sotatercept
Winrevair · ATC code C02KX06
Also known as: Sotatersept
- Key facts
- Active substance
- sotatercept
- ATC code
- C02KX06
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Winrevair 45 mg powder and solvent for solution for injection / Winrevair 60 mg powder and solvent for solution for injection · Winrevair 45 mg powder for solution for injection / Winrevair 60 mg powder for solution for injection
- Marketing authorisation holder
- Merck Sharp & Dohme B.V.
- Information as of
- 2026-10-28
Key facts
Sotatercept (Winrevair) is an activin signalling inhibitor given by subcutaneous injection. It is used with other therapies for pulmonary arterial hypertension.
What it is used for
- Pulmonary arterial hypertension (PAH) in adults with WHO Functional Class II, III and IV, in combination with other PAH therapies.
Dosing
- Once every 3 weeks as a single subcutaneous injection based on body weight.
- Start with a single dose of 0.3 mg/kg; target dose and dose adjustments in the full text.
- Measure haemoglobin and platelets before the first dose; starting is contraindicated if platelets are consistently < 50 × 10^9/L.
- Monitor haemoglobin and platelets before each of the first 5 doses, then every 3 to 6 months.
Contraindications
- Hypersensitivity to the active substance or any of the excipients.
- Platelet counts consistently < 50 × 10^9/L before starting treatment.
Important warnings
- Erythrocytosis (increased haemoglobin) may increase the risk of thromboembolic events and hyperviscosity.
- Severe thrombocytopenia, more frequent with prostacyclin infusion.
- Serious bleeding (including gastrointestinal and intracranial) in 4.3% to 7.0% of patients; do not give during a serious bleed.
- Record the product name and batch number.
Side effects
- Very common: epistaxis (45.3%), headache (26.7%), telangiectasia (26.3%), diarrhoea (25.6%), increased haemoglobin, thrombocytopenia, dizziness, back pain, rash, gastrointestinal bleeding, gingival bleeding.
- Most frequent serious reactions: thrombocytopenia, epistaxis and dizziness (each < 1.2%).
Interactions
- No interaction studies have been performed.
Pregnancy and breastfeeding
- Not recommended during pregnancy; pregnancy testing before starting.
- Effective contraception during treatment and for at least 4 months after the last dose.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- WinrevairMerck Sharp & Dohme B.V. · EMEA/H/C/005647
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Winrevair
- Liechtenstein
- Winrevair
- Norway
- Winrevair
EMA – Article 57 product data (EU/EEA), 2026-10-29
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Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Winrevair – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/winrevair-epar-product-information_en.pdf
Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.