ALECENSA

Alectinib

Anaplastic lymphoma kinase (ALK)-positive, metastatic NSCLC.

PO 600 mg bd starting dose. 1st dose reduction: 450 mg bd; 2nd dose reduction: 300 mg bd. Patient w/ severe hepatic impairment (Child-Pugh C) 450 mg bd.

Should be taken with food: Swallow whole, do not open or dissolve the contents of cap.

Hepatotoxicity; ILD/pneumonitis; renal impairment; symptomatic bradycardia; myalgia/musculoskeletal pain; creatine phosphokinase (CPK) elevations; hemolytic anemia. Promptly investigate for ILD/pneumonitis in patient who presents w/ worsening of resp symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough & fever). Monitor heart rate & BP regularly. Assess CPK levels every 2 wk for the 1st mth of treatment, & as clinically indicated. Monitor liver function tests eg, ALT, AST, & total bilirubin every 2 wk during the 1st 3 mth of treatment, then once a mth thereafter & as clinically indicated. Increased exposure of alectinib in patients w/ severe hepatic impairment (Child-Pugh C). Safety has not been studied in patients w/ severe renal impairment (CrCl <30 mL/min) or end-stage renal disease. Female of reproductive potential must use effective contraception during treatment & for 1 wk after final dose. Males w/ female partners of reproductive potential must use effective contraception during treatment & for 3 mth following final dose. Advise pregnant women of the potential risk to a fetus. Advise a lactating woman not to breastfeed during treatment & for 1 wk after the final dose. Elderly ≥65 yr. Childn.

Constipation, nausea, diarrhea, vomiting, fatigue, edema, myalgia, rash, vision disorders, hyperbilirubinemia, increased AST, increased alkaline phosphatase, increased ALT, increased creatinine, increased CPK, hypocalcemia, hyperglycemia, hyponatremia, hypokalemia, hypophosphatemia, anemia, lymphopenia. Previously untreated ALK-positive metastatic NSCLC: Dysgeusia, bradycardia, renal impairment, hypoalbuminemia, hyperkalemia, increased γ-glutamyl transferase, neutropenia. ALK-positive metastatic NSCLC previously treated w/ crizotinib: Cough, headache, dyspnea, back pain, increased wt.

Targeted Cancer Therapy

L01ED03 - alectinib ; Belongs to the class of anaplastic lymphoma kinase (ALK) inhibitors. Used in the treatment of cancer.

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