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Enzalutamide Pregnancy and Breastfeeding Warnings

Enzalutamide is also known as: Xtandi

Medically reviewed on October 31, 2016

Enzalutamide Pregnancy Warnings

Animal studies have shown evidence of maternal toxicity and impaired male fertility including hypospermatogenesis and atrophy of the prostate, seminal vesicles, and epididymides. Studies in animals have also revealed embryo-fetal developmental toxicity and lethality, increased post-implantation loss and resorptions, decreased anogenital distance, cleft palate, and absent palatine bone. The drug may cause fetal harm when administered to a pregnant woman as use of an androgen receptor inhibitor could affect fetus development. There are no controlled data in human pregnancy.

US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Use in women who are or may become pregnant is contraindicated.

US FDA pregnancy category: X

Comments: Male patients should be encouraged to use adequate methods of contraception during and for at least 3 months after therapy if engaged in sexual activity with pregnant women and/or women of childbearing potential.

See references

Enzalutamide Breastfeeding Warnings

This drug is not indicated for use in female patients.

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

The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Xtandi (enzalutamide)." Astellas Pharma US, Inc, Deerfield, IL.

References for breastfeeding information

  1. "Product Information. Xtandi (enzalutamide)." Astellas Pharma US, Inc, Deerfield, IL.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

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