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Alunbrig

brigatinib
ALK TKI FDA Approved 2017 Takeda
Route
Oral
Half-Life
25 hrs
FDA Approved
2017
Manufacturer
Takeda
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1. Indications and Usage

NSCLC: ALK-positive metastatic NSCLC.

2. Dosage and Administration

90 mg daily ×7 days lead-in, then 180 mg daily.

3. Dosage Forms and Strengths

Tablets: 30 mg, 90 mg, 180 mg

4. Contraindications

None listed.

5. Warnings and Precautions
  • ILD/Pneumonitis: Monitor first week especially.
  • Hypertension: 21% incidence.
  • Visual Disturbances: Withhold for Grade ≥3.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Nausea (40%), Diarrhea (38%), Fatigue (36%), Cough (34%), Headache (28%), Rash (24%), Hypertension (21%), Vomiting (23%)

Nausea
40%
Diarrhea
38%
Fatigue
36%
Cough
34%
Headache
28%
Rash
24%
Hypertension
21%
Vomiting
23%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

Strong CYP3A Inhibitors: Reduce dose by 50%.
Strong CYP3A Inducers: Avoid.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Brigatinib targets ALK, ROS1, and IGF-1R with activity against multiple ALK resistance mutations.

Pharmacokinetics

Tmax: 1-4h. Protein binding: 91%. t½: 25h. Feces 65%, urine 25%.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Alunbrig Trials on ClinicalTrials.gov ↗ 📚 PubMed: Alunbrig Clinical Trials ↗
FDA-Approved Tumor Types

Alunbrig has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Non-Small Cell Lung Cancer
External Resources
📋 DailyMed Label ↗ 🏛️ FDA Drugs@FDA ↗ 🔬 ClinicalTrials.gov ↗ 📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Alunbrig. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Alunbrig (brigatinib) approved for?

Alunbrig (brigatinib) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Alunbrig (brigatinib) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Alunbrig (brigatinib) work?

Brigatinib targets ALK, ROS1, and IGF-1R with activity against multiple ALK resistance mutations.

What are the most common side effects?

Nausea (40%), Diarrhea (38%), Fatigue (36%), Cough (34%), Headache (28%), Rash (24%), Hypertension (21%), Vomiting (23%) Nausea 40% Diarrhea 38% Fatigue 36% Cough 34% Headache 28% Rash 24% Hypertension 21% Vomiting 23%

← All Therapies Full Prescribing Information ↗