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ALECENSA(alectinib)capsules
2016-07-07 06:10:09 来源: 作者: 【 】 浏览:428次 评论:0

新型抗癌药Alecensa(alectinib)获批准上市,治疗ALK-阳性肺癌
ALECENSA Rx
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ALECENSA
Respiratory and thoracic cancers  Only 4 drugs may be compared at once
Generic Name and Formulations:
Alectinib 150mg; caps.
Company:
Genentech, Inc.
 
Select therapeutic use: Respiratory and thoracic cancers
Indications for ALECENSA:
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.

Adult:
Swallow whole. Take with food. 600mg twice daily until disease progression or unacceptable toxicity. Dose modifications or dose reduction schedule: see full labeling.

Children:
Not established.

Warnings/Precautions:
Monitor liver function tests (eg, ALT, AST, total bilirubin) every 2 weeks for the first 2 months, then periodically during treatment; test more frequently if transaminase and bilirubin elevated; withhold, resume at reduced dose, or permanently discontinue based on severity. eva luate if presence of worsening respiratory symptoms; withhold if ILD/pneumonitis diagnosed; permanently discontinue if no other cause identified. Monitor HR, BP regularly. If non-life-threatening symptomatic bradycardia occurs, withhold until asymptomatic or HR ≥60bpm; permanently discontinue in case(s) of recurrence or life-threatening bradycardia if no contributing concomitant medication identified. Assess CPK every 2 weeks for the first month and as clinically indicated; withhold, resume, or reduce dose based on severity. Pregnancy. Females of reproductive potential should use effective contraception during treatment and for 1 week after final dose; males should use effective contraception during treatment and for 3 months after final dose. Nursing mothers: not recommended (during and for 1 week after final dose).

Interactions:
Increased bradycardia with concomitant antihypertensives or other drugs known to cause bradycardia.

Pharmacological Class:
Kinase inhibitor.

Adverse Reactions:
Fatigue, constipation, edema, myalgia; hepatotoxicity, ILD/pneumonitis, bradycardia, CPK elevation, embryo-fetal toxicity.

Generic Availability:
NO

How Supplied:
Caps—240

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=42c49deb-713b-427a-9670-08af08adcffb 

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