Alectinib
Alectinib is a targeted cancer medicine used to treat ALK-positive non-small cell lung cancer, both after surgery and when the cancer has spread (metastatic).
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Alectinib (Alecensa) is a targeted medicine that blocks the faulty ALK gene signal driving ALK-positive non-small cell lung cancer, and, on the market for about a decade, it is a preferred first choice once the cancer has spread and is also given after surgery to lower the chance of return. For a cancer medicine it is usually well tolerated, and constipation, tiredness and muscle aches are what people notice most. Promptly report yellowing skin or eyes, new cough or breathlessness, unexplained muscle pain or severe belly pain, since liver injury, lung inflammation, muscle damage and pancreatitis are its serious risks. Expect regular blood tests and heart rate checks throughout.
Clinical pearls
- Take each dose with a meal and swallow the capsules whole, since food raises absorption about threefold.
- Liver blood tests run every two weeks for the first three months, then monthly, so keep those appointments.
- Heartburn medicines like esomeprazole do not lower its levels, but heart-slowing drugs such as beta blockers can worsen a slow pulse.
- Use effective contraception during treatment and afterward, for five weeks (women) or three months (men with partners who can become pregnant).
Patient information guide A plain-language walkthrough of Alectinib, written from its FDA label.
What Alectinib is used for
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Alectinib treats ALK-positive non-small cell lung cancer (NSCLC), confirmed by an FDA-approved test.
- Alecensa is used after tumor removal in adults with ALK-positive NSCLC when the tumor is 4 cm or larger or node positive.
- Alecensa is used to treat adults with ALK-positive metastatic NSCLC.
How Alectinib works
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Alectinib is a tyrosine kinase inhibitor. It blocks ALK, a protein that drives growth in some lung cancers, and also targets RET. Blocking ALK shuts down signals the tumor cells depend on and lowers their viability.
Lab studies showed activity against several mutant forms of ALK, including some found in patients whose cancer progressed on crizotinib. Alectinib also showed activity in tumors implanted in the brains of mice.
Alectinib dosage
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Alecensa capsules are taken by mouth twice daily with food. Swallow them whole.
- After surgery, treatment is meant to last a total of 2 years unless the cancer returns or side effects are unacceptable.
- For metastatic disease, it continues until the cancer progresses or side effects are unacceptable.
- If you miss a dose or vomit after a dose, take your next dose at the usual time.
- Your doctor may lower the dose or pause treatment if side effects occur. People with severe liver impairment use a lower dose.
Follow your prescriber and the label for your exact dose.
Dosing details from the FDA-approved label
From the Alectinib prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Adjuvant treatment of resected NSCLC
- 600 mg orally twice daily with food
- For a total of 2 years or until disease recurrence or unacceptable toxicity
- Metastatic NSCLC
- 600 mg orally twice daily with food
- Until disease progression or unacceptable toxicity
- Severe hepatic impairment (Child-Pugh C)
- 450 mg orally twice daily
- Hepatic impairment dose
- Dose reduction for adverse reactions: first dose reduction
- 450 mg taken orally twice daily
- Starting dose is 600 mg taken orally twice daily
- Dose reduction for adverse reactions: second dose reduction
- 300 mg taken orally twice daily
- Discontinue if patients are unable to tolerate the 300 mg twice daily dose
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION 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 scheduled time. 2.3 Recommended Dosage for Hepatic Impairment The recommended dose of ALECENSA in patients with severe hepatic impairment (Child-Pugh C) is 450 mg orally twice daily [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3) ]. 2.4 Dose Modifications for Adverse Reactions The dose reduction schedule for ALECENSA is provided in Table 2 . Table 2: ALECENSA Dose Reduction Schedule Dose Reduction Schedule Dose Level Starting dose 600 mg taken orally twice daily First dose reduction 450 mg taken orally twice daily Second dose reduction 300 mg taken orally twice daily Discontinue if patients are unable to tolerate the 300 mg twice daily dose. Recommendations for dose modifications of ALECENSA in case of adverse reactions are provided in Table 3 .
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Alectinib side effects
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The most common side effects in studies were:
Common side effects
- Liver test changes (hepatotoxicity)
- Constipation
- Tiredness (fatigue)
- Muscle pain (myalgia)
- Swelling (edema)
- Rash
- Cough
When to get medical help
- Call your doctor if you have yellowing of the skin or eyes, or other signs of liver problems. Your liver will be checked with blood tests.
- Get help if you have new or worsening breathing problems, cough or fever. These can be signs of lung inflammation (ILD/pneumonitis).
- Report unexplained muscle pain, tenderness or weakness right away.
- Tell your doctor if you feel dizzy, faint, or have a slow heartbeat (bradycardia).
- Report any signs of kidney problems, including changes in kidney blood tests.
- Tell your doctor if you suspect hemolytic anemia (red blood cells breaking down too fast).
- Seek help for severe stomach pain, which may signal pancreatitis, a risk when triglycerides (blood fats) get very high.
Other effects included slow heart rate, vision changes, sun sensitivity and taste changes. Serious reactions include liver injury, lung inflammation, kidney problems, muscle breakdown, hemolytic anemia and pancreatitis. Call your doctor promptly about these.
Alectinib warnings and precautions
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- Liver injury: Severe liver problems occurred, mostly in the first 3 months. Liver blood tests are done every 2 weeks for 3 months, then monthly.
