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LAZCLUZE lazertinib 80 mg Tablet, Film Coated, 90-count — NDC 57894-0080-90 package photo

LAZCLUZE lazertinib 80 mg Tablet, Film Coated, 90-count

by Janssen Biotech, Inc. · 1 BOTTLE in 1 CARTON (57894-080-90) / 90 TABLET, FILM COATED in 1 BOTTLE
NDC 57894-0080-90
🏷️ FDA NDC (as labeled) 57894-080-90 billing pads the product segment with a zero
This package
Contains90-count Pack sizes2 compare ↓
Also priced by: Part D plans $316.78/unit — full pricing hub ↓
Also comes in: 60 tablets 57894-0080-60
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 57894-080-90
Product NDC 57894-080
11-digit billing NDC 57894008090
RxCUI 2691156, 2691162, 2691164, 2691166
UNII 4A2Y23XK11
Application # NDA219008
SPL Set ID c417f9ee-2027-4ed5-92ad-3c19266de16c
Established class (EPC) Kinase Inhibitor
Mechanism of action Kinase Inhibitors; Cytochrome P450 3A4 Inhibitors; Breast Cancer Resistance Protein Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-08-20
Route ORAL
Dosage form TABLET, FILM COATED
Substance LAZERTINIB
GPI-14 21360048300320
GCN Seq No 086442
GCN 56157
HICL code 049822
Ingredient (HICL) Lazertinib Mesylate
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 LAZCLUZE 80 MG TABLET
FDB brand name Lazcluze
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 57894-080-90 — 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 → 57894-0080-90. 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) Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors
How it works Kinase Inhibitors, Cytochrome P450 3A4 Inhibitors, Breast Cancer Resistance Protein 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

LabelerJanssen Biotech, Inc.
Application holderJANSSEN BIOTECH INC
FDA applicationNDA219008 (NDA)
Labeler code57894
First marketedAug 2024
Product typeHuman Prescription Drug
Portfolio36 products on file
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 LAZCLUZE 80 MG TABLET Ingredient Lazertinib Mesylate
📖 What it is MedlinePlus · NLM

Lazertinib is used in to treat certain types of non-small cell lung cancer (NSCLC). Lazertinib 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 stop the spread of cancer cells.

Read the full MedlinePlus article ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 purple / yellow
ShapeOval
ImprintLZ;80
Size14 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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • 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 G7515SW10N
    A waxy liquid derived from vegetable oil and fatty acids. It works as an emulsifier and solubilizer to help blend oil and water-based ingredients together and improve how the medicine dissolves and is absorbed in the body.
  • 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 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • 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.

11 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 systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $316.78 $28,510.47 / 90 tablets
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lazcluze 80 mgthis 57894-0080-90 Janssen 90 tablets — — 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

🏛️
2024
First FDA approval
Aug 2024
📍
2026
Currently FDA-listed
2 years listed
🛡️
2041
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 Aug 2041. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Aug 19, 2024 RLD RS ⏳ ~14.9 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 9593098 — drug substance (U-3985)
US 9593098 — drug substance (U-3985)
US 11981659 — method of use (U-3985)
US 11981659 — method of use (U-3985)
US 11850248 — method of use (U-3985)
US 11850248 — method of use (U-3985)
US 11879013 — method of use (U-3985)
US 11879013 — method of use (U-3985)
US 12599606 — method of use (U-4511)
US 12599606 — method of use (U-4512)
US 11453656 — drug substance
US 12138351 — drug product
US 12318390 — drug product
US 11453656 — drug substance
US 12318390 — drug product
US 12138351 — drug product
Exclusivity NCE
Exclusivity NCE
2024 2026 2028 2030 2032 2034 2036 2038 2040
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 (16)
PatentTypeUse codeExpires
US 9593098 ↗ Drug substance U-3985 Oct 13, 2035
US 9593098 ↗ Drug substance U-3985 Oct 13, 2035
US 11981659 ↗ Method of use U-3985 Apr 18, 2038
US 11981659 ↗ Method of use U-3985 Apr 18, 2038
US 11850248 ↗ Method of use U-3985 Aug 1, 2041
US 11850248 ↗ Method of use U-3985 Aug 1, 2041
US 11879013 ↗ Method of use U-3985 May 21, 2040
US 11879013 ↗ Method of use U-3985 May 21, 2040
US 12599606 ↗ Method of use U-4511 May 14, 2040
US 12599606 ↗ Method of use U-4512 May 14, 2040
US 11453656 ↗ Drug substance — Apr 18, 2038
US 12138351 ↗ Drug product — Apr 13, 2041
US 12318390 ↗ Drug product — Apr 18, 2038
US 11453656 ↗ Drug substance — Apr 18, 2038
US 12318390 ↗ Drug product — Apr 18, 2038
US 12138351 ↗ Drug product — Apr 13, 2041
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Aug 19, 2029
NCENew Chemical Entity (5-year)Aug 19, 2029
Common questions
Is there a generic version of LAZCLUZE 80 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for LAZCLUZE 80 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Aug 2041 — 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.

