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Brigatinib Dosage

Medically reviewed by Drugs.com. Last updated on Sep 12, 2019.

Applies to the following strengths: 90 mg; 30 mg; 180 mg; 90 mg-180 mg

Usual Adult Dose for Non-Small Cell Lung Cancer

Initial dose: 90 mg orally once a day for the first 7 days
Maintenance dose: If initial dose is tolerated during the first 7 days, increase to 180 mg orally once a day
Duration of therapy: Until disease progression or unacceptable toxicity

Use: Treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib

Renal Dose Adjustments

Mild to moderate renal impairment (CrCl 30 to 89 mL/min): No adjustment recommended.
Severe renal impairment (CrCl 15 to 29 mL/min): Reduce once daily dose by approximately 50% (i.e., from 180 mg to 90 mg OR 90 mg to 60 mg).

Liver Dose Adjustments

Mild (Child-Pugh A) to moderate (Child-Pugh B) hepatic impairment: No adjustment recommended.
Severe (Child-Pugh C) hepatic impairment: Reduce once daily dose by approximately 40% (i.e., from 180 mg to 120 mg, OR 120 mg to 90 mg, OR 90 mg to 60 mg).

Dose Adjustments

DOSE REDUCTION FOR ADVERSE REACTIONS:
STARTING DOSE 90 MG ONCE A DAY:
-First reduction: 60 mg once a day
-Second reduction: Permanently discontinue therapy.
-Third reduction: N/A
STARTING DOSE 180 MG ONCE A DAY:
-First reduction: 120 mg once a day
-Second reduction: 90 mg once a day
-Third reduction: 60 mg once a day

Comments:
-Once the dose is reduced, do not subsequently increase the dose.
-Permanently discontinue this drug if patients are unable to tolerate 60 mg once a day.
-Dosing interruption of 14 days or longer (for reasons other than adverse reactions): Resume at 90 mg once a day for 7 days before increasing to the previously tolerated dose.

STRONG OR MODERATE CYP450 3A INHIBITORS:
-Avoid concomitant use.
-If concomitant use of a strong CYP450 3A inhibitor cannot be avoided, reduce the once a day dose of this drug by approximately 50% (i.e., from 180 mg to 90 mg OR from 90 mg to 60 mg).
-If coadministration of a moderate CYP450 3A inhibitor cannot be avoided, reduce the once daily dose of this drug by approximately 40% (i.e., from 180 mg to 120 mg, OR 120 mg to 90 mg, OR from 90 mg to 60 mg).
-After discontinuation of a strong or moderate CYP450 3A inhibitor, resume the dose of this drug that was tolerated prior to initiating the CYP450 3A inhibitor.

MODERATE CYP450 3A INDUCERS:
-Avoid concomitant use.
-If coadministration of a moderate CYP450 3A inducer cannot be avoided, increase the once daily dose of this drug in 30 mg increments after 7 days of therapy with the current dose as tolerated, up to a maximum of twice the dose that was tolerated prior to initiating the moderate CYP450 3A inducer.
-After discontinuation of a moderate CYP450 3A inducer, resume the dose of this drug that was tolerated prior to initiating the moderate CYP450 3A inducer.

