ecreased exposure. (7.3)
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 4/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
2.2 Dose Modifications for Adverse Reactions
2.3 Dose Modification for Strong CYP3A Inhibitors
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Interstitial Lung Disease (ILD)/Pneumonitis
5.2 Hypertension
5.3 Bradycardia
5.4 Visual Disturbance
5.5 Creatine Phosphokinase (CPK) Elevation
5.6 Pancreatic Enzyme Elevation
5.7 Hyperglycemia
5.8 Embryo-Fetal Toxicity
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience
7 DRUG INTERACTIONS
7.1 Drugs That May Increase Brigatinib Plasma Concentrations
7.2 Drugs That May Decrease Brigatinib Plasma Concentrations
7.3 Drugs That May Have Their Plasma Concentrations Altered by Brigatinib
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Renal Impairment
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed.
1 INDICATIONS AND USAGE
ALUNBRIG 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 [see CLINICAL STUDIES (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
The recommended dosing regimen for ALUNBRIG is:
90 mg orally once daily for the first 7 days;
if 90 mg is tolerated during the first 7 days, increase the dose to 180 mg orally once daily.
Administer ALUNBRIG until disease progression or unacceptable toxicity.
If ALUNBRIG is interrupted for 14 days or longer for reasons other than adverse reactions, resume treatment at 90 mg once daily for 7 days before increasing to the previously tolerated dose.
ALUNBRIG may be taken with or without food. Instruct patients to swallow tablets whole. Do not crush or chew tablets.
If a dose of ALUNBRIG is missed or vomiting occurs after taking a dose, do not administer an additional dose and take the next dose of ALUNBRIG at the scheduled time.
2.2 Dose Modifications for Adverse Reactions
ALUNBRIG dose modification levels are summarized in Table 1.
Table 1: Recommended ALUNBRIG Dose Reduction Levels
Dose Reduction Levels
Dose First Second Third
* Not applicable
90 mg once daily 60 mg once daily permanently discontinue N/A*
180 mg once daily 120 mg once daily 90 mg once daily 60 mg once daily
Once reduced for adverse reactions, do not subsequently increase the dose of ALUNBRIG. Permanently discontinue ALUNBRIG if patients ar |
