Alecinix (Alectinib) 150 MG – 60 Capsules

Description

Alecinix (Alectinib) is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to Crizotinib.

Alecinix Capsule: Each capsule contains Alectinib Hydrochloride INN equivalent to Alectinib 150 mg

Product Features:

Dosing and Administration

The recommended dose of Alecinix is 150 mg orally twice daily. Administer Alectinib until disease progression or unacceptable toxicity. The recommended dose of Alectiib in patients with severe hepatic impairment (Child-Pugh C) is 150 mg orally twice daily. Alecinix should be taken with food. Do not open or dissolve the contents of the capsule. If a dose of Alecinix is missed or vomiting occurs after taking a dose of Alecinix , take the next dose at the scheduled time.

How does it work

Alecinix is a tyrosine kinase inhibitor that targets ALK and RET. In nonclinical studies, Alectinib inhibited ALK phosphorylation and ALK-mediated activation of the downstream signaling proteins STAT3 and AKT, and decreased tumor cell viability in multiple cell lines harboring ALK fusions, amplifications, or activating mutations. The major active metabolite of Alectinib , M4, showed similar in vitro potency and activity.

Warning and Precautions

• Hepatotoxicity: Monitor liver laboratory tests every 2 weeks during the first 3 months of treatment, then once a month and as clinically indicated, with more frequent testing in patients who develop transaminase and bilirubin elevations. In case of severe ALT, AST, or bilirubin elevations, withhold, then reduce dose, or permanently discontinue Alectinib.
• Interstitial Lung Disease (ILD)/Pneumonitis: Immediately withhold Alecinix in patients diagnosed with ILD/pneumonitis and permanently discontinue if no other potential causes of ILD/pneumonitis have been identified.
• Renal Impairment: Withhold Alecinix for severe renal impairment, then resume Alectinib at reduced dose upon recovery or permanently discontinue.
• Bradycardia: Monitor heart rate and blood pressure regularly. If symptomatic, withhold Alecinix then reduce dose, or permanently discontinue.
• Severe Myalgia and Creatine Phosphokinase (CPK) Elevation: Assess CPK every 2 weeks during the first month of treatment and in patients reporting unexplained muscle pain, tenderness, or weakness. In case of severe CPK elevations, withhold, then resume or reduce dose.
• Embryo-Fetal Toxicity: Alectinib can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

Adverse reaction

The following adverse reactions discuss in greater detail in other sections of the label:

• Hepatotoxicity
• Interstitial Lung Disease (ILD)/Pneumonitis
• Renal Impairment
• Bradycardia
• Severe Myalgia and Creatine Phosphokinase (CPK) Elevation
• Embryo-Fetal Toxicity

Drug Interactions

No pharmacokinetic interactions with Alecinix requiring dosage adjustment have identified.

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