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

Medicare Part D (outpatient prescription) spending for Lazcluze — 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 Lazcluze. 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
$21.75M
Claims incl. refills
1.2K
Beneficiaries
578
Spend / beneficiary
$37,636.56
Spend / claim
$17,459.01
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 LAZCLUZE (this brand).

Top reported reactions

Rash134
Infusion Related Reaction81
Paronychia45
Neuropathy Peripheral42
Fatigue39
Diarrhoea35
Nausea28

Reporter sex

706 reports

Serious outcomes

Death32
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 330 12
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 NDCDescription Marketing startStatus
57894-0080-60 1 BOTTLE in 1 CARTON (57894-080-60) / 60 TABLET, FILM COATED in 1 BOTTLE 2024-08-20 Active
57894-0080-90 You're viewing this 1 BOTTLE in 1 CARTON (57894-080-90) / 90 TABLET, FILM COATED in 1 BOTTLE 2024-08-20 Active

Pack size FAQ

What quantity is in NDC 57894-0080-90?
NDC 57894-0080-90 is a 90-count package — 1 bottle in 1 carton / 90 tablet, film coated in 1 bottle.
What is the difference between NDC 57894-0080-90 and NDC 57894-0080-60?
Both are LAZCLUZE lazertinib 80 mg Tablet, Film Coated — the drug itself is identical. NDC 57894-0080-90 is the 90-count package, while NDC 57894-0080-60 is the 60 tablets package.
What NDC number is used to bill for this package of LAZCLUZE lazertinib 80 mg Tablet, Film Coated?
Bill NDC 57894-0080-90 — the 11-digit billing format is 57894008090. 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) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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 57894-080-90, 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: 57894-0080-90, written without dashes as 57894008090. 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 57894-0080-90, the first segment (57894) is the labeler code FDA assigned to Janssen Biotech, Inc.; the middle segment (0080) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (90) 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 Janssen Biotech, 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 60 tablets (57894-0080-60). 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?
Janssen Biotech, 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 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 107 words ▾

1 INDICATIONS AND USAGE LAZCLUZE, in combination with amivantamab, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test [see Dosage and Administration (2.1) ] . LAZCLUZE is a kinase inhibitor indicated in combination with amivantamab for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage of LAZCLUZE is 240 mg orally once daily with or without food, given in combination with amivantamab. ( 2.2 ) Continue treatment until disease progression or unacceptable toxicity. ( 2.2 ) Administer LAZCLUZE any time prior to amivantamab when given on the same day.

( 2.2 ) Refer to the amivantamab prescribing information for recommended amivantamab dosing information. ( 2.2 ) Administer prophylactic and concomitant medications to reduce the risk of dermatologic adverse reactions. ( 2.3 ) Administer anticoagulant prophylaxis to reduce the risk of venous thromboembolic events (VTE) for the first four months of treatment.

( 2.3 )

2.1Patient Selection Select patients for the first-line treatment of NSCLC with LAZCLUZE, in combination with amivantamab, based on the presence of EGFR exon 19 deletions or exon 21 L858R substitution mutations in tumor or plasma specimens [see Clinical Studies (14) ] . If these mutations are not detected in a plasma specimen, test tumor tissue. Information on FDA-approved tests is available at: http://www.fda.gov/CompanionDiagnostics .

2.2Recommended Dosage and Administration Recommended Dosage and Administration The recommended dosage of LAZCLUZE is 240 mg orally once daily administered in combination with amivantamab, with or without food. Swallow LAZCLUZE tablets whole. Do not crush, split, or chew.

Continue treatment until disease progression or unacceptable toxicity. Administer LAZCLUZE any time prior to amivantamab when given on the same day. Refer to the amivantamab prescribing information for recommended amivantamab dosing information.

