Tremfya

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ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS



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This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions.

1. NAME OF THE MEDICINAL PRODUCT

Tremfya 100 mg solution for injection in pre-filled syringe.
Tremfya 100 mg solution for injection in pre-filled pen.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Tremfya 100 mg solution for injection in pre-filled syringe

Each pre-filled syringe contains 100 mg of guselkumab in 1 mL solution.

Tremfya 100 mg solution for injection in pre-filled pen

Each pre-filled pen contains 100 mg of guselkumab in 1 mL solution.

Guselkumab is a fully human immunoglobulin G1 lamda (IgG1λ) monoclonal antibody (mAb) to the
interleukin (IL)-23 protein, produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA 
technology.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection (injection)

The solution is clear and colourless to light yellow.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Tremfya is indicated for the treatment of moderate to severe plaque psoriasis in adults who are 
candidates for systemic therapy.

4.2 Posology and method of administration

Tremfya is intended for use under the guidance and supervision of a physician experienced in the 
diagnosis and treatment of plaque psoriasis.

Posology
The recommended dose of Tremfya is 100 mg by subcutaneous injection at weeks 0 and 4, followed 
by a maintenance dose every 8 weeks.

Consideration should be given to discontinuing treatment in patients who have shown no response 
after 16 weeks of treatment.

Elderly (≥ 65 years)
No dose adjustment is required (see section 5.2).
There is limited information in subjects aged ≥ 65 years.



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Renal or hepatic impairment
Tremfya has not been studied in these patient populations. No dose recommendations can be made.
For further information on elimination of guselkumab, see section 5.2.

Paediatric population
The safety and efficacy of Tremfya in children and adolescents below the age of 18 years have not yet 
been established. No data are available.

Method of administration
Subcutaneous use. If possible, areas of the skin that show psoriasis should be avoided as injection 
sites.

After proper training in subcutaneous injection technique, patients may inject Tremfya if a physician 
determines that this is appropriate. However, the physician should ensure appropriate medical 
follow-up of patients. Patients should be instructed to inject the full amount of Tremfya according to 
the ‘Instructions for use’ provided in the carton.
For further instructions on preparation and special precautions for handling, see section 6.6 and the 
‘Instructions for use’ leaflet.

4.3 Contraindications

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

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

4.4 Special warnings and precautions for use

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

Infections
Tremfya may increase the risk of infection. Treatment with Tremfya should not be initiated in patients 
with any clinically important active infection until the infection resolves or is adequately treated.

Patients treated with Tremfya should be instructed to seek medical advice if signs or symptoms of 
clinically important chronic or acute infection occur. If a patient develops a clinically important or 
serious infection or is not responding to standard therapy, the patient should be monitored closely and 
Tremfya should be discontinued until the infection resolves.

Pre-treatment evaluation for tuberculosis
Prior to initiating treatment with Tremfya, patients should be evaluated for tuberculosis (TB) infection.
Patients receiving Tremfya should be monitored for signs and symptoms of active TB during and after 
treatment. Anti-TB therapy should be considered prior to initiating Tremfya in patients with a past 
history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

Hypersensitivity
Serious hypersensitivity reactions have been reported in the post-marketing setting. Some cases 
occurred several days after treatment with guselkumab, including cases with urticaria and dyspnoea. If 
a serious hypersensitivity reaction occurs, administration of Tremfya should be discontinued 
immediately and appropriate therapy initiated.

Immunisations
Prior to initiating therapy with Tremfya, completion of all appropriate immunisations should be 
considered according to current immunisation guidelines. Live vaccines should not be used 



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concurrently in patients treated with Tremfya. No data are available on the response to live or inactive 
vaccines.

Before live viral or live bacterial vaccination, treatment with Tremfya should be withheld for at least 
12 weeks after the last dose and can be resumed at least 2 weeks after vaccination. Prescribers should 
consult the Summary of Product Characteristics of the specific vaccine for additional information and 
guidance on concomitant use of immunosuppressive agents post-vaccination.

4.5 Interaction with other medicinal products and other forms of interaction

Interactions with CYP450 substrates
In a Phase 1 study in subjects with moderate to severe plaque psoriasis, changes in systemic exposures 
(Cmax and AUCinf) of midazolam, S-warfarin, omeprazole, dextromethorphan, and caffeine after a 
single dose of guselkumab were not clinically relevant, indicating that drug interactions between 
guselkumab and substrates of various CYP enzymes (CYP3A4, CYP2C9, CYP2C19, CYP2D6, and 
CYP1A2) are unlikely. There is no need for dose adjustment when co-administering guselkumab and 
CYP450 substrates.

Concomitant immunosuppressive therapy or phototherapy
The safety and efficacy of Tremfya in combination with immunosuppressants, including biologics, or 
phototherapy have not been evaluated.

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 12 weeks after treatment.

Pregnancy
There are no data from the use of guselkumab 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 Tremfya in pregnancy.

Breast-feeding
It is unknown whether guselkumab is excreted in human milk. Human IgGs are known to be excreted 
in breast milk during the first few days after birth, and decrease to low concentrations soon afterwards; 
consequently, a risk to the breast-fed infant during this period cannot be excluded. A decision should 
be made whether to discontinue, or abstain from initiating treatment with Tremfya, taking into account 
the benefit of breast-feeding to the child and the benefit of Tremfya therapy to the woman. See 
section 5.3 for information on the excretion of guselkumab in animal (cynomolgus monkey) milk.

Fertility
The effect of guselkumab on human fertility has not been evaluated. Animal studies do not indicate 
direct or indirect harmful effects with respect to fertility (see section 5.3).

4.7 Effects on ability to drive and use machines

Tremfya 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 drug reaction (ADR) was upper respiratory infection.



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Tabulated list of adverse reactions

Table 1 provides a list of adverse reactions from psoriasis clinical studies as well as from 
post-marketing experience. The adverse reactions are classified by MedDRA 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).

Table 1: List of adverse reactions
System Organ Class Frequency ADR
Infections and infestations Very common Upper respiratory infections

Common Gastroenteritis
Common Herpes simplex infections
Common Tinea infections

Immune system disorders Uncommon Hypersensitivity
Nervous system disorders Common Headache
Gastrointestinal disorders Common Diarrhoea
Skin and subcutaneous tissue disorders Common Urticaria

Uncommon Rash
Musculoskeletal and connective tissue 
disorders

Common Arthralgia

General disorders and administration 
site conditions

Common Injection site erythema
Uncommon Injection site pain

Description of selected adverse reactions
Gastroenteritis
In two phase III clinical studies through the placebo-controlled period, gastroenteritis occurred more 
frequently in the Tremfya-treated group (1.1%) than in the placebo group (0.7%). Through Week 156,
4.9% of all Tremfya-treated patients reported gastroenteritis. Adverse reactions of gastroenteritis were 
non-serious and did not lead to discontinuation of Tremfya through Week 156.

Injection site reactions
In two phase III clinical studies through Week 48, 0.7% of Tremfya injections and 0.3% of placebo 
injections were associated with injection site reactions. Through Week 156, 0.5% of Tremfya 
injections were associated with injection site reactions. Adverse reactions of injection site erythema 
and injection site pain were generally mild to moderate in severity; none were serious, and none led to 
discontinuation of Tremfya.

Immunogenicity
The immunogenicity of Tremfya was evaluated using a sensitive and drug-tolerant immunoassay. In 
pooled phase II and phase III analyses, fewer than 6% of patients treated with Tremfya developed 
antidrug antibodies in up to 52 weeks of treatment. Of the patients who developed antidrug antibodies, 
approximately 7% had antibodies that were classified as neutralizing, which equates to 0.4% of all 
patients treated with Tremfya. In pooled phase III analyses, approximately 9% of patients treated with 
Tremfya developed antidrug antibodies in up to 156 weeks of treatment. Antidrug antibodies were not 
associated with lower efficacy or development of injection-site reactions.

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 intravenous doses of guselkumab up to 987 mg (10 mg/kg) have been administered in healthy 
volunteers and single subcutaneous doses of guselkumab up to 300 mg have been administered in 

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


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patients with plaque psoriasis in clinical studies without dose-limiting toxicity. In the event of 
overdosage, monitor the patient for any signs or symptoms of adverse reactions and administer 
appropriate symptomatic treatment immediately.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC16.

Mechanism of action
Guselkumab is a human IgG1λ monoclonal antibody (mAb) that binds selectively to the interleukin 23 
(IL-23) protein with high specificity and affinity. IL-23, a regulatory cytokine, affects the 
differentiation, expansion, and survival of T cell subsets, (e.g., Th17 cells and Tc17 cells) and innate 
immune cell subsets, which represent sources of effector cytokines, including IL-17A, IL-17F and 
IL-22 that drive inflammatory disease. In humans, selective blockade of IL-23 was shown to 
normalize production of these cytokines.

