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Alunbrig Dosage

Generic name: brigatinib 30mg
Dosage form: tablet, film coated

Medically reviewed on February 7, 2018.

Recommended Dosing

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.

Table 1: Recommended ALUNBRIG Dose Reduction Levels
Dose Dose Reduction Levels
First Second Third
*
Not applicable
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.

Table 2: Recommended ALUNBRIG Dose Modifications for Adverse Reactions
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
*
Graded per National Cancer Institute Common Terminology Criteria for Adverse Events. Version 4.0 (NCI CTCAE v4).
Interstitial Lung Disease (ILD) /Pneumonitis
[see Warnings and Precautions (5.1)]
Grade 1
  • If new pulmonary symptoms occur during the first 7 days of treatment, withhold ALUNBRIG until recovery to baseline, then resume at 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 treatment, withhold ALUNBRIG until recovery to baseline, then resume at same dose.
  • If ILD/pneumonitis recurs, permanently discontinue ALUNBRIG.
Grade 2
  • If new pulmonary symptoms occur during the first 7 days of treatment, withhold ALUNBRIG until recovery to baseline. Resume at next lower dose (Table 1) and do not dose escalate if ILD/pneumonitis is suspected.
  • If new pulmonary symptoms occur after the first 7 days of treatment, withhold ALUNBRIG until recovery to baseline. If ILD/pneumonitis is suspected, resume at next lower dose (Table 1); otherwise, resume at same dose.
  • If ILD/pneumonitis recurs, permanently discontinue ALUNBRIG.
Grade 3 or 4 Permanently discontinue ALUNBRIG for ILD/pneumonitis.
Hypertension
[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)
  • Withhold ALUNBRIG until hypertension has recovered to Grade 1 or less (SBP less than 140 mmHg and DBP less than 90 mmHg), then resume ALUNBRIG at next lower dose (Table 1).
  • Recurrence: withhold ALUNBRIG until recovery to Grade 1 or less, and resume at next lower dose (Table 1) or permanently discontinue treatment.
Grade 4 hypertension (life-threatening consequences, urgent intervention indicated)
  • Withhold ALUNBRIG until recovery to Grade 1 or less, and resume at next lower dose (Table 1) or permanently discontinue treatment.
  • Recurrence: permanently discontinue ALUNBRIG for recurrence of Grade 4 hypertension.
Bradycardia (HR less than 60 bpm)
[see Warnings and Precautions (5.3)]
Symptomatic bradycardia
  • Withhold ALUNBRIG 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 ALUNBRIG 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 ALUNBRIG at next lower dose (Table 1) upon recovery to asymptomatic bradycardia or to resting heart rate of 60 bpm or above.
Bradycardia with life-threatening consequences, urgent intervention indicated
  • Permanently discontinue ALUNBRIG if no contributing concomitant medication is identified.
  • If contributing concomitant medication is identified and discontinued or dose-adjusted, resume ALUNBRIG at next lower dose (Table 1) 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 ALUNBRIG.
Visual Disturbance
[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).
Lipase/Amylase Elevation
[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.
Other Grade 3
  • Withhold ALUNBRIG until recovery to baseline, then resume at same dose.
  • Recurrence: withhold ALUNBRIG until recovery to baseline, then resume at next lower dose or discontinue ALUNBRIG (Table 1).
Grade 4
  • First occurrence: either withhold ALUNBRIG until recovery to baseline and resume at next lower dose (Table 1) or permanently discontinue.
  • Permanently discontinue ALUNBRIG for recurrence.

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.

Further information

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

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