TREMFYA

This medicinal product is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which it is indicated. Posology Crohn’s disease The recommended induction dose is: • 200 mg administered by intravenous infusion at Week 0, Week 4, and Week 8.

See SmPC for Tremfya 200 mg concentrate for solution for infusion. or • 400 mg administered by subcutaneous injection (given as two consecutive injections of 200 mg each) at Week 0, Week 4 and Week 8. After completion of the induction dose regimen, the recommended maintenance dose starting at Week 16 is 100 mg administered by subcutaneous injection every 8 weeks (q8w).

1). For the 100 mg dose, see SmPC for Tremfya 100 mg solution for injection. Immunomodulators and/or corticosteroids may be continued during treatment with guselkumab. In patients who have responded to treatment with guselkumab, corticosteroids may be reduced or discontinued in accordance with standard of care.

Consideration should be given to discontinuing treatment in patients who have shown no evidence of therapeutic benefit after 24 weeks of treatment. Ulcerative colitis The recommended induction dose is: • 200 mg administered by intravenous infusion at week 0, week 4 and week 8.

See SmPC for Tremfya 200 mg concentrate for solution for infusion. or • 400 mg administered by subcutaneous injection (given as two consecutive injections of 200 mg each) at Week 0, Week 4 and Week 8. After completion of the induction dose regimen, the recommended maintenance dose starting at Week 16 is 100 mg administered by subcutaneous injection every 8 weeks (q8w).

1). For the 100 mg dose, see SmPC for Tremfya 100 mg solution for injection. Immunomodulators and/or corticosteroids may be continued during treatment with guselkumab. In patients who have responded to treatment with guselkumab, corticosteroids may be reduced or discontinued in accordance with standard of care.

Consideration should be given to discontinuing treatment in patients who have shown no evidence of therapeutic benefit after 24 weeks of treatment. Missed dose If a dose is missed, the dose should be administered as soon as possible.

Thereafter, dosing should be resumed at the regular scheduled time. 2). 2). Renal or hepatic impairment Tremfya has not been studied in these patient populations. These conditions are generally not expected to have any significant impact on the pharmacokinetics of monoclonal antibodies, and no dose adjustments are considered necessary.

Summary of the safety profile The most common adverse reaction was respiratory tract infections (approximately 8% of patients in ulcerative colitis, 11% of patients in the Crohn’s disease studies, and 15% of patients in the psoriasis and psoriatic arthritis clinical studies).

The overall safety profile in patients treated with Tremfya is similar for patients with psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. Tabulated list of adverse reactions Table 1 provides a list of adverse reactions from 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 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).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 6%). 7% of patients in the q8w group. Based on laboratory assessments, most transaminase increases (ALT and AST) were ≤ 3 x upper limit of normal (ULN).

Transaminase increases from > 3 to ≤ 5 x ULN and > 5 x ULN were low in frequency, occurring more often in the guselkumab q4w group compared with the guselkumab q8w group (Table 2). A similar pattern of frequency by severity and by treatment group was observed through the end of the 2- year Phase III psoriatic arthritis clinical study.

6% a placebo-controlled period. b patients randomised to placebo at baseline and crossed over to guselkumab are not included. c number of patients with at least one post-baseline assessment for the specific laboratory test within the time period.

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

Patients treated with guselkumab 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 treatment should be discontinued until the infection resolves.

Pre-treatment evaluation for tuberculosis Prior to initiating treatment, patients should be evaluated for tuberculosis (TB) infection. Patients receiving guselkumab should be monitored for signs and symptoms of active TB during and after treatment.

Anti-TB therapy should be considered prior to initiating treatment in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. 8). Some serious hypersensitivity reactions occurred several days after treatment with guselkumab, including cases with urticaria and dyspnoea.

If a serious hypersensitivity reaction occurs, administration of guselkumab should be discontinued immediately and appropriate therapy initiated. 8). When prescribing guselkumab q4w in psoriatic arthritis, it is recommended to evaluate liver enzymes at baseline and thereafter according to routine patient management.

If increases in alanine aminotransferase [ALT] or aspartate aminotransferase [AST] are observed and drug-induced liver injury is suspected, treatment should be temporarily interrupted until this diagnosis is excluded. Immunisations Prior to initiating therapy, completion of all appropriate immunisations should be considered according to current immunisation guidelines.

1. 4).