Generic name: brigatinib 30mg
Dosage form: tablet, film coated
Medically reviewed on February 7, 2018.
The recommended dosing regimen for ALUNBRIG is:
- 90 mg orally once daily for the first 7 days;
- if 90 mg is tolerated during the first 7 days, increase the dose to 180 mg orally once daily.
Administer ALUNBRIG until disease progression or unacceptable toxicity.
If ALUNBRIG is interrupted for 14 days or longer for reasons other than adverse reactions, resume treatment at 90 mg once daily for seven days before increasing to the previously tolerated dose.
ALUNBRIG may be taken with or without food. Instruct patients to swallow tablets whole. Do not crush or chew tablets.
If a dose of ALUNBRIG is missed or vomiting occurs after taking a dose, do not administer an additional dose and take the next dose of ALUNBRIG at the scheduled time.
Dose Modifications for Adverse Reactions
ALUNBRIG dose modification levels are summarized in Table 1.
|Dose||Dose Reduction Levels|
|90 mg once daily||60 mg once daily||permanently discontinue||N/A*|
|180 mg once daily||120 mg once daily||90 mg once daily||60 mg once daily|
Once reduced for adverse reactions, do not subsequently increase the dose of ALUNBRIG. Permanently discontinue ALUNBRIG if patients are unable to tolerate the 60 mg once daily dose.
Recommendations for dose modifications of ALUNBRIG for the management of adverse reactions are provided in Table 2.
|Adverse Reaction||Severity*||Dose Modification|
|bpm = beats per minute; DBP = diastolic blood pressure; HR = heart rate; SBP = systolic blood pressure; ULN = upper limit of normal|
|Interstitial Lung Disease (ILD) /Pneumonitis
[see Warnings and Precautions (5.1)]
|Grade 3 or 4||Permanently discontinue ALUNBRIG for ILD/pneumonitis.|
[see Warnings and Precautions (5.2)]
|Grade 3 hypertension (SBP greater than or equal to 160 mmHg or DBP greater than or equal to 100 mmHg, medical intervention indicated, more than one antihypertensive drug, or more intensive therapy than previously used indicated)||
|Grade 4 hypertension (life-threatening consequences, urgent intervention indicated)||
|Bradycardia (HR less than 60 bpm)
[see Warnings and Precautions (5.3)]
|Bradycardia with life-threatening consequences, urgent intervention indicated||
[see Warnings and Precautions (5.4)]
|Grade 2 or 3 visual disturbance||Withhold ALUNBRIG until recovery to Grade 1 or baseline, then resume at the next lower dose (Table 1).|
|Grade 4 visual disturbance||Permanently discontinue ALUNBRIG.|
|Creatine Phosphokinase (CPK) Elevation
[see Warnings and Precautions (5.5)]
|Grade 3 CPK elevation (greater than 5.0 × ULN)||Withhold ALUNBRIG until recovery to Grade 1 or less (less than or equal to 2.5 × ULN) or to baseline, then resume ALUNBRIG at same dose.|
|Grade 4 CPK elevation (greater than 10.0 × ULN) or recurrence of Grade 3 elevation||Withhold ALUNBRIG until recovery to Grade 1 or less (less than or equal to 2.5 × ULN) or to baseline, then resume ALUNBRIG at next lower dose (Table 1).|
[see Warnings and Precautions (5.6)]
|Grade 3 lipase or amylase elevation (greater than 2.0 × ULN)||Withhold ALUNBRIG until recovery to Grade 1 or less (less than or equal to 1.5 × ULN) or to baseline, then resume ALUNBRIG at same dose.|
|Grade 4 lipase or amylase elevation (greater than 5.0 × ULN) or recurrence of Grade 3 elevation||Withhold ALUNBRIG until recovery to Grade 1 or less (less than or equal to 1.5 × ULN) or to baseline, then resume ALUNBRIG at next lower dose (Table 1).|
|Hyperglycemia [see Warnings and Precautions (5.7)]||Grade 3 (greater than 250 mg/dL or 13.9 mmol/L) or greater||If adequate hyperglycemic control cannot be achieved with optimal medical management, withhold ALUNBRIG until adequate hyperglycemic control is achieved and consider reduction to the next dose (Table 1) or permanently discontinue ALUNBRIG.|
Dose Modification for Strong CYP3A Inhibitors
Avoid concomitant use of strong CYP3A inhibitors during treatment with ALUNBRIG [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)]. If concomitant use of a strong CYP3A inhibitor cannot be avoided, reduce the ALUNBRIG once daily dose by approximately 50% (i.e., from 180 mg to 90 mg, or from 90 mg to 60 mg). After discontinuation of a strong CYP3A inhibitor, resume the ALUNBRIG dose that was tolerated prior to initiating the strong CYP3A inhibitor.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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- Drug class: multikinase inhibitors