Levels of IL-23 are elevated in the skin of patients with plaque psoriasis. In in vitro models, 
guselkumab was shown to inhibit the bioactivity of IL-23 by blocking its interaction with cell surface 
IL-23 receptor, disrupting IL-23-mediated signaling, activation and cytokine cascades. Guselkumab 
exerts clinical effects in plaque psoriasis through blockade of the IL-23 cytokine pathway.

Pharmacodynamic effects
In a phase I study, treatment with guselkumab resulted in reduced expression of IL-23/Th17 pathway 
genes and psoriasis-associated gene expression profiles, as shown by analyses of mRNA obtained 
from lesional skin biopsies of patients with plaque psoriasis at Week 12 compared to baseline. In the 
same phase I study, treatment with guselkumab resulted in improvement of histological measures of 
psoriasis at Week 12, including reductions in epidermal thickness and T-cell density. In addition, 
reduced serum IL-17A, IL-17F and IL-22 levels compared to placebo were observed in guselkumab
treated patients in phase II and phase III studies. These results are consistent with the clinical benefit 
observed with guselkumab treatment in plaque psoriasis.

Clinical efficacy and safety
The efficacy and safety of guselkumab was assessed in three randomised, double-blind, active 
controlled phase III studies in adult patients with moderate to severe plaque psoriasis, who were 
candidates for phototherapy or systemic therapy.

VOYAGE 1 and VOYAGE 2
Two studies (VOYAGE 1 and VOYAGE 2) evaluated the efficacy and safety of guselkumab versus 
placebo and adalimumab in 1829 adult patients. Patients randomised to guselkumab (N=825) received 
100 mg at Weeks 0 and 4, and every 8 weeks (q8w) thereafter through Week 48 (VOYAGE 1) and 
Week 20 (VOYAGE 2). Patients randomised to adalimumab (N=582) received 80 mg at Week 0 and 
40 mg at Week 1, followed by 40 mg every other week (q2w) through Week 48 (VOYAGE 1) and 
Week 23 (VOYAGE 2). In both studies, patients randomised to placebo (N=422) received guselkumab 
100 mg at Weeks 16, 20 and q8w thereafter. In VOYAGE 1, all patients, including those randomised 
to adalimumab at Week 0, started to receive open-label guselkumab q8w at Week 52. In VOYAGE 2, 
patients randomised to guselkumab at Week 0 who were Psoriasis Area and Severity Index (PASI) 90 
responders at Week 28 were re-randomised to either continue treatment with guselkumab q8w 
(maintenance treatment) or receive placebo (withdrawal treatment). Withdrawal patients re-initiated 
guselkumab (dosed at time of retreatment, 4 weeks later and q8w thereafter) when they experienced at 
least a 50% loss of their Week 28 PASI improvement. Patients randomised to adalimumab at Week 0 
who were PASI 90 non-responders received guselkumab at Weeks 28, 32 and q8w thereafter. In 
VOYAGE 2, all patients started to receive open-label guselkumab q8w at Week 76.



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Baseline disease characteristics were consistent for the study populations in VOYAGE 1 and 2 with a 
median body surface area (BSA) of 22% and 24%, a median baseline PASI score of 19 for both 
studies, a median baseline dermatology quality of life index (DLQI) score of 14 and 14.5, a baseline 
investigator global assessment (IGA) score of severe for 25% and 23% of patients, and a history of 
psoriatic arthritis for 19% and 18% of patients, respectively.

Of all patients included in VOYAGE 1 and 2, 32% and 29% were naïve to both conventional systemic
and biologic therapy, 54% and 57% had received prior phototherapy, and 62% and 64% had received 
prior conventional systemic therapy, respectively. In both studies, 21% had received prior biologic 
therapy, including 11% who had received at least one anti-tumour necrosis factor alpha (TNFα) agent, 
and approximately 10% who had received an anti-IL-12/IL-23 agent.

The efficacy of guselkumab was evaluated with respect to overall skin disease, regional disease (scalp, 
hand and foot and nails) and quality of life and patient reported outcomes. The co-primary endpoints 
in VOYAGE 1 and 2 were the proportion of patients who achieved an IGA score of cleared or 
minimal (IGA 0/1) and a PASI 90 response at Week 16 versus placebo (see Table 2).

Overall skin disease
Treatment with guselkumab resulted in significant improvements in the measures of disease activity 
compared to placebo and adalimumab at Week 16 and compared to adalimumab at Weeks 24 and 48. 
The key efficacy results for the primary and major secondary study endpoints are shown in Table 2
below.

Table 2: Summary of Clinical Responses in VOYAGE 1 and VOYAGE 2
Number of patients (%)

VOYAGE 1 VOYAGE 2
Placebo
(N=174)

Guselkumab
(N=329)

Adalimumab
(N=334)

Placebo
(N=248)

Guselkumab
(N=496)

Adalimumab
(N=248)

Week 16
PASI 75 10 (5.7) 300 (91.2)a 244 (73.1)b 20 (8.1) 428 (86.3)a 170 (68.5)b

PASI 90 5 (2.9) 241 (73.3)c 166 (49.7)b 6 (2.4) 347 (70.0)c 116 (46.8)b

PASI 100 1 (0.6) 123 (37.4)a 57 (17.1)d 2 (0.8) 169 (34.1)a 51 (20.6)d

IGA 0/1 12 (6.9) 280 (85.1)c 220 (65.9)b 21 (8.5) 417 (84.1)c 168 (67.7)b

IGA 0 2 (1.1) 157 (47.7)a 88 (26.3)d 2 (0.8) 215 (43.3)a 71 (28.6)d

Week 24
PASI 75 - 300 (91.2) 241 (72.2)e - 442 (89.1) 176 (71.0)e

PASI 90 - 264 (80.2) 177 (53.0)b - 373 (75.2) 136 (54.8)b

PASI 100 - 146 (44.4) 83 (24.9)e - 219 (44.2) 66 (26.6)e

IGA 0/1 - 277 (84.2) 206 (61.7)b - 414 (83.5) 161 (64.9)b

IGA 0 - 173 (52.6) 98 (29.3)b - 257 (51.8) 78 (31.5)b

Week 48
PASI 75 - 289 (87.8) 209 (62.6)e - - -
PASI 90 - 251 (76.3) 160 (47.9)b - - -
PASI 100 - 156 (47.4) 78 (23.4)e - - -
IGA 0/1 - 265 (80.5) 185 (55.4)b - - -
IGA 0 - 166 (50.5) 86 (25.7)b - - -

a
p < 0.001 for comparison between guselkumab and placebo.

b
p < 0.001 for comparison between guselkumab and adalimumab for major secondary endpoints.

c
p < 0.001 for the comparisons between guselkumab and placebo for the co-primary endpoints.

d
comparisons between guselkumab and adalimumab were not performed.

e
p < 0.001 for comparison between guselkumab and adalimumab.

Response over time
Guselkumab demonstrated rapid onset of efficacy, with a significantly higher percent improvement in 
PASI as compared with placebo as early as Week 2 (p < 0.001). The percentage of patients achieving a 
PASI 90 response was numerically higher for guselkumab than adalimumab starting at Week 8 with 
the difference reaching a maximum around Week 20 (VOYAGE 1 and 2) and maintained through 
Week 48 (VOYAGE 1) (see Figure 1).



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Figure 1: Percent of Subjects Who Achieved a PASI 90 Response Through Week 48 by Visit 
(Subjects Randomised at Week 0) in VOYAGE 1

Week

P
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o

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S

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 (
%

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Placebo
(n=174)

Guselkumab
(n=329)

Adalimumab
(n=334)

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In VOYAGE 1, for patients receiving continuous guselkumab treatment, the PASI 90 response rate
was maintained from Week 52 through Week 156. For patients randomised to adalimumab at Week 0
who crossed over to guselkumab at Week 52, the PASI 90 response rate increased from Week 52 
through Week 76 and was then maintained through Week 156 (see Figure 2).

Figure 2: Percent of Subjects Who Achieved a PASI 90 Response by Visit in the Open-Label 
Phase in VOYAGE 1

The efficacy and safety of guselkumab was demonstrated regardless of age, gender, race, body weight, 
plaques location, PASI baseline severity, concurrent psoriatic arthritis, and previous treatment with a 
biologic therapy. Guselkumab was efficacious in conventional systemic-naive, biologic-naive, and 
biologic-exposed patients.



