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Sorafenib Pregnancy and Breastfeeding Warnings

Sorafenib is also known as: Nexavar

Medically reviewed on August 6, 2018

Sorafenib Pregnancy Warnings

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 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.

Use should be avoided.

AU TGA pregnancy category: D
US FDA pregnancy category: D

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.

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

References for pregnancy information

  1. "Product Information. Nexavar (sorafenib)." Bayer Pharmaceutical Inc, West Haven, CT.

References for breastfeeding information

  1. "Product Information. Nexavar (sorafenib)." Bayer Pharmaceutical Inc, West Haven, CT.

Further information

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

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