Sotatercept

WINREVAIR

What it isActivin ligand trap rebalancing BMPR-II signaling; pulmonary arterial hypertension.

Why this oneIt targets proliferative vascular remodeling rather than simply adding another vasodilator.

What limits itMonitor hemoglobin and platelets; bleeding, erythrocytosis, and telangiectasia limit use.

FDA label

FDA dosing	Population	Start	Target	Max
Pulmonary arterial hypertension (WHO Group 1)	Adults	0.3 mg/kg SC	0.7 mg/kg SC every 3 weeks	0.7 mg/kg every 3 weeks

Renal No adjustment needed (no clinically significant PK differences in mild-to-severe impairment or ESRD on dialysis)

Hepatic Undefined (effect of hepatic impairment not studied)

Every-3-week dosing; if a dose is >3 days late, adjust schedule to maintain 3-week intervals; for delays >9 weeks restart at 0.3 mg/kg

Subcutaneous injection (abdomen, upper thigh, or upper arm); reconstitute per instructions
Obtain hemoglobin and platelet count before first dose; do not initiate if platelets <50,000/mm3
Check Hgb and platelets before each dose for the first 5 doses (or longer if unstable), then periodically
Females of reproductive potential: effective contraception during and ≥4 months after final dose

Pregnancy May cause fetal harm based on animal studies; use effective contraception during and ≥4 months after final dose

Lactation No human data; breastfeeding not recommended during treatment and for 4 months after final dose

NO BOXED WARNINGS

Principal riskBleeding, erythrocytosis, telangiectasia

Direct muscarinic antagonism0 / 4