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In VOYAGE 2, 88.6% of patients receiving guselkumab maintenance treatment at Week 48 were 
PASI 90 responders compared to 36.8% of patients who were withdrawn from treatment at Week 28
(p < 0.001). Loss of PASI 90 response was noted as early as 4 weeks after withdrawal of guselkumab
treatment with a median time to loss of PASI 90 response of approximately 15 weeks. Among patients 
who were withdrawn from treatment and subsequently re-initiated guselkumab, 80% regained a 
PASI 90 response when assessed 20 weeks after initiation of retreatment.

In VOYAGE 2, among 112 patients randomised to adalimumab who failed to achieve a PASI 90 
response at Week 28, 66% and 76% achieved a PASI 90 response after 20 and 44 weeks of treatment 
with guselkumab, respectively. In addition, among 95 patients randomised to guselkumab who failed 
to achieve a PASI 90 response at Week 28, 36% and 41% achieved a PASI 90 response with an 
additional 20 and 44 weeks of continued treatment with guselkumab, respectively. No new safety 
findings were observed in patients who switched from adalimumab to guselkumab.

Regional disease
In VOYAGE 1 and 2, significant improvements were seen in scalp, hand and foot, and nail psoriasis
(as measured by the Scalp-specific Investigator Global Assessment [ss-IGA], Physician’s Global 
Assessment of Hands and/or Feet [hf-PGA], Fingernail Physician’s Global Assessment [f-PGA] and 
Nail Psoriasis Severity Index [NAPSI], respectively) in guselkumab treated patients compared to
placebo treated patients at Week 16 (p < 0.001, Table 3). Guselkumab demonstrated superiority 
compared to adalimumab for scalp and hand and foot psoriasis at Week 24 (VOYAGE 1 and 2) and
Week 48 (VOYAGE 1) (p ≤ 0.001, except for hand and foot psoriasis at Week 24 [VOYAGE 2] and 
Week 48 [VOYAGE 1], p < 0.05).

Table 3: Summary of Regional Disease Responses in VOYAGE 1 and VOYAGE 2
VOYAGE 1 VOYAGE 2

Placebo Guselkumab Adalimumab Placebo Guselkumab Adalimumab
ss-IGA (N)a 145 277 286 202 408 194
ss-IGA 0/1b, n (%)

Week 16 21 (14.5) 231 (83.4)c 201 (70.3)d 22 (10.9) 329 (80.6)c 130 (67.0)d

hf-PGA (N)a 43 90 95 63 114 56
hf-PGA 0/1b, n (%)

Week 16 6 (14.0) 66 (73.3)e 53 (55.8)d 9 (14.3) 88 (77.2)e 40 (71.4)d

f-PGA (N)a 88 174 173 123 246 124
f-PGA 0/1, n (%)

Week 16 14 (15.9) 68 (39.1)e 88 (50.9)d 18 (14.6) 128 (52.0)e 74 (59.7)d

NAPSI (N)a 99 194 191 140 280 140
Percent Improvement, mean (SD)

Week 16 -0.9 (57.9) 34.4 (42.4)e 38.0 (53.9)d 1.8 (53.8) 39.6 (45.6)e 46.9 (48.1)d

a
Includes only subjects with ss-IGA, f-PGA, hf-PGA score ≥ 2 at baseline or baseline NAPSI score > 0.

b
Includes only subjects achieving ≥ 2-grade improvement from baseline in ss-IGA and/or hf-PGA.

c
p < 0.001 for comparison between guselkumab and placebo for the major secondary endpoint.

d
comparisons between guselkumab and adalimumab were not performed.

e
p < 0.001 for comparison between guselkumab and placebo.

Health-related quality of life / Patient reported outcomes
Across VOYAGE 1 and 2 significantly greater improvements in health-related quality of life as 
measured by Dermatology Life Quality Index (DLQI) and in patient-reported psoriasis symptoms 
(itching, pain, burning, stinging and skin tightness) and signs (skin dryness, cracking, scaling, 
shedding or flaking, redness and bleeding) as measured by the Psoriasis Symptoms and Signs Diary 
(PSSD) were observed in guselkumab patients compared to placebo patients at Week 16 (Table 4). 
Signs of improvement on patient-reported outcomes were maintained through Week 24 (VOYAGE 1 
and 2) and Week 48 (VOYAGE 1). In VOYAGE 1, for patients receiving continuous guselkumab 
treatment, these improvements were maintained in the open-label phase through Week 156 (Table 5).



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Table 4: Summary of Patient Reported Outcomes at Week 16 in VOYAGE 1 and VOYAGE 2
VOYAGE 1 VOYAGE 2

Placebo Guselkumab Adalimumab Placebo Guselkumab Adalimumab
DLQI, subjects with 
baseline score

170 322 328 248 495 247

Change from baseline, mean (standard deviation)
Week 16 -0.6 (6.4) -11.2 (7.2)c -9.3 (7.8)b -2.6 (6.9) -11.3 (6.8)c -9.7 (6.8)b

PSSD Symptom 
score, subjects with 
baseline score > 0

129 248 273 198 410 200

Symptom score = 0, n (%)
Week 16 1 (0.8) 67 (27.0)a 45 (16.5)b 0 112 (27.3)a 30 (15.0)b

PSSD Sign score, 
subjects with 
baseline score > 0

129 248 274 198 411 201

Sign score = 0, n (%)
Week 16 0 50 (20.2)a 32 (11.7)b 0 86 (20.9)a 21 (10.4)b

a
p < 0.001 for comparison between guselkumab and placebo.

b
comparisons between guselkumab and adalimumab were not performed.

c
p < 0.001 for comparison between guselkumab and placebo for major secondary endpoints.

Table 5: Summary of Patient Reported Outcomes in the Open-Label Phase in VOYAGE 1
Guselkumab Adalimumab-Guselkumab

Week 76 Week 156 Week 76 Week 156
DLQI score > 1 at baseline, n 445 411 264 251
Subjects with DLQI 0/1 337 (75.7%) 307 (74.7%) 198 (75.0%) 190 (75.7%)
PSSD Symptom Score, subjects 
with baseline score > 0

347 319 227 214

Symptom score = 0, n (%) 136 (39.2%) 129 (40.4%) 99 (43.6%) 96 (44.9%)
PSSD Sign score, subjects with 
baseline score > 0

347 319 228 215

Sign score = 0, n (%) 102 (29.4%) 93 (29.2%) 71 (31.1%) 69 (32.1%)

In VOYAGE 2, guselkumab patients had significantly greater improvement from baseline compared 
to placebo in health-related quality of life, anxiety and depression, and work limitation measures at 
Week 16, as measured by the 36-item Short Form (SF-36) health survey questionnaire, Hospital 
Anxiety and Depression Scale (HADS), and Work Limitations Questionnaire (WLQ), respectively.
The improvements in SF-36, HADS and WLQ were all maintained through Week 48 and in the 
open-label phase through Week 156 among patients randomised to maintenance therapy at Week 28.

NAVIGATE
The NAVIGATE study examined the efficacy of guselkumab in patients who had an inadequate 
response (ie, who had not achieved a ‘cleared’ or ‘minimal’ response defined as IGA ≥ 2) to 
ustekinumab at Week 16. All patients (N=871) received open-label ustekinumab (45 mg ≤100 kg and 
90 mg >100 kg) at Weeks 0 and 4. At Week 16, 268 patients with an IGA ≥ 2 score were randomised
to either continue ustekinumab treatment (N=133) q12w, or to initiate guselkumab treatment (N=135) 
at Weeks 16, 20, and q8w thereafter. Baseline characteristics for randomised patients were similar to 
those observed in VOYAGE 1 and 2.

After randomisation, the primary endpoint was the number of post-randomisation visits between 
Weeks 12 and 24 at which patients achieved an IGA score 0/1 and had ≥ 2 grade improvement.
Patients were examined at four week intervals for a total of four visits. Among patients who
inadequately responded to ustekinumab at the time of randomisation, significantly greater
improvement of efficacy was observed in patients who switched to guselkumab treatment compared to 
patients who continued ustekinumab treatment. Between 12 and 24 weeks after randomisation,
guselkumab patients achieved an IGA score 0/1 with ≥ 2 grade improvement twice as often as 
ustekinumab patients (mean 1.5 vs 0.7 visits, respectively, p < 0.001). Additionally, at 12 weeks after 
randomisation a higher proportion of guselkumab patients compared to ustekinumab patients achieved 
an IGA score 0/1 and ≥ 2 grade improvement (31.1% vs. 14.3%, respectively; p = 0.001) and a 



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PASI 90 response (48% vs 23%, respectively, p < 0.001). Differences in response rates between 
guselkumab and ustekinumab treated patients were noted as early as 4 weeks after randomisation 
(11.1% and 9.0%, respectively) and reached a maximum 24 weeks after randomisation (see Figure 3).
No new safety findings were observed in patients who switched from ustekinumab to guselkumab.

