Respiratory and thoracic cancers:
Indications for ALUNBRIG:
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.
Swallow whole. Initially 90mg once daily for first 7 days; if tolerated, increase to 180mg once daily until disease progression or unacceptable toxicity. If dose interrupted for ≥14 days (not due to adverse reactions), resume at 90mg daily for 7 days then re-titrate. Concomitant strong or moderate CYP3A inhibitors: avoid; if strong inhibitor required, reduce Alunbrig dose by ~50%; if moderate inhibitor required, reduce Alunbrig dose by ~40%. Concomitant moderate CYP3A inducers: avoid; if required, increase Alunbrig dose in 30mg increments after 7 days of current Alunbrig dose as tolerated; up to max twice the Alunbrig dose prior to initiating the moderate inducer. Severe hepatic impairment (Child-Pugh C): reduce Alunbrig dose by ~40%. Severe renal impairment: (CrCl 15–29mL/min): reduce Alunbrig dose by ~50%. Dose modifications for adverse reactions: see full labeling.
Monitor for new or worsening respiratory symptoms esp. during 1st week of initiation; if occurs, withhold and evaluate for ILD/pneumonitis; resume at same dose for Grade 1 or reduced dose for Grade 2 severity; permanently discontinue for Grade 3/4 or recurrent Grade 1/2 ILD/pneumonitis. Monitor BP after 2 weeks and at least monthly thereafter; withhold for Grade 3 hypertension despite optimal antihypertensive therapy; resume at reduced dose upon improvement to Grade 1 severity; consider permanent discontinuation for Grade 4 or recurrent Grade 3 hypertension. Monitor HR and BP regularly; if symptomatic bradycardia occurs, withhold and evaluate any concomitant drugs that are known to cause bradycardia; resume at same or reduced dose after resolution; discontinue for life-threatening bradycardia if no contributing concomitant medication identified. Withhold and evaluate for new or worsening visual symptoms of Grade ≥2 severity; resume at reduced doses upon recovery to Grade 1 or baseline; permanently discontinue for Grade 4 visual disturbances. Monitor CPK, lipase, and amylase levels during treatment; withhold for Grade 3/4 elevation; resume at same or reduced dose upon recovery to Grade 1 or baseline. Assess fasting serum glucose prior to initiation and periodically thereafter; if not adequately controlled with optimal antihyperglycemics, withhold then consider dose reduction, or permanently discontinue based on severity. severe hepatic or severe renal impairment. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Use effective non-hormonal contraception during and for at least 4 months (females) or 3 months (males w. female partners) after final dose. Nursing mothers: not recommended (during and for 1 week after final dose).
Avoid concomitant strong or moderate CYP3A inhibitors (eg, itraconazole); see Adults. Avoid grapefruit or grapefruit juice. Avoid concomitant strong or moderate CYP3A inducers (eg, rifampin); see Adults. May reduce efficacy of sensitive CYP3A substrates (eg, hormonal contraceptives). Caution with antihypertensives that cause bradycardia.
Nausea, diarrhea, fatigue, cough, headache; ILD/pneumonitis, hypertension, bradycardia, visual disturbances, CPK elevation, pancreatic enzyme elevation, hyperglycemia, possible infertility in males.
Tabs 30mg—30; 90mg—7, 30; 180mg—23, 30; Initiation pack—7 (90mg) + 23 (180mg)