Abbreviated SmPC:
This medicine is subject to additional monitoring.
NEMLUVIO 30 mg powder and solvent for solution for injection in pre-filled pen (nemolizumab).
Indications: Moderate-to-severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy, adults with prurigo nodularis. Posology: AD: 60 mg initial (2 x 30 mg), then 30 mg Q4W; after 16 weeks, responders: 30 mg Q8W. Can be used with or without TCS; TCI may be used for problem areas only. PN: <90 kg, 60 mg initial then 30 mg Q4W; ≥90 kg, 60 mg initial then 60 mg Q4W. Missed dose: administer ASAP, then resume schedule. Administration: Subcutaneous injection to front upper thighs or abdomen (avoid 5 cm around navel); upper arm only by caregiver/HCP. For initial 60 mg, use two different injection sites, rotate sites. Do not inject into tender/inflamed/swollen/damaged skin, bruises, scars or open wounds. Contraindication: Hypersensitivity to active substance or excipients. Warnings/precautions: Traceability (record name and batch no.). Systemic hypersensitivity reactions may occur (stop treatment and treat appropriately). Vaccinations: complete age-appropriate vaccines before treatment where possible; avoid live vaccines; no data on response to non-live vaccines. Adverse reactions: Most common, AD: urticaria. Most common, PN: headache, dermatitis atopic, eczema, eczema nummular. Common: headache (incl. tension headache), urticaria, injection site reactions; uncommon: angioedema; rare: injection site oedema. MAH: Galderma (U.K.) Limited, Evergreen House North, Grafton Place, London NW1 2DX, United Kingdom.
References:
1. Ständer S, et al. Rapid improvement of itch with nemolizumab in atopic dermatitis and prurigo nodularis phase 3 studies. J Eur Acad Dermatol Venereol. 2025;00:1-9. 2. Ständer S, et al. Abstract presented at: International Congress of Dermatology; June 18-21, 2025; Rome.
