What is WINREVAIR (Sotatercept-csrk)?

WINREVAIR (Sotatercept-csrk) is a recombinant activin receptor type IIA-Fc (ActRIIA-Fc) fusion protein.

It blocks certain signals in the body. Specifically, it binds to and inhibits activin A and other TGF- β superfamily ligands.

It corrects the imbalance between pro-proliferative (ActRIIA/Smad2/3-mediated) and anti-proliferative (BMPRII/Smad1/5/8 mediated) signaling mechanisms.

By improving the bad inflammatory signals, it inhibits vascular proliferation, prevents blood vessels and right ventricular remodeling, and improves hemodynamics.

What is WINREVAIR (Sotatercept-csrk) Used For?

WINREVAIR (Sotatercept-csrk) was approved on 26th March 2024 by the FDA for treating patients with WHO Class 1 Pulmonary Arterial Hypertension.

Class 1 Pulmonary arterial hypertension affects young adults primarily women. There are no identifiable causes of Class 1 Pulmonary Arterial Hypertension. Hence, it is termed Idiopathic pulmonary hypertension.

The FDA approved WINREVAIR (Sotatercept-csrk) for such patients to stop the progression of pulmonary arterial hypertension, reduce arterial resistance, improve functional status, and prevent clinical worsening of the disease.

How is WINREVAIR (Sotatercept-csrk) Administered?

It is administered as a subcutaneous injection in a dose of 0.3 mg/kg, administered every 3 weeks.

The dose is calculated based on body weight, hemoglobin levels, and platelet counts.

What are some serious side effects of Winrevair?

Winrevair causes a rise in hemoglobin as a result of its effects on red cell production (erythrocytosis).

Marked erythrocytosis can lead to thrombosis and hyperviscosity syndrome.

In addition, it is associated with severe thrombocytopenia resulting in life-threatening bleeding. The dose needs to be adjusted in patients who develop thrombocytopenia.

In patients with a baseline platelet count of less than 50000/ul, it is better to avoid using it.

The drug can also harm the fetus and should be avoided in pregnant women and women intending to become pregnant.

It may also impair fertility.

Other less serious side effects include:

  • Headache
  • Epistaxis
  • Rash
  • Telangiectasia
  • Diarrhea
  • Dizziness
  • Erythema

A rise in systemic blood pressure has also been observed with Winrevair treatment.