Zilucoplan Pregnancy and Breastfeeding Warnings

Brand names: Zilbrysq

Zilucoplan Pregnancy Warnings

Safety has not been established during pregnancy.
-According to some authorities: This drug is only recommended for use during pregnancy if the benefit outweighs the risk.
-According to some authorities: Use is not recommended during pregnancy and in women of childbearing potential not using contraception.

AU TGA pregnancy category: D
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.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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.

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Zilucoplan Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.
-According to some authorities: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comments:
-This drug is expected to be degraded in the maternal circulation and infant's gastrointestinal tract and is unlikely to be absorbed by a breastfed infant or adversely affect the infant. However, risk to newborns or infants cannot be excluded.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown.
-Potential adverse effects in the breastfed child due to this drug or the mother's underlying condition should be considered.

See references

Further information

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

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