Beleodaq Pregnancy Warnings
The drug can cause fetal harm as it targets actively dividing cells. It may cause teratogenicity and embryo-fetal lethality due to its genotoxicity. 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. If the drug is used during pregnancy or if pregnancy occurs, advise the patient of potential harm to the fetus.
US FDA pregnancy category: D
Comments: Use of adequate methods of contraception should be encouraged.
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Beleodaq Breastfeeding Warnings
Use is not recommended and 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