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CABOMETYX cabozantinib 40 mg Tablet, 15-count — NDC 42388-0025-37 package photo

CABOMETYX cabozantinib 40 mg Tablet, 15-count

by Exelixis, Inc. · 15 TABLET in 1 BOTTLE (42388-025-37)
NDC 42388-0025-37
🏷️ FDA NDC (as labeled) 42388-025-37 billing pads the product segment with a zero
This package
Contains15-count Pack sizes4 compare ↓
Also priced by: Part D plans $866.35/unit — full pricing hub ↓
Also comes in: 15 tablets 42388-0025-57 30 tablets 42388-0025-26 30 tablets 42388-0025-46
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 10, 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) 42388-025-37
Product NDC 42388-025
11-digit billing NDC 42388002537
RxCUI 1790161, 1790167, 1790169, 1790171, 1790173, 1790175
UNII DR7ST46X58
Application # NDA208692
SPL Set ID 3850cce2-6137-42e5-a792-d318c4a4b3b5
Established class (EPC) Kinase Inhibitor
Mechanism of action Protein Kinase Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-04-25
Route ORAL
Dosage form TABLET
Substance CABOZANTINIB S-MALATE
GPI-14 21533010100330
GPI class Cabometyx
GCN Seq No 075945
GCN 41147
HICL code 039815
Ingredient (HICL) Cabozantinib S-Malate
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 CABOMETYX 40 MG TABLET
FDB brand name Cabometyx
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 42388-025-37 — 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 → 42388-0025-37. 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) Other protein kinase inhibitors
How it works Protein 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

LabelerExelixis, Inc.
Application holderEXELIXIS INC
FDA applicationNDA208692 (NDA)
Labeler code42388
First marketedApr 2016
Product typeHuman Prescription Drug
Portfolio6 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 CABOMETYX 40 MG TABLET Ingredient Cabozantinib S-Malate
📗 Our plain-language guide HelloPharmacist
  • Cabozantinib is a targeted therapy that blocks signals cancer cells use to grow and spread. Depending on which product you have, it's approved for kidney cancer, liver cancer, thyr...
  • What exactly does cabozantinib do, and why was I prescribed it?
  • Yes — this one really matters. Both Cabometyx and Cometriq must be taken without food, because eating (especially a fatty meal) can increase how much the drug gets into your bloods...
  • Does it matter if I eat before taking my dose?
📖 Read our full Cabozantinib guide →
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 yellow
ShapeRound
ImprintXL;20
Size6 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 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • 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 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 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 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 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 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.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

10 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 $866.35 $12,995.30 / 15 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
Cabometyx 40 mgthis 42388-0025-37 Exelixis, 15 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

