NDC 50242-0130-01 — ALECENSA ALECTINIB HYDROCHLORIDE 150 mg

🆔 Identity & classification

FDA NDC (as labeled) 50242-130-01

Product NDC 50242-130

11-digit billing NDC 50242013001

NCPDP billing unit EA — each (per item)

RxCUI 1727479, 1727485

UNII P9YY73LO6J

Application # NDA208434

SPL Set ID 42c49deb-713b-427a-9670-08af08adcffb

Established class (EPC) Kinase Inhibitor

Mechanism of action Kinase Inhibitors

DEA schedule Non-controlled

Marketing category NDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2015-12-11

Route ORAL

Dosage form CAPSULE

Substance ALECTINIB HYDROCHLORIDE

GCN Seq No 075271

GCN 40299

HICL code 042895

Ingredient (HICL) Alectinib Hcl

HIC1 code V

Therapeutic class — broad (HIC1) Neoplasms

HIC2 code V1

Therapeutic class — intermediate (HIC2) Antineoplastic Drugs

HIC3 code V1Q

Therapeutic class — specific (HIC3) Antineoplastic Systemic Enzyme Inhibitors

AHFS code 10:00.00.00

AHFS class Antineoplastic Agents

FDB label name ALECENSA 150 MG CAPSULE

FDB brand name Alecensa

Legend status F — Federal legend — prescription drug or device

Why two NDCs? The FDA registers this code as 50242-130-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 50242-0130-01. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Kinase Inhibitor class.

Pharmacologic class Kinase Inhibitor

Drug family (ATC) Anaplastic lymphoma kinase (ALK) inhibitors

How it works Kinase Inhibitors

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerGenentech, Inc.

Application holderHOFFMANN-LA ROCHE INC

FDA applicationNDA208434 (NDA)

Labeler code50242

First marketedDec 2015

Product typeHuman Prescription Drug

Portfolio93 products on file

🔎 All NDCs from Genentech, Inc.

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name ALECENSA 150 MG CAPSULE Ingredient Alectinib Hcl

📖 What it is MedlinePlus · NLM

Alectinib is used to treat a certain type of non-small-cell lung cancer (NSCLC) that has spread to other parts of the body. Alectinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

It matters a lot, actually. Taking Alecensa with food — especially a meal with some fat in it — dramatically increases how much of the drug your body absorbs. Without food, you abs...
Why does it matter that I take Alecensa with food?
Mild constipation, muscle aches, fatigue, and some swelling are common and usually manageable — let your care team know, but these aren't emergencies. You should call your doctor r...
What side effects should I just watch for versus ones that mean I need to call my doctor right away?

📖 Read our full Alectinib guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Alectinib Hydrochloride — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Alectinib Hydrochloride (74 interactions) — ranked by severity →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color white

ShapeCapsule

ImprintALE;150;mg

Size19 mm

ScoringNot scored

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII UTY7PDF93L
A plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
UNII R12CBM0EIZ
A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
UNII 5C69YCD2YJ
Carrageenan is a natural thickener and stabilizer extracted from red seaweed. It's used in medicines to create gel-like textures, improve consistency, and help keep ingredients from separating during storage.
UNII L06K8R7DQK
A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
UNII 4PC054V79P
A fatty acid derived from glycerin and oleic acid (a natural oil component). It acts as an emulsifier to help mix oil and water-based ingredients, and serves as a lubricant and surfactant in the formulation.
UNII RFW2ET671P
Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII 660YQ98I10
Potassium chloride is a mineral salt used in medicines as a buffer and to help maintain the proper pH balance and stability of the formulation during storage and use.
UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

16 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	$80.20	$19,247.38 / 240 capsules
Medicare drug plans payPart D · Q2 2026	$81.82	$19,636.25 / 240 capsules

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Alecensa 150 mgthis 50242-0130-01	Genentech,	240 capsules	—	—	FDA listed	—

About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2015

First FDA approval

Dec 2015

📍

2026

Currently FDA-listed

11 years listed

🛡️

2035

Latest patent/protection listed

not a guaranteed launch date

🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Apr 2035. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.

📅 FDA approved Dec 11, 2015 RLD RS ⏳ ~8.6 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book

US 10350214 — drug product

US 11433076 — drug product

US 9126931 — drug substance

US 9440922 — drug product

US 9365514 — drug product

Exclusivity I-947

Exclusivity ODE-477

2015 2017 2019 2021 2023 2025 2027 2029 2031 2033 2035

Today

LOE

Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo

🏛️FDA exclusivity

FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.

