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 coadministration with strong or moderate CYP3A inhibitors. If coadministration of a strong or moderate CYP3A inhibitor cannot be avoided, reduce the dose of ALUNBRIG
Avoid coadministration with strong or moderate CYP3A inducers. If coadministration of moderate CYP3A inducers cannot be avoided, increase the dose of ALUNBRIG
Coadministration of ALUNBRIG with sensitive CYP3A substrates, including hormonal contraceptives, can result in decreased concentrations and loss of efficacy of sensitive 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: Verify pregnancy status in females of reproductive potential prior to initiating ALUNBRIG. 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 effectiveness 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.
Hepatic and Renal Impairment: No dose adjustment is recommended for patients with mild or moderate hepatic impairment or mild or moderate renal impairment. Reduce the dose of ALUNBRIG for patients with severe hepatic impairment or severe renal impairment
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