Relugolix Pregnancy and Breastfeeding Warnings

Brand names: Orgovyx

Relugolix Pregnancy Warnings

Safety and efficacy have not been established during pregnancy.

US FDA pregnancy category: Not assigned.

Risk summary: -Based on animal studies and the drug mechanism of action, this drug can cause fetal harm and loss of pregnancy.

Comments:
-Patients should be advised of the potential risk to the fetus.
-This drug may impair fertility.
-Advise males with female partners of reproductive potential to use effective contraception during therapy and for at least 2 weeks after the last dose.

Animal studies have revealed evidence of embryo-fetal lethality at maternal exposures that were 0.3 times the human exposure at the recommended dose of 120 mg daily based on AUC. There are no controlled data on 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.

See references

Relugolix Breastfeeding Warnings

Safety has not been established.

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant are unknown.
- If a mother requires treatment, it is not a reason to discontinue breastfeeding. However, until more data are available, it should only be used with close infant monitoring during breastfeeding.

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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