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ALUNBRIG® (brigatinib) Adds New Tablet Strengths to Facilitate Dosing
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ALUNBRIG® (brigatinib) Adds New Tablet Strengths
ALUNBRIG® (brigatinib) 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.
Takeda Oncology is pleased to announce new tablet strengths are now available for ALUNBRIG. With the introduction of 90-mg and 180-mg tablets, ALUNBRIG is the only ALK inhibitor with a one-tablet, once-daily recommended dosing regimen that can be taken with or without food. Additionally, to assist patients who are starting on ALUNBRIG, the new Initiation Pack provides the first-month supply of the recommended dosing regimen in a single package.
PRODUCT INFORMATION
Trade Name Description National Drug Code
ALUNBRIG (brigatinib)
180-mg tablets
Bottle of 23 tablets NDC 63020-180-23
Bottle of 30 tablets NDC 63020-180-30
ALUNBRIG (brigatinib)
90-mg tablets
Bottle of 7 tablets NDC 63020-090-07
Bottle of 30 tablets NDC 63020-090-30
ALUNBRIG (brigatinib)
30-mg tablets
Bottle of 30 tablets NDC 63020-113-30
ALUNBRIG (brigatinib)
Initiation Pack
1 carton containing:
1 bottle of 90-mg tablets (7 count)
1 bottle of 180-mg tablets (23 count)
NDC 63020-198-30
SELECTED IMPORTANT SAFETY INFORMATION
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 evaluate for ILD/pneumonitis. Upon recovery, either dose reduce or permanently discontinue ALUNBRIG.
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.
Bradycardia: Monitor heart rate and blood pressure regularly during treatment. If symptomatic, withhold ALUNBRIG, then dose reduce or permanently discontinue.
Visual Disturbance: Advise patients to report visual symptoms. Withhold ALUNBRIG and obtain ophthalmologic evaluation, then dose reduce or permanently discontinue ALUNBRIG.
Creatine Phosphokinase (CPK) Elevation: Monitor CPK levels regularly during treatment. Based on the severity, withhold ALUNBRIG, then resume or reduce dose.
Pancreatic Enzyme Elevation: Monitor lipase and amylase levels regularly during treatment. Based on the severity, withhold ALUNBRIG, then resume or reduce dose.
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.
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.
ADVERSE REACTIONS
The most common adverse reactions (≥25%) with ALUNBRIG were nausea, diarrhea, fatigue, cough, and headache.
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.
CYP3A Inducers: Avoid concomitant use of ALUNBRIG with strong CYP3A inducers.
CYP3A Substrates: Hormonal contraceptives may be ineffective due to decreased exposure.
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed.
Please see the full Prescribing Information.
We hope you find this information useful. To learn more about ALUNBRIG, please visit www.ALUNBRIG.com/hcp.
Takeda Oncology


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