Dabrafenib Pregnancy and Breastfeeding Warnings

Brand names: Tafinlar

Medically reviewed by Drugs.com. Last updated on Mar 7, 2024.

Dabrafenib Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk summary: Based on animal studies and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman; insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-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.
-Pregnancy status of patients of childbearing potential should be verified before starting this drug.
-Females of childbearing potential should be advised to use effective contraception during therapy and for at least 2 weeks after the last dose; a nonhormonal method of contraception is recommended since this drug can render hormonal contraceptives ineffective.
---If this drug is used in combination with trametinib, females of childbearing potential should be advised to use effective contraception during therapy and for at least 16 weeks after the last dose of trametinib.
-To avoid potential drug exposure to pregnant partners and female partners of childbearing potential, male patients (including those who have had vasectomies) with female partners of childbearing potential should be advised to use condoms during therapy and for at least 2 weeks after the last dose.
---If this drug is used in combination with trametinib, male patients should use condoms during therapy and for at least 16 weeks after the last dose of trametinib.

Animal studies have revealed evidence of teratogenicity and embryotoxicity. After administration to rats during organogenesis, developmental toxicity (including embryolethality, ventricular septal defects, and variation in thymic shape) was observed at 300 mg/kg/day (about 3 times the human exposure at the recommended adult dose based on AUC); at 20 mg/kg/day or greater (equivalent to the human exposure at the recommended adult dose based on AUC), rats showed delayed skeletal development and reduced fetal body weight. There are no controlled data in human pregnancy.

Female patients of childbearing potential should be advised that this drug may impair fertility. A reduction in fertility was seen in female rats at dose exposures equivalent to the human exposure at the recommended adult dose; a reduction in the number of corpora lutea was observed in pregnant rats at dose exposures about 3 times the human exposure at the recommended adult dose. Male patients should be advised of the potential risk for impaired spermatogenesis, which may be irreversible. Effects on spermatogenesis have been seen in animals treated with this drug at dose exposures up to 3 times the human exposure at the recommended adult dose.

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.

See references

Dabrafenib Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 2 weeks after the last dose.
-According to some authorities: 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:
-No information is available on the clinical use of this drug during breastfeeding.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential adverse effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
-Because this drug is highly bound to plasma proteins, the amount in milk is likely to be low.

See references

Further information

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

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