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Ponatinib Pregnancy and Breastfeeding Warnings

Ponatinib is also known as: Iclusig

Ponatinib Pregnancy Warnings

FDA pregnancy category: D Use of ponatinib should be avoided during pregnancy due to its potential for fetal harm. Comments: Encourage use of adequate methods of contraception.

In animals, embryofetal toxicities (fetal soft tissue and skeletal alterations) resulted at doses corresponding to 24% of the human AUC. Although no fertility studies were conducted, ponatinib may impair male and female fertility. Toxicology studies observed effects on male and female reproductive organs including degeneration of epithelium of the testes and follicular atresia in the ovary with associated endometrial atrophy. There are no controlled data in human pregnancy. 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.

Ponatinib Breastfeeding Warnings

A decision should be made to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Unknown The effects in the nursing infant are unknown.

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