Sotatercept at a glance
Medicine class
Activin signalling inhibitor and recombinant ActRIIA-Fc fusion protein
Licensed use
Add-on treatment for adults with PAH in WHO functional classes II, III or IV
Administration
Injection under the skin after the powder has been reconstituted
Key monitoring
Regular haemoglobin and platelet measurements
Home injection
Possible after approval and training from the specialist team
What is Sotatercept used for?
The UK licence covers:
Treatment of PAH in adults with WHO functional class II, III or IV, in combination with other PAH therapies.
How does Sotatercept work?
Excessive activin signalling contributes to abnormal cell growth and remodelling in the pulmonary arteries. Sotatercept traps activin-related proteins, helping rebalance growth signals within these blood vessels.
Sotatercept preparations and strengths
Injection
Route: Parenteral
Strengths: 45 mg, 60 mg
How to take Sotatercept
Treatment is guided by a specialist PAH team. The powder must be mixed with the supplied solvent before injection.
For self-injection, use the abdomen or upper thigh. A trained healthcare professional may also use the upper arm.
Rotate injection sites and avoid bruised, tender or scarred skin.
Do not prepare or inject it at home until you have received training and your technique has been confirmed.
Gently swirl during preparation; do not shake.
Use the reconstituted solution promptly and no later than four hours after mixing.
Sotatercept side effects
Common or expected effects
- Nosebleeds
- Headache or dizziness
- Diarrhoea
- Small visible blood vessels on the skin
- Skin rash or redness
- Back pain
- Bleeding gums
- Injection-site itching
- Raised blood pressure
- Increased haemoglobin or reduced platelet count
Get urgent medical advice
- Easy bruising, prolonged bleeding or persistent nosebleeds suggesting a low platelet count
- Gastrointestinal, intracranial or other serious bleeding
- Markedly increased haemoglobin, which may increase the risk of blood clots or hyperviscosity
- Worsening low blood-oxygen levels associated with an intrapulmonary shunt
Sotatercept in pregnancy
Sotatercept is not recommended during pregnancy because human data are unavailable and animal studies found reproductive toxicity. Pregnancy testing is recommended before treatment. Use effective contraception during treatment and for at least four months after the last injection. Contact the specialist team promptly if pregnancy occurs or is suspected.
Sotatercept while breastfeeding
It is unknown whether sotatercept enters human milk, and risk to the baby cannot be excluded. Breastfeeding should stop during treatment and for four months after the last injection; discuss feeding options with the specialist team.
Sotatercept interactions
Formal interaction studies have not been performed. Particular attention is needed for combinations that may increase bleeding risk.
Antithrombotic medicines, including anticoagulants and antiplatelets
Serious bleeding was more likely in patients receiving these medicines, so bleeding risk and symptoms require review.
Prostacyclin infusion therapy
Low platelet counts were reported more often, and concomitant therapy was associated with serious bleeding events.
Common questions about Sotatercept
Answers are fully visible for fast scanning and source review.
What is sotatercept used for?
It is used with other treatments for PAH in adults with WHO functional class II, III or IV symptoms.
Is sotatercept a cure for PAH?
No. It is an add-on treatment intended to improve control of PAH, which generally requires continuing specialist management.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.