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Apalutamide Pregnancy and Breastfeeding Warnings

Apalutamide is also known as: Erleada

Medically reviewed by Last updated on Mar 27, 2018.

Apalutamide Pregnancy Warnings

Animal studies have not been conducted. May cause fetal harm. 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.

Use is contraindicated.

US FDA pregnancy category: Not assigned.

Risk Summary: Not indicated for use in females as this drug can cause fetal harm and potential loss of pregnancy.

-May impair fertility in males of reproductive potential.
-Male patients with female partners of reproductive potential should use effective contraception during treatment and for 3 months after the last dose.

See references

Apalutamide Breastfeeding Warnings

This drug is not indicated for use in women.

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

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Erleada (apalutamide)." Janssen Biotech, Inc., Horsham, PA, PA.

References for breastfeeding information

  1. "Product Information. Erleada (apalutamide)." Janssen Biotech, Inc., Horsham, PA, PA.

Further information

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