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Alunbrig

BRIGATINIB

Manufacturer: Takeda Pharmaceuticals America, Inc.

Score: 141.0

Quick Summary

Alunbrig (Brigatinib) is a kinase inhibitor used for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC). The recommended dosage is 90 mg orally once daily for the first 7 days, then increased to 180 mg orally once daily. Important safety information includes warnings for interstitial lung disease (ILD)/pneumonitis, hypertension, bradycardia, visual disturbance, and creatine phosphokinase (CPK) elevation. There are no contraindications. Special population considerations include use during pregnancy, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Treatment of adult patients with ALK-positive metastatic NSCLC
  • Efficacy in patients who have progressed on crizotinib
  • Improved progression-free survival and overall response rate compared to crizotinib

Important Safety Information

Warning

ILD/pneumonitis, hypertension, bradycardia, visual disturbance, and CPK elevation

Contraindications

Adverse Reactions

  • Diarrhea
  • Fatigue
  • Nausea
  • Rash
  • Cough
  • Myalgia
  • Headache
  • Hypertension
  • Vomiting
  • Dyspnea

Dosing Recommendations

General Guidance

Reduce dose for strong or moderate CYP3A inhibitors, increase dose for moderate CYP3A inducers

ALK-positive metastatic NSCLC

Adult Dose

90 mg orally once daily for the first 7 days, then increased to 180 mg orally once daily

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Can cause fetal harm
  • Advise pregnant women of potential risk

Nursing Mothers

Pediatric Use

  • Not established

Geriatric Use

  • No overall differences in safety or effectiveness observed between patients ≥65 years and younger patients