🧪Product / substance patents

Patents covering the active ingredient, product, formulation, or related drug features.

🎯Method-of-use patents

Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.

🛈 What do these terms mean?

Patent: Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent: Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent: Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent: A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label: A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity: FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV: A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS: Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating: FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity): The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (5)

Patent	Type	Use code	Expires
US 10350214 ↗	Drug product	—	Apr 24, 2035
US 11433076 ↗	Drug product	—	Apr 24, 2035
US 9126931 ↗	Drug substance	—	May 29, 2031
US 9440922 ↗	Drug product	—	Jun 9, 2030
US 9365514 ↗	Drug product	—	Mar 4, 2032

FDA exclusivity

Code	What it grants	Expires
I-947	New indication (3-year)	Apr 18, 2027
ODE-477	Orphan Drug Exclusivity (7-year)	Apr 18, 2031

Common questions

Is there a generic version of ALECENSA 150 MG CAPSULE?

No FDA-approved generic equivalent is currently listed in the FDA Orange Book for ALECENSA 150 MG CAPSULE. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Apr 2035 — an estimate, not a guaranteed launch date.

The FDA approved a generic — why can’t I get it at my pharmacy yet?

FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.

Why do different websites show different generic release dates?

Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.

What does “FDA listed” mean?

It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.

What does a patent or protection date mean here?

It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).

What does “current Orange Book estimate” mean?

It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.

Can a generic come out before the last patent expires?

Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.

Can a generic come out after the listed dates?

Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.

What is the difference between patents and exclusivity?

Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.

Why are there multiple patent dates?

One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.

Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 50242-0130-01, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

1.9K

Units reimbursed last 4 qtrs

443.4K

Gross reimbursed last 4 qtrs

$35.56M

Avg / prescription

$18,280.98

Avg / unit

$80.1974

Latest quarter Q4 2025

454Rx

Fee-for-service vs managed care ⓘ

53% FFS 47% MCO

Fee-for-service · 1,028 Rx Managed care · 917 Rx

State Medicaid map

Units reimbursed · per 100k residents

20.7637

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 Maine 637 /100k

2 Hawaii 631 /100k

3 Oregon 615 /100k

4 California 330 /100k

5 New York 288 /100k

6 Massachusetts 270 /100k

7 Nevada 263 /100k

8 Michigan 262 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

240 capsules this page50242-0130-01 1,945 Rx · $35,556,498

240 capsules50242-0130-86 No Medicaid data

Drug total (last 4 qtrs): 1,945 Rx · 443,362 units · $35,556,498 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Alecensa — the program that covers self-administered drugs. 1 manufacturer.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Alecensa. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$104.09M

Claims incl. refills

5.6K

Beneficiaries

2.3K

Spend / beneficiary

$45,434.60

Spend / claim

$18,475.45

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for ALECENSA (this brand).

Top reported reactions

Death705

Fatigue518

Constipation445

Rash257

Dyspnoea234

Disease Progression210

Myalgia209

Age at onset

Child13

Adolescent9

Adult1,245

Elderly1,042

Reporter sex

Male · 40%

Female · 60%

Serious outcomes

Hospitalization1,280

Life-threatening70

Disabling49

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
50242-0130-01 You're viewing this	1 BOTTLE, PLASTIC in 1 CARTON (50242-130-01) / 240 CAPSULE in 1 BOTTLE, PLASTIC	2015-12-11	Active
50242-0130-86	1 BOTTLE, PLASTIC in 1 CARTON (50242-130-86) / 240 CAPSULE in 1 BOTTLE, PLASTIC	2017-10-10	Active

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 50242-0130-01?

NDC 50242-0130-01 is a 240-count package — 1 bottle, plastic in 1 carton / 240 capsule in 1 bottle, plastic.

What is the difference between NDC 50242-0130-01 and NDC 50242-0130-86?

Both are ALECENSA ALECTINIB HYDROCHLORIDE 150 mg Capsule — the drug itself is identical. NDC 50242-0130-01 is the 240-count package, while NDC 50242-0130-86 is the 240 capsules package.

What NDC number is used to bill for this package of ALECENSA ALECTINIB HYDROCHLORIDE 150 mg Capsule?

