Alectinib is a kinase inhibitor. It is available as capsules for oral use. MedsAcross supplies Alectinib for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
ALECENSA is a kinase inhibitor indicated for: adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive) as detected by an FDA-approved test. treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
600 mg orally twice daily. Administer ALECENSA with food. Patient Selection Select patients with resectable tumors for the adjuvant treatment of NSCLC with ALECENSA based on the presence of ALK positivity in tumor tissue. Select patients for the treatment of metastatic NSCLC with ALECENSA based on the presence of ALK positivity in tumor tissue or plasma specimens. If ALK rearrangements are not detected in a plasma specimen, test tumor tissue if feasible. Information on FDA-approved tests for the detection of ALK rearrangements in NSCLC is available at http://www.fda.gov/CompanionDiagnostics.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
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 ALECENSA. Interstitial Lung Disease (ILD)/Pneumonitis: Immediately withhold ALECENSA in patients diagnosed with ILD/pneumonitis and permanently discontinue if no other potential causes of ILD/pneumonitis have been identified. Renal Impairment: Withhold ALECENSA for severe renal impairment, then resume ALECENSA at reduced dose upon recovery or permanently discontinue. Bradycardia: Monitor heart rate and blood pressure regularly. If symptomatic, withhold ALECENSA then reduce dose, or permanently discontinue.
Source: US FDA prescribing information
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 Hemolytic Anemia Hypertriglyceridemia Leading to Pancreatitis Embryo-Fetal Toxicity The most common adverse reactions (incidence ≥20%) were hepatotoxicity, constipation, fatigue, myalgia, edema, rash and cough.
Source: US FDA prescribing information
Store in the original container to protect from light and moisture.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Alectinib, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Alecensa 150 mg capsuleOral | Genentech | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Alectinib in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 1 presentations of Alectinib and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Alectinib, including Alecensa.
Yes. The US FDA first approved Alectinib on 11 December 2015, according to Drugs@FDA.
Yes. Alectinib has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Alectinib is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Alectinib is classified under ATC code L01ED03 (Alectinib).
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