🏛️
2016
First FDA approval
Apr 2016
📍
2026
Currently FDA-listed
10 years listed
🛡️
2033
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 Jul 2033. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Apr 25, 2016 RLD RS ⏳ ~6.8 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 10039757 — method of use (U-1480)
US 10034873 — method of use (U-2488)
US 10034873 — method of use (U-2488)
US 10039757 — method of use (U-1480)
US 12128039 — method of use (U-1220)
US 12128039 — method of use (U-1220)
US 12128039 — method of use (U-1220)
US 12128039 — method of use (U-1480)
US 12128039 — method of use (U-1480)
US 12128039 — method of use (U-1480)
US 12128039 — method of use (U-2488)
US 12128039 — method of use (U-2488)
US 12128039 — method of use (U-2488)
US 12128039 — method of use (U-3225)
US 12128039 — method of use (U-3225)
US 12128039 — method of use (U-3225)
US 12128039 — method of use (U-4131)
US 12128039 — method of use (U-4156)
US 12128039 — method of use (U-4156)
US 12128039 — method of use (U-4131)
US 12128039 — method of use (U-4156)
US 12128039 — method of use (U-4131)
US 11098015 — method of use (U-4131)
US 11098015 — method of use (U-4156)
US 11098015 — method of use (U-4156)
US 11098015 — method of use (U-4131)
US 11098015 — method of use (U-4156)
US 11098015 — method of use (U-4131)
US 10039757 — method of use (U-1480)
US 10034873 — method of use (U-2488)
US 11098015 — method of use (U-2488)
US 11098015 — method of use (U-1220)
US 11098015 — method of use (U-1480)
US 11098015 — method of use (U-2488)
US 11098015 — method of use (U-1220)
US 11098015 — method of use (U-1480)
US 11098015 — method of use (U-2488)
US 11098015 — method of use (U-1220)
US 11098015 — method of use (U-1480)
US 8877776 — drug substance (U-3225)
US 11098015 — method of use (U-3225)
US 11098015 — method of use (U-3225)
US 8877776 — drug substance (U-3225)
US 8877776 — drug substance (U-3225)
US 11098015 — method of use (U-3225)
US 9724342 — drug product
US 9724342 — drug product
US 7579473 — drug substance
US 11298349 — drug product
US 11091440 — drug product
US 11298349 — drug product
US 11091440 — drug product
US 11091439 — drug substance
US 7579473 — drug substance
US 9724342 — drug product
US 11091440 — drug product
US 11091439 — drug substance
US 7579473 — drug substance
US 11091439 — drug substance
US 11298349 — drug product
Exclusivity ODE-227
Exclusivity ODE-375
Exclusivity ODE-530
Exclusivity ODE-227
Exclusivity ODE-375
Exclusivity ODE-530
Exclusivity ODE-227
Exclusivity ODE-375
Exclusivity ODE-530
2016 2018 2020 2022 2024 2026 2028 2030 2032
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 (60)
PatentTypeUse codeExpires
US 10039757 ↗ Method of use U-1480 Jul 18, 2031
US 10034873 ↗ Method of use U-2488 Jul 18, 2031
US 10034873 ↗ Method of use U-2488 Jul 18, 2031
US 10039757 ↗ Method of use U-1480 Jul 18, 2031
US 12128039 ↗ Method of use U-1220 Feb 10, 2032
US 12128039 ↗ Method of use U-1220 Feb 10, 2032
US 12128039 ↗ Method of use U-1220 Feb 10, 2032
US 12128039 ↗ Method of use U-1480 Feb 10, 2032
US 12128039 ↗ Method of use U-1480 Feb 10, 2032
US 12128039 ↗ Method of use U-1480 Feb 10, 2032
US 12128039 ↗ Method of use U-2488 Feb 10, 2032
US 12128039 ↗ Method of use U-2488 Feb 10, 2032
US 12128039 ↗ Method of use U-2488 Feb 10, 2032
US 12128039 ↗ Method of use U-3225 Feb 10, 2032
US 12128039 ↗ Method of use U-3225 Feb 10, 2032
US 12128039 ↗ Method of use U-3225 Feb 10, 2032
US 12128039 ↗ Method of use U-4131 Feb 10, 2032
US 12128039 ↗ Method of use U-4156 Feb 10, 2032
US 12128039 ↗ Method of use U-4156 Feb 10, 2032
US 12128039 ↗ Method of use U-4131 Feb 10, 2032
US 12128039 ↗ Method of use U-4156 Feb 10, 2032
US 12128039 ↗ Method of use U-4131 Feb 10, 2032
US 11098015 ↗ Method of use U-4131 Jan 15, 2030
US 11098015 ↗ Method of use U-4156 Jan 15, 2030
US 11098015 ↗ Method of use U-4156 Jan 15, 2030
US 11098015 ↗ Method of use U-4131 Jan 15, 2030
US 11098015 ↗ Method of use U-4156 Jan 15, 2030
US 11098015 ↗ Method of use U-4131 Jan 15, 2030
US 10039757 ↗ Method of use U-1480 Jul 18, 2031
US 10034873 ↗ Method of use U-2488 Jul 18, 2031
US 11098015 ↗ Method of use U-2488 Jan 15, 2030
