ALUNBRIG tablets should be swallowed whole. Do not crush or chew tablets.
If a dose of ALUNBRIG is missed or vomiting occurs after taking a dose, do not administer an additional dose. The next dose should be taken at the scheduled time.
To assist patients starting on ALUNBRIG, the first-month supply of the recommended dosing regimen is available in an Initiation Pack that contains one bottle of 90-mg tablets (7 count) and one bottle of 180-mg tablets (23 count)
ALUNBRIG is available in 180-mg, 90-mg, and 30-mg tablets
Dosage Forms and Storage
ALUNBRIG is available in:
180-mg tablets: oval, white to off-white film-coated tablet with “U13” debossed on one side and plain on the other side
90-mg tablets: oval, white to off-white film-coated tablet with “U7” debossed on one side and plain on the other side
30-mg tablets: round, white to off-white film-coated tablet with “U3” debossed on one side and plain on the other side
Not actual size.
Store at controlled room temperature 68°F to 77°F (20°C to 25°C). Excursion is permitted between 59°F to 86°F (15°C to 30°C)
Avoid concomitant use with strong CYP3A inhibitors. If concomitant use of a strong CYP3A inhibitor is unavoidable, reduce the dose of ALUNBRIG
Avoid concomitant use with strong CYP3A inducers
ALUNBRIG induces CYP3A in vitro and may decrease concentrations of CYP3A substrates
Coadministration of ALUNBRIG with CYP3A substrates, including hormonal contraceptives, can result in decreased concentrations and loss of efficacy of CYP3A substrates
Pregnancy: ALUNBRIG can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus
Lactation: 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 adverse reactions in breastfed infants, advise lactating women not to breastfeed during treatment with ALUNBRIG
Females and Males of Reproductive Potential: Advise females of reproductive potential to use effective contraception during treatment and for at least 4 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for at least 3 months after final dose. ALUNBRIG may cause reduced fertility in males
Pediatric: The safety and efficacy of ALUNBRIG in pediatric patients have not been established
Geriatric: Clinical studies of ALUNBRIG did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. Of the 222 patients in ALTA, 19.4% were 65-74 years and 4.1% were 75 years or older. No clinically relevant differences in safety or efficacy were observed between patients ≥65 and younger patients
Hepatic and Renal Impairment: No dose adjustment is recommended for patients with mild hepatic impairment or mild or moderate renal impairment. The safety of ALUNBRIG in patients with moderate or severe hepatic impairment or severe renal impairment has not been studied
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