Alectinib: uses, dosing, side effects & brands
Alectinib is a kinase inhibitor sold in the U.S. under one brand, for non-small-cell lung carcinoma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Kinase Inhibitor
- Treats
- Non-Small-Cell Lung Carcinoma
- Available as
- Capsule
- Sold as
- Alecensa
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How alectinib is dosed
From the FDA label for Alecensa (application NDA208434). Other alectinib products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
600 mg orally twice daily. Administer ALECENSA with food. ( 2.2 ) 2.1 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 [see Indications and Usage (1.1) and Clinical Studies (14.1) ]. Select patients for the treatment of metastatic NSCLC with ALECENSA based on the presence of ALK positivity in tumor tissue or plasma specimens [see Indications and Usage (1.2) and Clinical Studies (14.2) ] . 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. 2.2 Dosing and Administration The recommended dosage information for ALECENSA is provided in Table 1 . Table 1: ALECENSA Recommended Dosage and Duration of Treatment Indication Recommended Dosage of ALECENSA Duration Adjuvant treatment of resected NSCLC 600 mg orally twice daily with food [see Clinical Pharmacology (12.3) ] For a total of 2 years or until disease recurrence or unacceptable toxicity Metastatic NSCLC Until disease progression or unacceptable toxicity Swallow capsules whole, do not open or dissolve the contents of the capsule. If a dose of ALECENSA is missed or vomiting occurs after taking a dose of ALECENSA, take the next dose at the…
Alectinib side effects
The following adverse reactions are discussed in greater detail in other sections of the label: Hepatotoxicity [see Warnings and Precautions (5.1) ] Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions (5.2) ] Renal Impairment [see Warnings and Precautions (5.3) ] Bradycardia [see Warnings and Precautions (5.4) ] Severe Myalgia and Creatine Phosphokinase (CPK) Elevation [see Warnings and Precautions (5.5) ] Hemolytic Anemia [see Warnings and Precautions (5.6) ] Embryo-Fetal Toxicity [see Warnings and Precautions (5.7) ] The most common adverse reactions (incidence ≥20%) were hepatotoxicity, constipation, fatigue, myalgia, edema, rash and cough. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical 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 reflects exposure to ALECENSA as a single agent at 600 mg orally twice daily in 533 patients in Studies NP28761, NP28673, ALEX and ALINA [see Clinical Studies (14) ]. Among 533 patients who received ALECENSA, 75% were exposed…
Who shouldn’t take alectinib
None. None. ( 4 )
Every alectinib product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Alecensa.
What alectinib pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| ALE;150;mg | 150 mg | white | capsule | — |
Alectinib and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for alectinib: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo information is available on the clinical use of alectinib during breastfeeding. Because alectinib is more than 99% bound to plasma proteins, the amount in milk is low. However, its half-life is about 33 hours and it might accumulate in the infant. The manufacturer recommends that breastfeeding be discontinued during alectinib therapy and for 1 week after the last dose.
National Institute of Child Health and Human Development, record revised July 15, 2023. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about alectinib
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 39 reports naming alectinib, and the FDA flagged 97% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- anaphylactoid reaction3 reports
- bradycardia3 reports
- malignant neoplasm progression3 reports
- oedema peripheral3 reports
- alanine aminotransferase increased2 reports
- anaemia2 reports
- aspartate aminotransferase increased2 reports
- blood bilirubin increased2 reports
Read these as a signal, not a rate. A report does not mean alectinib caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is alectinib?
Alecensa (Alectinib Hydrochloride) is a kinase inhibitor used to treat Non-Small-Cell Lung Carcinoma.
What kind of drug is alectinib?
The FDA classifies alectinib as a kinase inhibitor. Kinase inhibitors block protein kinases, the enzymes that relay 'grow and divide' signals inside cells. By shutting down the overactive kinase signals that a tumor depends on, they help slow or stop cancer cells from multiplying. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take alectinib with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run alectinib against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does alectinib come in?
Across the brands we track, alectinib is currently marketed as capsule, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic alectinib?
We do not currently list a generic-labelled alectinib product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Alectinib: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/alectinib
- MLA
- “Alectinib: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/alectinib.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for alectinib on DailyMed (NIH) ↗.