HIGHLIGHTS OF PRESCRIBING INFORMATION
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
INDICATIONS AND USAGE
ALUNBRIG is a kinase inhibitor 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. (1)
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. (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 30 mg and 90 mg (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Interstitial Lung Disease (ILD)/Pneumonitis: Occurred in 9.1% of patients at the recommended dose. Monitor for new or worsening respiratory symptoms, particularly during the first week of treatment. Withhold ALUNBRIG for new or worsening respiratory symptoms and promptly eva luate for ILD/pneumonitis. Upon recovery, either dose reduce or permanently discontinue ALUNBRIG. (2.2, 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. (2.2, 5.2)
Bradycardia: Monitor heart rate and blood pressure regularly during treatment. If symptomatic, withhold ALUNBRIG, then dose reduce or permanently discontinue. (2.2, 5.3)
Visual Disturbance: Advise patients to report visual symptoms. Withhold ALUNBRIG and obtain ophthalmologic eva luation, then dose reduce or permanently discontinue ALUNBRIG. (2.2, 5.4)
Creatine Phosphokinase (CPK) Elevation: Monitor CPK levels regularly during treatment. Based on the severity, withhold ALUNBRIG, then resume or reduce dose. (2.2, 5.5)
Pancreatic Enzyme Elevation: Monitor lipase and amylase levels regularly during treatment. Based on the severity, withhold ALUNBRIG, then resume or reduce dose. (2.2, 5.6)
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. (2.2, 5.7)
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use a non-hormonal method of effective contraception. (5.8, 8.1, 8.3)
ADVERSE REACTIONS
The most common adverse reactions (≥25%) with ALUNBRIG were nausea, diarrhea, fatigue, cough, and headache. (6)
To report SUSPECTED ADVERSE REACTIONS, contact ARIAD Pharmaceuticals, Inc. at 1-844-217-6468 or www.alunbrig.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
CYP3A Inhibitors: Avoid concomitant use of ALUNBRIG with strong CYP3A inhibitors. If concomitant use of a strong CYP3A inhibitor is unavoidable, reduce the dose of ALUNBRIG. (2.3, 7.1)
CYP3A Inducers: Avoid concomitant use of ALUNBRIG with strong CYP3A inducers. (7.2)
CYP3A Substrates: Hormonal contraceptives may be ineffective due to d |