Figure 3: Percent of Subjects Who Achieved an IGA Score of Cleared (0) or Minimal (1) and 
at least a 2-grade improvement in IGA from Week 0 Through Week 24 by Visit 
After Randomisation in NAVIGATE

P
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%

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Week After Randomisation

Guselkumab (n=135) Ustekinumab (n=133)

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ECLIPSE
Efficacy and safety of guselkumab were also investigated in a double-blind study compared to
secukinumab. Patients were randomised to receive guselkumab (N=534; 100 mg at Week 0, 4 and q8w 
thereafter), or secukinumab (N=514; 300 mg at Week 0, 1, 2, 3, 4, and q4w thereafter). The last dose 
was at week 44 for both treatment groups.

Baseline disease characteristics were consistent with a population of moderate to severe plaque 
psoriasis with a median BSA of 20%, a median PASI score of 18, and an IGA score of severe for 24% 
of patients.

Guselkumab was superior to secukinumab as measured by the primary endpoint of PASI 90 response 
at Week 48 (84.5% versus 70.0%, p < 0.001). Comparative PASI response rates are presented in 
Table 6.

Table 6: PASI Response Rates in ECLIPSE
Number of patients (%)

Guselkumab (N=534) Secukinumab (N=514)
Primary Endpoint
PASI 90 response at Week 48 451 (84.5%) a 360 (70.0%)
Major Secondary Endpoints
PASI 75 response at both Week 12 and 
Week 48

452 (84.6%) b 412 (80.2%)

PASI 75 response at Week 12 477 (89.3%) c 471 (91.6%)
PASI 90 response at Week 12 369 (69.1%) c 391 (76.1%)
PASI 100 response at Week 48 311 (58.2%) c 249 (48.4%)



12

a p < 0.001 for superiority
b p < 0.001 for non-inferiority, p=0.062 for superiority
c formal statistical testing was not performed

Guselkumab and secukinumab PASI 90 response rates through Week 48 are presented in Figure 4.

Figure 4: Percent of Subjects Who Achieved a PASI 90 Response Through Week 48 by Visit 
(Subjects Randomised at Week 0) in ECLIPSE

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

5.2 Pharmacokinetic properties

Absorption
Following a single 100 mg subcutaneous injection in healthy subjects, guselkumab reached a mean 
(± SD) maximum serum concentration (Cmax) of 8.09 ± 3.68 mcg/mL by approximately 5.5 days post 
dose.

Steady-state serum guselkumab concentrations were achieved by Week 20 following subcutaneous 
administrations of 100 mg guselkumab at Weeks 0 and 4, and every 8 weeks thereafter. The mean 
(± SD) steady-state trough serum guselkumab concentrations in two phase III studies were 
1.15 ± 0.73 mcg/mL and 1.23 ± 0.84 mcg/mL.

The absolute bioavailability of guselkumab following a single 100 mg subcutaneous injection was 
estimated to be approximately 49% in healthy subjects.

Distribution
Mean volume of distribution during the terminal phase (Vz) following a single intravenous 
administration to healthy subjects ranged from approximately 7 to 10 L across studies.



13

Biotransformation
The exact pathway through which guselkumab is metabolized has not been characterized. As a human 
IgG mAb, guselkumab is expected to be degraded into small peptides and amino acids via catabolic
pathways in the same manner as endogenous IgG.

Elimination
Mean systemic clearance (CL) following a single intravenous administration to healthy subjects
ranged from 0.288 to 0.479 L/day across studies. Mean half-life (T1/2) of guselkumab was 
approximately 17 days in healthy subjects and approximately 15 to 18 days in patients with plaque 
psoriasis across studies.

Linearity/non-linearity
The systemic exposure of guselkumab (Cmax and AUC) increased in an approximately 
dose-proportional manner following a single subcutaneous injection at doses ranging from 10 mg to 
300 mg in healthy subjects or patients with plaque psoriasis.

Elderly patients
No specific studies have been conducted in elderly patients. Of the 1384 plaque psoriasis patients 
exposed to guselkumab and included in the population pharmacokinetic analysis, 70 patients were 
65 years of age or older, including 4 patients who were 75 years of age or older. Population 
pharmacokinetic analyses indicated there were no apparent changes in CL/F estimate in patients 
≥ 65 years of age compared to patients < 65 years of age, suggesting no dose adjustment is needed for 
elderly patients.

Patients with renal or hepatic impairment
No specific study has been conducted to determine the effect of renal or hepatic impairment on the 
pharmacokinetics of guselkumab. Renal elimination of intact guselkumab, an IgG mAb, is expected to
be low and of minor importance; similarly, hepatic impairment is not expected to influence clearance 
of guselkumab as IgG mAbs are mainly eliminated via intracellular catabolism.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety
pharmacology, repeat-dose toxicity, toxicity to reproduction and pre- and post-natal development.

In repeat-dose toxicity studies in cynomolgus monkeys, guselkumab was well tolerated via
intravenous and subcutaneous routes of administration. A weekly subcutaneous dose of 50 mg/kg to 
monkeys resulted in exposure (AUC) and Cmax values that were at least 49-fold and >200-fold higher, 
respectively, than those measured in the human clinical PK study. Additionally, there were no adverse 
immunotoxicity or cardiovascular safety pharmacology effects noted during the conduct of the 
repeat-dose toxicity studies or in a targeted cardiovascular safety pharmacology study in cynomolgus 
monkeys.

There were no preneoplastic changes observed in histopathology evaluations of animals treated up to 
24-weeks, or following the 12-week recovery period during which drug was detectable in the serum.

No mutagenicity or carcinogenicity studies were conducted with guselkumab.

Guselkumab could not be detected in breast milk from cynomolgus monkeys as measured at post-natal 
day 28.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Histidine



14

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

2 years.

6.4 Special precautions for storage

Store in a refrigerator (2°C–8°C). Do not freeze.
Keep the pre-filled syringe or pre-filled pen in the outer carton in order to protect from light.

6.5 Nature and contents of container

Tremfya 100 mg solution for injection in pre-filled syringe
1 mL solution in a pre-filled glass syringe with a fixed needle and a needle shield, assembled in an 
automatic needle guard.
Tremfya is available in a pack containing one pre-filled syringe and in a multipack containing 2 (2 
packs of 1) pre-filled syringes.

Not all pack sizes may be marketed.

Tremfya 100 mg solution for injection in pre-filled pen
1 mL solution in a pre-filled glass syringe assembled in a pre-filled pen with an automatic needle 
guard.
Tremfya is available in a pack containing one pre-filled pen and in a multipack containing 2 (2 packs 
of 1) pre-filled pens.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

After removing the pre-filled syringe or pre-filled pen from the refrigerator, keep the pre-filled syringe 
or pre-filled pen inside the carton and allow to reach room temperature by waiting for 30 minutes 
before injecting Tremfya. The pre-filled syringe or pre-filled pen should not be shaken.

Prior to use, a visual inspection of the pre-filled syringe or pre-filled pen is recommended. The 
solution should be clear, colourless to light yellow, and may contain a few small white or clear 
particles. Tremfya should not be used if the solution is cloudy or discoloured, or contains large 
particles.

Each Tremfya pack is provided with an ‘Instructions for use’ leaflet that fully describes the 
preparation and administration of the pre-filled syringe or pre-filled pen.

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



15

7. MARKETING AUTHORISATION HOLDER

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

8. MARKETING AUTHORISATION NUMBER(S)

EU/1/17/1234/001 1 pre-filled syringe
EU/1/17/1234/002 1 pre-filled pen
EU/1/17/1234/003 2 pre-filled pens
EU/1/17/1234/004 2 pre-filled syringes

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 10 November 2017

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/


16

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



17

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

Name and address of the manufacturers of the biological active substance
Biogen Inc. (BIIB)
5000 Davis Drive
Research Triangle Park
NC27709
USA

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
2333CB 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

The requirements for submission of periodic safety update reports 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.

The marketing authorisation holder shall submit the first periodic safety update report for this product 
within 6 months following authorisation.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT

 Risk management plan (RMP)

The 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.



18

ANNEX III

LABELLING AND PACKAGE LEAFLET



19

A. LABELLING



20

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED SYRINGE CARTON TEXT (100 mg)

1. NAME OF THE MEDICINAL PRODUCT

Tremfya 100 mg solution for injection in pre-filled syringe
guselkumab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled syringe contains 100 mg of guselkumab in 1 mL.

3. LIST OF EXCIPIENTS

Excipients: sucrose, histidine, histidine monohydrochloride monohydrate, polysorbate 80, water for 
injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

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

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.
Do not freeze.



21

Keep the pre-filled syringe in the outer carton in order to protect from light.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

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

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/17/1234/001

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Tremfya 100 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:
SN:
NN:



22

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR 1 PRE-FILLED SYRINGE (100 mg) AS INTERMEDIATE PACK / 
COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Tremfya 100 mg solution for injection in pre-filled syringe
guselkumab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled syringe contains 100 mg of guselkumab in 1 mL.

3. LIST OF EXCIPIENTS

Excipients: sucrose, histidine, histidine monohydrochloride monohydrate, polysorbate 80, water for 
injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

1 pre-filled syringe
Component of a multipack, cannot be sold separately

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.



23

Do not freeze.

Keep the pre-filled syringe in the outer carton in order to protect from light.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

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

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/17/1234/004

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Tremfya 100 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA



24

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR PRE-FILLED SYRINGE MULTIPACK COMPRISING 2 PACKS
(INCLUDING BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Tremfya 100 mg solution for injection in pre-filled syringe
guselkumab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled syringe contains 100 mg of guselkumab in 1 mL.

3. LIST OF EXCIPIENTS

Excipients: sucrose, histidine, histidine monohydrochloride monohydrate, polysorbate 80, water for 
injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

Multipack: 2 (2 packs of 1) pre-filled syringes

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.



25

Keep the pre-filled syringe in the outer carton in order to protect from light.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

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

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/17/1234/004 (2 packs, each containing 1 pre-filled syringe)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Tremfya 100 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:
SN:
NN:



26

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE LABEL TEXT (100 mg)

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

Tremfya 100 mg
injection
guselkumab
SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 mL

6. OTHER



27

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED PEN CARTON TEXT (100 mg)

1. NAME OF THE MEDICINAL PRODUCT

Tremfya 100 mg solution for injection in pre-filled pen
guselkumab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled pen contains 100 mg of guselkumab in 1 mL.

3. LIST OF EXCIPIENTS

Excipients: sucrose, histidine, histidine monohydrochloride monohydrate, polysorbate 80, water for 
injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

1 pre-filled pen

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.



28

Keep the pre-filled pen in the outer carton in order to protect from light.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

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

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/17/1234/002

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Tremfya 100 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:
SN:
NN:



29

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR 1 PRE-FILLED PEN (100 mg) AS INTERMEDIATE PACK / COMPONENT 
OF A MULTIPACK (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Tremfya 100 mg solution for injection in pre-filled pen
guselkumab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled pen contains 100 mg of guselkumab in 1 mL.

3. LIST OF EXCIPIENTS

Excipients: sucrose, histidine, histidine monohydrochloride monohydrate, polysorbate 80, water for 
injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

1 pre-filled pen
Component of a multipack, cannot be sold separately

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



30

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.
Do not freeze.

Keep the pre-filled pen in the outer carton in order to protect from light.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

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

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/17/1234/003

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Tremfya 100 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA



31

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR PRE-FILLED PEN MULTIPACK COMPRISING 2 PACKS (INCLUDING 
BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Tremfya 100 mg solution for injection in pre-filled pen
guselkumab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled pen contains 100 mg of guselkumab in 1 mL.

3. LIST OF EXCIPIENTS

Excipients: sucrose, histidine, histidine monohydrochloride monohydrate, polysorbate 80, water for 
injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

Multipack: 2 (2 packs of 1) pre-filled pens

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.



32

Do not freeze.

Keep the pre-filled pen in the outer carton in order to protect from light.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

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

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/17/1234/003 (2 packs, each containing 1 pre-filled pen)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Tremfya 100 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA
PC:
SN:
NN:



33

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED PEN LABEL TEXT (100 mg)

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

Tremfya 100 mg
injection
guselkumab
SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 mL

6. OTHER



34

B. PACKAGE LEAFLET



35

Package leaflet: Information for the user

Tremfya 100 mg solution for injection in pre-filled syringe
guselkumab

This medicine is subject to additional monitoring. This will allow quick identification of new 
safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What Tremfya is and what it is used for

Tremfya contains the active substance guselkumab which is a type of protein called a monoclonal 
antibody.

This medicine works by blocking the activity of a protein called IL-23, which is present at increased 
levels in people with psoriasis.

Tremfya is used to treat adults with moderate to severe “plaque psoriasis”, an inflammatory condition 
affecting the skin and nails.

Tremfya can improve the condition of the skin and appearance of nails and reduce symptoms, such as 
scaling, shedding, flaking, itching, pain and burning.

2. What you need to know before you use Tremfya

Do not use Tremfya
 if you are allergic to guselkumab or any of the other ingredients of this medicine (listed in 

section 6). If you think you may be allergic, ask your doctor for advice before using Tremfya
 if you have an active infection, including active tuberculosis

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Tremfya:
 if you are being treated for an infection
 if you have an infection that does not go away or that keeps coming back
 if you have tuberculosis or have been in close contact with someone with tuberculosis



36

 if you think you have an infection or have symptoms of an infection (see below under ‘Look out 
for infections and allergic reactions’)

 if you have recently had a vaccination or if you are due to have a vaccination during treatment 
with Tremfya.

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

Look out for infections and allergic reactions
Tremfya can potentially cause serious side effects, including allergic reactions and infections. You 
must look out for signs of these conditions while you are taking Tremfya. Stop using Tremfya and tell
your doctor or seek medical help immediately if you notice any signs indicating a possible serious 
allergic reaction or an infection.

Signs of infections may include fever or flu like symptoms; muscle aches; cough; shortness of breath; 
burning when you urinate or urinating more often than usual; blood in your phlegm (mucus); weight 
loss; diarrhoea or stomach pain; warm, red, or painful skin or sores on your body which are different 
from your psoriasis.

Serious allergic reactions, which can include symptoms of hives and shortness of breath, have 
occurred with Tremfya (see “Serious side effects” in section 4).

Children and adolescents
Tremfya is not recommended for children and adolescents under 18 years of age because it has not 
been studied in this age group.

Other medicines and Tremfya
Tell your doctor or pharmacist:
 if you are using, have recently used or might use any other medicines.
 if you recently had or are due to have a vaccination. You should not be given certain types of 

vaccines (live vaccines) while using Tremfya.

Pregnancy and breast-feeding
 Tremfya should not be used in pregnancy as the effects of this medicine in pregnant women are 

not known. If you are a woman of childbearing potential, you are advised to avoid becoming 
pregnant and must use adequate contraception while using Tremfya and for at least 12 weeks
after the last Tremfya dose. Talk to your doctor if you are pregnant, think you may be pregnant 
or are planning to have a baby.

 Talk to your doctor if you are breast-feeding or are planning to breast-feed. You and your doctor 
should decide if you will breast-feed or use Tremfya.

Driving and using machines
Tremfya is unlikely to influence your ability to drive and use machines.

3. How to use Tremfya

Always use this medicine exactly as your doctor or nurse has told you. Check with your doctor, nurse 
or pharmacist if you are not sure.

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

 The dose is 100 mg (the content of 1 pre-filled syringe) given by injection under the skin 
(subcutaneous injection). This may be given by your doctor or nurse.

 After the first dose, you will have the next dose 4 weeks later, and then every 8 weeks.



37

At the start, your doctor or nurse will inject Tremfya. However, you may decide together with your 
doctor to give Tremfya yourself in which case you will get the appropriate training on how to inject 
Tremfya. Talk to your doctor or nurse if you have any questions about giving yourself an injection. It 
is important not to try to inject yourself until you have been trained by your doctor or nurse.

For detailed instructions on how to use Tremfya, carefully read the ‘Instructions for use’ leaflet before 
use, which is included in the carton.

If you use more Tremfya than you should
If you have received more Tremfya than you should or the dose has been given sooner than prescribed, 
inform your doctor.

If you forget to use Tremfya
If you have forgotten to inject a dose of Tremfya, inform your doctor.

If you stop using Tremfya
You should not stop using Tremfya without speaking to your doctor first. If you stop treatment, 
symptoms of psoriasis may come back.

4. Possible side effects

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

Serious side effects
Tell your doctor or seek medical help immediately if you get any of the following side effects:

Possible serious allergic reaction - the signs may include:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue or throat
- severe itching of the skin, with a red rash or raised bumps

Other side effects
The following side effects are all mild to moderate. If any of these side effects becomes severe, tell 
your doctor, pharmacist or nurse immediately.

Some side effects are very common (may affect more than 1 in 10 people):
- upper respiratory infections

Some side effects are common (may affect up to 1 in 10 people):
- headache
- joint pain (arthralgia)
- diarrhoea
- stomach flu (gastroenteritis)
- redness at the injection site
- hives
- fungal infection of the skin, for instance between the toes (e.g., athlete’s foot)
- herpes simplex infections

Some side effects are uncommon (may affect up to 1 in 100 people):
- pain at the injection site
- allergic reaction
- skin rash

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 



38

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 Tremfya

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the syringe label and on the outer 
carton after “EXP”. The expiry date refers to the last day of that month.

Keep the pre-filled syringe in the outer carton in order to protect it from light.

Store in a refrigerator (2°C–8°C). Do not freeze.

Do not shake.

Do not use this medicine if you notice that the medicine is cloudy or discoloured, or contains large 
particles. Before use, remove the carton from the refrigerator and keep the pre-filled syringe inside the 
carton and allow to reach room temperature by waiting for 30 minutes.

This medicine is for single use only. 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 Tremfya contains
- The active substance is guselkumab. Each pre-filled syringe contains 100 mg of guselkumab in 

1 mL solution.
- The other ingredients are histidine, histidine monohydrochloride monohydrate, polysorbate 80, 

sucrose and water for injections.

What Tremfya looks like and contents of the pack
Solution for injection (injection). Tremfya is a clear, colourless to light yellow solution. It is supplied 
as a carton pack containing one single-dose glass syringe and as a multipack containing 2 (2 packs of 
1) single-dose pre-filled syringes. Not all pack sizes may be marketed.

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

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

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

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


39

België/Belgique/Belgien
Janssen-Cilag NV
Antwerpseweg 15-17
B-2340 Beerse
Tel/Tél: +32 14 64 94 11

Lietuva
UAB "JOHNSON & JOHNSON"
Konstitucijos pr. 21C
LT-08130 Vilnius
Tel: +370 5 278 68 88

България
„Джонсън & Джонсън България” ЕООД
ж.к. Младост 4
Бизнес Парк София, сграда 4
София 1766
Тел.: +359 2 489 94 00

Luxembourg/Luxemburg
Janssen-Cilag NV
Antwerpseweg 15-17
B-2340 Beerse
Belgique/Belgien
Tél/Tel: +32 14 64 94 11

Česká republika
Janssen-Cilag s.r.o.
Walterovo náměstí 329/1
CZ-158 00 Praha 5 – Jinonice
Tel.: +420 227 012 227

Magyarország
Janssen-Cilag Kft.
Nagyenyed u. 8-14
H-Budapest, 1123
Tel.: +36 1 884 2858

Danmark
Janssen-Cilag A/S
Bregnerødvej 133
DK-3460 Birkerød
Tlf: +45 45 94 82 82

Malta
AM MANGION LTD.
Mangion Building, Triq Ġdida fi Triq Valletta
MT-Ħal-Luqa LQA 6000
Tel: +356 2397 6000

Deutschland
Janssen-Cilag GmbH
Johnson & Johnson Platz 1
D-41470 Neuss
Tel: +49 2137 955 955

Nederland
Janssen-Cilag B.V.
Graaf Engelbertlaan 75
NL-4837 DS Breda
Tel: +31 76 711 1111

Eesti
UAB "JOHNSON & JOHNSON" Eesti filiaal
Lõõtsa 2
EE-11415 Tallinn
Tel: +372 617 7410

Norge
Janssen-Cilag AS
Postboks 144
NO-1325-Lysaker
Tlf: +47 24 12 65 00

Ελλάδα
Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε.
Λεωφόρος Ειρήνης 56
GR-151 21 Πεύκη, Αθήνα
Tηλ: +30 210 80 90 000

Österreich
Janssen-Cilag Pharma GmbH
Vorgartenstraße 206B
A-1020 Wien
Tel: +43 1 610 300

España
Janssen-Cilag, S.A.
Paseo de las Doce Estrellas, 5-7
E-28042 Madrid
Tel: +34 91 722 81 00

Polska
Janssen-Cilag Polska Sp. z o.o.
ul. Iłżecka 24
PL-02-135 Warszawa
Tel.: +48 22 237 60 00

France
Janssen-Cilag
1, rue Camille Desmoulins, TSA 91003
F-92787 Issy Les Moulineaux, Cedex 9
Tél: 0 800 25 50 75 / +33 1 55 00 40 03

Portugal
Janssen-Cilag Farmacêutica, Lda.
Lagoas Park, Edifício 9
PT-2740-262 Porto Salvo
Tel: +351 21 43 68 600



40

Hrvatska
Johnson & Johnson S.E. d.o.o.
Oreškovićeva 6h
10010 Zagreb
Tel: +385 1 6610 700

România
Johnson & Johnson România SRL
Str. Tipografilor nr. 11-15
Clădirea S-Park, Corp B3-B4, Etaj 3
013714 Bucureşti, ROMÂNIA
Tel: +40 21 207 1800

Ireland
Janssen Sciences Ireland UC
Barnahely
Ringaskiddy
IRL – Co. Cork P43 FA46
Tel: +353 1 800 709 122

Slovenija
Johnson & Johnson d.o.o.
Šmartinska cesta 53
SI-1000 Ljubljana
Tel: +386 1 401 18 00

Ísland
Janssen-Cilag AB
c/o Vistor hf.
Hörgatúni 2
IS-210 Garðabær
Sími: +354 535 7000

Slovenská republika
Johnson & Johnson, s.r.o.
CBC III, Karadžičova 12
SK-821 08 Bratislava
Tel: +421 232 408 400

Italia
Janssen-Cilag SpA
Via M.Buonarroti, 23
I-20093 Cologno Monzese MI
Tel: +39 02 2510 1

Suomi/Finland
Janssen-Cilag Oy
Vaisalantie/Vaisalavägen 2
FI-02130 Espoo/Esbo
Puh/Tel: +358 207 531 300

Κύπρος
Βαρνάβας Χατζηπαναγής Λτδ
Λεωφόρος Γιάννου Κρανιδιώτη 226
Λατσιά
CY-2234 Λευκωσία
Τηλ: +357 22 207 700

Sverige
Janssen-Cilag AB
Box 4042
SE-16904 Solna
Tel: +46 8 626 50 00

Latvija
UAB "JOHNSON & JOHNSON" filiāle Latvijā
Mūkusalas iela 101
Rīga, LV-1004
Tel: +371 678 93561

United Kingdom
Janssen-Cilag Ltd.
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire HP12 4EG - UK
Tel: +44 1 494 567 444

This leaflet was last revised in

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



41

Instructions for use
Tremfya

Pre-filled syringe

Important

If your doctor decides that you or a caregiver may be able to give your injections 
of Tremfya at home, you should receive training on the right way to prepare and 
inject Tremfya using the pre-filled syringe before attempting to inject.

Please read these Instructions for use before using the Tremfya pre-filled syringe 
and each time you get a refill. There may be new information. This instruction 
guide does not take the place of talking with your doctor about your medical 
condition or your treatment. Please also read the Package Leaflet carefully before 
starting your injection and discuss any questions you may have with your doctor 
or nurse.

The Tremfya pre-filled syringe is intended for injection under the skin, not into 
the muscle or vein. After injection, the needle will retract into the body of the 
device and lock into place.

Storage information
Store in refrigerator at 2° to 8°C. Do not freeze.

Keep Tremfya and all medicines out of reach of children.

Do not shake the pre-filled syringe at any time.

SINGLE-USE



42

Pre-filled syringe at-a-glance

Before injection

Plunger
Do not hold or pull 
plunger at any time.

Safety guard

Finger flange

Body
Hold syringe body below finger flange.

Viewing window

Needle cover
Do not remove until you are ready 
to inject Tremfya (See Step 2).



43

After injection

You will need these supplies:
• 1 Alcohol swab
• 1 Cotton ball or gauze pad
• 1 Adhesive bandage
• 1 Sharps container (See Step 3)

Plunger locks

Safety guard 
activates

Needle retracts
into the body



44

Inspect carton

Remove carton with the pre-filled syringe from the refrigerator.

Keep the pre-filled syringe in the carton and let it sit on a flat surface at room 
temperature for at least 30 minutes before use.

Do not warm any other way.

Check the expiration date (‘EXP’) on the back panel of the carton.

Do not use if the expiration date has passed.

Do not inject if the perforations on the carton are broken.

Call your doctor or pharmacist for a refill.

Choose injection site

Select from the following areas for your injection:

• Front of thighs (recommended)

• Lower abdomen

Do not use the 5-centimetre area around your belly-button.

• Back of upper arms (if a caregiver is giving you the injection)

Do not inject into skin that is tender, bruised, red, scaly or hard.

Do not inject into areas with scars or stretch marks.

