Leuprolide Pregnancy and Breastfeeding Warnings

Brand names: Camcevi, Eligard, Fensolvi, Lupron, Lupron Depot, Lupron Depot-Gyn, Lupron Depot-PED, Viadur

Medically reviewed by Drugs.com. Last updated on Oct 17, 2023.

Leuprolide Pregnancy Warnings

Use is contraindicated.

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

Risk Summary: There are no available data in pregnant women to inform a drug-related risk. Based on findings from animal studies and its mechanism of action, this drug may cause fetal harm when administered to a pregnant woman.

Comments:
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-This drug should not be used during pregnancy. If a patient becomes pregnant during treatment, the drug must be discontinued, and the patient should be apprised of the potential harm to the fetus.
-If any doses are missed, breakthrough bleeding or ovulation may occur, with the possibility of conception.
-Expected hormonal changes brought about by this drug increase the risk of pregnancy loss.
-Adequate methods of contraception should be encouraged, as this drug may impair fertility in males and females of reproductive potential.

Animal studies have shown reproductive toxicity and major fetal malformations at doses less than the human dose (based on body surface area). Additionally, there was increased fetal mortality and decreased fetal weight in animals. 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.

See references

Leuprolide Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
-According to some authorities: Use is contraindicated.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments:
-The effects in the nursing infant or on milk production are unknown.
-Because many drugs are excreted in human milk, and the potential for serious adverse reactions in a breastfed child, a decision should be made to discontinue breastfeeding or to discontinue the drug, considering the importance of this drug to the mother.

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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