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Dabrafenib Pregnancy and Breastfeeding Warnings

Dabrafenib is also known as: Tafinlar

Dabrafenib Pregnancy Warnings

Animal studies have revealed teratogenicity and embryotoxicity at doses 3 times greater than the human exposure at the recommended dose based on AUC. At does equivalent to the human exposure, animals demonstrated delays in skeletal development and reduced fetal body weight. Findings in animals also indicate this drug may impair female and male fertility. In female animals, reduction in fertility (at dose exposures equivalent to the human exposure) and a reduced number of ovarian corpora lutea (at dose exposures 3 times the human exposure) were noted; testicular degeneration/depletion was observed in male animals in repeat-dose studies. There is insufficient data in human pregnancy to assess the risks. 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.

Use is not recommended unless the potential benefit to the mother outweighs the possible risk to the fetus. AU TGA pregnancy category: D US FDA pregnancy category: Not Assigned Comments: -Based on animal studies, this drug may cause fetal harm and impair fertility. -This drug may decrease the efficacy of hormonal contraceptives; counsel female patients of reproductive potential to use an effective non-hormonal method of contraception during treatment and for 2 to 4 weeks after the last dose of this drug and 4 months after the last dose of trametinib when given in combination with this drug. -Advise male patients of the potential risk for impaired spermatogenesis, which may be irreversible.

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Dabrafenib Breastfeeding Warnings

Breastfeeding is not recommended during treatment and for 2 weeks following the last dose. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: -Since this drug is a large protein molecule with a molecular weight of about 147,000, the drug amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract. -The effects on the breastfed infant and on milk production 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: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

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