Sotatercept

FDA label

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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

Instructions

• 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

Available strengths

• inj 45, 60 mg

Cautions

• Erythrocytosis (thromboembolic events/hyperviscosity)
• Severe thrombocytopenia (bleeding risk)
• Serious bleeding (do not administer during serious bleeding)
• Embryo-fetal toxicity
• Impaired fertility (female and male)

Adverse reactions

• Infections
• Epistaxis
• Telangiectasia
• Diarrhea
• Headache
• Rash
• Increased hemoglobin
• Dizziness
• Erythema
• Gingival bleeding

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