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Olaparib Pregnancy and Breastfeeding Warnings

Olaparib is also known as: Lynparza

Olaparib Pregnancy Warnings

In animal studies, this drug was teratogenic and caused embryo-fetal toxicity in rats at exposures below those in patients receiving the recommended human dose. Toxicities included increased post-implantation loss, and major malformations of the eyes (anophthalmia, microphthalmia), vertebrae/ribs (extra rib or ossification center; fused or absent neural arches, ribs, and sternebrae), skull (fused exoccipital) and diaphragm (hernia) at dose levels from 0.3% to 11% of the human exposure at the recommended dose. Additional abnormalities were found in the pelvic girdle, lung, thymus, liver, ureter, and umbilical artery. There are no controlled data in human pregnancy. US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use should be avoided as this drug can cause fetal harm based on its mechanism of action and findings in animals. US FDA pregnancy category: D Comments: Female patients of reproductive potential should be encouraged to use effective contraception during treatment and for at least one month after receiving the last dose of this drug.

See references

Olaparib Breastfeeding Warnings

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: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Lynparza (olaparib)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

References for breastfeeding information

  1. "Product Information. Lynparza (olaparib)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

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