Alunbrig Dosage/Direction for Use

ALK Testing: A validated ALK assay is necessary for the selection of ALK-positive NSCLC patients. ALK-positive NSCLC status should be established prior to initiation of brigatinib therapy.
Dosage: The recommended starting dose of brigatinib is 90 mg once daily for the first 7 days, then 180 mg once daily.
Treatment should continue as long as clinical benefit is observed.
If a dose of brigatinib is missed or vomiting occurs after taking a dose, an additional dose should not be administered and the next dose of brigatinib should be taken at the scheduled time.
Dose Adjustments: Dosing interruption and/or dose reduction may be required based on individual safety and tolerability.
Brigatinib dose reduction levels are summarized in Table 8. (See Table 8.)

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Permanently discontinue brigatinib if patient is unable to tolerate the 60 mg once daily dose.
If brigatinib is interrupted for 14 days or longer for reasons other than adverse reactions, treatment should be resumed at 90 mg once daily for 7 days before increasing to the previously tolerated dose.
Recommendations for dose modifications of brigatinib for the management of adverse reactions are summarized in Table 9. (See Table 9.)

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Special Patient Populations: Elderly Patients: The limited data on the safety and efficacy of brigatinib in patients aged 65 years and older suggest that a dose adjustment is not required in elderly patients. There are limited data on patients over 85 years of age.
Pediatric Patients: The safety and efficacy of brigatinib in patients less than 18 years of age have not been established. No data are available.
Impaired Renal Function: No dose adjustment of brigatinib is required for patients with mild or moderate renal impairment (estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m²). The dose of brigatinib should be reduced by approximately 50% (e.g., from 180 mg to 90 mg, or from 90 mg to 60 mg) for patients with severe renal impairment (eGFR <30 mL/min/1.73 m²) (see Pharmacology: Pharmacokinetics under Actions).
Impaired Hepatic Function: No dose adjustment of brigatinib is required for patients with mild hepatic impairment (Child-Pugh class A) or moderate hepatic impairment (Child-Pugh class B). The dose of brigatinib should be reduced by approximately 40% (e.g., from 180 mg to 120 mg, 120 mg to 90 mg, or from 90 mg to 60 mg) for patients with severe hepatic impairment (Child-Pugh class C) (see Pharmacology: Pharmacokinetics under Actions).
Method of Administration: Brigatinib is for oral use. The tablets should be swallowed whole and with water. Do not crush or chew tablets.
Brigatinib may be taken with or without food.