Darolutamide Pregnancy and Breastfeeding Warnings

Brand names: Nubeqa

Medically reviewed by Drugs.com. Last updated on Sep 13, 2023.

Darolutamide Pregnancy Warnings

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, 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.

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.

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

Further information

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

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