1. Prepare for your injection

30
MIN



45

Clean injection site

Wash your hands well with soap and warm water.

Wipe your chosen injection site with an alcohol swab and allow it to dry.

Do not touch, fan or blow on the injection site after you have cleaned it.

Inspect liquid

Take the pre-filled syringe out of the carton.

Check the liquid in the viewing window. It should be clear to slightly yellow and 
may contain tiny white or clear particles. You may also see one or more air 
bubbles.

This is normal.

Do not inject if the liquid is cloudy or discoloured, or has large particles. If you 
are uncertain, call your doctor or pharmacist for a refill.



46

Remove needle cover

Hold syringe by the body and pull needle cover straight off.

It is normal to see a drop of liquid.

Inject within 5 minutes of removing the needle cover.

Do not put needle cover back on, as this may damage the needle.

Do not touch needle or let it touch any surface.

Do not use the Tremfya pre-filled syringe if it is dropped. Call your doctor or 
pharmacist for a refill.

Position fingers and insert needle

Place your thumb, index and middle fingers directly under the finger flange, 
as shown.

Do not touch plunger or area above finger flange as this may cause the needle 
safety device to activate.

Use your other hand to pinch skin at the injection site. Position syringe at about 
a 45 degree angle to the skin.

It is important to pinch enough skin to inject under the skin and not into the 
muscle.

Insert needle with a quick, dart-like motion.

2. Inject Tremfya using the pre-filled syringe



47

Release pinch and reposition hand

Use your free hand to grasp the body of the syringe.

Press plunger

Place thumb from the opposite hand on the plunger and press the plunger all 
the way down until it stops.

Release pressure from plunger

The safety guard will cover the needle and lock into place, removing the needle 
from your skin.



48

Throw the used pre-filled syringe away

Put your used syringe in a sharps disposal container right away after use.

Make sure you dispose of the bin as instructed by your doctor or nurse when the 
container is full.

Check injection site

There may be a small amount of blood or liquid at the injection site. Hold 
pressure over your skin with a cotton ball or gauze pad until any bleeding stops.

Do not rub the injection site.

If needed, cover injection site with a bandage.

Your injection is now complete!

Need help?

Call your doctor to talk about any questions you may have. For additional 
assistance or to share your feedback refer to the Package Leaflet for your local 
representative contact information.

3. After your injection



49

Package leaflet: Information for the user

Tremfya 100 mg solution for injection in pre-filled pen
guselkumab

This medicine is subject to additional monitoring. This will allow quick identification of new 
safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What Tremfya is and what it is used for

Tremfya contains the active substance guselkumab which is a type of protein called a monoclonal 
antibody.

This medicine works by blocking the activity of a protein called IL-23, which is present at increased 
levels in people with psoriasis.

Tremfya is used to treat adults with moderate to severe “plaque psoriasis”, an inflammatory condition 
affecting the skin and nails.

Tremfya can improve the condition of the skin and appearance of nails and reduce symptoms, such as 
scaling, shedding, flaking, itching, pain and burning.

2. What you need to know before you use Tremfya

Do not use Tremfya
 if you are allergic to guselkumab or any of the other ingredients of this medicine (listed in 

section 6). If you think you may be allergic, ask your doctor for advice before using Tremfya
 if you have an active infection, including active tuberculosis

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Tremfya:
 if you are being treated for an infection
 if you have an infection that does not go away or that keeps coming back



50

 if you have tuberculosis or have been in close contact with someone with tuberculosis
 if you think you have an infection or have symptoms of an infection (see below under ‘Look out 

for infections and allergic reactions’)
 if you have recently had a vaccination or if you are due to have a vaccination during treatment 

with Tremfya.

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

Look out for infections and allergic reactions
Tremfya can potentially cause serious side effects, including allergic reactions and infections. You 
must look out for signs of these conditions while you are taking Tremfya. Stop using Tremfya and tell 
your doctor or seek medical help immediately if you notice any signs indicating a possible serious 
allergic reaction or an infection.

Signs of infections may include fever or flu like symptoms; muscle aches; cough; shortness of breath; 
burning when you urinate or urinating more often than usual; blood in your phlegm (mucus); weight 
loss; diarrhoea or stomach pain; warm, red, or painful skin or sores on your body which are different 
from your psoriasis.

Serious allergic reactions, which can include symptoms of hives and shortness of breath, have 
occurred with Tremfya (see “Serious side effects” in section 4).

Children and adolescents
Tremfya is not recommended for children and adolescents under 18 years of age because it has not 
been studied in this age group.

Other medicines and Tremfya
Tell your doctor or pharmacist:
 if you are using, have recently used or might use any other medicines.
 if you recently had or are due to have a vaccination. You should not be given certain types of 

vaccines (live vaccines) while using Tremfya.

Pregnancy and breast-feeding
 Tremfya should not be used in pregnancy as the effects of this medicine in pregnant women are 

not known. If you are a woman of childbearing potential, you are advised to avoid becoming 
pregnant and must use adequate contraception while using Tremfya and for at least 12 weeks
after the last Tremfya dose. Talk to your doctor if you are pregnant, think you may be pregnant 
or are planning to have a baby.

 Talk to your doctor if you are breast-feeding or are planning to breast-feed. You and your doctor 
should decide if you will breast-feed or use Tremfya.

Driving and using machines
Tremfya is unlikely to influence your ability to drive and use machines.

3. How to use Tremfya

Always use this medicine exactly as your doctor or nurse has told you. Check with your doctor, nurse
or pharmacist if you are not sure.

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

 The dose is 100 mg (the content of 1 pre-filled pen) given by injection under the skin 
(subcutaneous injection). This may be given by your doctor or nurse.

 After the first dose, you will have the next dose 4 weeks later, and then every 8 weeks.



51

At the start, your doctor or nurse will inject Tremfya. However, you may decide together with your 
doctor to give Tremfya yourself in which case you will get the appropriate training on how to inject 
Tremfya. Talk to your doctor or nurse if you have any questions about giving yourself an injection. It 
is important not to try to inject yourself until you have been trained by your doctor or nurse.

For detailed instructions on how to use Tremfya, carefully read the ‘Instructions for use’ leaflet before 
use, which is included in the carton.

If you use more Tremfya than you should
If you have received more Tremfya than you should or the dose has been given sooner than prescribed, 
inform your doctor.

If you forget to use Tremfya
If you have forgotten to inject a dose of Tremfya, inform your doctor.

If you stop using Tremfya
You should not stop using Tremfya without speaking to your doctor first. If you stop treatment, 
symptoms of psoriasis may come back.

4. Possible side effects

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

Serious side effects
Tell your doctor or seek medical help immediately if you get any of the following side effects:

Possible serious allergic reaction - the signs may include:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue or throat
- severe itching of the skin, with a red rash or raised bumps

Other side effects
The following side effects are all mild to moderate. If any of these side effects becomes severe, tell 
your doctor, pharmacist or nurse immediately.

Some side effects are very common (may affect more than 1 in 10 people):
- upper respiratory infections

Some side effects are common (may affect up to 1 in 10 people):
- headache
- joint pain (arthralgia)
- diarrhoea
- stomach flu (gastroenteritis)
- redness at the injection site
- hives
- fungal infection of the skin, for instance between the toes (e.g., athlete’s foot)
- herpes simplex infections

Some side effects are uncommon (may affect up to 1 in 100 people):
- pain at the injection site
- allergic reaction
- skin rash



52

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine.

5. How to store Tremfya

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the pre-filled pen label and on the 
outer carton after “EXP”. The expiry date refers to the last day of that month.

Keep the pre-filled pen in the outer carton in order to protect it from light.

Store in a refrigerator (2°C–8°C). Do not freeze.

Do not shake.

Do not use this medicine if you notice that the medicine is cloudy or discoloured, or contains large 
particles. Before use, remove the carton from the refrigerator and keep the pre-filled pen inside the 
carton and allow to reach room temperature by waiting for 30 minutes.

This medicine is for single use only. 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 Tremfya contains
- The active substance is guselkumab. Each pre-filled pen contains 100 mg of guselkumab in 

1 mL solution.
- The other ingredients are histidine, histidine monohydrochloride monohydrate, polysorbate 80, 

sucrose and water for injections.

What Tremfya looks like and contents of the pack
Solution for injection (injection). Tremfya is a clear, colourless to light yellow solution. It is supplied 
as a carton pack containing one single-dose pre-filled pen and as a multipack containing 2 (2 packs of 
1) single-dose pre-filled pens. Not all pack sizes may be marketed.