Missed Dose If a patient misses a dose of LAZCLUZE within 12 hours, instruct patients to take the missed dose. If more than 12 hours has passed since the dose was to be given, instruct the patient to take the next dose at its scheduled time. Vomiting If vomiting occurs any time after taking LAZCLUZE, instruct the patient to take the next dose at its next regularly scheduled time.

2.3Prophylactic and Concomitant Medications Venous Thromboembolic Events When initiating treatment with LAZCLUZE in combination with amivantamab, administer anticoagulant prophylaxis to reduce the risk of venous thromboembolic events (VTE) for the first four months of treatment [see Warnings and Precautions (5.1) ]. If there are no signs or symptoms of VTE during the first four months of treatment, consider discontinuation of anticoagulant prophylaxis at the discretion of the healthcare provider. Dermatologic Adverse Reactions When initiating treatment with LAZCLUZE in combination with amivantamab, prophylactic and concomitant medications are recommended to reduce the risk and severity of dermatologic adverse reactions [see Warnings and Precautions (5.3) ] .

Administer an oral antibiotic (doxycycline or minocycline, 100 mg orally twice daily) starting on Day 1 for the first 12 weeks of treatment. After completion of oral antibiotic treatment, administer antibiotic lotion to the scalp (clindamycin 1% topical once daily) for the next 9 months of treatment. Administer non-comedogenic skin moisturizer (ceramide-based or other formulations that provide long-lasting skin hydration and exclude drying agents) on the face and whole body (except scalp).

Wash hands and feet with 4% chlorhexidine solution once daily. Limit sun exposure during and for 2 months after treatment. Advise patients to wear protective clothing and use broad-spectrum UVA/UVB sunscreen to reduce the risk of dermatologic adverse reactions.

2.4Dosage Modifications for Adverse Reactions The recommended LAZCLUZE dose reductions for adverse reactions are presented in Table 1. Table 1: Recommended Dose Reductions for Adverse Reactions for LAZCLUZE Dose at which the adverse reaction occurred 1 st Dose Reduction 2 nd Dose Reduction 3 rd Dose Reduction 240 mg once daily (one 240 mg tablet) 160 mg once daily (two 80 mg tablets) 80 mg once daily (one 80 mg tablet) Discontinue LAZCLUZ…

💊 Dosage Forms and Strengths 69 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets : 80 mg and 240 mg. ( 3 ) Tablets 80 mg tablets: yellow, oval film-coated tablet, debossed with "LZ" on one side and "80" on the other side. Each tablet contains 80 mg of lazertinib. 240 mg tablets: reddish purple, oval film-coated tablet, debossed with "LZ" on one side and "240" on the other side. Each tablet contains 240 mg of lazertinib.

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Venous Thromboembolic Events (VTE) : Prophylactic anticoagulation is recommended for the first four months of treatment. Monitor for signs and symptoms of VTE and treat as medically appropriate. Withhold LAZCLUZE and amivantamab based on severity.

Once anticoagulant treatment has been initiated, resume LAZCLUZE and amivantamab at the same dose at the discretion of the healthcare provider. Permanently discontinue amivantamab and continue LAZCLUZE for recurrent VTE despite therapeutic anticoagulation. ( 2.3 , 2.4 , 5.1 ) Interstitial Lung Disease (ILD)/Pneumonitis : Monitor for new or worsening symptoms indicative of ILD/pneumonitis.

Withhold LAZCLUZE and amivantamab in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed. ( 2.4 , 5.2 ) Dermatologic Adverse Reactions : Can cause severe rash including acneiform dermatitis. At treatment initiation, prophylactic and concomitant medications are recommended.

Withhold, reduce the dose or permanently discontinue LAZCLUZE and amivantamab based on severity. ( 2.3 , 2.4 , 5.3 ) Hepatotoxicity : Can cause severe hepatotoxicity (including increased ALT and AST). Withhold, reduce the dose, or permanently discontinue LAZCLUZE and amivantamab based on severity.

( 2.4 , 5.4 ) Ocular Adverse Reactions : Promptly refer patients with new or worsening signs and symptoms of ocular adverse reactions, including keratitis, to an ophthalmologist for evaluation. Withhold, reduce the dose, or permanently discontinue amivantamab and continue LAZCLUZE based on severity. ( 5.5 ) Embryo-Fetal Toxicity : Can cause fetal harm.

Advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 5.6 , 8.1 , 8.3 )

5.1Venous Thromboembolic Events LAZCLUZE in combination with amivantamab can cause serious and fatal venous thromboembolic events (VTE), including deep venous thrombosis (DVT) and pulmonary embolism (PE). The majority of these events occurred during the first four months of therapy [see Adverse Reactions (6.1) ] . In MARIPOSA [see Adverse Reactions (6.1) ] , VTE occurred in 36% of patients receiving LAZCLUZE in combination with amivantamab, including Grade 3 in 10% and Grade 4 in 0.5% of patients.

On-study VTEs occurred in 1.2% of patients (n=5) while receiving anticoagulation therapy. There were two fatal cases of VTE (0.5%), 7% of patients had VTE leading to dose interruptions of LAZCLUZE, 0.5% of patients had VTE leading to dose reductions of LAZCLUZE, and 1.9% of patients permanently discontinued LAZCLUZE due to VTE. The median time to onset of VTEs was 84 days (range: 6 to 777).

Administer prophylactic anticoagulation for the first four months of treatment [see Dosage and Administration (2.3) ] . The use of Vitamin K antagonists is not recommended. Monitor for signs and symptoms of VTE and treat as medically appropriate.

Withhold LAZCLUZE and amivantamab based on severity [see Dosage and Administration (2.4) ]. Once anticoagulant treatment has been initiated, resume LAZCLUZE and amivantamab at the same dose level at the discretion of the healthcare provider. In the event of VTE recurrence despite therapeutic anticoagulation, permanently discontinue amivantamab.

Continue treatment with LAZCLUZE at the same dose level at the discretion of the healthcare provider [see Dosage and Administration (2.4) ] . Refer to the amivantamab prescribing information for recommended amivantamab dosage modification.

5.2Interstitial Lung Disease (ILD)/Pneumonitis LAZCLUZE in combination with amivantamab can cause interstitial lung disease (ILD)/pneumonitis. In MARIPOSA [see Adverse Reactions (6.1) ], ILD/pneumonitis occurred in 3.1% of patients treated with LAZCLUZE in combination with amivantamab, including Grade 3 in 1.0% and Grade 4 in 0.2% of patients. There was one fatal case (0.2%) of ILD/pneumonitis and 2.9% of patients permanently discontinued LAZCLUZE and amivantamab due to ILD/pneumonitis [s…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere in the labeling: Venous Thromboembolic Events [see Warnings and Precautions (5.1) ] Interstitial Lung Disease/Pneumonitis [see Warnings and Precautions (5.2) ] Dermatologic Adverse Reactions [see Warnings and Precautions (5.3) ] Hepatotoxicity [see Warnings and Precautions (5.4) ] Ocular Toxicity [see Warnings and Precautions (5.5) ] LAZCLUZE in Combination with Amivantamab The most common adverse reactions (≥ 20%) were rash, nail toxicity, infusion-related reaction (amivantamab), musculoskeletal pain, edema, stomatitis, VTE, paresthesia, fatigue, diarrhea, constipation, COVID-19, hemorrhage, dry skin, decreased appetite, pruritus, and nausea.

( 6.1 ) The most common Grade 3 or 4 laboratory abnormalities (≥ 2%) were decreased albumin, decreased sodium, increased ALT, decreased potassium, decreased hemoglobin, increased AST, increased GGT, and increased magnesium. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-526-7736 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 data described in WARNINGS AND PRECAUTIONS and below reflect exposure to LAZCLUZE in combination with amivantamab in 421 previously untreated patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R substitution mutations in MARIPOSA [see Clinical Studies (14) ] .

Patients received LAZCLUZE 240 mg orally once daily in combination with amivantamab intravenously at 1,050 mg (for patients < 80 kg) or 1,400 mg (for patients ≥ 80 kg) once weekly for 4 weeks, then every 2 weeks thereafter starting at week 5. Among the 421 patients who received LAZCLUZE in combination with amivantamab, 84% were exposed to LAZCLUZE for ≥ 6 months and 73% were exposed to LAZCLUZE for > 1 year. The median age of patients who received LAZCLUZE in combination with amivantamab was 64 years (25 to 88); 64% were female; 59% were Asian, 38% were White, 1.7% were American Indian or Alaska Native, 0.7% were Black or African American, 1% were of unknown or other races; 13% were Hispanic or Latino; 67% had Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 1, 33% had ECOG PS of 0; 60% had EGFR exon 19 deletions, and 40% had EGFR exon 21 L858R substitution mutations.

