Active Ingredient: Brigatinib
Brigatinib is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.
Brigatinib is indicated as monotherapy for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 90 milligrams brigatinib, once daily, over the duration of 7 days. Afterwards, oral, between 90 milligrams brigatinib and 180 milligrams brigatinib, once daily.
The recommended starting dose of brigatinib is 90 mg once daily for the first 7 days, then 180 mg once daily.
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.
If a dose is missed or vomiting occurs after taking a dose, an additional dose should not be administered and the next dose should be taken at the scheduled time. Treatment should continue as long as clinical benefit is observed.
Dosing interruption and/or dose reduction may be required based on individual safety and tolerability.
Brigatinib dose reduction levels are summarised in Table 1.
Table 1. Recommended brigatinib dose reduction levels:
| Dose | Dose reduction levels | ||
|---|---|---|---|
| First | Second | Third | |
| 90 mg once daily (first 7 days) | reduce to 60 mg once daily | permanently discontinue | not applicable |
| 180 mg once daily | reduce to 120 mg once daily | reduce to 90 mg once daily | reduce to 60 mg once daily |
Brigatinib should be permanently discontinued if patient is unable to tolerate the 60 mg once daily dose.
Recommendations for dose modifications of brigatinib for the management of adverse reactions are summarised in Table 2.
Table 2. Recommended brigatinib dose modifications for adverse reactions:
Brigatinib may be taken with or without food.
Grapefruit or grapefruit juice may increase plasma concentrations of brigatinib and should be avoided.
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