Bosutinib Pregnancy Warnings
Use is not recommended.
US FDA pregnancy category: Not assigned.
Risk Summary: Based on findings from animal studies and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman.
Comments:
-Females of reproductive potential should have a pregnancy test prior to starting treatment with this drug.
-Advise females of reproductive potential to use effective contraception (methods that result in less than 1% pregnancy rates) during treatment and for at least 2 weeks after the last dose.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
Animal studies have revealed evidence of increased embryonic resorptions, decreased implantations, and reduced number of viable embryos. Fetal anomalies (e.g., fused sternebrae, various visceral observations) and an approximate 6% decrease in fetal body weight were also observed. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.
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