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Dabrafenib Pregnancy and Breastfeeding Warnings

Dabrafenib is also known as: Tafinlar

Dabrafenib Pregnancy Warnings

Dabrafenib was teratogenic and embryotoxic in rats at exposures 3 times the human clinical exposure at the recommended dose. There are no controlled data in human pregnancy. Effects on spermatogenesis have been observed in animals. Male patients should be advised of the potential risk for impaired spermatogenesis, and to seek counseling on fertility and family planning options prior to starting treatment. 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.

FDA pregnancy category: D Dabrafenib can cause fetal harm. Use dabrafenib only if clearly needed and benefit outweighs potential risk. Comments: Female patients of reproductive potential should use a highly effective non-hormonal method of contraception during treatment and for at least 2 weeks after treatment with dabrafenib or 4 months after combination treatment with trametinib. Dabrafenib can render hormonal contraceptives ineffective.

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Dabrafenib Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue dabrafenib, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Unknown The effects in the nursing infant are unknown.

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References for pregnancy information

  1. "Product Information. Tafinlar (dabrafenib)." GlaxoSmithKline, Research Triangle Park, NC.
  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. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Tafinlar (dabrafenib)." GlaxoSmithKline, Research Triangle Park, NC.
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):

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