US 11098015 ↗ Method of use U-1220 Jan 15, 2030
US 11098015 ↗ Method of use U-1480 Jan 15, 2030
US 11098015 ↗ Method of use U-2488 Jan 15, 2030
US 11098015 ↗ Method of use U-1220 Jan 15, 2030
US 11098015 ↗ Method of use U-1480 Jan 15, 2030
US 11098015 ↗ Method of use U-2488 Jan 15, 2030
US 11098015 ↗ Method of use U-1220 Jan 15, 2030
US 11098015 ↗ Method of use U-1480 Jan 15, 2030
US 8877776 ↗ Drug substance U-3225 Oct 8, 2030
US 11098015 ↗ Method of use U-3225 Jan 15, 2030
US 11098015 ↗ Method of use U-3225 Jan 15, 2030
US 8877776 ↗ Drug substance U-3225 Oct 8, 2030
US 8877776 ↗ Drug substance U-3225 Oct 8, 2030
US 11098015 ↗ Method of use U-3225 Jan 15, 2030
US 9724342 ↗ Drug product — Jul 9, 2033
US 9724342 ↗ Drug product — Jul 9, 2033
US 7579473 ↗ Drug substance — Aug 14, 2026
US 11298349 ↗ Drug product — Feb 10, 2032
US 11091440 ↗ Drug product — Jan 15, 2030
US 11298349 ↗ Drug product — Feb 10, 2032
US 11091440 ↗ Drug product — Jan 15, 2030
US 11091439 ↗ Drug substance — Jan 15, 2030
US 7579473 ↗ Drug substance — Aug 14, 2026
US 9724342 ↗ Drug product — Jul 9, 2033
US 11091440 ↗ Drug product — Jan 15, 2030
US 11091439 ↗ Drug substance — Jan 15, 2030
US 7579473 ↗ Drug substance — Aug 14, 2026
US 11091439 ↗ Drug substance — Jan 15, 2030
US 11298349 ↗ Drug product — Feb 10, 2032
FDA exclusivity
CodeWhat it grantsExpires
ODE-227Orphan Drug Exclusivity (7-year)Jan 14, 2026
ODE-375Orphan Drug Exclusivity (7-year)Sep 17, 2028
ODE-530Orphan Drug Exclusivity (7-year)Mar 26, 2032
ODE-227Orphan Drug Exclusivity (7-year)Jan 14, 2026
ODE-375Orphan Drug Exclusivity (7-year)Sep 17, 2028
ODE-530Orphan Drug Exclusivity (7-year)Mar 26, 2032
ODE-227Orphan Drug Exclusivity (7-year)Jan 14, 2026
ODE-375Orphan Drug Exclusivity (7-year)Sep 17, 2028
ODE-530Orphan Drug Exclusivity (7-year)Mar 26, 2032
Common questions
Is there a generic version of CABOMETYX 40 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for CABOMETYX 40 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jul 2033 — 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 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.
30 tablets42388-0025-46 2,468 Rx · $58,302,708
30 tablets42388-0025-26 No Medicaid data
15 tablets this page42388-0025-37 No Medicaid data
15 tablets42388-0025-57 No Medicaid data
Drug total (last 4 qtrs): 2,468 Rx · 67,223 units · $58,302,708 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 Cabometyx — 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 Cabometyx. 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
$397.9M
Claims incl. refills
15.9K
Beneficiaries
7.1K
Spend / beneficiary
$56,248.38
Spend / claim
$24,979.66
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
42388-0025-26 30 TABLET in 1 BOTTLE (42388-025-26) 2016-04-25 Active
42388-0025-37 You're viewing this 15 TABLET in 1 BOTTLE (42388-025-37) 2019-02-27 Active
42388-0025-46 1 BOTTLE in 1 CARTON (42388-025-46) / 30 TABLET in 1 BOTTLE 2023-01-09 Active
42388-0025-57 1 BOTTLE in 1 CARTON (42388-025-57) / 15 TABLET in 1 BOTTLE 2023-01-09 Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 42388-0025-37?
NDC 42388-0025-37 is a 15-count package — 15 tablet in 1 bottle.
What is the difference between NDC 42388-0025-37 and NDC 42388-0025-57?
Both are CABOMETYX cabozantinib 40 mg Tablet — the drug itself is identical. NDC 42388-0025-37 is the 15-count package, while NDC 42388-0025-57 is the 15 tablets package.
What NDC number is used to bill for this package of CABOMETYX cabozantinib 40 mg Tablet?
Bill NDC 42388-0025-37 — the 11-digit billing format is 42388002537. 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?
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📄 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 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE CABOMETYX is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC). ( 1.1 ) patients with advanced renal cell carcinoma, as a first-line treatment in combination with nivolumab ( 1.1 ) patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib ( 1.2 ) adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible ( 1.3 ) adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET).

( 1.4 ) adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic neuroendocrine tumors (epNET). ( 1.4 )

1.1Renal Cell Carcinoma CABOMETYX is indicated for the treatment of patients with advanced renal cell carcinoma (RCC). CABOMETYX, in combination with nivolumab, is indicated for the first-line treatment of patients with advanced RCC.

1.2Hepatocellular Carcinoma CABOMETYX is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

1.3Differentiated Thyroid Cancer CABOMETYX is indicated for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible.

1.4Neuroendocrine Tumors CABOMETYX is indicated for the treatment of adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET). CABOMETYX is indicated for the treatment of adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic neuroendocrine tumors (epNET).

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Do NOT substitute CABOMETYX tablets with cabozantinib capsules. ( 2.1 ) Administer on an empty stomach at least 1 hour before or at least 2 hours after eating. ( 2.2 ) Stop treatment with CABOMETYX at least 3 weeks prior to scheduled surgery, including dental surgery.

( 2.1 ) Recommended Dose: RCC (Single Agent): 60 mg orally, once daily. ( 2.2 ) RCC (Combination Therapy): 40 mg orally, once daily with: 240 mg nivolumab every 2 weeks by intravenous infusion; -OR- 480 mg nivolumab every 4 weeks by intravenous infusion; -OR- 600 mg nivolumab and 10,000 units hyaluronidase every 2 weeks administered subcutaneously; -OR- 1,200 mg nivolumab and 20,000 units hyaluronidase every 4 weeks administered subcutaneously. ( 2.2 ) HCC: 60 mg orally, once daily.

( 2.2 ) DTC, pNET, epNET Adult patients and pediatric patients 12 years of age and older with bodyweight greater than or equal to 40 kg: 60 mg orally once daily. ( 2.2 ) Pediatric patients 12 years of age and older with bodyweight less than 40 kg: 40 mg orally once daily. (2.2)

2.1Important Dosage Information and Recommended Evaluation and Testing Before Initiating CABOMETYX Do not substitute CABOMETYX tablets with cabozantinib capsules. Stop treatment with CABOMETYX 3 weeks prior to scheduled surgery, including dental surgery to reduce the risk of hemorrhage. Do not administer CABOMETYX for at least 2 weeks after major surgery and until adequate wound healing [see Warnings and Precautions (5.1 , 5.11 , 5.12) ] .

2.2Recommended Dosage Administer CABOMETYX on an empty stomach. Administer at least 1 hour before or at least 2 hours after eating [see Clinical Pharmacology (12.3) ] . Swallow CABOMETYX tablets whole.

Do not crush, chew, or split CABOMETYX tablets. Do not take a missed dose within 12 hours of the next dose. Modify the CABOMETYX dose for patients taking drugs known to moderately or strongly induce CYP3A4 or strongly inhibit CYP3A4 and for patients with moderate hepatic impairment [see Dosage and Administration (2.4 , 2.5 , 2.6) ] .

