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Pegcetacoplan ophthalmic Pregnancy and Breastfeeding Warnings

Brand names: Syfovre

Medically reviewed by Drugs.com. Last updated on Oct 23, 2023.

Pegcetacoplan ophthalmic Pregnancy Warnings

In embryo fetal development studies, subcutaneous administration of this drug to pregnant monkeys resulted in increased incidences of abortions and stillbirths at doses of 28 mg/kg/day (approximately 1040-fold higher than the maximum recommended human ophthalmic dose [MRHOD] based on exposure [AUC]). No adverse maternal or fetal effects were observed at subcutaneous doses of 7 mg/kg/day (approximately 470-fold higher than the MRHOD). There are no controlled data in human pregnancy.

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.

Benefit should outweigh risk.

US FDA pregnancy category: Not assigned.

Risk summary: No adequate data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Systemic exposure of this drug after ocular administration is low.
-Women of childbearing potential should use effective contraception during treatment with this drug and for 40 days after the last dose.

See references

Pegcetacoplan ophthalmic Breastfeeding Warnings

Caution is recommended.

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

Comments:
-This drug was detected in the milk of lactating monkeys after subcutaneous administration but was not detected in the serum of nursing infant monkeys.
-Exercise caution when administering this drug to a nursing woman, as this drug may harm the growth and development of an infant.

See references

See also

References for pregnancy information

  1. Product Information. Syfovre (pegcetacoplan ophthalmic). Apellis Pharmaceuticals, Inc. 2023.

References for breastfeeding information

  1. Product Information. Syfovre (pegcetacoplan ophthalmic). Apellis Pharmaceuticals, Inc. 2023.

Further information

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