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

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

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

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


53

België/Belgique/Belgien
Janssen-Cilag NV
Antwerpseweg 15-17
B-2340 Beerse
Tel/Tél: +32 14 64 94 11

Lietuva
UAB "JOHNSON & JOHNSON"
Konstitucijos pr. 21C
LT-08130 Vilnius
Tel: +370 5 278 68 88

България
„Джонсън & Джонсън България” ЕООД
ж.к. Младост 4
Бизнес Парк София, сграда 4
София 1766
Тел.: +359 2 489 94 00

Luxembourg/Luxemburg
Janssen-Cilag NV
Antwerpseweg 15-17
B-2340 Beerse
Belgique/Belgien
Tél/Tel: +32 14 64 94 11

Česká republika
Janssen-Cilag s.r.o.
Walterovo náměstí 329/1
CZ-158 00 Praha 5 – Jinonice
Tel.: +420 227 012 227

Magyarország
Janssen-Cilag Kft.
Nagyenyed u. 8-14
H-Budapest, 1123
Tel.: +36 1 884 2858

Danmark
Janssen-Cilag A/S
Bregnerødvej 133
DK-3460 Birkerød
Tlf: +45 45 94 82 82

Malta
AM MANGION LTD.
Mangion Building, Triq Ġdida fi Triq Valletta
MT-Ħal-Luqa LQA 6000
Tel: +356 2397 6000

Deutschland
Janssen-Cilag GmbH
Johnson & Johnson Platz 1
D-41470 Neuss
Tel: +49 2137 955 955

Nederland
Janssen-Cilag B.V.
Graaf Engelbertlaan 75
NL-4837 DS Breda
Tel: +31 76 711 1111

Eesti
UAB "JOHNSON & JOHNSON" Eesti filiaal
Lõõtsa 2
EE-11415 Tallinn
Tel: +372 617 7410

Norge
Janssen-Cilag AS
Postboks 144
NO-1325-Lysaker
Tlf: +47 24 12 65 00

Ελλάδα
Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε.
Λεωφόρος Ειρήνης 56
GR-151 21 Πεύκη, Αθήνα
Tηλ: +30 210 80 90 000

Österreich
Janssen-Cilag Pharma GmbH
Vorgartenstraße 206B
A-1020 Wien
Tel: +43 1 610 300

España
Janssen-Cilag, S.A.
Paseo de las Doce Estrellas, 5-7
E-28042 Madrid
Tel: +34 91 722 81 00

Polska
Janssen-Cilag Polska Sp. z o.o.
ul. Iłżecka 24
PL-02-135 Warszawa
Tel.: +48 22 237 60 00

France
Janssen-Cilag
1, rue Camille Desmoulins, TSA 91003
F-92787 Issy Les Moulineaux, Cedex 9
Tél: 0 800 25 50 75 / +33 1 55 00 40 03

Portugal
Janssen-Cilag Farmacêutica, Lda.
Lagoas Park, Edifício 9
PT-2740-262 Porto Salvo
Tel: +351 21 43 68 600



54

Hrvatska
Johnson & Johnson S.E. d.o.o.
Oreškovićeva 6h
10010 Zagreb
Tel: +385 1 6610 700

România
Johnson & Johnson România SRL
Str. Tipografilor nr. 11-15
Clădirea S-Park, Corp B3-B4, Etaj 3
013714 Bucureşti, ROMÂNIA
Tel: +40 21 207 1800

Ireland
Janssen Sciences Ireland UC
Barnahely
Ringaskiddy
IRL – Co. Cork P43 FA46
Tel: +353 1 800 709 122

Slovenija
Johnson & Johnson d.o.o.
Šmartinska cesta 53
SI-1000 Ljubljana
Tel: +386 1 401 18 00

Ísland
Janssen-Cilag AB
c/o Vistor hf.
Hörgatúni 2
IS-210 Garðabær
Sími: +354 535 7000

Slovenská republika
Johnson & Johnson, s.r.o.
CBC III, Karadžičova 12
SK-821 08 Bratislava
Tel: +421 232 408 400

Italia
Janssen-Cilag SpA
Via M.Buonarroti, 23
I-20093 Cologno Monzese MI
Tel: +39 02 2510 1

Suomi/Finland
Janssen-Cilag Oy
Vaisalantie/Vaisalavägen 2
FI-02130 Espoo/Esbo
Puh/Tel: +358 207 531 300

Κύπρος
Βαρνάβας Χατζηπαναγής Λτδ
Λεωφόρος Γιάννου Κρανιδιώτη 226
Λατσιά
CY-2234 Λευκωσία
Τηλ: +357 22 207 700

Sverige
Janssen-Cilag AB
Box 4042
SE-16904 Solna
Tel: +46 8 626 50 00

Latvija
UAB "JOHNSON & JOHNSON" filiāle Latvijā
Mūkusalas iela 101
Rīga, LV-1004
Tel: +371 678 93561

United Kingdom
Janssen-Cilag Ltd.
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire HP12 4EG - UK
Tel: +44 1 494 567 444

This leaflet was last revised in

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



55

Instructions for use
Tremfya

Pre-filled pen

Important

If your doctor decides that you or a caregiver may be able to give your injections 
of Tremfya at home, you should receive training on the right way to prepare and 
inject Tremfya using the pre-filled pen.

Please read these Instructions for use before using the Tremfya pre-filled pen 
and each time you get a new pre-filled pen. There may be new information. This 
instruction guide does not take the place of talking with your doctor about your 
medical condition or your treatment.

Please also read the Package Leaflet carefully before starting your injection and 
discuss any questions you may have with your doctor or nurse.

Storage information
Store in refrigerator at 2° to 8°C.

Do not freeze.

Keep Tremfya and all medicines out of reach of children.

Do not shake your pre-filled pen at any time.

Need help?

Call your doctor to talk about any questions you may have. For additional 
assistance or to share your feedback refer to the Package Leaflet for your local 
representative contact information.

SINGLE-USE DEVICE



56

Pre-filled pen at-a-glance

You will need these supplies:
• 1 Alcohol swab
• 1 Cotton ball or gauze pad
• 1 Adhesive bandage
• 1 Sharps container (See Step 3)

Green Body

Window

Bottom Cap

Needle Guard

Handle



57

Inspect carton

Remove carton with the pre-filled pen from the refrigerator.

Keep pre-filled pen in the carton and let it sit on a flat surface at room 
temperature for at least 30 minutes before use.

Do not warm any other way.

Check the expiration date (‘EXP’) on the carton.

Do not use if the expiration date has passed.

Do not inject if perforations on the carton are broken.

Call your doctor or pharmacist for a new pre-filled pen.

Choose injection site

Select from the following areas for your injection:

• Front of thighs (recommended)

• Lower abdomen

Do not use the 5-centimetre area around your belly-button.

• Back of upper arms (if a caregiver is giving you the injection)

Do not inject into skin that is tender, bruised, red, scaly, hard or has scars or 
stretch marks.

1. Prepare for your injection

MIN

EXP



58

Wash hands

Wash your hands well with soap and warm water.

Clean injection site

Wipe your chosen injection site with an alcohol swab and allow it to dry.

Do not touch, fan or blow on the injection site after you have cleaned it.

Inspect liquid in window

Take the pre-filled pen out of the carton.

Check the liquid in the window. It should be clear to slightly yellow and may 
contain tiny white or clear particles. You may also see one or more air bubbles.

This is normal.

Do not inject if the liquid is cloudy or discoloured, or has large particles. If you 
are uncertain, call your doctor or pharmacist for a new pre-filled pen.



59

Twist and pull off bottom cap

Keep hands away from the needle guard after the cap is removed.

Inject within 5 minutes of removing the cap.

Do not put the cap back on, this could damage the needle.

Do not use the pre-filled pen if it is dropped after removing the cap.

Call your doctor or pharmacist for a new pre-filled pen.

Place on skin

Position the pre-filled pen straight onto the skin (about 90 degrees relative to 
injection site).

2. Inject Tremfya using the pre-filled pen

90°



60

Push handle straight down

Medication injects as you push. Do this at a speed that is comfortable for you.

Do not lift the pre-filled pen during the injection. The needle guard will lock and 
the full dose will not be delivered.

Complete injection

Injection is complete when the handle is pushed all the way down, you hear a 
click, and the green body is no longer visible.

Lift straight up

The yellow band indicates that the needle guard is locked.

click



61

Throw the used pre-filled pen away

Put your used pre-filled pen in a sharps disposal container right away after use.

Make sure you dispose of the bin as instructed by your doctor or nurse when the 
container is full.

Check injection site

There may be a small amount of blood or liquid at the injection site. Hold 
pressure over your skin with a cotton ball or gauze pad until any bleeding stops.

Do not rub the injection site.

If needed, cover injection site with a bandage.

Your injection is now complete!

3. After your injection


	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