omitant 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.
2.3 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.
3 DOSAGE FORMS AND STRENGTHS
30 mg, round, white to off-white film-coated tablet with "U3" debossed on one side and plain on the other side
90 mg, oval, white to off-white film-coated tablet with "U7" debossed on one side and plain on the other side
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
5.1 Interstitial Lung Disease (ILD)/Pneumonitis
Severe, life-threatening, and fatal pulmonary adverse reactions consistent with interstitial lung disease (ILD)/pneumonitis have occurred with AL |
