Winrevair Application Scope

Winrevair™ (sotatercept-csrk) is the first FDA-approved activin signaling inhibitor for adults with pulmonary arterial hypertension (PAH), enhancing exercise capacity, improving WHO functional class, and reducing the risk of clinical worsening events.

winrevair

Characteristics

Ingredients:
- Sotatercept-csrk

Properties: Sotatercept-csrk is a recombinant fusion protein that acts as an activin signaling inhibitor, targeting the TGF-β superfamily pathways.
Packaging Specification: Available in single-dose vials containing either 45 mg or 60 mg of lyophilized powder for subcutaneous injection.

Storage:
- Store refrigerated at 2°C to 8°C (36°F to 46°F)
- Do not freeze
- Keep in original packaging to protect from light.
Expiry Date: Refer to the expiration date printed on the vial label and packaging
Executive Standard: Manufactured by FDA and EMA regulatory standards
Approval Number: FDA approval granted in March 2024.
Date of Revision: May 9, 2025.
Manufacturer: Merck Sharp & Dohme LLC (U.S.); Merck Sharp & Dohme B.V., Haarlem, The Netherlands (EU).

Guidelines for the Use of Winrevair

Dosage and Administration: Administered via subcutaneous injection every 3 weeks.
- Starting dose: 0.3 mg/kg
- Target dose: 0.7 mg/kg, adjusted based on hemoglobin and platelet levels.

Adverse Reactions: Common side effects (≥10%) include headache, nosebleeds, rash, telangiectasia, diarrhea, dizziness, and erythema.
Contraindications: No known contraindications.
Precautions:
- Monitor for erythrocytosis; elevated hemoglobin levels may increase the risk of thromboembolic events.
- Monitor for thrombocytopenia; decreased platelet counts may increase bleeding risk.
- Advise patients on the potential risk of serious bleeding, especially if on prostacyclin therapy or antithrombotic agents.
- Potential embryo-fetal toxicity; advise effective contraception during treatment and for 4 months after the final dose.

Interactions

Drug Interactions: Moderate interactions observed with efgartigimod alfa and rozanolixizumab.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.