Bill NDC 50242-0130-01 — the 11-digit billing format is 50242013001. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	✓ Available

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 50242-130-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 50242-0130-01, written without dashes as 50242013001. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 50242-0130-01, the first segment (50242) is the labeler code FDA assigned to Genentech, Inc.; the middle segment (0130) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Genentech, Inc.. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 1 other package presentation of this same product, including 240 capsules (50242-0130-86). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

Genentech, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage 146 words ▾

1 INDICATIONS AND USAGE 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. ( 1.1 ) treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test. ( 1.2 )

1.1Adjuvant Treatment of Resected ALK-Positive Non-Small Cell Lung Cancer (NSCLC) ALECENSA is indicated as 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 [see Dosage & Administration (2.1) ].

1.2Treatment of Metastatic ALK-Positive NSCLC ALECENSA is indicated for the treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test [see Dosage & Administration (2.1) ] .

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION 600 mg orally twice daily. Administer ALECENSA with food. ( 2.2 )

2.1Patient 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.

2.2Dosing 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.

2.3Recommended 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) ].

2.4Dose 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 .

Table 3: ALECENSA Dose Modifications for Adverse Reactions Criteria ALT = alanine transaminase; AST = aspartate transaminase; ULN = upper limit of normal; ILD = interstitial lung disease; CPK = blood creatine phosphokinase ALECENSA Dose Modification ALT or AST elevation of greater than 5 times upper limit of normal (ULN) with total bilirubin less than or equal to 2 times ULN Temporarily withhold until recovery to baseline or to less than or equal to 3 times ULN, then resume at reduced dose as per Table 2 . ALT or AST elevation greater than 3 times ULN with total bilirubin elevation greater than 2 times ULN in the absence of cholestasis or hemolysis Permanently discontinue ALECENSA.

Total bilirubin elevation of greater than 3 times ULN Temporarily withhold until recovery to baseline or to less than or equal to 1.5 times ULN, then resume at reduced dose as per Table 2 . Any grade treatment-related interstitial lung disease (ILD)/pneumonitis Permanently discontinue ALECENSA. Grade 3 renal impairment Temporarily withhold until serum creatinine recovers to less than or equal to 1.5 times ULN, then resume at reduced dose.

Grade 4 renal impairment Permanently discontinue ALECENSA. Symptomatic bradycardia Withhold ALECENSA until recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above. If contributing concomitant medication is identified and discontinued, or its dose is adjusted, resume ALECENSA at previous dose upon recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above.

If no contributing concomitant medication is identified, or if contributing concomitant medications are not discontinued or dose modified, resume ALECENSA at reduced dose (see Table 2 ) upon recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above. Bra…

💊 Dosage Forms and Strengths 35 words ▾

3 DOSAGE 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. Capsules: 150 mg ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 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 ALECENSA. ( 2.4 , 5.1 ) 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.

( 2.4 , 5.2 ) Renal Impairment: Withhold ALECENSA for severe renal impairment, then resume ALECENSA at reduced dose upon recovery or permanently discontinue. ( 2.4 , 5.3 ) Bradycardia: Monitor heart rate and blood pressure regularly. If symptomatic, withhold ALECENSA then reduce dose, or permanently discontinue.

( 2.4 , 5.4 ) 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. ( 2.4 , 5.5 ) Hemolytic Anemia: If hemolytic anemia is suspected, withhold ALECENSA.

If hemolytic anemia is confirmed, consider resuming at a reduced dose upon resolution or permanently discontinue. ( 5.6 ) Severe Hypertriglyceridemia Leading to Pancreatitis: Monitor serum triglycerides before initiation and periodically during treatment. In patients with hypertriglyceridemia, monitor for signs and symptoms of acute pancreatitis.

Withhold or permanently discontinue ALECENSA based on severity. ( 2.4 , 5.7 ) Embryo-Fetal Toxicity: ALECENSA can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

( 5.8 , 8.1 , 8.3 )

5.1Hepatotoxicity Severe hepatotoxicity, including drug-induced liver injury, occurred in patients treated with ALECENSA. In the pooled safety population [see Adverse Reactions (6.1) ] of patients who received ALECENSA, hepatotoxicity occurred in 41% of patients and the incidence of Grade ≥ 3 hepatotoxicity was 8%. In the ALINA study, hepatotoxicity occurred in 61% of patients treated with ALECENSA and the incidence of Grade ≥ 3 hepatotoxicity was 4.7%.

The majority (72% of 136 patients) of elevated transaminases occurred during the first 3 months of treatment. Treatment discontinuation due to hepatotoxicity occurred in 3.6% of patients who received ALECENSA in the pooled safety population and 1.6% of patients treated in the ALINA study. In the pooled safety population, concurrent elevations in ALT or AST greater than or equal to 3 times the ULN and total bilirubin greater than or equal to 2 times the ULN, with normal alkaline phosphatase, occurred in less than 1% of patients treated with ALECENSA.