The recommended dosages of CABOMETYX are presented in Table 1. Table 1. Recommended Dosage for CABOMETYX Indication Recommended Dosage Duration Renal Cell Carcinoma Single Agent 60 mg orally once daily Until disease progression or unacceptable toxicity Combination Therapy 40 mg orally once daily in combination with: 240 mg nivolumab every 2 weeks (30- minute intravenous infusion); -OR- 480 mg nivolumab every 4 weeks (30- minute intravenous infusion); -OR- 600 mg nivolumab and 10,000 units hyaluronidase administered subcutaneously over approximately 3-5 minutes every 2 weeks; -OR- 1,200 mg nivolumab and 20,000 units hyaluronidase administered subcutaneously over approximately 3-5 minutes every 4 weeks CABOMETYX Until disease progression or unacceptable toxicity Nivolumab -OR- nivolumab and hyaluronidase Until disease progression or unacceptable toxicity for up to 2 years Hepatocellular Carcinoma 60 mg orally once daily Until disease progression or unacceptable toxicity Differentiated Thyroid Cancer and Neuroendocrine Tumors Adult Patients and Pediatric Patients 12 years of age and older with bodyweight greater than or equal to 40 kg: 60 mg orally once daily Pediatric patients 12 years of age and older with bodyweight less than 40 kg: 40 mg orally once daily Until disease progression or unacceptable toxicity

2.3Dosage Modifications for Adverse Reactions Withhold CABOMETYX for: Intolerable Grade 2 adverse reactions Grade 3 or 4 adverse reactions Osteonecrosis of the jaw Upon resolution/improvement (i.e., return to baseline or resolution to Grade 1) of an adverse reaction, reduce the dose as follows: Table 2. Recommended Dosage Reductions for CABOMETYX for Adverse Reactions Recommended Dosage First Dosage Reduction To Second Dosage Reduction To CABOMETYX 60 mg daily in adult and pediatric patients 12 years of age and older with bodyweight greater than or equal to 40 kg 40 mg daily 20 mg daily If previously receiving lowes…

💊 Dosage Forms and Strengths 81 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 60 mg: yellow film-coated, oval shaped with no score, and debossed with "XL" on one side and "60" on the other side. 40 mg: yellow film-coated, triangle shaped with no score, and debossed with "XL" on one side and "40" on the other side. 20 mg: yellow film-coated, round with no score, and debossed with "XL" on one side and "20" on the other side. Tablets: 60 mg, 40 mg, 20 mg. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hemorrhage: Do not administer CABOMETYX if recent history of hemorrhage. ( 5.1 ) Perforations and Fistulas: Monitor for symptoms. Discontinue CABOMETYX for Grade 4 fistula or perforation.

( 5.2 ) Thromboembolic Events: Discontinue CABOMETYX for myocardial infarction or serious venous or arterial thromboembolic events. ( 5.3 ) Hypertension and Hypertensive Crisis: Monitor blood pressure regularly. Interrupt for hypertension that is not adequately controlled with anti-hypertensive therapy.

Discontinue CABOMETYX for hypertensive crisis or severe hypertension that cannot be controlled with anti-hypertensive therapy. ( 5.4 ) Cardiac Failure: Monitor patients for signs and symptoms of cardiac failure throughout treatment. ( 5.5 ) Diarrhea: May be severe.

Interrupt CABOMETYX until diarrhea resolves or decreases to ≤Grade 1, resume at reduced dose. Recommend standard antidiarrheal treatments. ( 5.6 ) Palmar-Plantar Erythrodysesthesia (PPE): Interrupt CABOMETYX treatment until PPE resolves or decreases to Grade 1.

( 5.7 ) Hepatotoxicity: When used in combination with nivolumab, higher frequencies of Grade 3 and 4 ALT and AST elevation may occur than with CABOMETYX alone. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider withholding CABOMETYX and/or nivolumab, initiating corticosteroid therapy, and/or permanently discontinuing the combination for severe or life- threatening hepatotoxicity.

( 5.8 ) Adrenal Insufficiency: When used in combination with nivolumab, primary or secondary adrenal insufficiency may occur. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold CABOMETYX and/or nivolumab depending on severity.

