Skip to Content

Bosutinib Pregnancy and Breastfeeding Warnings

Bosutinib is also known as: Bosulif

Medically reviewed on December 27, 2017

Bosutinib Pregnancy Warnings

Use is not recommended.

US FDA pregnancy category: D

Comments: If this drug is used during pregnancy, or the patient becomes pregnant while taking bosutinib, she should be apprised of the potential hazard to the fetus. Use of adequate methods of contraception should be encouraged during and for at least 30 days after completing treatment.

Animal studies have shown reproductive toxicity and fetal anomalies with an approximate 6% decrease in fetal body weight. Fetal exposure to bosutinib-derived radioactivity during pregnancy was shown in a placental-transfer study in pregnant rats. There are no controlled data in human pregnancy.

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

Bosutinib Breastfeeding Warnings

A decision should be made to discontinue breast-feeding 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

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Bosulif (bosutinib)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

References for breastfeeding information

  1. "Product Information. Bosulif (bosutinib)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

Further information

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