Sotatercept

Pronunciation: so-ta-TER-sept.

Generic name
sotatercept
Drug class
Activin signalling inhibitor
Form
Powder for injection (45 mg, 60 mg), reconstituted before use
Route
Subcutaneous injection
Legal status
Prescription-only, specialist-initiated (pulmonary hypertension)

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia

Australia: Winrevair (3) · Full directory

What sotatercept is and how it works

Sotatercept is a prescription-only injectable medicine for pulmonary arterial hypertension (PAH), a serious condition involving high blood pressure in the arteries of the lungs. It is a first-in-class treatment that works on a different pathway than older PAH medicines and is usually added to other PAH treatments. (1)

Sotatercept is given as an injection under the skin every 3 weeks, with regular blood tests to check your haemoglobin (red blood cell) and platelet levels, since this medicine can affect both. Your specialist will adjust your dose or delay treatment based on these results.

Mechanism of action: how sotatercept works

Sotatercept is an activin signalling inhibitor -- it traps activins and related growth factors involved in the abnormal blood vessel remodelling that drives pulmonary arterial hypertension, addressing the underlying disease process rather than just symptoms. (1)

What sotatercept is used for

Pulmonary arterial hypertension (PAH)

Used in adults with pulmonary arterial hypertension (WHO Group 1) to improve exercise capacity and functional class, and to reduce the risk of the condition getting worse, including hospital admission, lung transplant, or death. Given alongside other PAH treatments. (1)

Before taking sotatercept

Do not take / not appropriate for

  • Do not use sotatercept if you are pregnant -- it can cause serious harm to a developing baby. (all countries) (1)

Tell your clinician about

  • Whether you are pregnant, could become pregnant, or are breastfeeding.
  • Any bleeding disorder, or if you take blood-thinning medicines or prostacyclin-based PAH medicines.
  • Your platelet count and haemoglobin level, if known.
  • Plans to have children -- this medicine may affect fertility in both women and men.
  • All other medicines you take.
(1)

How to take sotatercept

  • Sotatercept is given as an injection under the skin, usually by a healthcare professional, every 3 weeks.
  • Blood tests to check your haemoglobin and platelet counts are needed before starting, before each of your first 5 doses, and periodically afterward -- your specialist may delay or adjust your dose based on the results.
  • Effective contraception is required during treatment and for at least 4 months after your last dose.
(1)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3)

Missed dose

If a dose is missed, it should be given within 3 days. If more than 3 days have passed, your care team will adjust your schedule to keep doses 3 weeks apart. This is managed by your treatment team.

Overdose

Contact your specialist or seek medical advice if too much sotatercept has been given. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Infections and nosebleeds.

What to notice: Infections and nosebleeds.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Small, visible dilated blood vessels on the skin (telangiectasia), usually appearing months after starting.

What to notice: Small, visible dilated blood vessels on the skin (telangiectasia), usually appearing months after starting.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Diarrhoea, headache, rash, dizziness, skin redness, and gum bleeding.

What to notice: Diarrhoea, headache, rash, dizziness, skin redness, and gum bleeding.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

A rise in haemoglobin (red blood cell) levels is common and monitored with blood tests.

What to notice: A rise in haemoglobin (red blood cell) levels is common and monitored with blood tests.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Serious warnings

Signs of too many red blood cells (erythrocytosis) — high caution

Symptoms: Headache, dizziness, or a flushed complexion -- often only found through blood tests.

Action: Your specialist checks your haemoglobin regularly and will delay or adjust your dose if levels rise too much. (1)

Signs of a low platelet count or bleeding — high caution

Symptoms: Unusual bruising, nosebleeds that don't stop easily, bleeding gums, or blood in urine or stool.

Action: Tell your specialist promptly -- this risk is higher if you also take blood-thinning medicines or certain other PAH treatments. Your specialist checks your platelet count regularly. (1)

Pregnancy — emergency

Symptoms: Not applicable -- this is about avoiding pregnancy while on treatment.