Serious adverse reactions occurred in 49% of patients who received LAZCLUZE in combination with amivantamab. Serious adverse reactions occurring in ≥ 2% of patients included VTE (11%), pneumonia (4%), rash and ILD/pneumonitis (2.9% each), COVID-19 (2.4%), and pleural effusion and infusion-related reaction (amivantamab) (2.1% each). Fatal adverse reactions occurred in 7% of patients who received LAZCLUZE in combination with amivantamab due to death not otherwise specified (1.2%); sepsis and respiratory failure (1% each); pneumonia, myocardial infarction, and sudden death (0.7% each); cerebral infarction, pulmonary embolism (PE), and COVID-19 infection (0.5% each); and ILD/pneumonitis, acute respiratory distress syndrome (ARDS), and cardiopulmonary arrest (0.2% each).

Permanent discontinuation of LAZCLUZE due to an adverse reaction occurred in 21% of patients. Adverse reactions which resulted in permanent discontinuation of LAZCLUZE in ≥ 1% of patients included ILD/pneumonitis, pneumonia, VTE, rash, respiratory failure, and sudden death. Dosage interruption of LAZCLUZE due to an adverse reaction occurred in 72% of patients.

Adverse reactions which required dosage interruption in ≥ 5% of patients were rash, nail toxicity, COVID-19, VTE, increased ALT, and increased AST. Dose reductions of LAZCLUZE due to an adverse reaction occurred in 42% of patients. Adverse reacti…

🔄 Drug Interactions 212 words ▾

7 DRUG INTERACTIONS Strong and moderate CYP3A4 inducers: Avoid concomitant use. ( 7.1 )

7.1Effect of Other Drugs on LAZCLUZE CYP3A4 Inducers Avoid concomitant use of LAZCLUZE with strong and moderate CYP3A4 inducers. Consider an alternate concomitant medication with no potential to induce CYP3A4. Lazertinib is a CYP3A4 substrate. Concomitant use with a strong or moderate CYP3A4 inducer decreased lazertinib concentrations [see Clinical Pharmacology (12.3) ] , which may reduce the efficacy of lazertinib.

7.2Effect of LAZCLUZE on Other Drugs Certain CYP3A4 Substrates Monitor for adverse reactions associated with a CYP3A4 substrate where minimal concentration changes may lead to serious adverse reactions, as recommended in the approved product labeling for the CYP3A4 substrate. Lazertinib is a weak CYP3A4 inhibitor. Concomitant use of LAZCLUZE increased concentrations of CYP3A4 substrates [see Clinical Pharmacology (12.3) ] , which may increase the risk of adverse reactions related to these substrates.

Certain BCRP Substrates Monitor for adverse reactions associated with a BCRP substrate where minimal concentration changes may lead to serious adverse reactions, as recommended in the approved product labeling for the BCRP substrate. Lazertinib is a BCRP inhibitor. Concomitant use of LAZCLUZE increased concentrations of BCRP substrates [see Clinical Pharmacology (12.3) ], which may increase the risk of adverse reactions related to these substrates.

👥 Use in Specific Populations ~3 min read ▾

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

8.1Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1) ] , LAZCLUZE can cause fetal harm when administered to a pregnant woman. There are no available data on the use of LAZCLUZE in pregnant women to inform a drug-associated risk. Oral administration of lazertinib to pregnant animals during the period of organogenesis resulted in reduced embryo-fetal survival and fetal body weight in rats and malformations in rabbits at exposures approximately 4 and 0.5 times, respectively, the human exposure at the recommended dose of 240 mg/day based on AUC (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 an embryo-fetal development study, pregnant rats received oral doses of 7.5, 30, or 60 mg/kg/day of lazertinib during the period of organogenesis (gestation day 6 to 17).

Lazertinib decreased fetal body weights in association with maternal toxicity at 60 mg/kg/day (approximately 4 times the human exposure at the recommended dose of 240 mg/day based on AUC). In a dose range-finding embryo-fetal development study, oral administration of a higher dose of lazertinib (75 mg/kg/day) to pregnant rats during the period of organogenesis resulted in increased post-implantation loss. In an embryo-fetal development study in rabbits, pregnant animals received oral doses of 5, 25, or 45 mg/kg/day of lazertinib during the period of organogenesis (gestation day 7 to 19).