( 5.9 ) Proteinuria: Monitor urine protein. Interrupt CABOMETYX until proteinuria resolves to ≤ Grade 1, resume CABOMETYX at a reduced dose. Discontinue for nephrotic syndrome.

( 5.10 ) Osteonecrosis of the jaw (ONJ): Withhold CABOMETYX for at least 3 weeks prior to invasive dental procedures and for development of ONJ. ( 5.11 ) Impaired Wound Healing: Withhold CABOMETYX for at least 3 weeks before elective surgery. Do not administer for at least 2 weeks following major surgery and adequate wound healing.

The safety of resumption of CABOMETYX after resolution of wound healing complications has not been established. ( 5.12 ) Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue CABOMETYX. ( 5.13 ) Thyroid Dysfunction: Monitor thyroid function before and during treatment with CABOMETYX.

( 5.14 ) Hypocalcemia: Withhold CABOMETYX and resume at reduced dose upon recovery or permanently discontinue CABOMETYX depending on severity. ( 5.15 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

( 5.16 , 8.1 , 8.3 )

5.1Hemorrhage CABOMETYX can cause severe and fatal hemorrhages. Do not administer CABOMETYX to patients who have a recent history of hemorrhage, including hemoptysis, hematemesis, or melena. The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX-treated patients in RCC, HCC, and DTC studies [see Adverse Reactions (6.1) ] .

Withhold CABOMETYX for 3 weeks prior to scheduled surgery, including dental surgery to reduce the risk of hemorrhage. Permanently discontinue CABOMETYX for Grade 3 or 4 hemorrhage and prior to surgery as recommended [see Dosage and Administration (2.3) , Warnings and Precautions (5.11 , 5.12) ] .

5.2Perforations and Fistulas CABOMETYX can cause gastrointestinal (GI) perforations and fistulas. Fistulas, including fatal cases, occurred in 1% of CABOMETYX-treated patients [see [see Adverse Reactions (6.1) ] . GI perforations, including fatal cases, occurred in 1% of CABOMETYX-treated patients. Monitor patients for signs and symptoms of fistulas and perforations, including abscess and sepsis. Discontinue CABOMETYX in patients…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed elsewhere in the labeling: Hemorrhage [see Warnings and Precautions (5.1) ] Perforations and Fistulas [see Warnings and Precautions (5.2) ] Thromboembolic Events [see Warnings and Precautions (5.3) ] Hypertension and Hypertensive Crisis [see Warnings and Precautions (5.4) ] Cardiac Failure [see Warnings and Precautions (5.5) ] Diarrhea [see Warnings and Precautions (5.6) ] Palmar-plantar Erythrodysesthesia [see Warnings and Precautions (5.7) ] Hepatotoxicity [see Warnings and Precautions (5.8) ] Adrenal Insufficiency [see Warnings and Precautions (5.9) ] Proteinuria [see Warnings and Precautions (5.10) ] Osteonecrosis of the Jaw [see Warnings and Precautions (5.11) ] Impaired Wound Healing [see Warnings and Precautions (5.12) ] Reversible Posterior Leukoencephalopathy Syndrome [see Warnings and Precautions (5.13) ] Thyroid Dysfunction [see Warnings and Precautions (5.14) ] Hypocalcemia [see Warnings and Precautions (5.15) ] The most common (≥ 20%) adverse reactions are: as a single agent: diarrhea, fatigue, PPE, decreased appetite, hypertension, nausea, vomiting, weight decreased, constipation.

( 6.1 ) in combination with nivolumab: diarrhea, fatigue, hepatotoxicity, PPE, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, dysgeusia, abdominal pain, cough, and upper respiratory tract infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Exelixis, Inc. at 1-855-500-3935 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trial 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 the WARNINGS AND PRECAUTIONS section and below reflect exposure to CABOMETYX as a single agent at 60 mg orally once daily until disease progression or unacceptable toxicity in 409 patients with RCC enrolled in a randomized, active-controlled trial (CABOSUN, METEOR), 467 patients with HCC enrolled in a randomized, placebo- controlled trial (CELESTIAL), 125 patients with DTC enrolled in a randomized, placebo- controlled trial (COSMIC-311), 195 patients with pNET or epNET enrolled in a randomized, placebo-controlled trial (CABINET), and at 40 mg CABOMETYX in combination with nivolumab 240 mg/m 2 every 2 weeks, in 320 patients with RCC enrolled in a randomized, active- controlled trial (CHECKMATE-9ER).

