Ibrutinib Pregnancy and Breastfeeding Warnings
Ibrutinib is also known as: Imbruvica
Ibrutinib Pregnancy Warnings
FDA pregnancy category: D If used during pregnancy, or if the patient becomes pregnant while on ibrutinib, the patient should be apprised of the potential hazard to the fetus. LEVEL 2 Ibrutinib at a dose of 80 mg/kg/day (14 times human exposure) in pregnant rats was associated with visceral malformations (heart and major vessels) and increased postimplantation loss. Ibrutinib at doses of 40 mg/kg/day (6 times human exposure) or greater was associated with decreased fetal weights. 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.
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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