Brand Name

Alunbrig

Generic Name
Brigatinib
View Brand Information
FDA approval date: April 28, 2017
Classification: Kinase Inhibitor
Form: Tablet, Kit

What is Alunbrig (Brigatinib)?

ALUNBRIG is indicated for the treatment of adult patients with anaplastic lymphoma kinase -positive metastatic non-small cell lung cancer as detected by an FDA-approved test [see Dosage and Administration.
Save this treatment for later
Sign Up
Not sure about your diagnosis?
Check Your Symptoms

Related Clinical Trials

General Use-results Survey of Alunbrig Tablets Non-small Cell Lung Cancer

Summary: This study is a survey in Japan of Brigatinib tablets used to treat Japanese people with non-small cell lung cancer. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. The main aim of the study is to check for side effects related to lung disease from Brigatinib. During the study, pa...

Effectiveness and Safety of Brigatinib Treatment as First-line Therapy Administered to ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients. Prospective, Multicenter, Observational Study

Summary: This is a study of brigatinib in adults with Non-Small Cell Lung Cancer (NSCLC). The main aim of this study is to learn about the time period in which the condition does not worsen after the participant has received brigatinib. Another aim is to learn about the overall rate of participants who respond to the treatment with brigatinib. Participants will receive brigatinib as part of their normal cl...

Optimization of Treatment With Brigatinib in Patients With Advanced NSCLC Harboring an ALK Rearrangement by LAT at the Time of Best Response: A Multicenter Open Phase Two Trial (OPTALK)

Summary: The goal of this clinical trial is to learn if the treatment by systemic Brigatinib (ALUNBRIG®) associated to local ablative therapy (LAT) treatment is improved if administered when the brigatinib works best in participants presenting an advanced non-small cells lung cancer with an ALK gene anomaly (this anomaly produces a defective protein that is responsible for the multiplication of cancer cell...

Brand Information

Alunbrig (brigatinib)
1INDICATIONS AND USAGE
ALUNBRIG is 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
2DOSAGE FORMS AND STRENGTHS
  • 180 mg: oval, white to off-white film-coated tablets with "U13" debossed on one side and plain on the other side
  • 90 mg: oval, white to off-white film-coated tablets with "U7" debossed on one side and plain on the other side
  • 30 mg: round, white to off-white film-coated tablets with "U3" debossed on one side and plain on the other side
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the prescribing information:
  • Interstitial Lung Disease (ILD)/Pneumonitis
  • Hypertension
  • Bradycardia
  • Visual Disturbance
  • Creatine Phosphokinase (CPK) Elevation
  • Pancreatic Enzymes Elevation
  • Hepatotoxicity
  • Hyperglycemia
  • Photosensitivity
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
5DESCRIPTION
Brigatinib is a kinase inhibitor. The chemical name for brigatinib is 5-chloro-N
Chemical Structure
Brigatinib is an off-white to beige/tan solid. The pK
ALUNBRIG is supplied for oral use as film-coated tablets containing 180 mg, 90 mg or 30 mg of brigatinib and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (Type A), magnesium stearate, and hydrophobic colloidal silica. The tablet coating consists of talc, polyethylene glycol, polyvinyl alcohol, and titanium dioxide.
6HOW SUPPLIED/STORAGE AND HANDLING
180 mg tablets: oval, white to off-white film-coated tablets with "U13" debossed on one side and plain on the other side; available in:
90 mg tablets: oval, white to off-white film-coated tablets with "U7" debossed on one side and plain on the other side; available in:
30 mg tablets: round, white to off-white film-coated tablets with "U3" debossed on one side and plain on the other side; available in:
90 mg / 7 count tablets (NDC 63020-090-07) and 180 mg / 23 count tablets (NDC 63020-180-23) are also available in a single carton as a one-month initiation pack:
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
8PRINCIPAL DISPLAY PANEL - 30 mg Tablet Bottle Carton
NDC 63020-113-30
ALUNBRIG
30 mg
Rx Only
30 Tablets
PRINCIPAL DISPLAY PANEL - 30 mg Tablet Bottle Carton
9PRINCIPAL DISPLAY PANEL - 90 mg Tablet Bottle Carton
NDC 63020-090-30
ALUNBRIG
90 mg
Rx Only
30 Tablets
PRINCIPAL DISPLAY PANEL - 90 mg Tablet Bottle Carton
10PRINCIPAL DISPLAY PANEL - 180 mg Tablet Bottle Carton
NDC 63020-180-30
ALUNBRIG
180 mg
Rx Only
30 Tablets
PRINCIPAL DISPLAY PANEL - 180 mg Tablet Bottle Carton
11PRINCIPAL DISPLAY PANEL - Kit Carton
NDC 63020-198-30
INITIATION PACK
ALUNBRIG
Rx Only | Oral Use
Usual Dose: One 90 mg tablet orally once daily for the first 7 days;
90 mg
7 Tablets
Take 1 tablet on
180 mg
23 Tablets
Take 1 tablet on
PRINCIPAL DISPLAY PANEL - Kit Carton