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Vismodegib Pregnancy and Breastfeeding Warnings

Vismodegib is also known as: Erivedge

Vismodegib Pregnancy Warnings

Animal studies have revealed evidence of embryotoxicity and teratogenicity. Malformations such as craniofacial anomalies, open perineum, and absent and/or fused digits have been reported. There are no controlled data in human pregnancy. The Hedgehog pathway plays a key role in embryogenesis. Malformations reported with the administration of hedgehog pathway inhibitors include severe midline defects, missing digits, and other irreversible malformations in the developing embryo or fetus. Fertility data from animal studies have shown that male and female fertility may be irreversibly impaired with vismodegib treatment. Women of childbearing potential should be counseled on fertility preservation strategies prior to treatment initiation. Instruct patients to immediately report any pregnancy exposure. US: Encourage participation in the Erivedge(R) pregnancy pharmacovigilance program by calling the Genentech Adverse Event Line at 1-888-835-2555 AU TGA pregnancy category X: Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of 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.

AU, UK: Use is contraindicated US: Use is not recommended during pregnancy. This drug can cause fetal harm when administered to a pregnant female based on its mechanism of action. AU TGA pregnancy category: X US FDA pregnancy category: D Comments: -Advise all patients of the risks of embryo-fetal death and severe birth defects and the need for contraception during and after treatment. -A pregnancy test should be performed within 7 days prior to initiating treatment and monthly during treatment. -Counsel all patients regarding pregnancy prevention and planning. UK: Women of childbearing potential (WCBP) are required to comply with the approved pregnancy prevention program. -Females must use two methods of recommended contraception during therapy and for 7 months (AU, US) or 24 months (UK) after the final dose. -Vismodegib is contained in semen. Males should use condoms with spermicide, even after a vasectomy, during sexual intercourse with females while being treated and for 2 months after the last dose.

See references

Vismodegib Breastfeeding Warnings

AU, UK: Use is contraindicated US: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: Vismodegib can harm a nursing infant. Nursing is contraindicated for 7 months after stopping the medication (AU). Women must not breastfeed for 24 months following the final dose (UK).

Animal studies have reported irreversible adverse effects on growing teeth and premature closure of the epiphyseal plate.

See references

References for pregnancy information

  1. "Product Information. Erivedge (vismodegib)." Genentech, South San Francisco, CA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. "Product Information. Erivedge (vismodegib)." Genentech, South San Francisco, CA.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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