Lazertinib caused maternal toxicity (reduced body weight and food consumption leading to moribund condition and early termination) and an increase in the incidence of skeletal malformations in the vertebra and skull (fused maxillary process/zygomatic arch) at 45 mg/kg/day (approximately 0.5 times the human exposure at the recommended dose of 240 mg/day based on AUC).

8.2Lactation Risk Summary There are no data on the presence of lazertinib or its metabolites in human milk or their effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with LAZCLUZE and for 3 weeks after the last dose. Refer to the amivantamab prescribing information for lactation information during treatment with amivantamab.

8.3Females and Males of Reproductive Potential Based on animal data and its mechanism of action, LAZCLUZE can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] . Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating LAZCLUZE. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with LAZCLUZE and for 3 weeks after the last dose.

Refer to the amivantamab prescribing information for recommended duration of contraception during treatment with amivantamab. Males Advise male patients with female partners of reproductive potential to use effective contraception during treatment with LAZCLUZE and for 3 weeks after the last dose. Infertility Based on findings in animals, LAZCLUZE may impair fertility in females and males of reproductive potential.

The effects on female fertility were reversible. The effects on male testes in animal studies were not reversible within a 2-week recovery period [see Nonclinical Toxicology (13.1) ].

8.4Pediatric Use The safety and effectiveness of LAZCLUZE in pediatric patients have not been established.

8.5Geriatric Use Of the 421 patients with locally advanced or metastatic NSCLC treated with LAZCLUZE in combination with amivantamab in MARIPOSA, 45% were 65 years and older and 12% were 75 years and older. No overall differences in safety or e…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1) ] , LAZCLUZE can cause fetal harm when administered to a pregnant woman. There are no available data on the use of LAZCLUZE in pregnant women to inform a drug-associated risk. Oral administration of lazertinib to pregnant animals during the period of organogenesis resulted in reduced embryo-fetal survival and fetal body weight in rats and malformations in rabbits at exposures approximately 4 and 0.5 times, respectively, the human exposure at the recommended dose of 240 mg/day based on AUC (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 an embryo-fetal development study, pregnant rats received oral doses of 7.5, 30, or 60 mg/kg/day of lazertinib during the period of organogenesis (gestation day 6 to 17).

Lazertinib decreased fetal body weights in association with maternal toxicity at 60 mg/kg/day (approximately 4 times the human exposure at the recommended dose of 240 mg/day based on AUC). In a dose range-finding embryo-fetal development study, oral administration of a higher dose of lazertinib (75 mg/kg/day) to pregnant rats during the period of organogenesis resulted in increased post-implantation loss. In an embryo-fetal development study in rabbits, pregnant animals received oral doses of 5, 25, or 45 mg/kg/day of lazertinib during the period of organogenesis (gestation day 7 to 19).

Lazertinib caused maternal toxicity (reduced body weight and food consumption leading to moribund condition and early termination) and an increase in the incidence of skeletal malformations in the vertebra and skull (fused maxillary process/zygomatic arch) at 45 mg/kg/day (approximately 0.5 times the human exposure at the recommended dose of 240 mg/day based on AUC).

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and effectiveness of LAZCLUZE in pediatric patients have not been established.

🧓 Geriatric Use 53 words ▾

8.5Geriatric Use Of the 421 patients with locally advanced or metastatic NSCLC treated with LAZCLUZE in combination with amivantamab in MARIPOSA, 45% were 65 years and older and 12% were 75 years and older. No overall differences in safety or effectiveness were observed between patients aged 65 and older and younger patients.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Lazertinib is a kinase inhibitor of epidermal growth factor receptor (EGFR) that inhibits EGFR exon 19 deletions and exon 21 L858R substitution mutations at lower concentrations than wild-type EGFR. In human NSCLC cells and mouse xenograft models of EGFR exon 19 deletions or EGFR L858R substitution mutations, lazertinib demonstrated anti-tumor activity. Treatment with lazertinib in combination with amivantamab increased in vivo anti-tumor activity compared to either agent alone in a mouse xenograft model of human NSCLC with an EGFR L858R mutation.

