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Apalutamide Pregnancy and Breastfeeding Warnings

Apalutamide is also known as: Erleada

Medically reviewed by Drugs.com. Last updated on Sep 9, 2020.

Apalutamide Pregnancy Warnings

Animal studies have not been conducted. May cause fetal harm. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. 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 contraindicated.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk Summary: The safety and efficacy of this drug have not been established in females. Based on its mechanism of action, it can cause fetal harm and loss of pregnancy. It is not indicated for use in females, so animal embryofetal developmental toxicology studies were not conducted.

Comments:
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-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 the mechanism of action and findings in an animal studies advise male patients with female partners of reproductive potential to use effective contraception during therapy and for 3 months after.
-This drug may impair fertility in males of reproductive potential.

See references

Apalutamide Breastfeeding Warnings

This drug is not indicated for use in females.

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.