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Gemcitabine Pregnancy and Breastfeeding Warnings

Brand names: Gemzar, Infugem

Medically reviewed by Last updated on Aug 14, 2023.

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 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.

Use should be avoided.

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

Risk Summary: Based on animal data and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman.

-This drug can harm a developing fetus.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-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.
-Because of the potential for genotoxicity, advise females of reproductive potential to use effective contraception during therapy and for 6 months after.
-Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during therapy and for 3 months after.

See references

Gemcitabine Breastfeeding Warnings

Use is contraindicated.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

-This drug may harm a nursing infant.
-The manufacturer recommends a breastfeeding abstinence period of 1 week after the last dose.
-Chemotherapy may adversely affect the normal microbiome and chemical makeup of breastmilk.
-Women who receive chemotherapy during pregnancy are more likely to have difficulty nursing their infant.

Most sources consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy. It might be possible to breastfeed safely during intermittent therapy after a period of abstinence.

See references

References for pregnancy information

  1. Product Information. Gemcitabine (gemcitabine). Mylan Institutional LLC. 2019.

References for breastfeeding information

  1. United States National Library of Medicine. Toxnet. Toxicology Data Network. 2013.
  2. Product Information. Gemcitabine (gemcitabine). Mylan Institutional LLC. 2019.

Further information

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