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Leuprolide Pregnancy and Breastfeeding Warnings

Leuprolide is also known as: Eligard, Lupron, Lupron Depot, Lupron Depot-Gyn, Lupron Depot-PED, Viadur

Medically reviewed on Mar 5, 2018

Leuprolide Pregnancy Warnings

Use is contraindicated.

AU TGA pregnancy category: D
US FDA pregnancy category: X

Comments:
-If a patient becomes pregnant during treatment, use should be discontinued. 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 hazard to the fetus.
-Patients should be advised that if they miss any doses, breakthrough bleeding or ovulation may occur with the potential for conception.
-This drug may cause spontaneous abortion.

Animal studies have shown reproductive toxicity. Additionally, there was increased fetal mortality and decreased fetal weights 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 X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

See references

Leuprolide Breastfeeding Warnings

Use is contraindicated.

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. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Lupron (leuprolide)." TAP Pharmaceuticals Inc, Deerfield, IL.

References for breastfeeding information

  1. "Product Information. Lupron (leuprolide)." TAP Pharmaceuticals Inc, Deerfield, IL.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

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

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