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Pegcetacoplan Pregnancy and Breastfeeding Warnings

Brand names: Empaveli

Medically reviewed by Drugs.com. Last updated on Jun 12, 2023.

Pegcetacoplan Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
According to some authorities, this drug is not recommended during pregnancy.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Risk Summary: Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Females of reproductive potential should have a pregnancy test prior to starting treatment.
-Untreated paroxysmal nocturnal hemoglobinuria (PNH) during pregnancy may cause adverse maternal and fetal outcomes.
-It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.
-Advise female patients of reproductive potential to use effective contraception during treatment and for at least 40 days after the last dose. Some authorities recommend using effective contraception for at least 8 weeks after the last dose.
-If this drug is used during pregnancy or if the patient becomes pregnant while taking it, the patient should be apprised of the potential harm to the fetus.

Animal reproduction studies conducted in cynomolgus monkeys using subcutaneous doses of 28 mg/kg/day (2.9 times the human exposure based on AUC) showed a statistically significant increase in abortions and stillbirths compared to the control group. No increase in abortions or stillbirths were seen 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.

PNH during pregnancy may cause adverse maternal outcomes, including worsening cytopenias, thrombotic events, infections, bleeding, miscarriages and increased maternal mortality, as well as adverse fetal outcomes, including fetal death and premature delivery.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain 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

This drug was detected in animal milk at concentration less than 1% of serum levels, but not in the serum of nursing infants.

Use is not recommended.

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

Comments:
The effects in the nursing infant are unknown. 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. Cerner Multum, Inc. Australian Product Information.
  2. Product Information. Empaveli (pegcetacoplan). Apellis Pharmaceuticals, Inc. 2021.
  3. Product Information. Aspaveli (pegcetacoplan). Swedish Orphan Biovitrum Ltd. 2022.

References for breastfeeding information

  1. Cerner Multum, Inc. Australian Product Information.
  2. Product Information. Empaveli (pegcetacoplan). Apellis Pharmaceuticals, Inc. 2021.
  3. Product Information. Aspaveli (pegcetacoplan). Swedish Orphan Biovitrum Ltd. 2022.

Further information

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