12.2Pharmacodynamics The exposure-response relationship and time-course of pharmacodynamic response of lazertinib have not been fully characterized. Cardiac Electrophysiology At a dose of 320 mg (1.3 times the approved recommended dosage) once daily, a mean increase in the QTc interval > 20 ms is unlikely.

12.3Pharmacokinetics Lazertinib pharmacokinetics are presented as mean (CV%) for descriptive parameters unless otherwise specified. Lazertinib maximum plasma concentration (C max ) and area under plasma concentration time curve (AUC) increased dose proportionally from 20 mg to 320 mg (0.08 to 1.3 times the approved recommended dosage) following a single administration and once daily administration. Lazertinib steady state plasma exposure was achieved by day 15 with approximately 2-fold accumulation for AUC.

Absorption The median time to reach C max is from 2 to 4 hours. Effect of Food A high-fat meal (800 to 1000 kcal, approximately 50% fat) did not have a clinically significant effect on lazertinib pharmacokinetics compared to that under fasted conditions. Distribution The mean apparent volume of distribution is 2680 L (51%).

Lazertinib is approximately 99.2% bound to human plasma proteins. Elimination The mean terminal half-life is 3.7 days (56%). The mean apparent clearance is

36.4L/h (47%). Metabolism Lazertinib is primarily metabolized by glutathione conjugation, either enzymatic via glutathione-S-transferase (GST) or non-enzymatic, as well as by CYP3A4. Excretion Following a single oral dose of radiolabeled lazertinib, approximately 86% of the dose was recovered in feces (< 5% as unchanged) and 4% in urine (< 0.2% as unchanged).

Specific Populations No clinically significant differences in pharmacokinetics of lazertinib were observed based on age (21 to 88 years), sex, body weight (28 to 122 kg), race (White, Asian, Black or African American), ethnicity (Hispanic/Latino or not Hispanic/Latino), baseline laboratory assessments (creatinine clearance, albumin, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase), mild or moderate renal impairment (eGFR 30 to 89 mL/min, estimated by CKD-EPI equation), mild [total bilirubin ≤ ULN and AST > ULN or total bilirubin ≤ 1.5 times ULN and any AST] or moderate [total bilirubin ≤ 1.5 to 3×ULN and any AST] hepatic impairment, ECOG performance status, EGFR mutation type, initial diagnosis cancer stage, prior therapies, brain metastasis, and history of smoking.

The effect of severe renal impairment (eGFR 15 to 29 mL/min), end-stage renal disease (eGFR < 15 mL/min) or severe hepatic impairment (total bilirubin > 3 times ULN with any AST) on the pharmacokinetics of lazertinib has not been studied. GSTM1 Genotype Patients with at least one GSTM1 normal function allele have 44% lower systemic levels of lazertinib compared with those with the two GSTM1 no-function alleles (i.e., no enzyme activity). No clinically significant differences in safety or efficacy were observed as a function of GSTM1 genotype in patients receiving LAZCLUZE in combination with amivantamab.

Drug Interactions Clinical Studies and Model-Informed Approaches Effect of CYP3A4 inducers on lazertinib: Concomitant use of rifampin (strong CYP3A4 inducer) with LAZCLUZE decreased lazertinib C max by 72% and AUC by 83%. Concomitant use of efavirenz (moderate CYP3A4 inducer) with LAZCLUZE is predicted to decre…

🧬 Mechanism of Action 85 words ▾

12.1Mechanism of Action Lazertinib is a kinase inhibitor of epidermal growth factor receptor (EGFR) that inhibits EGFR exon 19 deletions and exon 21 L858R substitution mutations at lower concentrations than wild-type EGFR. In human NSCLC cells and mouse xenograft models of EGFR exon 19 deletions or EGFR L858R substitution mutations, lazertinib demonstrated anti-tumor activity. Treatment with lazertinib in combination with amivantamab increased in vivo anti-tumor activity compared to either agent alone in a mouse xenograft model of human NSCLC with an EGFR L858R mutation.

📦 How Supplied / Storage and Handling 91 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING LAZCLUZE ® (lazertinib) tablets are available in the strengths and packages listed below: Tablet Strength Description Package Configuration NDC Number 80 mg Yellow, oval, film-coated, debossed with "LZ" on one side and "80" on the other side 60-count bottle NDC 57894-080-60 240 mg Reddish purple, oval, film-coated, debossed with "LZ" on one side and "240" on the other side 30-count bottle NDC 57894-240-30 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] .