- Lung inflammation (ILD/pneumonitis): Report new cough, fever or shortness of breath. Treatment is stopped permanently if no other cause is found.
- Kidney problems: These occurred, including fatal cases. Treatment may be paused, lowered or stopped.
- Slow heart rate: Heart rate and blood pressure are checked regularly.
- Muscle pain and CPK elevation: CPK (a muscle enzyme) is checked every 2 weeks in the first month.
- Hemolytic anemia: Treatment is paused if suspected.
- High triglycerides and pancreatitis: Triglycerides are checked before and during treatment.
- Pregnancy: It can cause fetal harm.
Alectinib interactions
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Few drug interactions were found in studies, but some points matter.
- Posaconazole (strong CYP3A inhibitor), rifampin (strong CYP3A inducer) and esomeprazole (acid reducer) did not meaningfully change alectinib levels.
- Alectinib is not expected to meaningfully change midazolam or repaglinide levels.
- Other medicines that slow the heart rate or lower blood pressure may need review if you develop a slow heartbeat.
- Food: take with food. A high-fat meal raised alectinib exposure about 3-fold in a study.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Alectinib
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- No contraindications are listed for Alecensa.
- Tell your doctor about any liver, kidney or heart rhythm problems.
- Severe liver impairment requires a lower dose. Mild or moderate liver or kidney impairment does not need a dose change.
- Severe kidney impairment has not been studied.
- Pregnancy can be harmed by this drug. Females who can become pregnant need a pregnancy test first and contraception during treatment and for 5 weeks after.
- Males with partners who can become pregnant should use contraception during treatment and for 3 months after.
- Do not breastfeed during treatment and for 1 week after.
- Not established for children.
- Adults 65 and older had more serious side effects and dose changes.
Alectinib overdose
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There is no experience with overdose and no specific antidote. Dialysis is likely to be ineffective because alectinib is highly bound to proteins in the blood. Seek emergency help or call poison control if you take too much.
What Alectinib does in the body
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In 221 patients, alectinib did not prolong the QTc interval (a heart rhythm measure) to any clinically relevant extent. Slow heart rate can still occur with treatment.
How your body processes Alectinib
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Alectinib peaks about 4 hours after a dose with food. Its absolute bioavailability is 37%, and a high-fat, high-calorie meal raised combined exposure about 3-fold. It is broken down by the liver enzyme CYP3A4 into an active metabolite, M4. Half-life is about 33 hours, and steady levels are reached by day 7. Most of the drug leaves in the stool, with very little in urine.
How to store Alectinib
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Do not store above 30°C (86°F). Store in the original container to protect from light and moisture.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Alectinib
74 supplements and herbal products have documented interactions with Alectinib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 4
- Moderate · 60
- Minor · 10
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Alectinib: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Alectinib — the kind of thing our pharmacy team would talk through with you at the counter.
What is alectinib for?
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How should I take it?
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What side effects should I expect?
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When should I call my doctor right away?
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Can I take this if I might become pregnant or am breastfeeding?
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Does it interact with other medicines?
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Is Alectinib available over the counter?
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When was Alectinib first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Alectinib on HelloPharmacist
Alectinib forms and strengths (how it comes)
Alectinib is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Capsule
How this form is used
- Alecensa is used as adjuvant treatment after tumor resection in adults with ALK-positive NSCLC (tumors 4 cm or larger or node positive).
- Alecensa is used to treat adults with ALK-positive metastatic NSCLC.
- Alecensa is taken by mouth twice daily with food.
- Swallow Alecensa capsules whole. Do not open or dissolve them.
- If you miss an Alecensa dose or vomit after taking it, take the next dose at the scheduled time.
Alectinib on the U.S. market: products, makers and brands
How Alectinib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 1 Alectinib product record with the FDA, mostly as capsule; the earliest marketing or approval year on record is 2013. Brand names on the directory include Alecensa; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (9) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
How widely Alectinib is used (Medicaid data)
A general measure of how commonly Alectinib is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Alectinib is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Alectinib prescribed? Of the 1,601 medications we measure, Alectinib ranks #1,196 by Medicaid prescriptions — more than 25% of them.
Utilization by Alectinib product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
alectinib 150 MG Oral Capsule
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1727479
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Alectinib, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 4 listed Alectinib NDCs with Medicaid activity.
Compare Alectinib products
A representative set of FDA-listed product records for Alectinib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 150 mg | Oral | Genentech, Inc. | NDA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Alectinib NDCs →
Alectinib side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Alectinib — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Alectinib in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Alectinib FDA approval history
How Alectinib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Alectinib recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Alectinib recalls since July 2021.
✅No Alectinib recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1727455 1 dose form · 1 strength
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Dose form (SCDF) Oral Capsule RxCUI 1727478In current FDA listingsClinical drug / strength (SCD) 150 MGRxCUI 1727479
Look up RxCUI 1727455 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Alectinib supply and shortage status
Whether Alectinib is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Alectinib brand names
Alectinib is sold under one brand name in the FDA directory — Alecensa. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Alectinib: manufacturers and labelers
One company lists Alectinib products with the FDA. By number of product records, the largest are Genentech, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Alectinib drug class (RxNorm)
Alectinib belongs to the Kinase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Alectinib page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Genentech, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →