Sotatercept-Winrevair drug labeling information

1. Common name: Sotatercept,Sotatercept

Product name: Winrevair

2. Who can use Sotercept? Indications

Sotatercept-Winrevair is indicated for the treatment of adults with pulmonary arterial hypertension (PAH) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events.

3. What are the side effects of Sotercept?

In clinical studies of soltercept, common adverse reactions included headache, epistaxis, rash, telangiectasia, diarrhea, dizziness, and erythema. Warnings and precautions related to soltercept include polycythemia, severe thrombocytopenia, serious bleeding, embryo-fetotoxicity, and impaired fertility.

4. How to use Sotexip

1. Recommended dose: Soterecept should be injected subcutaneously every 3 weeks according to the patient's weight. The starting dose of soltercept is 0.3 mg/kg; maintenance (target) dose: 0.7 mg/kg subcutaneously every 3 weeks.

2. Medication management: Obtain hemoglobin and platelet counts before taking the first dose; if the platelet count is less than 50,000/mm3 (less than 50 x 10[9]/L), do not start treatment. Increase to target dose only after verifying acceptable hemoglobin and platelet counts.

5. How to store Sotexip

Soltercept for injection is a white to off-white lyophilized cake or powder in appearance and is supplied in single-dose vials (45 mg or 60 mg) packaged in a kit containing a measuring syringe and a safety needle. Refrigerate vial in original carton at 2°C to 8°C (36°F to 46°F) to protect from light. Do not freeze. The kit should be kept in the refrigerator until ready to be used. Unused kits can be left outside the refrigerator (max 25°C/77°F) for up to 24 hours.

6. How does Saltsip work?

Sotecept is a recombinant activin receptor typeIIA-Fc (ActRIIA-Fc) fusion protein, an activin signaling inhibitor that can bind activinA and other TGF-β superfamily ligands. Therefore, soltercept improves the balance between pro-proliferative (ActRIIA/Smad2/3-mediated) and anti-proliferative (BMPRII/Smad1/5/8-mediated) signals, thereby regulating vascular proliferation. In a rat model of PAH, soltercept analogues reduced inflammation and inhibited the proliferation of endothelial and smooth muscle cells in diseased vasculature. These cellular changes were associated with vessel wall thinning, partial reversal of right ventricular remodeling, and hemodynamic improvements.

7. What will happen if you take too much Sotercept?

In healthy volunteers, the 1 mg/kg dose of soltercept resulted in an increase in hemoglobin associated with hypertension; both improved with phlebotomy. In the event of overdose, closely monitor for increases in hemoglobin and blood pressure and provide appropriate supportive care. Sotecept is not dialyzable.

8. Pharmacodynamics

In the Phase 3 STELLAR study, the decrease in PVR from baseline was statistically significantly greater in the sotercept group compared with placebo. The median treatment difference in PVR between solterceptand placebo was -235 dynes*seconds/cm5 (95% confidence interval: -288, -181; p<0.001). Based on exposure-response analysis, steady-state exposure to soltercept at the 0.7 mg/kg dose was associated with a near-maximal reduction in PVR.

Reference materials:https://www.drugs.com/mtm/sotatercept.html