Venclexta Pregnancy Warnings
Animal studies have revealed evidence of embryotoxicity, increased post-implantation loss, and decreased fetal body weight. 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.
AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.
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.
Use is not recommended.
AU TGA pregnancy category: C
US FDA pregnancy category: Not Assigned.
Risk Summary: This drug may cause fetal harm when administered to a pregnant woman. In animal studies, it was fetotoxic at exposures 1.2 times the recommended human dose when given during the period of organogenesis.
Comments:
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-Advise female patients of reproductive potential to avoid becoming pregnant during therapy and for at least 30 days after.
-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.
-Based on findings in animals, this drug may compromise male fertility.
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