📦 Storage and Handling 23 words ▾

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] .

📋 Description 175 words ▾

11 DESCRIPTION LAZCLUZE ® tablets contain lazertinib, a kinase inhibitor for oral use. Lazertinib is present as lazertinib mesylate hydrate with a molecular weight of 668.77 and molecular formula of C 30 H 34 N 8 O 3 ∙CH 4 O 3 S∙H 2 O. The chemical name is N -[5-[[4-[4-[(Dimethylamino)methyl]-3-phenyl-1 H -pyrazol-1-yl]pyrimidin-2-yl]amino]-4-methoxy-2-(morpholin-4-yl)phenyl]acrylamide methanesulfonate hydrate (1:1:1).

Lazertinib mesylate hydrate is soluble or practically insoluble in aqueous media, and slightly soluble to freely soluble in organic solvents over a wide range of pH values. The structural formula is: LAZCLUZE (lazertinib) film-coated tablets contain 80 mg or 240 mg of lazertinib, equivalent to 93.86 and 281.58 mg lazertinib mesylate (calculated on anhydrous basis), respectively. The inactive ingredients are croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, and silica hydrophobic colloidal.

The tablet coating consists of glycerol monocaprylocaprate type I, iron oxide black (in 240 mg strength tablets), iron oxide red (in 240 mg strength tablets), iron oxide yellow (in 80 mg strength tablets), macrogol (PEG) polyvinyl alcohol graft copolymer, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Venous Thromboembolic Events Advise patients of the risks of serious and life threatening venous thromboembolic events (VTE), including deep venous thrombosis and pulmonary embolism. Advise patients that prophylactic anticoagulants are recommended to be used for the first four months of treatment.

Advise patients to immediately contact their healthcare provider for signs and symptoms of venous thromboembolism [see Warnings and Precautions (5.1) ] . Interstitial Lung Disease/Pneumonitis Advise patients of the risks of interstitial lung disease (ILD)/pneumonitis. Advise patients to immediately contact their healthcare provider for new or worsening respiratory symptoms [see Warnings and Precautions (5.2) ] .

Dermatologic Adverse Reactions Advise patients of the risk of dermatologic adverse reactions. Advise patients that prophylactic oral antibiotics are recommended starting on Day 1 for the first 12 weeks of treatment and, after completion of oral antibiotic treatment, topical antibiotic lotion to the scalp for the next 9 months of treatment. Advise patients to use non-comedogenic skin moisturizer (ceramide-based or other formulations that provide long-lasting skin hydration and exclude drying components) on the face and whole body (except scalp) and 4% chlorhexidine solution to wash hands and feet, while on treatment.

Advise patients to limit direct sun exposure during and for 2 months after treatment, to wear protective clothing, and to use broad-spectrum UVA/UVB sunscreen to reduce the risk and severity of dermatologic adverse reactions [see Warnings and Precautions (5.3) ]. Hepatotoxicity Advise patients of the risks of hepatotoxicity, and that they will need to undergo liver function tests before and during treatment. Advise patients to immediately contact their healthcare provider if they develop signs or symptoms of hepatotoxicity [see Warnings and Precautions (5.4) ].

Ocular Toxicity Advise patients of the risk of ocular adverse reactions. Advise patients to contact their ophthalmologist if they develop eye symptoms. Advise discontinuation of contact lenses until symptoms are evaluated [see Warnings and Precautions (5.5) ] .

Embryo-Fetal Toxicity Advise females of reproductive potential of the potential risk to a fetus, to use effective contraception during treatment with LAZCLUZE and for 3 weeks after the last dose, and to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.6) , Use in Specific Populations (8.1 , 8.3) ]. Refer to the amivantamab prescribing information for recommended duration of contraception during treatment with amivantamab. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with LAZCLUZE and for 3 weeks after the last dose [see Use in Specific Populations (8.3) ].

Lactation Advise women not to breastfeed during treatment with LAZCLUZE and for 3 weeks after the last dose [see Use in Specific Populations (8.2) ] . Refer to the amivantamab prescribing information for lactation information during treatment with amivantamab. Infertility Advise males and females of reproductive potential of the potential risk for impaired fertility with LAZCLUZE [see Nonclinical Toxicology (13.1) ] .

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 57894-0071-01 · Janssen 57894-0100-60 · Janssen →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.