Zilucoplan Pregnancy and Breastfeeding Warnings

Brand names: Zilbrysq

Medically reviewed by Drugs.com. Last updated on Apr 8, 2024.

Zilucoplan Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not Assigned

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

Comments:
-This drug may cause fetal harm.
-Male fertility may be compromised by this drug.

Animal studies have revealed evidence of fetal harm. Subcutaneous administration of this drug to pregnant monkeys resulted in an increase in embryofetal death at all doses (0, 1, 2, or 4 mg/kg/day). There are no controlled data in human pregnancy.

This drug caused irreversible testicular germ cell depletion or degeneration in male monkeys at all doses (0, 1, 2, or 4 mg/kg/day) at the end of the 13-week dosing period and after the 8-week recovery period. A no-effect dose for testicular germ cell degeneration was not identified.

Based on the data from an in-vitro human placental transfer model, this drug can be transferred into the fetal compartment at a rate of 0.5% at a steady-state plasma concentration of 10 mcg/mL. The clinical significance of this data in human pregnancies is unknown.

Last paragraphs:
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

Zilucoplan Breastfeeding Warnings

Benefit to mother should outweigh risk to the infant.

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

Comments:
-No information is available on the clinical use of this drug during breastfeeding.
-The developmental and health benefits of breastfeeding should be considered, along with the mother's clinical need for this drug and potential adverse effects on the infant.

This drug is expected to be degraded in the maternal circulation and infant's gastrointestinal tract. It is unlikely to be absorbed by a breastfed infant or adversely affect the infant. No special precautions are recommended.

See references

Further information

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