Capecitabine Pregnancy and Breastfeeding Warnings

Brand names: Xeloda

Medically reviewed by Drugs.com. Last updated on May 27, 2024.

Capecitabine Pregnancy Warnings

Use should be avoided.
According to some authorities: Use is contraindicated

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

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

Comments:
-There are insufficient data available on use of this drug in pregnant women to inform a drug-associated risk.
-Verify the pregnancy status of females of reproductive potential prior to initiating treatment.
-Advise females of reproductive potential to use effective contraception during treatment and for 6 months after the last dose.
-Based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose.
-Fertility may be impaired by this drug.

Animal studies have revealed evidence of embryolethality and teratogenicity. Administration of this drug to pregnant animals during the period of organogenesis resulted in malformations and embryofetal death in mice, and fetal lethality in pregnant monkeys. Adverse outcomes in mice and monkeys occurred at doses lower than the exposure (AUC) in patients receiving the recommended dose, approximately 0.2 and 0.6 times AUC values, respectively. This drug and its metabolites have been shown to cross the placenta in animal studies. There are no controlled data in human pregnancy.

Impairment of fertility was observed in both male and female animals. In female mice, administration of this drug resulted in disruption of the estrous cycle, leading to a subsequent failure of mating; effects on fertility were reversible after drug discontinuation. In male mice, degenerative changes and decrease in the number of spermatocytes and spermatids were observed.

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

Capecitabine Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for at least 1 to 2 weeks after the last dose.
According to some authorities: Use is contraindicated

Excreted into human milk: Unknown; however, limited data suggests this drug was undetectable in breastmilk after administration
Excreted into animal milk: Yes, in significant amounts

Comments:
-There is a potential for serious adverse reactions in the breastfed infant.
-Chemotherapy may adversely affect the normal microbiome and chemical makeup of breastmilk.
-According to some experts, it might be possible to safely breastfeed if administration of this drug is intermittent and if there is a 24 hour period of breastfeeding abstinence before resuming nursing; however, monitoring of the infant's complete blood count with differential is advisable.

See references

Further information

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