ALUNBRIG® (brigatinib) Prescribing Information

ALUNBRIG is indicated as monotherapy for the treatment of adult patients with:1

  • anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (aNSCLC) previously not treated with an ALK inhibitor
  • ALK+ aNSCLC previously treated with crizotinib

ALUNBRIG demonstrated a generally manageable safety profile in the phase Ill ALTA-1L clinical trial2

Adverse events

The most common (>25%) adverse events of any grade in the ALTA-1L trial included
gastrointestinal events, increased blood creatine phosphokinase (CPK), cough and increased aspartate aminotransferase.2 Consult the Summary of Product Characteristics for full safety information.1

Any grade TEAEs reported in ALTA-1L in ≥20% of patients (any arm) or that differed by ≥10% between the ALUNBRIG and crizotinib arms (excluding laboratory abnormalities)2

Bar chart comparing any grade treatment-emergent adverse events between two treatment arms in a phase III advanced lung cancer trial

Adapted from Camidge R et al, 2021 [+ suppl)2

Grade ≥3 TEAEs reported in ALTA-1L in ≥2% of patients (in either arm, excluding laboratory abnormalities)2

Bar chart comparing grade three or higher treatment- emergent adverse events between two treatment arms in a phase III advanced lung cancer trial

Adapted from Camidge R et al, 2021 [+ suppl)2

Laboratory abnormalities that were reported in >10% of patients in the ALTA-1L study

Any grade laboratory abnormalities that were reported in ALTA-1L in >10% of patients 
in any arm or that differed by >5% between the ALUNBRIG arm and the crizotinib arm2

Bar chart showing any grade laboratory abnormalities reported in a phase III advanced lung cancer trial

Grade ≥3 laboratory abnormalities that were reported in ALTA-1L in ≥2% patients in either arm2

Bar chart showing grade three or higher laboratory abnormalities reported in a phase III advanced lung cancer trial

Adapted from Camidge R et al, 20212

Dose modifications and discontinuation rates in each study arm2

ALUNBRIG
(n-136)		 Crizotinib
(n-136)
Discontinuation
rates due to AEs
13% icon
9% icon
Dose modification
due to AEs
44% icon
25% icon
  • Dose reductions due to asymptomatic laboratory abnormalities were required as per study protocol3
  • The most common reason for dose reduction in the ALUNBRIG group was increased CPK (18%). Other adverse events resulting in dose modification
in more than one patient included: increased lipase (7%), increased amylase (4%), hypertension (3%), increased AST (2%), increased ALT (1%), nausea (1%). pneumonitis (1%), erythema (1%) and pruritic rash (1%)2

AEs of special interest: interstitial lung disease (ILD)

  • Early-onset ILD/ pneumonitis (within 8 days of treatment initiation) was reported in 3% (4/136) of patients who were treated with ALUNBRIG and was not reported in any patients treated with crizotinib1,3
  • ILD/ pneumonitis at any time was reported in 6% (8/136) of patients who were treated with ALUNBRIG and 2% (3/137) of patients treated with crizotinib3

Special warnings and precautions for the use of ALUNBRIG

Dr Sharmistha Ghosh discusses special considerations for cardiac adverse events and skin toxicities arising from ALUNBRIG treatment

Time to watch: 4 mins 17 secs

Time to watch: 3 mins 7 secs

Special warnings and precautions1
Pulmonary adverse reactions Monitor for new/ worsening respiratory symptoms (dyspnoea, cough etc), particularly in the first week of treatment. Promptly investigate evidence of pneumonitis. Withhold ALUNBRIG if pneumonitis is suspected. Modify dose accordingly.
Hypertension Regularly monitor blood 
pressure; avoid 
bradycardia‑causing 
medicinal products; 
modify dose as necessary.
Bradycardia Use caution when administering with bradycardia‑causing medicinal products; monitor heart rate and blood pressure; modify dose as necessary.
Visual disturbance Consider referral for ophthalmic evaluation and dose reduction for new or worsening severe visual symptoms.
CPK elevation Regularly monitor CPK levels and muscle pain or weakness; modify dose as necessary.
Elevated pancreatic enzymes Regularly monitor lipase and amylase; modify dose as necessary.
Hepatotoxicity Assess liver function prior to treatment initiation, every 2 weeks during the first 3 months of treatment, then periodically thereafter; modify dose as necessary.
Hyperglycaemia Monitor fasting serum glucose prior to initiation of and during treatment; modify dose as necessary.
Drug-drug interactions Avoid concomitant use of strong CYP3A inhibitors or reduce dose of ALUNBRIG if unavoidable. Avoid concomitant use of strong and moderate CYP3A inducers. Avoid grapefruit or grapefruit juice. Avoid coadministration with CYP3A substrates that have a narrow therapeutic index (eg alfentanil, fentanyl, quinidine, cyclosporine, sirolimus, tacrolimus). Monitor closely if coadministered with substrates of P‑gp, BCRP, OCT1, MATE1 or MATE2K transporters with a narrow therapeutic index (eg digoxin, dabigatran, methotrexate)
Photosensitivity and photodermatosis Patients should be advised to avoid prolonged sun exposure while taking ALUNBRIG, and for at least 5 days after discontinuation of treatment. When outdoors, patients should be advised to wear a hat and protective clothing, and to use a broad-spectrum ultraviolet A (UVA)/ ultraviolet B (UVB) sunscreen and lip balm (SPF ≥30) to help protect against potential sunburn. For severe photosensitivity reactions (≥ Grade 3), ALUNBRIG should be withheld until recovery to baseline. The dose should be modified accordingly.
Fertility Women of childbearing potential should be advised to use effective non-hormonal contraception during treatment with ALUNBRIG and for at least 4 months following the final dose. Men with female partners of childbearing potential should be advised to use effective contraception during treatment and for at least 3 months after the last dose of ALUNBRIG.
Lactose ALUNBRIG contains lactose monohydrate, so should be avoided in patients with any hereditary galactose/ lactose intolerance or malabsorption problems

For more information, please refer to the ALUNBRIG Summary of Product Characteristics.

What impact does ALUNBRIG have on
HRQoL outcomes
in ALTA-1L?

Find out more >

HCP Pocket Guide

A practical guide for HCPs managing patients on ALUNBRIG that includes guidance on how to start patients and manage toxicities.


Find out more >
References and Abbreviations

GERD, gastroesophageal reflux disease; ALT, alanine aminotransferase; AST, aspartate aminotransferase; ILD, interstitial lung disease; CPK, creatine phosphokinase.

1. ALUNBRIG (brigatinib) Summary of Product Characteristics. Available at: medicines.org.uk. Accessed June 2026; 2. Camidge D R, Kim H R et al. Brigatinib versus crizotinib in ALK inhibitor‑naive advanced ALK‑positive NSCLC: final results of phase 3 ALTA-1L trial. J Thorac Oncol 2021;16:2091-2108 (+ suppl); 3. Camidge D R, Kim H R et al. Brigatinib versus crizotinib in ALK‑positive non‑small‑cell lung cancer: study protocol. N Engl J Med 2018;379:2027-2039

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