections such as chest infections, or skin infections or shingles that could have serious 
complications. Tell your doctor if you have any kind of infection that will not go away or keeps 
coming back. Your doctor may decide that you should not use Stelara until the infection goes 
away. Also tell your doctor if you have any open cuts or sores as they might get infected.

Shedding of skin – increase in redness and shedding of skin over a larger area of the body 
may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious 
skin conditions. You should tell your doctor straight away if you notice any of these signs.

Other side effects

Common side effects (may affect up to 1 in 10 people):
 Diarrhoea
 Nausea
 Vomiting
 Feeling tired
 Feeling dizzy
 Headache
 Itching (‘pruritus’)
 Back, muscle or joint pain
 Sore throat
 Redness and pain where the injection is given
 Sinus infection

Uncommon side effects (may affect up to 1 in 100 people):
 Tooth infections
 Vaginal yeast infection
 Depression
 Blocked or stuffy nose
 Bleeding, bruising, hardness, swelling and itching where the injection is given
 Feeling weak



101

 Drooping eyelid and sagging muscles on one side of the face (‘facial palsy’ or ‘Bell’s 
palsy’), which is usually temporary

 A change in psoriasis with redness and new tiny, yellow or white skin blisters, sometimes 
accompanied by fever (pustular psoriasis)

 Peeling of the skin (skin exfoliation)
 Acne

Rare side effects (may affect up to 1 in 1000 people)
 Redness and shedding of skin over a larger area of the body, which may be itchy or 

painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural change 
in the type of psoriasis symptoms (erythrodermic psoriasis)

 Inflammation of small blood vessels, which can lead to a skin rash with small red or 
purple bumps, fever or joint pain (vasculitis)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 Stelara

 Keep this medicine out of the sight and reach of children.
 Store in a refrigerator (2°C–8°C). Do not freeze.
 Keep the pre-filled syringe in the outer carton in order to protect from light.
 If needed, individual Stelara pre-filled syringes may also be stored at room temperature up to 

30°C for a maximum single period of up to 30 days in the original carton in order to protect
from light. Record the date when the pre-filled syringe is first removed from the refrigerator and 
the discard date in the spaces provided on the outer carton. The discard date must not exceed the 
original expiry date printed on the carton. Once a syringe has been stored at room temperature
(up to 30°C), it should not be returned to the refrigerator. Discard the syringe if not used within 
30 days at room temperature storage or by the original expiry date, whichever is earlier.

 Do not shake Stelara pre-filled syringes. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine:
 After the expiry date which is stated on the label and the carton after ‘EXP’. The expiry date 

refers to the last day of that month.
 If the liquid is discoloured, cloudy or you can see other foreign particles floating in it (see 

section 6 ‘What Stelara looks like and contents of the pack’).
 If you know, or think that it may have been exposed to extreme temperatures (such as 

accidentally frozen or heated).
 If the product has been shaken vigorously.

Stelara is for single use only. Any unused product remaining in the syringe should be thrown away.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Stelara contains
 The active substance is ustekinumab. Each pre-filled syringe contains 90 mg ustekinumab in 

1 mL.
 The other ingredients are L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 

80, sucrose and water for injections.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000134.jsp&mid=WC0b01ac0580022c59


102

What Stelara looks like and contents of the pack
Stelara is a clear to slightly opalescent (having a pearl-like shine), colourless to light yellow solution 
for injection. The solution may contain a few small translucent or white particles of protein. It is 
supplied as a carton pack containing 1 single-dose, glass 1 mL pre-filled syringe. Each pre-filled 
syringe contains 90 mg ustekinumab in 1 mL of solution for injection.

Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer
Janssen Biologics B.V.
Einsteinweg 101
2333 CB Leiden
The Netherlands

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder:

België/Belgique/Belgien
Janssen-Cilag NV
Tel/Tél: + 32 14 64 94 11
janssen@jacbe.jnj.com

Lietuva
UAB "JOHNSON & JOHNSON"
Tel: +370 5 278 68 88
lt@its.jnj.com

България
„Джонсън & Джонсън България” ЕООД
Тел.: +359 2 489 94 00
jjsafety@its.jnj.com

Luxembourg/Luxemburg
Janssen-Cilag NV
Tél/Tel: +32 14 64 94 11
janssen@jacbe.jnj.com

Česká republika
Janssen-Cilag s.r.o.
Tel: +420 227 012 227

Magyarország
Janssen-Cilag Kft.
Tel.: +36 1 884 2858
janssenhu@its.jnj.com

Danmark
Janssen-Cilag A/S
Tlf: +45 4594 8282
jacdk@its.jnj.com

Malta
AM MANGION LTD
Tel: +356 2397 6000

Deutschland
Janssen-Cilag GmbH
Tel: +49 2137 955 955
jancil@its.jnj.com

Nederland
Janssen-Cilag B.V.
Tel: +31 76 711 1111
janssen@jacnl.jnj.com

Eesti
UAB "JOHNSON & JOHNSON" Eesti filiaal
Tel: +372 617 7410
ee@its.jnj.com

Norge
Janssen-Cilag AS
Tlf: + 47 24 12 65 00
jacno@its.jnj.com

Ελλάδα
Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε.
Tηλ: +30 210 80 90 000

Österreich
Janssen-Cilag Pharma GmbH
Tel: +43 1 610 300 



103

España
Janssen-Cilag, S.A.
Tel: +34 91 722 81 00
contacto@its.jnj.com

Polska
Janssen-Cilag Polska Sp. z o.o.
Tel.: + 48 22 237 60 00

France
Janssen-Cilag
Tél: 0 800 25 50 75 / +33 1 55 00 40 03
medisource@its.jnj.com

Portugal
Janssen-Cilag Farmacêutica, Lda.
Tel: +351 214 368 600

Hrvatska
Johnson & Johnson S.E. d.o.o.
Tel: +385 1 6610 700
jjsafety@JNJCR.JNJ.com

România
Johnson & Johnson România SRL
Tel: +40 21 207 1800

Ireland
Janssen Sciences Ireland UC
Tel: +353 1 800 709 122

Slovenija
Johnson & Johnson d.o.o.
Tel. +386 1 401 18 00
Janssen_safety_slo@its.jnj.com

Ísland
Janssen-Cilag AB
c/o Vistor hf.
Sími: +354 535 7000
janssen@vistor.is

Slovenská republika
Johnson & Johnson, s.r.o.
Tel: +421 232 408 400

Italia
Janssen-Cilag SpA
Tel: 800.688.777 / +39 02 2510 1
janssenita@its.jnj.com

Suomi/Finland
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300
jacfi@its.jnj.com

Κύπρος
Βαρνάβας Χατζηπαναγής Λτδ
Tηλ: +357 22 207 700

Sverige
Janssen-Cilag AB
Tfn: +46 8 626 50 00
jacse@its.jnj.com

Latvija
UAB "JOHNSON & JOHNSON" filiāle 
Latvijā
Tel: +371 678 93561
lv@its.jnj.com

United Kingdom
Janssen-Cilag Ltd.
Tel: +44 1 494 567 444

This leaflet was last revised in {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/.

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


104

Instructions for administration

At the start of treatment, your healthcare provider will assist you with your first injection. However, 
you and your doctor may decide that you may inject Stelara yourself. If this happens, you will get 
training on how to inject Stelara. Talk to your doctor if you have any questions about giving yourself 
an injection.
 Do not mix Stelara with other liquids for injection
 Do not shake Stelara pre-filled syringes. This is because strong shaking may damage the 

medicine. Do not use the medicine if it has been shaken strongly.

Figure 1 shows what the pre-filled syringe looks like.

