• Respiratory and thoracic cancers

Alunbrig Generic Name & Formulations

General Description

Brigatinib 30mg, 90mg, 180mg; tabs.

Pharmacological Class

Kinase inhibitor.

How Supplied

Tabs 30mg—30; 90mg—7, 30; 180mg—23, 30; Initiation pack—7 (90mg) + 23 (180mg)

Generic Availability


Alunbrig Indications


In adults with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test.

Alunbrig Dosage and Administration


Swallow whole. 90mg once daily for first 7 days; then increase to 180mg once daily. Continue until disease progression or unacceptable toxicity. If dose interrupted for ≥14 days (not due to adverse reactions), resume at 90mg daily for 7 days then re-titrate. Concomitant strong or moderate CYP3A inhibitors: avoid; if strong inhibitor required, reduce Alunbrig dose by ~50%; if moderate inhibitor required, reduce Alunbrig dose by ~40%. Concomitant moderate CYP3A inducers: avoid; if required, increase Alunbrig dose in 30mg increments after 7 days of current Alunbrig dose as tolerated; up to max twice the Alunbrig dose prior to initiating the moderate inducer. Severe hepatic impairment (Child-Pugh C): reduce Alunbrig dose by ~40%. Severe renal impairment: (CrCl 15–29mL/min): reduce Alunbrig dose by ~50%. Dose modifications for adverse reactions: see full labeling.


Not established.

Alunbrig Contraindications

Not Applicable

Alunbrig Boxed Warnings

Not Applicable

Alunbrig Warnings/Precautions


Monitor for new or worsening respiratory symptoms esp. during 1st week of initiation; if occurs, withhold and evaluate for ILD/pneumonitis; reduce dose or permanently discontinue based on severity. Control BP prior to initiation; monitor after 2 weeks and at least monthly thereafter; withhold, reduce dose, or permanently discontinue based on severity. Monitor HR and BP regularly; if symptomatic bradycardia occurs, withhold and evaluate any concomitant drugs known to cause bradycardia; resume at same or reduced dose after resolution; discontinue for life-threatening bradycardia if no contributing concomitant medication identified. Withhold and evaluate for new or worsening visual symptoms of Grade ≥2; reduce dose or permanently discontinue based on severity. Monitor CPK, lipase, and amylase levels during treatment; withhold for Grade 3/4 elevation; resume at same or reduced dose upon recovery to Grade 1 or baseline. Assess fasting serum glucose prior to initiation and periodically thereafter; if not adequately controlled with optimal antihyperglycemics, withhold then consider dose reduction, or permanently discontinue based on severity. Advise to limit sun exposure during and for at least 5 days after treatment discontinuation. Severe hepatic or severe renal impairment. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Advise to use effective non-hormonal contraception during and for at least 4 months (females of reproductive potential) or 3 months (males w. female partners) after final dose. Nursing mothers: not recommended (during and for 1 week after final dose).

Alunbrig Pharmacokinetics

See Literature

Alunbrig Interactions


Avoid concomitant strong or moderate CYP3A inhibitors (eg, itraconazole); see Adults. Avoid grapefruit or grapefruit juice. Avoid concomitant strong or moderate CYP3A inducers (eg, rifampin); see Adults. May reduce efficacy of sensitive CYP3A substrates (eg, hormonal contraceptives). Caution with antihypertensives that cause bradycardia.

Alunbrig Adverse Reactions

Adverse Reactions

Diarrhea, fatigue, nausea, rash, cough, myalgia, headache, hypertension, vomiting, dyspnea; pneumonia, ILD/pneumonitis, pyrexia, pulmonary embolism, asthenia, photosensitivity; possible infertility in males.

Alunbrig Clinical Trials

See Literature

Alunbrig Note

Not Applicable

Alunbrig Patient Counseling

See Literature