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Ibrutinib Pregnancy and Breastfeeding Warnings

Ibrutinib is also known as: Imbruvica

Ibrutinib Pregnancy Warnings

Use should be avoided US FDA pregnancy category: D Comments: -Women of childbearing potential should use highly effective contraceptive measures while taking this drug and for 3 months after stopping treatment. -If used during pregnancy or if the patient becomes pregnant while on this drug, the patient should be apprised of the potential hazard to the fetus.

This drug may cause fetal harm when administered to a pregnant woman. Animal studies have shown evidence of visceral malformations (heart and major vessels) and increased postimplantation loss at doses of 80 mg/kg/day, approximately 14 times the exposure (AUC) in patients with mantle cell lymphoma (MCL) and 20 times the exposure in patients with chronic lymphocytic leukemia. A decrease in fetal weights was observed at doses of 40 mg/kg/day or greater, approximately 6 times the exposure (AUC) in MCL patients. There are no adequate and well-controlled studies in pregnant women. 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.

Ibrutinib 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 The effects in the nursing infant are unknown.

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