Three patients with Grades 3–4 AST/ALT elevations had drug-induced liver injury (documented by liver biopsy in two cases). Monitor liver function tests including ALT, AST, and total bilirubin 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. Based on the severity of the adverse drug reaction, withhold ALECENSA and resume at a reduced dose or permanently discontinue ALECENSA as described in Table 3 [see Dosage and Administration (2.4) ].

5.2Interstitial Lung Disease (ILD)/Pneumonitis ILD/pneumonitis occurred in patients treated with ALECENSA. In the pooled safety population [see Adverse Reactions (6.1) ] , ILD/pneumonitis occurred in 1.3% of patients treated with ALECENSA with 0.4% of patients experiencing Grade 3 ILD/pneumonitis. Five patients (0.9%) in the pooled safety population discontinued ALECENSA due to ILD/pneumonitis.

The median time-to-onset of Grade 3 or higher ILD/pneumonitis was 2.1 months (range: 0.6 months to…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS 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) ] Hypertriglyceridemia Leading to Pancreatitis [see Warnings and Precautions (5.7) ] Embryo-Fetal Toxicity [see Warnings and Precautions (5.8) ] 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 .

6.1Clinical 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 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 for 6 months or longer and 64% were exposed for greater than one year. In this pooled safety population, the most common (≥ 20%) adverse reactions were hepatotoxicity (41%), constipation (39%), fatigue (36%), myalgia (31%), edema (29%), rash (23%) and cough (21%). The most common (≥ 2%) Grade 3 or 4 laboratory abnormalities were increased CPK (6%), decreased hemoglobin (4.4%), increased ALT (4.2%), increased bilirubin (4.0%) and increased AST (3.4%).

Adjuvant Treatment of Resected ALK-Positive NSCLC The safety of ALECENSA was evaluated in ALINA, a multi-center, open-label, randomized trial for the adjuvant treatment of patients with resected ALK-positive NSCLC [ see Clinical Studies (14.1) ]. At the time of DFS analysis, the median duration of exposure was 23.9 months for ALECENSA and 2.1 months for platinum-based chemotherapy. Serious adverse reactions occurred in 13% of patients treated with ALECENSA; the most frequent serious adverse reactions (≥ 1%) were pneumonia (3.9%), appendicitis (3.1%), and acute myocardial infarction (1.6%).

Permanent discontinuation of ALECENSA due to an adverse event occurred in 5% of patients; the most frequent adverse reactions (≥ 1%) that led to treatment discontinuation were pneumonitis and hepatotoxicity. Dosage interruptions of ALECENSA due to an adverse reaction occurred in 27% of patients. Adverse reactions which required dosage interruption in ≥ 2% of patients included hepatotoxicity, increased blood CPK, COVID-19, myalgia, abdominal pain, and pneumonia.

Dose reductions of ALECENSA due to an adverse reaction occurred in 26% of patients. Adverse reactions which required dose reductions in ≥ 2% of patients included hepatotoxicity, increased blood CPK, rash, bradycardia and myalgia. Table 4 and 5 summarize the common adverse reactions and laboratory abnormalities observed in ALINA.

Table 4: Adverse Reactions (≥ 10%) in Patients Treated with ALECENSA in ALINA Adverse Reaction ALECENSA N=128 Chemotherapy N=120 All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%) Based on NCI CTCAE v5.0 Hepatobiliary System Disorders Hepatotoxicity Includes increased alanine aminotransferase, increased aspartate aminotransferase, increased bile acids, increased conjugated bilirubin, increased blood bilirubin, increased unconjugated blood bilirubin, increased gamma-glutamyltransferase, hepatotoxicity, hyperbilirubinemia, increased liver function test, ocular icterus and increased transaminases.

61

4.7All events are Grade 3. 13 0 G…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Do not breastfeed. ( 8.2 )

8.1Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action, ALECENSA can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on ALECENSA use in pregnant women. Administration of alectinib to pregnant rats and rabbits by oral gavage during the period of organogenesis resulted in embryo-fetal toxicity and abortion at maternally toxic doses with exposures approximately 2.7-fold those observed in humans treated with alectinib at 600 mg twice daily (see Data ) .

Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In a preliminary rabbit embryo-fetal study, administration of alectinib by oral gavage during the period of organogenesis resulted in abortion or complete embryo-fetal mortality at a maternally toxic dose of 27 mg/kg/day (approximately 2.9-fold the estimated area under the curve (AUC 0-24h,ss ) in humans treated with alectinib 600 mg twice daily) in three of six pregnant rabbits.

The remaining three pregnant rabbits in this group had few live fetuses, decreased fetal and placental weights, and retroesophageal subclavian artery. In a rat preliminary embryo-fetal development study, administration of alectinib during organogenesis resulted in complete litter loss in all pregnant rats at 27 mg/kg/day (approximately 4.5-fold the estimated AUC 0-24h,ss in humans treated with alectinib 600 mg twice daily). Doses greater than or equal to 9 mg/kg/day (approximately 2.7-fold the estimated human AUC 0-24h,ss in humans treated with alectinib 600 mg twice daily), resulted in maternal toxicity as well as developmental toxicities including decreased fetal weight, dilated ureter, thymic cord, small ventricle and thin ventricle wall, and reduced number of sacral and caudal vertebrae.

8.2Lactation Risk Summary There are no data on the presence of alectinib or its metabolites in human milk, the effects of alectinib on the breastfed child, or its effects on milk production. Because of the potential for serious adverse reactions in breastfed children from alectinib, advise a lactating woman not to breastfeed during treatment with ALECENSA and for 1 week after the last dose.

8.3Females and Males of Reproductive Potential ALECENSA can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] . Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating ALECENSA [see Use in Specific Populations (8.1) ]. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with ALECENSA and for 5 weeks after the last dose [see Use in Specific Populations (8.1) ] .

Males Based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with ALECENSA and for 3 months following the last dose [see Nonclinical Toxicology (13.1) ].

8.4Pediatric Use The safety and effectiveness of ALECENSA in pediatric patients have not been established. Animal Data Juvenile animal studies have not been conducted using alectinib. In general toxicology studies, treatment of rats with doses of alectinib resulting in exposures greater than or equal to approximately 4.5-fold those in humans treated with alectinib at 600 mg twice daily resulted in changes in the growing teeth and bones.

Findings in teeth included discoloration and changes in tooth size along with histopathological disarrangement of the ameloblast and odontoblast layers. There were also decreases in the trabecular bone and increased osteoclast activity in the femur and sternum.

8.5 Geriatric Use Nineteen percent of the 533 patients studied in NP28761, NP…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action, ALECENSA can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on ALECENSA use in pregnant women. Administration of alectinib to pregnant rats and rabbits by oral gavage during the period of organogenesis resulted in embryo-fetal toxicity and abortion at maternally toxic doses with exposures approximately 2.7-fold those observed in humans treated with alectinib at 600 mg twice daily (see Data ) .

Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In a preliminary rabbit embryo-fetal study, administration of alectinib by oral gavage during the period of organogenesis resulted in abortion or complete embryo-fetal mortality at a maternally toxic dose of 27 mg/kg/day (approximately 2.9-fold the estimated area under the curve (AUC 0-24h,ss ) in humans treated with alectinib 600 mg twice daily) in three of six pregnant rabbits.

The remaining three pregnant rabbits in this group had few live fetuses, decreased fetal and placental weights, and retroesophageal subclavian artery. In a rat preliminary embryo-fetal development study, administration of alectinib during organogenesis resulted in complete litter loss in all pregnant rats at 27 mg/kg/day (approximately 4.5-fold the estimated AUC 0-24h,ss in humans treated with alectinib 600 mg twice daily). Doses greater than or equal to 9 mg/kg/day (approximately 2.7-fold the estimated human AUC 0-24h,ss in humans treated with alectinib 600 mg twice daily), resulted in maternal toxicity as well as developmental toxicities including decreased fetal weight, dilated ureter, thymic cord, small ventricle and thin ventricle wall, and reduced number of sacral and caudal vertebrae.

🧒 Pediatric Use 105 words ▾

8.4Pediatric Use The safety and effectiveness of ALECENSA in pediatric patients have not been established. Animal Data Juvenile animal studies have not been conducted using alectinib. In general toxicology studies, treatment of rats with doses of alectinib resulting in exposures greater than or equal to approximately 4.5-fold those in humans treated with alectinib at 600 mg twice daily resulted in changes in the growing teeth and bones.

Findings in teeth included discoloration and changes in tooth size along with histopathological disarrangement of the ameloblast and odontoblast layers. There were also decreases in the trabecular bone and increased osteoclast activity in the femur and sternum.

