About Briganix (Brigatinib)

BRIGANIX is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

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DOSAGE AND ADMINISTRATION:

90 mg orally once daily for the first 7 days; if tolerated, increase to 180 mg orally once daily.May be taken with or without food.

WARNINGS AND PRECAUTIONS:

  • Administer BRIGANIX until disease progression or unacceptable toxicity
  • If BRIGANIX is interrupted for 14 days or longer for reasons other than adverse reactions, resume treatment at 90 mg once daily for 7 days before increasing to the previously tolerated dose
  • BRIGANIX tablets should be swallowed whole. Do not crush or chew tablets
  • If a dose of BRIGANIX is missed or vomiting occurs after taking a dose, do not administer an additional dose. Take next dose at the scheduled time
  • Avoid grapefruit or grapefruit juice as it may increase plasma concentrations of BRIGANIX
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