Spevigo

Treatment should be initiated and supervised by physicians experienced in the management of patients with inflammatory skin diseases. Treatment can be initiated with the pre-filled syringe as a subcutaneous injection to prevent GPP flares (please refer to the Summary of Product Characteristics for Spevigo 150 mg and 300 mg solution for injection in pre-filled syringe) or with an intravenous dose of spesolimab to treat a GPP flare.

Posology The recommended dose for GPP flare treatment in adults and adolescents from 12 years of age and weighing at least 40 kg is a single dose of 900 mg (two vials of 450 mg) administered as an intravenous infusion. eDoc-001183254 - Version 4.

0 3 Spevigo has not been studied in patients weighing less than 40 kg. 2). If flare symptoms persist, an additional 450 mg dose (one vial of 450 mg) may be administered 1 week after the initial dose. 4). Clinical data for concomitant use of other GPP treatments with spesolimab is limited.

g. 5). Special populations Elderly No dose adjustment is required. Renal or hepatic impairment Spesolimab has not been formally studied in these patient populations. These conditions are generally not expected to have any clinically relevant impact on the pharmacokinetics of monoclonal antibodies and no dose adjustments are considered necessary.

Paediatric population The safety and efficacy of spesolimab in children less than 12 years of age has not been established. No data are available. Method of administration This medicinal product is for intravenous infusion only. It should not be administered as an intravenous push or bolus.

2 micron) over 90 minutes. No other infusion should be administered in parallel via the same intravenous access. 4). 6.

9%) (see Description of selected adverse reactions). Tabulated list of adverse reactions Table 1 provides a list of the adverse reactions reported in clinical trials as well as in the post- marketing setting. The adverse reactions are listed by MedDRA System Organ Class (SOC) and frequency category 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 (frequency cannot be estimated from the available data).

6% of patients treated with placebo. 9%) in the spesolimab group and no patient in the placebo group. 3% of patients treated witheDoc-001183254 - Version 4. 0 7 placebo. 2%) in the Spevigo group and no patient in the placebo group. Infections observed in clinical trials with spesolimab were generally mild to moderate with no distinct pattern regarding pathogen or type of infection.

Hypersensitivity Hypersensitivity comprises immediate systemic hypersensitivity reactions, including anaphylactic reaction. Immediate systemic hypersensitivity reactions have been reported in open-label extension trials and the post-marketing setting.

Injection site reactions Injection site reactions include erythema, swelling, pain, induration, warmth, exfoliation, papule, pruritus, rash, and urticaria at the injection site. Injection site reactions were typically mild to moderate in severity.

Paediatric population The available data for adolescents are limited. 1). Overall, the safety profile in adolescents treated with spesolimab (n = 6) was consistent with the safety profile in adults and no new safety concerns have been identified.

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.

eDoc-001183254 - Version 4. 8). In patients with a chronic infection or a history of recurrent infection, the potential risks and expected clinical benefits of treatment should be considered prior to prescribing spesolimab. Treatment with spesolimab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

Patients should be instructed to seek medical advice if signs or symptoms of clinically important infection occur after treatment with spesolimab. Pre-treatment evaluation for tuberculosis Prior to initiating treatment with spesolimab, patients should be evaluated for tuberculosis (TB) infection.

3). Anti-TB therapy should be considered prior to initiating spesolimab treatment in patients with latent TB, a history of TB or possible previous exposure to people with active tuberculosis in whom an adequate course of treatment cannot be confirmed.

After spesolimab treatment, patients should be monitored for signs and symptoms of active TB. Hypersensitivity and infusion-related reactions Hypersensitivity and infusion-related reactions may occur with monoclonal antibodies such as spesolimab.

Hypersensitivity may include immediate reactions such as anaphylaxis and delayed reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). 8). 3). , systemic anti-histamines and/or corticosteroids). 2). Use in patients with an immediate, life-threatening GPP flare There is no experience from the use of spesolimab in patients with an immediate, life-threatening flare of GPP or a flare requiring intensive care treatment.

5). 1). Concomitant use of other immunosuppressants and spesolimab is not recommended. g. eDoc-001183254 - Version 4. 0 5 Re-treatment Very limited efficacy and safety data are available for re-treatment with spesolimab for a subsequent new flare.

4). g. 4).