Alecinix Capsule:
Each capsule contains Alectinib Hydrochloride INN equivalent to Alectinib 150 mg.
Indication:
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.
Alectinib as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
DOSAGE AND ADMINISTRATION
Patient Selection
Select patients for the treatment of metastatic NSCLC with Alectinib based on the presence of ALK positivity in tumor specimens.
Dosing and Administration
The recommended dose of Alectinib is 600 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 450 mg orally twice daily.
Alectinib should be taken with food. Do not open or dissolve the contents of the capsule. If a dose of Alectinib is missed or vomiting occurs after taking a dose of Alectinib, take the next dose at the scheduled time.
How does it work:
Alectinib 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.
Alectinib and M4 demonstrated in vitro and in vivo activity against multiple mutant forms of the ALK enzyme, including some mutations identified in NSCLC tumors in patients who have progressed on Crizotinib.
In mouse models implanted with tumors carrying ALK fusions, administration of Alectinib resulted in antitumor activity and prolonged survival, including in mouse models implanted intracranially with ALK-driven tumor cell lines.
Side effect:
WARNINGS 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 Alectinib in patients diagnosed with ILD/pneumonitis and permanently discontinue if no other potential causes of ILD/pneumonitis have been identified.
- Renal Impairment: Withhold Alectinib 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 Alectinib 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.
CONTRAINDICATIONS
None
ADVERSE REACTIONS
The following adverse reactions are discussed 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 Alectinib requiring dosage adjustment have been identified.
Storage Conditions
Store at below 300C and dry place, away from light and moisture. Keep out of the reach of children.
Presentation & Packaging
Alecinix Capsule: Each commercial box contains 120 Capsules in a HDPE bottle.