🧓 Geriatric Use 85 words ▾

8.5Geriatric Use Nineteen percent of the 533 patients studied in NP28761, NP28673, ALEX and ALINA were 65 years of age and older (3.2% were 75 years of age and older). No overall differences in effectiveness were observed based on age. Exploratory analysis suggests a higher incidence of serious adverse events (38% vs 25%), more frequent adverse events leading to treatment discontinuations (18% vs 6%) and dose modifications (48% vs 35%) in patients 65 years or older as compared to those younger than 65 years.

🆘 Overdosage 43 words ▾

10 OVERDOSAGE 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.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action 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.

12.2Pharmacodynamics Cardiac Electrophysiology The ability of alectinib to prolong the QT interval was assessed in 221 patients administered ALECENSA 600 mg twice daily in clinical studies. ALECENSA did not prolong the QTc (QT corrected for heart rate) interval to any clinically relevant extent. One patient had a maximum post-baseline QTcF value of greater than 500 msec, and one patient had a maximum QTcF change from baseline of greater than 60 msec.

12.3Pharmacokinetics The pharmacokinetics of alectinib and its major active metabolite M4 have been characterized in patients with ALK-positive NSCLC and healthy subjects. In patients with ALK-positive NSCLC, the geometric mean (coefficient of variation %) steady-state maximal concentration (C max,ss ) for alectinib was 665 ng/mL (44%) and for M4 was 246 ng/mL (45%) with peak to trough concentration ratio of 1.2. The geometric mean steady-state area under the curve from 0 to 12 hours (AUC 0-12h,ss ) for alectinib was 7,430 ng*h/mL (46%) and for M4 was 2,810 ng*h/mL (46%).

Alectinib exposure is dose proportional across the dose range of 460 mg to 900 mg (i.e., 0.75 to 1.5 times the approved recommended dosage) under fed conditions. Alectinib and M4 reached steady-state concentrations by day 7. The geometric mean accumulation was approximately 6-fold for both alectinib and M4.

Absorption Alectinib reached maximal concentrations at 4 hours following administration of ALECENSA 600 mg twice daily under fed conditions in patients with ALK-positive NSCLC. The absolute bioavailability of alectinib was 37% (90% CI: 34%, 40%) under fed conditions. A high-fat, high-calorie meal increased the combined exposure (AUC 0-inf ) of alectinib plus M4 by 3.1-fold (90% CI: 2.7, 3.6) following oral administration of a single 600 mg dose of ALECENSA.

Distribution The apparent volume of distribution is 4,016 L for alectinib and 10,093 L for M4. Alectinib and M4 are bound to human plasma proteins greater than 99%, independent of drug concentration. Alectinib concentrations in the cerebrospinal fluid in patients with ALK-positive NSCLC approximate estimated alectinib free concentrations in the plasma.

In vitro studies suggest that alectinib is not a substrate of P-glycoprotein (P-gp), but M4 is a substrate of P-gp. Alectinib and M4 are not substrates of breast cancer resistance protein (BCRP), organic anion-transporting polypeptide (OATP) 1B1, or OATP1B3. Elimination The apparent clearance (CL/F) is

81.9L/hour for alectinib and 217 L/hour for M4. The geometric mean elimination half-life is 33 hours for alectinib and 31 hours for M4 in patients with ALK-positive NSCLC. Metabolism Alectinib is metabolized by CYP3A4 to its major active metabolite M4.

The geometric mean metabolite/parent exposure ratio at steady-state is 0.40. M4 is subsequently metabolized by CYP3A4. Alectinib and M4 were the main circulating moieties in plasma, constituting 76% of the total radioactivity.

Excretion Ninety-eight percent of the radioactivity was excreted in feces following oral administration of a single radiolabeled dose of alect…

🧬 Mechanism of Action 125 words ▾

12.1Mechanism of Action 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.

📦 How Supplied / Storage and Handling 58 words ▾

16 HOW 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: 240 capsules per bottle: NDC 50242-130-01 Storage and stability: Do not store above 30°C (86°F). Store in the original container to protect from light and moisture.

📦 Storage and Handling 20 words ▾

Storage and stability: Do not store above 30°C (86°F). Store in the original container to protect from light and moisture.

📋 Description 158 words ▾

11 DESCRIPTION ALECENSA (alectinib) is a kinase inhibitor for oral administration. The molecular formula for alectinib is C 30 H 34 N 4 O 2 ∙ HCl. The molecular weight is 482.62 g/mol (free base form) and 519.08 g/mol (hydrochloride salt).

Alectinib is described chemically as 9-ethyl-6, 6-dimethyl-8-[4-(morpholin-4-yl)piperidin-1-yl]-11-oxo-6, 11-dihydro-5 H -benzo[ b ]carbazole-3-carbonitrile hydrochloride. The chemical structure of alectinib is shown below: 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: carboxymethylcellulose calcium, hydroxypropylcellulose, lactose monohydrate, magnesium stearate and sodium lauryl sulfate.

The capsule shell contains carnauba wax, carrageenan, corn starch, hypromellose, potassium chloride and titanium dioxide (E171). The printing ink contains carnauba wax, FD&C Blue No. 2 aluminum lake (E132), glyceryl monooleate, red iron oxide (E172), white shellac and yellow iron oxide (E172).

Chemical Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Inform patients of the following: Hepatotoxicity Inform patients of the signs and symptoms of bilirubin and hepatic transaminase elevations. Advise patients to contact their healthcare provider immediately for signs or symptoms of bilirubin and hepatic transaminase elevations [see Warnings and Precautions (5.1) ].

Interstitial Lung Disease (ILD)/Pneumonitis Inform patients of the risks of severe ILD/pneumonitis. Advise patients to contact their healthcare provider immediately to report new or worsening respiratory symptoms [see Warnings and Precautions (5.2) ]. Renal Impairment Inform patients of the risk of severe and potentially fatal renal impairment.

Advise patients to contact their healthcare provider immediately for change in urine color, reduced urine output, or new or worsening swelling in the legs and feet [see Warnings and Precautions (5.3) ] . Bradycardia Inform patients that symptoms of bradycardia including dizziness, lightheadedness, and syncope can occur while taking ALECENSA. Advise patients to contact their healthcare provider immediately to report these symptoms and to inform their healthcare provider about the use of any heart or blood pressure medications [see Warnings and Precautions (5.4) ] .

Severe Myalgia/CPK Elevation Inform patients of signs and symptoms of myalgia, including unexplained and/or persistent muscle pain, tenderness, or weakness. Advise patients to contact their healthcare provider immediately to report new or worsening symptoms of muscle pain or weakness [see Warnings and Precautions (5.5) ] . Hemolytic Anemia Advise patients to contact their healthcare provider immediately if they develop any signs or symptoms of hemolytic anemia [see Warnings and Precautions (5.6) ].

Severe Hypertriglyceridemia Leading to Pancreatitis Inform patients that ALECENSA can cause an increase in serum triglyceride levels, which can lead to pancreatitis. Advise patients that their treatment may be temporarily stopped based on their test results. Advise patients to contact their healthcare provider immediately if they develop signs and symptoms of pancreatitis, such as abdominal pain accompanied by nausea, vomiting, and/or fever [see Warnings and Precautions (5.7) ].

Photosensitivity Inform patients of the signs and symptoms of photosensitivity. Advise patients to avoid prolonged sun exposure while taking ALECENSA and for at least 7 days after study drug discontinuation and to use proper protection from the sun. Advise patients to use a broad spectrum ultraviolet A (UVA)/ultraviolet B (UVB) sunscreen and lip balm (SPF ≥ 50) to help protect against potential sunburn [see Adverse Reactions (6.1) ] .

Embryo-Fetal Toxicity ALECENSA can cause fetal harm if taken during pregnancy. Advise a pregnant woman and females of reproductive potential of the potential risk to a fetus [see Warnings and Precautions (5.6) and Use in Specific Populations (8.1 , 8.3) ] . Advise females of reproductive potential to use effective contraception during treatment with ALECENSA and for 5 weeks after the last dose of ALECENSA.

Advise patients to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.6) and Use in Specific Populations (8.1 , 8.3) ] . Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ALECENSA and for 3 months after the last dose [see Use in Specific Populations (8.3) and Nonclinical Toxicology (13.1) ]. Lactation Advise women not to breastfeed during treatment with ALECENSA and for 1 week after the last dose [see Use in Specific Populations (8.2) ].

Administration Instruct patients to take ALECENSA twice a day. Advise patients to take ALECENSA with food and to swallow ALECENSA capsules whole [see Dosage and Administration (2.2) ]. Missed Dose Advise patients that if a dose of ALECENSA is missed…

Glossary — plain-language definitions of medical terms used in this label:

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

in vivo: In a living person or animal rather than in a laboratory dish.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

active metabolite: A substance made when the body breaks down a medicine that still has an effect of its own.

adjuvant: Extra treatment given after the main treatment to lower the chance that the cancer comes back.

adverse event: Any unwanted medical problem that happens during treatment, whether or not the medicine actually caused it.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

alkaline phosphatase: An enzyme measured in a blood test; higher levels can point to problems with the liver, bile ducts, or bones.

