Sotatercept Pregnancy and Breastfeeding Warnings

Brand names: Winrevair

Medically reviewed by Drugs.com. Last updated on May 6, 2024.

Sotatercept Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: Based on findings from animal studies, this drug may cause fetal harm when administered to a pregnant woman. No data available on use of this drug in pregnant women to inform a drug-associated risk.

Comments:
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Pregnancy testing prior to treatment is recommended for females of reproductive potential.
-Counsel females of reproductive potential to use an effective method of contraception during treatment and for at least 4 months after the final dose.
-There are risks to the mother and the fetus associated with pulmonary arterial hypertension in pregnancy.
-This drug may impair male and female fertility.
-Report exposure during pregnancy to the Merck Sharp & Dohme, LLC Adverse Event reporting line at 1-877-888-4231.

Animal studies have revealed evidence of embryofetal lethality and teratogenicity. Administration of this drug to pregnant animals during the period of organogenesis resulted in embryofetal mortality, alterations to growth, and structural variations at exposures approximately 0.6- to 4-fold the maximum recommended human dose based on AUC. There are no controlled data in human pregnancy.

Based on findings in animals, this drug may impair female and male fertility. In male rats, although adverse histologic changes in reproductive organs were not reversible after a 13-week period, functional fertility demonstrated reversibility.

In patients with pulmonary arterial hypertension, pregnancy is associated with an increased rate of maternal and fetal morbidity and mortality, including spontaneous abortion, intrauterine growth restriction, and premature labor.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

See references

Sotatercept Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 4 months after the last dose.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-There are no data on the presence of this drug in human milk or the effects of this drug on milk production.
-The effects in the nursing infant are unknown; there is a potential for serious adverse reactions.
-Report exposure during lactation to the Merck Sharp & Dohme, LLC Adverse Event reporting line at 1-877-888-4231.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer