These highlights do not include all the information needed to use ALUNBRIG safely and effectively. See full prescribing information for ALUNBRIG.
ALUNBRIG® (brigatinib) tablets, for oral use
Initial U.S. Approval: 2017
RECENT MAJOR CHANGES
Dosage and Administration
Dosage Modifications for Adverse Reactions (2.3) 2/2022
Warnings and Precautions
Hepatic Enzymes Elevation (5.7) 2/2022
Warnings and Precautions, Photosensitivity (5.9) 9/2021
INDICATIONS AND USAGE
ALUNBRIG is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. (1, 2.1)
DOSAGE AND ADMINISTRATION
90 mg orally once daily for the first 7 days; then increase to 180 mg orally once daily. May be taken with or without food. (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 180 mg, 90 mg, or 30 mg. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Interstitial Lung Disease (ILD)/Pneumonitis: Monitor for new or worsening respiratory symptoms, particularly during the first week of treatment. Withhold ALUNBRIG for new or worsening respiratory symptoms and promptly evaluate for ILD/pneumonitis. Upon recovery, either dose reduce or permanently discontinue ALUNBRIG. (2.3, 5.1)
Hypertension: Monitor blood pressure after 2 weeks and then at least monthly during treatment. For severe hypertension, withhold ALUNBRIG, then dose reduce or permanently discontinue. (2.3, 5.2)
Bradycardia: Monitor heart rate and blood pressure regularly during treatment. If symptomatic, withhold ALUNBRIG, then dose reduce or permanently discontinue. (2.3, 5.3)
Visual Disturbance: Advise patients to report visual symptoms. Withhold ALUNBRIG and obtain ophthalmologic evaluation, then dose reduce or permanently discontinue ALUNBRIG. (2.3, 5.4)
Creatine Phosphokinase (CPK) Elevation: Monitor CPK levels regularly during treatment. Based on the severity and with muscle pain or weakness, withhold ALUNBRIG, then resume or reduce dose. (2.3, 5.5)
Pancreatic Enzymes Elevation: Monitor lipase and amylase levels regularly during treatment. Based on the severity, withhold ALUNBRIG, then resume or reduce dose. (2.3, 5.6)
Hepatotoxicity: Monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin levels regularly during treatment. Based on severity, withhold dose, then resume at lower level. (2.3, 5.7)
Hyperglycemia: Assess fasting serum glucose prior to starting ALUNBRIG and regularly during treatment. If not adequately controlled with optimal medical management, withhold ALUNBRIG, then consider dose reduction or permanently discontinue, based on severity. (2.3, 5.8)
Photosensitivity: Advise patients to limit sun exposure. Based on severity withhold ALUNBRIG, then resume at the same dose, reduce the dose, or permanently discontinue. (2.3, 5.9)
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. (5.10, 8.1, 8.3)
ADVERSE REACTIONS
The most common adverse reactions (≥25%) with ALUNBRIG were diarrhea, fatigue, nausea, rash, cough, myalgia, headache, hypertension, vomiting, and dyspnea. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-844-217-6468 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
CYP3A Inhibitors: Avoid coadministration of ALUNBRIG with strong or moderate CYP3A inhibitors. If coadministration of a strong or moderate CYP3A inhibitor is unavoidable, reduce the dose of ALUNBRIG. (2.4, 7.1)
CYP3A Inducers: Avoid coadministration of ALUNBRIG with strong or moderate CYP3A inducers. If coadministration of a moderate CYP3A inducer is unavoidable, increase the dose of ALUNBRIG. (2.5, 7.1)
USE IN SPECIFIC POPULATIONS
Hepatic Impairment: Reduce the dose of ALUNBRIG for patients with severe hepatic impairment. (2.6, 8.6)
Renal Impairment: Reduce the dose of ALUNBRIG for patients with severe renal impairment. (2.7, 8.7)
Lactation: Advise not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 2/2022
