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Cabozantinib Pregnancy and Breastfeeding Warnings

Cabozantinib is also known as: Cabometyx, Cometriq

Cabozantinib Pregnancy Warnings

Animal studies have revealed embryofetal toxicity and teratogenic effects. Data from animals also showed male and female fertility impairment. There are no controlled data in human pregnancy, and the effect of this drug on human fertility is unknown. 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.

This drug should be used during pregnancy only if clearly needed. US FDA pregnancy category: D Comments: -All patients and their partners should be encouraged to use effective contraception during treatment and for at least 4 months after treatment completion, and advised to consider fertility preservation before treatment. -Patients using contraceptive steroids should use an additional contraceptive method, such as a barrier method, since the effect of this drug on contraceptive steroids has not been investigated and unchanged contraceptive effect may not be guaranteed.

See references

Cabozantinib Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug, and for at least 4 months after treatment completion. 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. "Product Information. Cometriq (cabozantinib)." Exelixis Inc, S San Francisco, CA.

References for breastfeeding information

  1. "Product Information. Cometriq (cabozantinib)." Exelixis Inc, S San Francisco, CA.

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