Alunbrig(brigatinib)
ALUNBRIG 30 MG Oral Tablet
NO BOXED WARNING
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Alunbrig FAQs
What is the risk of taking ALUNBRIG during pregnancy?Based on its mechanism of action and findings in animals, ALUNBRIG can cause fetal harm when administered to a pregnant woman. There are no clinical data on the use of ALUNBRIG in pregnant women. Administration of brigatinib to pregnant rats during the period of organogenesis resulted in dose-related skeletal anomalies, increased post-implantation loss, malformations, and decreased fetal body weight. Advise pregnant women of the potential risk to a fetus.
What is the estimated background risk of birth defects and miscarriage in pregnant women?In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Is it safe to take ALUNBRIG while breastfeeding?There are no data regarding the secretion of brigatinib in human milk or its effects on the breastfed infant or milk production. Because of the potential for adverse reactions in breastfed infants, advise lactating women not to breastfeed during treatment with ALUNBRIG and for 1 week following the final dose.
What precautions should females and males of reproductive potential take while taking ALUNBRIG?Females of reproductive potential should verify pregnancy status prior to initiating ALUNBRIG and use effective contraception during treatment and for at least 4 months after the final dose. Males with female partners of reproductive potential should also use effective contraception during treatment and for at least 3 months after the final dose. ALUNBRIG may cause reduced fertility in males based on findings in animal studies.
Is ALUNBRIG safe for use in pediatric patients?The safety and effectiveness of ALUNBRIG in pediatric patients have not been established.
Is ALUNBRIG safe for use in geriatric patients?No overall differences in safety or effectiveness were observed between patients aged 65 years and older and younger patients in clinical studies.
Are dose adjustments necessary for patients with hepatic or renal impairment?Reduce the dose of ALUNBRIG for patients with severe hepatic impairment (Child-Pugh C) and severe renal impairment (creatinine clearance 15 to 29 mL/min). No dose adjustment is recommended for patients with mild or moderate hepatic impairment (Child-Pugh A or B) or mild or moderate renal impairment (creatinine clearance 30 to 89 mL/min).
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