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Rucaparib Pregnancy and Breastfeeding Warnings

Rucaparib is also known as: Rubraca

Rucaparib Pregnancy Warnings

This drug may cause fetal harm when administered to pregnant women based on findings from animal studies and its mechanism of action. US FDA pregnancy category: Not Assigned Comments: -Perform pregnancy testing in females of reproductive potential prior to treatment initiation. -Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose. -Apprise pregnant women of the potential fetal risk of this drug.

Animal studies showed administration of this drug during organogenesis resulted in embryo-fetal death/post-implantation loss (100% early resorptions) at doses 50 mg/kg/day or greater with maternal systemic exposures approximately 0.04 times the AUC in patients receiving the recommended human dose of 600 mg twice a day. Although no fertility studies have been conducted, 3-month repeat-dose general toxicology studies in animals showed this drug had no effects on male and female reproductive organs at doses up to 100 mg/kg/day and 20 mg/kg/day, which resulted in systemic exposures of approximately 0.3 and 0.09 times the human AUC at the recommended dose. 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 during treatment and for 2 weeks after the final dose of this drug because of the potential for serious adverse reactions in breastfed infants. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant and milk production are unknown.

See references

References for pregnancy information

  1. "Product Information. Rubraca (rucaparib)." Clovis Oncology Inc, Boulder, CO.

References for breastfeeding information

  1. "Product Information. Rubraca (rucaparib)." Clovis Oncology Inc, Boulder, CO.

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