ALT: A liver enzyme (alanine aminotransferase) checked by a blood test; raised levels can signal that the liver is irritated or damaged.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

antidote: A treatment that reverses or counteracts the effects of a specific medicine or poison.

AST: A liver enzyme (aspartate aminotransferase) measured in a blood test; higher levels may point to liver or sometimes muscle injury.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

BCRP: A protein pump that moves certain drugs out of cells, affecting how much of the drug is absorbed.

bilirubin: A yellow substance the liver normally clears from the blood; high levels can turn the skin or the whites of the eyes yellow.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

Child-Pugh: A scoring system doctors use to grade how severe long-term liver disease is, often to help set the right medicine dose.

cholestasis: A slowing of bile flow out of the liver; bile is the fluid that helps digest fat, and this backup can cause itching and yellow skin.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

contraception: Methods used to prevent pregnancy, such as birth control pills, condoms, or an intrauterine device.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

CYP3A4: One of the most important liver and gut enzymes, responsible for breaking down a large share of all medicines.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dose reduction: Lowering the amount of a medicine, often to ease side effects or fit a person's needs.

edema: Swelling caused by extra fluid trapped in the body's tissues.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

embryo-fetal toxicity: Harm to a developing baby in the womb, such as birth defects, slowed growth, or loss of the pregnancy.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hemoglobin: The iron-containing protein inside red blood cells that carries oxygen throughout the body.

hemolysis: The breaking apart of red blood cells, which can lower the number of cells available to carry oxygen.

hemolytic anemia: A shortage of red blood cells caused by them breaking apart faster than the body can replace them.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

hepatotoxicity: Damage to the liver caused by a medicine or other substance.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hyperbilirubinemia: A higher-than-normal level of bilirubin in the blood, which can cause yellowing of the skin or eyes.

hypertriglyceridemia: A higher-than-normal level of triglycerides, a type of fat, in the blood.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

interstitial lung disease: A group of conditions in which the tissue around the lungs' air sacs becomes scarred or inflamed, making breathing harder.

lactation: The making and release of milk from a mother's breasts after giving birth.

liver function tests: Blood tests that check how well the liver is working and whether it is irritated or damaged.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

metabolite: A new substance formed when the body breaks a medicine down.

myalgia: Muscle pain or aching.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

Nonclinical Toxicology: The label section summarizing safety findings from laboratory and animal studies, rather than from studies in people.

OATP: A group of transporter proteins that carry certain drugs into cells, especially in the liver.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

P-glycoprotein: A tiny pump in cells that pushes certain medicines back out, affecting how much of a medicine is absorbed or stays in the body.

P-gp: A protein pump in cells that pushes certain drugs back out, limiting how much is absorbed or reaches tissues.

pancreatitis: Painful swelling of the pancreas, an organ behind the stomach that helps digest food and control blood sugar.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

photosensitivity: An unusually strong skin reaction, such as burning or rash, after being in sunlight or other ultraviolet light.

pneumonitis: Inflammation of the lung tissue that is not caused by an infection and can lead to cough and breathlessness.

potency: How much of a medicine is needed to produce a given effect; a more potent medicine works at a smaller dose.

QTc: A number from a heart tracing (ECG) that measures the heart's electrical recovery time, adjusted for the heart rate.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

reproductive potential: The ability to have children, meaning a person who could become pregnant or could father a child.

serum creatinine: A waste product measured in a blood test; higher levels can mean the kidneys are not filtering as well as normal.

substrate: A drug or other substance that a particular enzyme or transporter acts on.

syncope: The medical term for fainting, a brief loss of consciousness from a temporary drop in blood flow to the brain.

transaminases: Liver enzymes measured in a blood test; higher-than-normal levels can be a sign that the liver is irritated or damaged.

trough: The lowest level a medicine reaches in the blood, just before the next dose is due.

ULN: The highest value considered normal for a lab test; results above it are flagged as elevated.

upper limit of normal: The highest value considered normal for a lab test; results above it are flagged as elevated.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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ALECENSA ALECTINIB HYDROCHLORIDE 150 mg Capsule, 240-count

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8.5 Geriatric Use Nineteen percent of the 533 patients studied in NP28761, NP…

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