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Pegcetacoplan Pregnancy and Breastfeeding Warnings

Medically reviewed by Drugs.com. Last updated on Jun 22, 2021.

Pegcetacoplan is also known as: Empaveli

Pegcetacoplan Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned.

Risk Summary: There are insufficient data on use in pregnant females to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Comments:
-Treatment of pregnant animals from the gestation period through parturition using subcutaneous doses of 28 mg/kg/day (2.9 times the human exposure based on AUC) resulted in a statistically significant increase in abortions or stillbirths compared to controls.
-Females of reproductive potential should have a pregnancy test prior to starting treatment.
-Advise female patients of reproductive potential to use effective contraception during treatment and for at least 40 days after the last dose.
-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.

Animal reproduction studies conducted using subcutaneous doses of 28 mg/kg/day (2.9 times the human exposure based on AUC) have not revealed increased abortions or stillbirths at a dose of 7 mg/kg/day (1.3 times the human exposure based on AUC). No developmental effects were observed in infants up to 6 months postpartum. Systemic exposure to this drug of less than 1% of maternal levels was detected in fetuses from animals treated with 28 mg/kg/day from the period of organogenesis through the second trimester. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

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

Pegcetacoplan Breastfeeding Warnings

Use is not recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comment: Because of the potential for serious adverse reactions in a nursing child, advise lactating women not to breastfeed during therapy and for at least 40 days after the last dose.

See references

References for pregnancy information

  1. "Product Information. Empaveli (pegcetacoplan)." Apellis Pharmaceuticals, Inc. (2021):

References for breastfeeding information

  1. "Product Information. Empaveli (pegcetacoplan)." Apellis Pharmaceuticals, Inc. (2021):

Further information

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