Tremfya

This medicinal product is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of plaque psoriasis. 45 mL pre-filled pen is for paediatric patients 6 years and older with a body weight less than 40 kg.

Each pre-filled pen is for single use in a single patient, and should be discarded immediately after use. Paediatric plaque psoriasis (6 to 17 years) Children from the age of 6 years with a body weight less than 40 kg The recommended dose is shown below in Table 1, up to a maximum of 45 mg, administered by subcutaneous injection at Weeks 0 and 4, followed by a maintenance dose every 8 weeks (q8w).

3 Table 1: Recommended dose of guselkumab for subcutaneous injection in paediatric patients with body weight less than 40 kg Body Weight (kg) (at time of dosing) Dose (mg) 12-15 kg 20 16-19 kg 25 20-23 kg 30 24-26 kg 35 27-30 kg 40 31-39 kg 45 Children from the age of 6 years with a body weight of 40 kg or more For children with a body weight of 40 kg, or more a 100 mg pre-filled syringe is available.

2 of the Tremfya 100 mg pre-filled syringe Summary of Product Characteristics. Consideration should be given to discontinuing treatment in paediatric patients who have shown no response 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. Special populations 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.

2. Paediatric population The safety and efficacy of Tremfya in patients less than 6 years have not been established. No data are available. Method of administration Subcutaneous use only. If possible, areas of the skin that show psoriasis should be avoided as injection sites.

Tremfya is not intended for self-administration by paediatric patients. After proper training in subcutaneous injection technique, a caregiver may inject Tremfya if a physician determines that this is appropriate. However, the physician should ensure appropriate medical follow-up of patients.

Caregivers should be instructed to inject the prescribed amount of solution according to the ‘Instructions for use’ provided in the carton. 6.

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

6 The overall safety profile in patients treated with Tremfya is similar for patients with psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease. Tabulated list of adverse reactions Table 2 provides a list of adverse reactions from psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease 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 3). 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). Immunisations Prior to initiating therapy, completion of all age-appropriate immunisations should be considered according to current immunisation guidelines.

Live vaccines should not be used concurrently in patients treated with guselkumab. No data are available on the response to live or inactive vaccines. Before live viral or live bacterial vaccination, treatment should be withheld for at least 12 weeks after the last dose and can be resumed at least 2 weeks after vaccination.

1. g. 4). 4