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.
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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
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
9PRINCIPAL DISPLAY PANEL - 90 mg Tablet Bottle Carton
NDC 63020-090-30
ALUNBRIG
90 mg
Rx Only
30 Tablets
10PRINCIPAL DISPLAY PANEL - 180 mg Tablet Bottle Carton
NDC 63020-180-30
ALUNBRIG
180 mg
Rx Only
30 Tablets
11PRINCIPAL DISPLAY PANEL - Kit Carton
NDC 63020-198-30
INITIATION PACK
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
