Brand Name

Alecensa

Generic Name
Alectinib
View Brand Information
FDA approval date: December 11, 2015
Classification: Kinase Inhibitor
Form: Capsule

What is Alecensa (Alectinib)?

ALECENSA is a kinase inhibitor indicated for: adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase -positive non-small cell lung cancer as detected by an FDA-approved test.

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Related Latest Advances

Long-term efficacy and safety of lorlatinib versus alectinib in anaplastic lymphoma kinase-positive advanced/metastatic non-small cell lung cancer: matching-adjusted indirect comparison.
Long-term efficacy and safety of lorlatinib versus alectinib in anaplastic lymphoma kinase-positive advanced/metastatic non-small cell lung cancer: matching-adjusted indirect comparison.
Journal: Journal of comparative effectiveness research
Published: December 15, 2025
Author Correction: Alectinib in combination with bevacizumab as first-line treatment in ALK-rearranged non-small cell lung cancer (ALEK-B): a single-arm, phase 2 trial.
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Brand Information

ALECENSA (ALECTINIB HYDROCHLORIDE)
1DOSAGE FORMS AND STRENGTHS
150 mg hard capsules, white, with "ALE" printed in black ink on the cap and "150 mg" printed in black ink on the body.
2CONTRAINDICATIONS
None.
3ADVERSE 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
  • Hemolytic Anemia
  • Embryo-Fetal Toxicity
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The pooled safety population described in the WARNINGS AND PRECAUTIONS reflect exposure to ALECENSA as a single agent at 600 mg orally twice daily in 533 patients in Studies NP28761, NP28673, ALEX and ALINA
4OVERDOSAGE
No experience with overdose is available. There is no specific antidote for overdose with ALECENSA. Alectinib and its major active metabolite M4 are > 99% bound to plasma proteins; therefore, hemodialysis is likely to be ineffective in the treatment of overdose.
5DESCRIPTION
ALECENSA (alectinib) is a kinase inhibitor for oral administration. The molecular formula for alectinib is C
Chemical Structure
Alectinib HCl is a white to yellow white powder or powder with lumps with a pKa of 7.05 (base).
ALECENSA is supplied as hard capsules containing 150 mg of alectinib (equivalent to 161.33 mg alectinib HCl) and the following inactive ingredients: lactose monohydrate, hydroxypropylcellulose, sodium lauryl sulfate, magnesium stearate, and carboxymethylcellulose calcium. The capsule shell contains hypromellose, carrageenan, potassium chloride, titanium dioxide, corn starch, and carnauba wax. The printing ink contains red iron oxide (E172), yellow iron oxide (E172), FD&C Blue No. 2 aluminum lake (E132), carnauba wax, white shellac, and glyceryl monooleate.
6HOW SUPPLIED/STORAGE AND HANDLING
Hard capsules, white 150 mg capsules with "ALE" printed in black ink on the cap and "150 mg" printed in black ink on the body, available in:
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Inform patients of the following:
8PRINCIPAL DISPLAY PANEL - 150 mg Capsule Bottle Carton
NDC 50242-130-01
Alecensa
150 mg
Each capsule contains 150 mg of alectinib
Rx only
240 capsules
Genentech
11008914
PRINCIPAL DISPLAY PANEL - 150 mg Capsule Bottle Carton