Sorafenib Pregnancy and Breastfeeding Warnings

Brand names: Nexavar

Medically reviewed by Drugs.com. Last updated on Mar 14, 2024.

Sorafenib Pregnancy Warnings

Use should be avoided.

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 may cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration during organogenesis resulted in embryofetal toxicities at maternal exposures that were significantly lower than human exposures at the recommended dose.

Comments:
-Based on its mechanism of action and findings in animals, this drug is teratogenic and embryotoxic to a developing fetus.
-Advise both men and women of childbearing potential to use effective birth control during therapy with this drug and for at least 2 weeks after the last dose. -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 embryotoxicity and teratogenicity at
maternal exposures that were significantly lower than the human exposures at the recommended dose. 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 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

Sorafenib Breastfeeding Warnings

Use should be avoided.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-This drug can harm a nursing infant.

No information is available on the use of this drug during breastfeeding. Because it is 99.5% bound to plasma proteins, the amount in milk is likely to be low; however, its half-life is 25 to 48 hours and it might accumulate in the infant.

See references

Further information

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

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