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Gemcitabine Pregnancy and Breastfeeding Warnings

Gemcitabine is also known as: Gemzar, Infugem

Medically reviewed on Apr 24, 2018

Gemcitabine Pregnancy Warnings

Animal studies have revealed evidence of embryotoxicity, fetotoxicity, and teratogenicity. Studies in male animals have revealed evidence of hypospermatogenesis, decreased fertility, and decreased implantations. 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 D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use is not recommended.

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

Comments:
-If the drug is used during pregnancy, or if the patient becomes pregnant while taking the drug, the patient should be apprised of the potential hazard to the fetus.

See references

Gemcitabine Breastfeeding Warnings

AU and UK: Use is contraindicated.
US: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: 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. Gemzar (gemcitabine)." Lilly, Eli and Company, Indianapolis, IN.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Gemzar (gemcitabine)." Lilly, Eli and Company, Indianapolis, IN.

Further information

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

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