Short Prescribing Information WINREVAIR® (Sotatercept) Powder and solvent for solution for injection

▼ This medicinal product is subject to additional monitoring. For further information, see the prescribing information (WINREVAIR®) at www.swissmedicinfo.ch.

WINREVAIR®: C: Sotatercept. I: In combination with standard pulmonary arterial hypertension (PAH) therapy, for the treatment of PAH in adult patients with WHO Functional Class II to III, to improve exercise capacity and to delay disease progression. Po: Adults: once every 3 weeks by subcutaneous injection according to patient weight; obtain hemoglobin (Hgb) and platelet count prior the first dose; starting dose: 0.3 mg/kg; review Hgb and platelet count prior increasing to target dose; target dose: 0.7 mg/kg every 3 weeks; dosage modifications due to hemoglobin increase or platelet count decrease: check Hgb level and platelet count at least before each dose for the first 5 doses; Mode of administration: After reconstitution, administer by subcutaneous injection in the abdomen (at least 5 cm from navel), upper arm or upper thigh. CI: Hypersensitivity to active substance/excipients. Pr: Erythrocytosis; severe thrombocytopenia; serious bleedings; embryo-fetal toxicity; impaired fertility. IA: No interaction studies performed. P/L: Pregnancy: not recommended, contraception; breastfeeding: not recommended. UE (very common): Thrombocytopenia, dizziness, headache, epistaxis, diarrhoea, telangiectasia, rash. P: Kit with 45 mg or 60 mg powder/vial and solvent for solution for injection available in two packs: Pack with 1 (or 2) vial with powder, 1 (or 2) pre-filled syringe with solvent, 1 dosing syringe, 1 (or 2) vial adapter, 1 needle for injection and 4 (or 8) alcohol wipes. C: B. MAH: MSD Merck Sharp & Dohme AG, Werftestrasse 4, 6005 Lucerne, Switzerland. (V1.0); CH-SOT-00052.

Before prescribing please consult the full prescribing information published on the homepage of Swissmedic (www.swissmedicinfo.ch).