SOTATERCEPT-CSRK

Other

Brand names: WINREVAIR

Oral

Mechanism of Action

12.1 Mechanism of Action Sotatercept-csrk, a recombinant activin receptor type IIA-Fc (ActRIIA-Fc) fusion protein, is an activin signaling inhibitor that binds to activin A and other TGF- β superfamily ligands. As a result, sotatercept-csrk improves the balance between the pro-proliferative (ActRIIA/Smad2/3-mediated) and anti-proliferative (BMPRII/Smad1/5/8-mediated) signaling to modulate vascular proliferation. In rat models of PAH, a sotatercept-csrk analog reduced inflammation and inhibited proliferation of endothelial and smooth muscle cells in diseased vasculature. These cellular changes were associated with thinner vessel walls, partial reversal of right ventricular remodeling, and improved hemodynamics.

Indications

1 INDICATIONS AND USAGE WINREVAIR™ is indicated for the treatment of adults with pulmonary arterial hypertension (PAH

Group 1 pulmonary hypertension) to improve exercise capacity and World Health Organization (WHO) functional class (FC)

and reduce the risk of clinical worsening events including hospitalization for PAH

lung transplantation and death [see Clinical Studies (14.1) ] . WINREVAIR is an activin signaling inhibitor indicated for the treatment of adults with pulmonary arterial hypertension (PAH

WHO Group 1 pulmonary hypertension) to improve exercise capacity and WHO functional class (FC)

and reduce the risk of clinical worsening events

Contraindications

• 4 CONTRAINDICATIONS None. None ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Erythrocytosis: If severe, may increase the risk of thromboembolic events and hyperviscosity syndrome
1 ) Severe Thrombocytopenia: May increase the risk of bleeding
2 ) Serious Bleeding: Serious bleeding events were reported and were more likely with concomitant prostacyclin and/or antithrombotic agents, or with low platelet counts
Do not administer WINREVAIR if the patient is experiencing serious bleeding

Known Side Effects

8 documented side effects by frequency

Headache

>10%

Diarrhea

>10%

Shortness of Breath

1-10%

Fatigue

1-10%

Dizziness

1-10%

Nausea

1-10%

Vomiting

0.1-1%

Limb Pain

0.1-1%

Community Discussions

No community discussions found for SOTATERCEPT-CSRK yet.

Compare With

0 available comparisons

No comparisons yet.

Formulations

Dosage Forms

Tablet

Route

Oral