Spesolimab

US prescribing information (SPEVIGO, Boehringer Ingelheim, label date 2026-04-08) — no UK SPC was retrieved, so verify against the UK SPC before publishing. Dosages above apply to adults and paediatric patients 12 years of age and older weighing at least 40 kg. Initiating or reinitiating subcutaneous treatment after an IV-treated flare: four weeks after intravenous treatment of a GPP flare, initiate or reinitiate subcutaneous spesolimab at 300 mg every 4 weeks — a subcutaneous loading dose is NOT required following treatment of a flare with intravenous spesolimab. If a patient flares while on subcutaneous treatment, the flare may be treated with intravenous spesolimab. The intravenous product must be diluted before use and is to be given only by a healthcare professional in a healthcare setting; do not mix with other medicinal products. When using the 150 mg/mL prefilled syringe, the 600 mg subcutaneous loading dose is to be given by a healthcare professional; subsequent 300 mg doses may be self-administered or given by a caregiver after proper training, and in patients 12 years and older administration should be supervised by an adult. Missed subcutaneous dose: administer as soon as possible, then resume the regular schedule. Before initiation: evaluate for active or latent tuberculosis (initiation is not recommended in active TB; consider treating latent TB first) and complete all age-appropriate vaccinations. PAEDIATRIC: safety and effectiveness established in patients 12 years and older weighing at least 40 kg, using the same fixed doses as adults (not a per-kg dose); not established below 12 years or below 40 kg.