DOSE MODIFICATIONS FOR ADVERSE REACTIONS:
INTERSTITIAL LUNG DISEASE (ILD)/PNEUMONITIS:
*GRADE 1:
-If new pulmonary symptoms occur during the first 7 days of therapy, withhold this drug until recovery to baseline, then resume at the same dose and do not escalate to 180 mg if ILD/pneumonitis is suspected.
-If new pulmonary symptoms occur after the first 7 days of therapy, withhold this drug until recovery to baseline, then resume at same dose.
-If ILD/pneumonitis recurs, permanently discontinue this drug.
*GRADE 2:
-If new pulmonary symptoms occur during the first 7 days of therapy, withhold this drug until recovery to baseline; resume at next lower dose and do not dose escalate if ILD/pneumonitis is suspected.
-If new pulmonary symptoms occur after the first 7 days of therapy, withhold this drug until recovery to baseline.
-If ILD/pneumonitis is suspected, resume at next lower dose; otherwise, resume at same dose.
-If ILD/pneumonitis recurs, permanently discontinue this drug.
*Grade 3 or 4: Permanently discontinue this drug.
HYPERTENSION:
*GRADE 3 (SBP 160 mmHg or greater or DBP 100 mmHg or greater, medical intervention indicated, more than 1 antihypertensive drug, or more intensive therapy than previously used indicated):
-Withhold dosing until recovery to Grade 1 or less (SBP less than 140 mmHg and DBP less than 90 mmHg) then resume at the next lower dose.
-Recurrence: Withhold the drug until recovery to Grade 1 or less and resume at next lower dose or permanently discontinue this drug.
GRADE 4 (life-threatening consequences, urgent intervention indicated):
-Withhold this drug until recovery to Grade 1 or less and resume at the next lower dose OR permanently discontinue this drug.
*GRADE 4 RECURRENCE: Permanently discontinue this drug.
BRADYCARDIA (HR less than 60 bpm):
*SYMPTOMATIC BRADYCARDIA:
-Withhold this drug until recovery to asymptomatic bradycardia or to a resting heart rate of 60 bpm or above.
-If a concomitant medication known to cause bradycardia is identified and discontinued or dose-adjusted, resume this drug at same dose upon recovery to asymptomatic bradycardia or to resting heart rate of 60 bpm or above.
-If no concomitant medication known to cause bradycardia is identified, or if contributing concomitant medications are not discontinued or dose-adjusted, resume this drug at next lower dose upon recovery to asymptomatic bradycardia or to resting heart rate of 60 bpm or above.
*LIFE-THREATENING BRADYCARDIA (urgent intervention indicated):
-Permanently discontinue this drug if no contributing concomitant medication is identified.
-If contributing concomitant medication is identified and discontinued or dose-adjusted, resume this drug at next lower dose upon recovery to asymptomatic bradycardia or to a resting heart rate of 60 bpm or above, with frequent monitoring as clinically indicated.
-Recurrence: Permanently discontinue this drug.
VISUAL DISTURBANCE:
*GRADE 2 OR 3: Withhold this drug until recovery to Grade 1 or baseline, then resume at the next lower dose.
*GRADE 4: Permanently discontinue this drug.
CREATINE PHOSPHOKINASE (CPK) ELEVATION:
*GRADE 3 CPK ELEVATION (greater than 5 times upper level of normal [ULN]):
-Withhold this drug until recovery to Grade 1 or less (2.5 x ULN or less) or to baseline, then resume at same dose.
*GRADE 4 (greater than 10 x ULN) or GRADE 3 RECURRENCE: Withhold this drug until recovery to Grade 1 or less (2.5 x ULN or less) or to baseline, then resume at the next lower dose.
LIPASE/AMYLASE ELEVATION:
*GRADE 3 (greater than 2 x ULN): Withhold this drug until recovery to Grade 1 or less (1.5 x ULN or less) or to baseline, then resume at the same dose.
*GRADE 4 (greater than 5 x ULN) or GRADE 3 RECURRENCE: Withhold dosing until recovery to Grade 1 or less (1.5 x ULN or less) or to baseline, then resume at the next lower dose.
HYPERGLYCEMIA:
*GRADE 3 (greater than 250 mg/dL OR 13.9 mmol/L) OR GREATER AND ADEQUATE HYPERGLYCEMIC CONTROL CANNOT BE ACHIEVED WITH OPTIMAL MEDICAL MANAGEMENT:
-Withhold this drug until adequate hyperglycemic control is achieved and consider reduction to the next lower dose OR permanently discontinue therapy.
OTHER ADVERSE REACTIONS:
*GRADE 3:
-Withhold this drug until recovery to baseline, then resume at the same dose.
-Recurrence: Withhold this drug until recovery to baseline, then resume at the next lower dose OR discontinue therapy.
*GRADE 4:
-Withhold dosing until recovery to baseline, then resume at the next lower dose OR permanently discontinue.
-Recurrence: Permanently discontinue therapy.

Precautions

CONTRAINDICATIONS:
-None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Swallow tablets whole; do not crush or chew.
-Administer with or without food.
-In the event of a missed or vomited dose, skip that dose and administer the next dose at the regularly scheduled time.

Storage requirements:
-Store at 20C to 25C (68F to 77F); excursions are permitted between 15C to 30C
(59F to 86F).

Monitoring:
-Cardiovascular: Blood pressure (at 2 weeks, then at least monthly), heart rate (during treatment)
-Endocrine: Fasting serum glucose (prior to treatment initiation, then periodically thereafter)
-Gastrointestinal: Amylase and lipase (during treatment)
-Musculoskeletal: Creatine phosphokinase levels (during treatment)
-Respiratory: New or worsening respiratory symptoms (during treatment, particularly during the first week)

Patient advice:
-This drug may cause side effects such as double vision; avoid potentially dangerous activities such as driving and operating machinery until you know how this drug affects you.
-Avoid grapefruit and grapefruit juice while taking this drug.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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