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Venetoclax Pregnancy and Breastfeeding Warnings

Venetoclax is also known as: Venclexta

Medically reviewed on Aug 9, 2018

Venetoclax Pregnancy Warnings

Animal studies have revealed fetotoxicity (increased post-implantation loss and decreased fetal body weight) at exposures approximately 1.2 times the human clinical exposure based on AUC at the recommended human dose (RHD) of 400 mg daily; however, no teratogenicity was observed. Data from animal studies suggest human male fertility may be compromised based on testicular toxicity (germ cell loss) observed at exposures as low as 0.5 times the human AUC exposure at the RHD. No effects have been observed on estrus cycles, mating, fertility, corpora lutea, uterine implants, or live embryos per litter at dosages up to 600 mg/kg/day. There are no controlled data in human pregnancy.

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.

This drug should be used during pregnancy only if the benefit outweighs the risk.

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.

-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.
-Females of reproductive potential should undergo pregnancy testing before treatment initiation, and be advised to avoid pregnancy and use effective contraception during therapy and for at least 30 days after the last dose.
-It is unknown if this drug can reduce the effectiveness of hormonal contraceptives; therefore, women using hormonal contraceptives should add a barrier method.
-Males of reproductive potential should be advised to consider sperm banking due to the fertility problems this drug may cause in men.

See references

Venetoclax Breastfeeding Warnings

Breastfeeding should be discontinued during use of this drug.

Excreted into human milk: Data not available.
Excreted into animal milk: Data not available.

Comments: The effects in the nursing infant and on milk production are unknown.

See references

References for pregnancy information

  1. "Product Information. Venclexta (venetoclax)." AbbVie US LLC, North Chicago, IL.

References for breastfeeding information

  1. "Product Information. Venclexta (venetoclax)." AbbVie US LLC, North Chicago, IL.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.