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Vemurafenib Pregnancy and Breastfeeding Warnings

Vemurafenib is also known as: Zelboraf

Medically reviewed on Nov 8, 2017

Vemurafenib Pregnancy Warnings

Animal studies have failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy. Based on its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. If the drug is used during pregnancy or if the patient becomes pregnant during therapy, the patient should be advised of the potential hazard to the developing fetus.

Use is not recommended during pregnancy unless the expected benefit outweighs the potential risk to the developing fetus.

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

Comments: Advise women and men of childbearing potential to use appropriate contraceptive measures during therapy and for at least 6 months after discontinuation of therapy.

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.

See references

Vemurafenib Breastfeeding Warnings

A decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the benefit of breast-feeding to the infant and the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Zelboraf (vemurafenib)." Genentech, South San Francisco, CA.

References for breastfeeding information

  1. "Product Information. Zelboraf (vemurafenib)." Genentech, South San Francisco, CA.

Further information

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