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Capecitabine Pregnancy and Breastfeeding Warnings

Capecitabine is also known as: Xeloda

Medically reviewed by Last updated on Sep 14, 2020.

Capecitabine Pregnancy Warnings

UK: Contraindicated
AU, US: Use is not recommended

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

-This drug can cause fetal harm when administered to a pregnant woman.
-Women of child bearing potential should be advised to avoid becoming pregnant while receiving treatment with this drug.
-If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be advised of the potential hazard to the fetus.
-This drug may cause degenerative changes in the testes, including decreases in the number of spermatocytes and spermatids in males.

This drug and/or its metabolites have been shown to cross the placenta in animal studies. It was shown to be teratogenic and embryolethal when administered orally during organogenesis. Teratogenic findings included cleft palate, anophthalmia, microphthalmia, oligodactyly, polydactyly, syndactyly, kinky tail and dilatation of cerebral ventricles. 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.

See references

Capecitabine Breastfeeding Warnings

UK: Contraindicated
AU, 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: Yes

Comment: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Xeloda (capecitabine)." Roche Laboratories, Nutley, NJ.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

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. Xeloda (capecitabine)." Roche Laboratories, Nutley, NJ.

Further information

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