ALECENSA安聖莎

ALECENSA

Manufacturer:

Roche

Distributor:

DKSH
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Alectinib
Indications/Uses
Anaplastic lymphoma kinase (ALK) +ve & metastatic non-small cell lung cancer (NSCLC).
Dosage/Direction for Use
PO 600 mg bd starting dose. 1st dose reduction: 450 mg bd; 2nd dose reduction: 300 mg bd.
Administration
Should be taken with food: Swallow whole, do not open or dissolve the contents of cap.
Special Precautions
Promptly investigate for interstitial lung disease (ILD)/pneumonitis in patient who presents w/ worsening of resp symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough & fever). Risk of symptomatic bradycardia. Monitor heart rate & BP regularly. Myalgia/musculoskeletal pain; creatine phosphokinase (CPK) elevations. Assess CPK levels every 2 wk for the 1st mth of treatment, & as clinically indicated. Renal impairment. Hepatotoxicity. 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. 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. Pregnancy & lactation. Elderly ≥65 yr. Childn.
Adverse Reactions
Increased AST & ALT, increased alkaline phosphatase, increased creatine phosphokinase, hyperbilirubinemia, hyperglycemia, hypocalcemia, hypokalemia, increased creatinine, hypophosphatemia, hyponatremia; anemia, lymphopenia; fatigue, edema; constipation, nausea, diarrhea, vomiting; myalgia, back pain; rash; cough; headache; increased wt, vision disorder.
ATC Classification
L01XE36 - alectinib ; Belongs to the class of protein kinase inhibitors, other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
ALECENSA cap 150 mg
Packing/Price
224's
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