Figure 1

1. Check the number of pre-filled syringes and prepare the materials:
Preparing for use of the pre-filled syringe
 Take the pre-filled syringe(s) out of the refrigerator. Let the pre-filled syringe stand outside the 

box for about half an hour. This will let the liquid come to a comfortable temperature for 
injection (room temperature). Do not remove the syringe’s needle cover while allowing it to 
reach room temperature

 Hold the pre-filled syringe by the body of the syringe with the covered needle pointing upward
 Do not hold by the plunger head, plunger, needle guard wings, or needle cover
 Do not pull back on the plunger at any time
 Do not remove the needle cover from the pre-filled syringe until instructed to do so
 Do not touch the needle guard activation clips (as indicated by asterisks * in Figure 1) to 

prevent prematurely covering the needle with the needle guard.

Check the pre-filled syringe(s) to make sure
 the number of pre-filled syringes and strength is correct

o If your dose is 90 mg you will get one 90 mg pre-filled syringe of Stelara.
 it is the right medicine
 it has not passed its expiry date
 the pre-filled syringe is not damaged
 the solution in the pre-filled syringe is clear to slightly opalescent (having a pearl-like shine) 

and colourless to light yellow
 the solution in the pre-filled syringe is not discoloured or cloudy and does not contain any 

foreign particles
 the solution in the pre-filled syringe is not frozen.

Get everything together that you need and lay out on a clean surface. This includes antiseptic wipes, a 
cotton ball or gauze, and a sharps container.

2. Choose and prepare the injection site:
Choose an injection site (see Figure 2)



105

 Stelara is given by injection under the skin (subcutaneously)
 Good places for the injection are the upper thigh or around the belly (abdomen) at least 5 cm 

away from the navel (belly button)
 If possible, do not use areas of skin that show signs of psoriasis
 If someone will assist in giving you the injection, then he or she may also choose the upper arms 

as an injection site.

Figure 2

Prepare the injection site
 Wash your hands very well with soap and warm water
 Wipe the injection site on the skin with an antiseptic wipe
 Do not touch this area again before giving the injection.

3. Remove the needle cover (see Figure 3):
 The needle cover should not be removed until you are ready to inject the dose
 Pick up the pre-filled syringe, hold the body of the syringe with one hand
 Pull the needle cover straight off and throw it away. Do not touch the plunger while you do this

Figure 3

 You may notice an air bubble in the pre-filled syringe or a drop of liquid at the end of the 
needle. These are both normal and do not need to be removed

 Do not touch the needle or allow it to touch any surface
 Do not use the pre-filled syringe if it is dropped without the needle cover in place. If this 

happens, please contact your doctor or pharmacist
 Inject the dose promptly after removing the needle cover.

4. Inject the dose:
 Hold the pre-filled syringe with one hand between the middle and index fingers and place the 

thumb on top of the plunger head and use the other hand to gently pinch the cleaned skin 
between your thumb and index finger. Do not squeeze it tightly

 Do not pull back on the plunger at any time
 In a single and swift motion, insert the needle through the skin as far as it will go (see Figure 4)

*Areas in gray are recommended injection sites.



106

Figure 4

 Inject all of the medication by pushing in the plunger until the plunger head is completely 
between the needle guard wings (see Figure 5)

Figure 5

 When the plunger is pushed as far as it will go, continue to keep the pressure on the plunger 
head, take out the needle and let go of the skin (see Figure 6)

Figure 6

 Slowly take your thumb off the plunger head to allow the empty syringe to move up until the 
entire needle is covered by the needle guard, as shown by Figure 7:

Figure 7



107

5. After the injection:
 Press an antiseptic wipe over the injection site for a few seconds after the injection.
 There may be a small amount of blood or liquid at the injection site. This is normal.
 You can press a cotton ball or gauze over the injection site and hold for 10 seconds.
 Do not rub the skin at the injection site. You may cover the injection site with a small adhesive 

bandage, if necessary.

6. Disposal:
 Used syringes should be placed in a puncture-resistant container, like a sharps container (see 

Figure 8). Never re-use a syringe, for your safety and health and for the safety of others.
Dispose of your sharps container according to your local regulations

 Antiseptic wipes and other supplies can be disposed of in your garbage.

Figure 8


	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