Short Prescribing Information WINREVAIR® (Sotatercept)
▼ This medicinal product is subject to additional monitoring. For further information, see the prescribing information (WINREVAIR®) at www.swissmedicinfo-pro.ch.
WINREVAIR®: C: Sotatercept. I: In combination with standard pulmonary arterial hypertension (PAH) therapy, for the long-term treatment of PAH in adult patients with WHO Functional Class II, III and IV. 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; limitation of clinical data: no PAH patients with HIV, portal hypertension, bilharzia, or PVOD were included. IA: No interaction studies performed. P/L: Pregnancy: not recommended, contraception; breastfeeding: not recommended. UE (very common): Thrombocytopenia, increased hemoglobin, dizziness, headache, epistaxis, diarrhoea, gingival bleeding, 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, Bürgenstrasse 8, 6005 Lucerne, Switzerland. (V2.1); CH-SOT-00052.
Before prescribing, please consult the full prescribing information, published on the website of Swissmedic (www.swissmedicinfo-pro.ch).