Sotatercept Side Effects

Applies to sotatercept: subcutaneous kit.

Warning

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Sotatercept can raise your hemoglobin levels, which can increase your risk of blood clots. Seek emergency medical help if you have:

signs of a blood clot in the lung--chest pain, sudden cough or shortness of breath, dizziness, coughing up blood; or
signs of a blood clot deep in the body--pain, swelling, or warmth in one leg.

Call your doctor at once if you have:

easy bruising, bleeding that will not stop, purple or red spots under your skin;
sudden weakness (especially on one side of the body), severe headache, problems with speech or vision, pounding in your neck or ears; or
bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Your treatment may be permanently discontinued if you have certain side effects.

Common side effects may include:

headache, dizziness;
nosebleed;
skin rash, skin redness;
small, visible blood vessels on the skin (spider veins); or
diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to sotatercept: subcutaneous kit.

General

The most common adverse reactions occurring in 10% of patients or greater included increased hemoglobin, decreased platelets, headache, epistaxis, rash, telangiectasia, diarrhea, dizziness, and erythema.^[Ref]

Cardiovascular

Frequency not reported: Increased blood pressure

Dermatologic

Very common (10% or more): Rash (20.2%), telangiectasia (16.6%), erythema (13.5%)

Gastrointestinal

Very common (10% or more): Diarrhea (15.3%)

Hematologic

Very common (10% or more): Increased hemoglobin (53%), decreased platelets (25%)

Common (1% to 10%): Serious bleeding (e.g., gastrointestinal, intracranial hemorrhage), severe thrombocytopenia (platelet count less than 50,000/mm3)