Skip to Content
Learn about Adcetris a treatment of Hodgkin Lymphoma

Bosutinib Pregnancy and Breastfeeding Warnings

Bosutinib is also known as: Bosulif

Medically reviewed by Drugs.com. Last updated on Nov 7, 2018.

Bosutinib Pregnancy Warnings

Use is not recommended.

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:
-Adequate methods of contraception should be encouraged.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Animal studies have revealed evidence of increased embryonic resorptions, decreased implantations, and reduced number of viable embryos. Fetal anomalies (e.g., fused sternebrae, various visceral observations) and an approximate 6% decrease in fetal body weight were also observed. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

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

Bosutinib Breastfeeding Warnings

Use is not recommended.

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.

Hide