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Brigatinib Dosage

Applies to the following strengths: 30 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

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 and Moderate Renal Impairment (CrCl 30 to 89 mL/min): No adjustment recommended.
-Severe Renal Impairment (CrCl 15 to 29 mL/min): Data not available.

Liver Dose Adjustments

-Mild Hepatic Impairment (total bilirubin within upper limit of normal [ULN] AND AST greater than ULN OR total bilirubin greater than 1 and up to 1.5 x ULN and any AST): No adjustment recommended.
-Moderate Hepatic Impairment (total bilirubin greater than 1.5 and up to 3 x ULN and any AST): Data not available.
-Severe Hepatic Impairment (total bilirubin greater than 3 x ULN and any AST): Data not available.

Dose Adjustments

DOSING INTERRUPTION OF 14 DAYS OR LONGER (for reasons other than adverse reactions): Resume treatment at 90 mg once a day for 7 days before increasing to the previously tolerated dose.

STRONG CYP450 3A INHIBITORS: Avoid concomitant use.
-IF CONCOMITANT USE 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).
-AFTER DISCONTINUATION OF STRONG CYP450 3A INHIBITOR: Resume the same dose of this drug that was tolerated prior to initiating the strong inhibitor.

DOSE REDUCTION LEVELS FOR ADVERSE REACTIONS:

IF STARTING DOSE 90 MG ONCE A DAY:
-First Reduction: 60 mg once a day
-Second Reduction: Permanently discontinue.
-Third Reduction: N/A

IF 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 if patients are unable to tolerate the 60 mg once a day dose.

INTERSTITIAL LUNG DISEASE (ILD)/PNEUMONITIS:
IF NEW PULMONARY SYMPTOMS OCCUR:
*GRADE 1: Withhold dosing until recovery to baseline, then resume at the same dose.
*GRADE 2:
-During First 7 Days: Withhold dosing until recovery to baseline, then resume at the next lower dose.
-After First 7 Days: Withhold dosing until recovery to baseline, then resume at the same dose OR resume at the next lower dose IF ILD/pneumonitis is suspected.
*GRADE 1/2 Occurs During First 7 Days AND ILD/Pneumonitis Suspected: Withhold dosing until recovery to baseline, then resume at the same dose and do not escalate dose to 180 mg.
*GRADE 3/4 OR ILD/Pneumonitis Occurs/Recurs: Permanently discontinue.

HYPERTENSION:
*GRADE 3 (SBP 160 mmHg or greater OR DBP 100 mmHg or greater, medical intervention indicated, more than 1 anti-hypertensive 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.
*GRADE 4 (life-threatening consequences, urgent intervention indicated) OR GRADE 3 RECURRENCE:
-Withhold dosing until recovery to Grade 1 or less, then resume at the next lower dose OR permanently discontinue.
*GRADE 4 RECURRENCE: Permanently discontinue.

BRADYCARDIA (HR less than 60 bpm):
*SYMPTOMATIC:
-Concomitant Medication Known to Cause Bradycardia is Identified AND Discontinued or Dose-Adjusted: Withhold dosing until recovery to asymptomatic bradycardia or to a resting heart rate of 60 bpm or above, then resume at the same dose.
-No Contributing Concomitant Medication OR Concomitant Medication NOT Discontinued or Dose-Adjusted: Withhold dosing until recovery to asymptomatic bradycardia or to a resting heart rate of 60 bpm or above, then resume at the next lower dose.
*LIFE-THREATENING (urgent intervention indicated):
-Contributing Concomitant Medication Identified AND Discontinued or Dose-Adjusted: Withhold dosing until recovery to asymptomatic bradycardia or to a resting heart rate of 60 bpm or above, then resume at the next lower dose, with frequent monitoring as clinically indicated.
-No Contributing Concomitant Medication is Identified OR For Recurrence: Permanently discontinue.

VISUAL DISTURBANCE:
*GRADE 2/3: Withhold dosing until recovery to Grade 1 or baseline, then resume at the same dose.
*GRADE 4: Permanently discontinue.

CREATINE PHOSPHOKINASE (CPK) ELEVATION:
*GRADE 3 (greater than 5 times upper level of normal [ULN]): Withhold dosing until recovery to Grade 1 or less (2.5 x ULN or less) or to baseline, then resume at the same dose.
*GRADE 4 (greater than 10 x ULN) or GRADE 3 RECURRENCE: Withhold dosing 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 dosing 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 dosing until adequate hyperglycemic control is achieved and consider reduction to the next lower dose OR permanently discontinue.

OTHER ADVERSE REACTION:
*GRADE 3: Withhold dosing until recovery to baseline, then resume at the same dose.
-Recurrence: Withhold dosing until recovery to baseline, then resume at the next lower dose OR discontinue.
*GRADE 4: Withhold dosing until recovery to baseline, then resume at the next lower dose OR permanently discontinue.
-Recurrence: Permanently discontinue.

Precautions

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 them.
-Administer with or without food.
-In the event of a missed or vomited dose, skip that dose and administer the next dose at the regular scheduled time.

Storage Requirements:
-Store at 20 to 25 degrees Celsius (68 to 77 degrees Fahrenheit); excursions are permitted between 15 to 30 degrees Celsius (59 to 86 degrees Fahrenheit).

General:
-This drug received accelerated FDA approval based on tumor response rate and duration; continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.

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.

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