Action: Sotatercept can seriously harm a developing baby. Use effective contraception during treatment and for at least 4 months after your last dose. Tell your specialist immediately if you become pregnant or think you might be. (1)

Interactions

  • Taking sotatercept together with prostacyclin-based PAH medicines or blood-thinning (antithrombotic) medicines increases the risk of serious bleeding -- your specialist will monitor you more closely. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Sotatercept must not be used in pregnancy -- it can cause serious harm to a developing baby. Effective contraception is required during treatment and for at least 4 months after the last dose. (1) (2) (3)

Breastfeeding

Breastfeeding is not recommended during treatment and for 4 months after the last dose. (1) (2) (3)

Children

Not established as safe/effective in children in the source reviewed. (1) (2) (3)

Elderly

No specific dose adjustment based on age alone is described in the source reviewed. (1) (2) (3)

Hepatic_impairment

Not established in the source reviewed for this dossier. (1) (2) (3)

Renal_impairment

Not established in the source reviewed for this dossier. (1) (2) (3)

Source_ids

US-DAILYMED-WINREVAIR-2026 (1) (2) (3)

Monitoring

Before starting

  • Haemoglobin level
  • Platelet count (must be at least 50,000/mm3 to start)
  • Pregnancy test if applicable

During treatment

  • Haemoglobin and platelet counts checked before each of the first 5 doses, then periodically.
  • Ongoing monitoring for bleeding, skin vascular changes, and pregnancy status.
(1)

Storage

Sotatercept is stored and prepared by the treatment centre; patients do not typically store or handle it themselves.

Professional information

Clinician-facing context only, sourced from the current US FDA prescribing information; verify against the current full label before prescribing.

United States

Indication: Pulmonary arterial hypertension (WHO Group 1)

Dose summary: Starting dose 0.3 mg/kg SC; target dose 0.7 mg/kg SC every 3 weeks. Delay >=3 weeks if Hgb rises >2.0 g/dL from prior dose and exceeds ULN, or >4.0 g/dL from baseline, or >2.0 g/dL above ULN. Delay if platelets fall below 50,000/mm3. Monitor Hgb/platelets before each of the first 5 doses, then periodically.

Renal context: Not established in the source reviewed for this dossier. (1)

Mechanism of action

Hepatic guidance

Not established in the source reviewed for this dossier.

Overdose note

No specific antidote described in the source reviewed; manage supportively and seek specialist guidance for suspected overdose. (1)

Frequently asked questions

Is sotatercept (Winrevair) available in the US, UK, Europe, Canada, and Australia?

Yes, it is approved in all of these regions, with UK, Canada, and Australia's approvals coordinated through a joint international regulatory review (the Access Consortium). New Zealand approval was not found in this research and should be confirmed locally. (1) (2) (3)

Can I take sotatercept if I'm pregnant?

No. Sotatercept must not be used in pregnancy because it can seriously harm a developing baby. Effective contraception is required during treatment and for at least 4 months after your last dose. (1)

Why do I need blood tests before every sotatercept dose at first?

Sotatercept can raise your haemoglobin (red blood cell) level too much, or lower your platelet count too much, so your care team checks these before each of your first 5 doses, then periodically afterward, and may delay a dose if either value moves outside a safe range. (1)

What is the mechanism of action of sotatercept?

Sotatercept is an activin signalling inhibitor -- it traps activins and related growth factors involved in the abnormal blood vessel remodelling that drives pulmonary arterial hypertension, addressing the underlying disease process rather than just symptoms. (1)

What is the generic name of Sotatercept?

The generic name is sotatercept. (1)

What class of drug is sotatercept?

Sotatercept is classed as: Activin signalling inhibitor. (1)

References

  1. WINREVAIR (sotatercept-csrk) -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Merck Sharp & Dohme LLC · United States · accessed 2026-07-29 · source 1
  2. European Commission approval of WINREVAIR (sotatercept)Merck & Co. corporate press releases · European Union · accessed 2026-07-29 · source 2
  3. MHRA, Health Canada, and TGA approvals of Winrevair via the Access Consortium joint reviewPMLiVE (UK MHRA approval report), Health Canada Notice of Compliance record, TGA ARTG register · United Kingdom / Canada / Australia · accessed 2026-07-29 · source 3

Brand names by country

Single-ingredient sotatercept names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Winrevair (1)FDA approved currently labeled · 45 mg, 60 mg · Merck Sharp & Dohme LLC

United Kingdom

  • Winrevair (3)MHRA approved confirmed · 45 mg · Merck Sharp & Dohme (UK) Limited

Canada

  • Winrevair (3)Health Canada Notice of Compliance 2024-08-28 · not specified in fetched source · Merck Canada Inc.

Australia

  • Winrevair (3)TGA ARTG registered 2024-11-08 · 45 mg, 60 mg · Merck Sharp & Dohme (Australia) Pty Ltd
View brands in additional countries.

European Union

Winrevair (2)