Rucaparib Pregnancy and Breastfeeding Warnings

Brand names: Rubraca

Medically reviewed by Drugs.com. Last updated on Jan 13, 2023.

Rucaparib Pregnancy Warnings

This drug should not be used during pregnancy unless clearly needed.

US FDA pregnancy category: Not assigned.

Risk summary: Based on animal studies and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman; no data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Pregnant patients should be apprised of the potential harm to the fetus.
-Pregnancy testing is recommended for patients of childbearing potential before starting this drug.
-Females of childbearing potential should be advised to avoid becoming pregnant and to use effective contraception during therapy and for 6 months after the last dose.
-Based on results from genetic toxicity and animal reproduction studies, male patients with female partners of childbearing potential or who are pregnant should be advised to use effective methods of contraception during therapy and for 3 months after the last dose.
-Male patients should be advised not to donate sperm during therapy and for 3 months after the last dose.

Animal studies have revealed evidence of embryofetal lethality. After administration of oral doses (ranging from 50 to 1000 mg/kg/day) to pregnant rats during organogenesis, postimplantation loss (100% early resorptions) was observed in all animals at doses at least 50 mg/kg/day (with maternal systemic exposures about 0.04 times the human exposure at the recommended dose based on 24-hour AUC). 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

Rucaparib Breastfeeding Warnings

Breastfeeding is not recommended or contraindicated during use of this drug and for 2 weeks after the last dose.

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

Comments:
-No information is available on the clinical use of this drug during breastfeeding.
-The effects in the nursing infant are unknown; there is the potential for serious adverse reactions. A risk to the neonate/infant cannot be excluded.

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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