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

A TKI with a recommended single tablet, once-daily dosing regimen1

In circumstances where dose is modified from the recommended dose, more than one tablet may need 
to be taken.

Recommended dosing regimen


The recommended starting dose of ALUNBRIG is:1

Infographic showing the recommended two-phase dosing schedule for an ALK inhibitor in advanced lung cancer
Photograph of a treatment starter pack containing colour-coded tablet inserts for the first month of treatment
Dosing particulars including dosing for hepatic and renal impairment1
  • If ALUNBRIG is interrupted for 14 days or longer for reasons other than adverse reactions, treatment should be resumed at 90 mg once daily for 7 days before increasing to the previously tolerated dose

  • Treatment should continue as long as clinical benefit is observed

  • For patients with severe hepatic impairment (Child-Pugh class C): a reduced starting dose of 60 mg once daily for the first 7 days, then 120 mg once daily is recommended

  • For patients with severe renal impairment (estimated glomerular filtration rate <30 mL/min): a reduced starting dose of 60 mg once daily for the first 7 days, then 90 mg once daily is recommended. Patients with severe renal impairment should be closely monitored for new or worsening respiratory symptoms that may indicate interstitial lung disease/ pneumonitis (for example dyspnoea or cough), particularly in the first week

  • If a dose is missed or vomiting occurs after taking a dose, an additional dose should not be administered and the next dose should be taken at the scheduled time

Please refer to the ALUNBRIG Summary of Product Characteristics for complete dosing information.1

ALUNBRIG starter pack1

The ALUNBRIG starter pack allows for a simple and convenient solution for patients to manage their first month of treatment.1

Close-up photograph of a colour-coded blue tablet insert labelled for treatment days one to seven Close-up photograph of a colour-coded green tablet insert labelled for treatment days eight to twenty-eight

The first insert (colour-coded blue) contains 7 x 90 mg tablets, clearly labelled for Days 1-7.

The second insert (colour-coded green) contains 21 x 180 mg tablets, clearly labelled for Days 8–28.

Dose reduction

Dosing interruption and/or dose reduction may be required based on individual safety and tolerability. Doses should be adjusted as follows:1

For 90 mg once daily
(recommended starting dose)
1st icon
   Reduce to 60 mg once daily
2nd icon
   Permanently discontinued
For 180 mg once daily
1st icon
   Reduce to 120 mg once daily
2nd icon
   Reduce to 90 mg once daily
3rd icon
   Reduce to 60 mg once daily

If patients cannot tolerate the 60 mg once-daily dose, discontinue ALUNBRIG permanently.



Please refer to the ALUNBRIG Summary of Product Characteristics for dose reduction recommendations for specific adverse events.1

ALUNBRIG packs

In addition to the starter pack, ALUNBRIG is available in a variety of strengths for convenient dosing according to your patients' needs:1

180 mg (green pack),
90 mg (blue pack) and
30 mg (orange pack) tablets

Photograph of three different pack sizes for an oral oncology treatment

Rationale for ALUNBRIG initiation and dosing

Why 180 mg once daily with a 7-day lead-in at 90 mg once daily?

Based on results seen in an initial phase II expansion study, the 90 mg lead-in appeared to decrease the incidence of pulmonary adverse events with early onset (compared with starting at 180 mg once daily directly)2

The mean plasma steady-state trough ALUNBRIG concentrations exceed levels preclinically defined to inhibit all tested crizotinib-resistant ALK mutations at once-daily ALUNBRIG dosing2

Exposure at the 180 mg dose* contributes to increased rate of response and durability of response, as well as CNS response, compared with the 90 mg dose3

The 90 mg once-daily arm is off label. The recommended starting dose of ALUNBRIG is 90 mg once daily for the first 7 days, then 180 mg once daily. Please refer to the Summary of Product Characteristics for full details.1

*180 mg once daily with 7-day lead-in at 90 mg once daily.

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 >

Managing adverse events
with ALUNBRIG

Find out more >
References and Abbreviations

TKI, tyrosine kinase inhibitor.

1. ALUNBRIG (brigatinib) Summary of Product Characteristics. Available at: medicines.org.uk. Accessed May 2026; 2. Gettinger S N, Bazhenova L A et al. Activity and safety of brigatinib in ALK-rearranged non-small-cell lung cancer and other malignancies: a single-arm, open-label, phase 1/2 trial. Lancet Oncol 2016;17:1683-96; 3. Gettinger S N, Huber R N et al. Long-term efficacy and safety of brigatinib in crizotinib-refractory ALK+ NSCLC: final results of the phase 1/2 and randomized phase 2 (ALTA) trials JTO Clin Res Rep 2022;3:100385

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