Nirogacestat Pregnancy and Breastfeeding Warnings

Brand names: Ogsiveo

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

Nirogacestat Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: Based on findings from animal studies and its mechanism of action, this drug can cause fetal harm or loss of pregnancy when administered to a pregnant woman.

Comments:
-There are no data available on the use of this drug in pregnant women to inform a drug-associated risk.
-The pregnancy status of females of reproductive potential should be verified prior to initiating treatment.
-Women of childbearing potential and males with female partners of reproductive potential should be counseled to use effective contraception during treatment and for 1 week after the last dose.
-Pregnant women should be apprised of the potential risk to a fetus.

Animal studies have revealed evidence of embryofetal toxicity and death after oral administration of this drug during the period of organogenesis in pregnant rats. Adverse embryofetal effects occurred at maternal drug exposures below the human exposure at the recommended dose and included decreased fetal body weights, pre- and post-implantation loss, and fetal subcutis edema. Impaired fertility in males and females was observed in animal studies and was attributed to interference with folliculogenesis and spermatogenesis. 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.

See references

Nirogacestat Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 1 week after the last dose.

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

Comments:
-The effects in the nursing infant are unknown; there is a potential for serious adverse reactions.
-There are no data on the presence of this drug or its metabolites in human milk, or on the effects of this drug on milk production.

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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