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Brigatinib Pregnancy and Breastfeeding Warnings

Brigatinib is also known as: Alunbrig

Brigatinib Pregnancy Warnings

Safety has not been established during pregnancy; this drug may cause fetal harm based on findings in animals and the mechanism of action. US FDA pregnancy category: Not Assigned Comments: -This drug induces CYP450 3A in vitro, potentially resulting in decreased concentrations and loss of efficacy of hormonal contraceptives and other CYP450 3A substrates. -Advise females of reproductive potential to use effective non-hormonal contraception during treatment with this drug and for at least 4 months following the final dose. -Due to the genotoxicity potential, advise male patients with female partners to use effective contraception during treatment and for at least 3 months after the last dose.

Animal studies have revealed evidence of dose-related skeletal and visceral anomalies, increased post-implantation loss, malformations, and decreased fetal body weight at doses as low as 0.7 and 1.26 times the human exposure by AUC at 180 mg once daily. Additionally, findings in the reproductive organs of male animals (e.g., testicular toxicity) indicate this drug may cause reduced fertility in males. There are no controlled data in human pregnancy. 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

Brigatinib Breastfeeding Warnings

Breastfeeding is not recommended during treatment and for 1 week following the last dose because of the potential for adverse reactions in breastfed infants. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant and on milk production are unknown.

See references

References for pregnancy information

  1. "Product Information. Alunbrig (brigatinib)." Ariad Pharmaceuticals Inc, Cambridge, MA.

References for breastfeeding information

  1. "Product Information. Alunbrig (brigatinib)." Ariad Pharmaceuticals Inc, Cambridge, MA.

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