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Darolutamide Pregnancy and Breastfeeding Warnings

Darolutamide is also known as: Nubeqa

Darolutamide Pregnancy Warnings

This drug is not indicated for use in female patients.

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, this drug can cause fetal harm and loss of pregnancy.

Comments:
-Advise male patients with female partners of reproductive potential to use effective contraception during therapy and for 1 week after.
-Based on animal studies, this drug may impair fertility in males of reproductive potential.

Animal studies not conducted with this drug. 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.

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.

See references

Darolutamide Breastfeeding Warnings

Safety has not been established.

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

Comments:
-The effects in the nursing infant are unknown.
-This drug is not indicated for use in female patients.

See references

References for pregnancy information

  1. "Product Information. Nubeqa (darolutamide)." Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ.

References for breastfeeding information

  1. "Product Information. Nubeqa (darolutamide)." Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ.

Further information

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

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