Renal Cell Carcinoma METEOR The safety of CABOMETYX was evaluated in METEOR, a randomized, open-label trial in which 331 patients with advanced renal cell carcinoma received CABOMETYX 60 mg once daily and 322 patients received everolimus 10 mg once daily until disease progression or unacceptable toxicity. Patients on both arms who had disease progression could continue treatment at the discretion of the investigator [see Clinical Studies (14) ] . The median duration of treatment was 7.6 months (range 0.3 – 20.5) for patients receiving CABOMETYX and 4.4 months (range 0.21 – 18.9) for patients receiving everolimus.

Adverse reactions which occurred in ≥ 25% of CABOMETYX-treated patients, in order of decreasing frequency, were: diarrhea, fatigue, nausea, decreased appetite, palmar-plantar erythrodysesthesia (PPE), hypertension, vomiting, weight decreased, and constipation. Grade 3-4 adverse reactions and laboratory abnormalities which occurred in ≥ 5% of patients were hypertension, diarrhea, fatigue, PPE, hyponatremia, hypophosphatemia, hypomagnesemia, lymphopenia, anemia, hypokalemia, and increased GGT. The dose was reduced in 60% of patients receiving CABOMETYX and in 24% of patients receiving everolimus.

Twenty percent (20%) of patients received CABOMETYX 20 mg once daily as their lowest dose. The most frequent adverse reactions leading to dose reduction in patients…

🔄 Drug Interactions 196 words ▾

7 DRUG INTERACTIONS Strong CYP3A4 inhibitors: Reduce the CABOMETYX dosage if coadministration cannot be avoided. ( 2.4 , 7.1 ) Strong or moderate CYP3A4 inducers: Increase the CABOMETYX dosage if coadministration cannot be avoided. ( 2.5 , 7.1 )

7.1Effects of Other Drugs on CABOMETYX Strong CYP3A4 Inhibitors Coadministration of a cabozantinib capsule formulation with a strong CYP3A4 inhibitor increased the exposure of cabozantinib, which may increase the risk of exposure-related adverse reactions [see Clinical Pharmacology (12.3) ] . Avoid coadministration of CABOMETYX with strong CYP3A4 inhibitors. Reduce the dosage of CABOMETYX if coadministration with strong CYP3A4 inhibitors cannot be avoided [see Dosage and Administration (2.4) ] .

Avoid grapefruit or grapefruit juice which may also increase exposure of cabozantinib. Strong or Moderate CYP3A Inducers Coadministration of a cabozantinib capsule formulation with a strong CYP3A4 inducer decreased the exposure of cabozantinib, which may reduce efficacy [see Clinical Pharmacology (12.3) ] . Avoid coadministration of CABOMETYX with strong or moderate CYP3A4 inducers.

Increase the dosage of CABOMETYX if coadministration with strong or moderate CYP3A4 inducers cannot be avoided [see Dosage and Administration (2.5) ] . Avoid St. John’s wort which may also decrease exposure of cabozantinib.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Hepatic Impairment: Reduce the CABOMETYX dosage for patients with moderate hepatic impairment. Avoid in patients with severe hepatic impairment. ( 2.6 , 8.6 ) Lactation: Advise not to breastfeed. ( 8.2 ) Pediatric Use: Monitor open growth plates in adolescent patients. Consider interrupting or discontinuing CABOMETYX if abnormalities occur. ( 8.4 )

8.1Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1) ] , CABOMETYX can cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk. In animal developmental and reproductive toxicology studies administration of cabozantinib to pregnant rats and rabbits during organogenesis resulted in embryofetal lethality and structural anomalies at exposures that were below those occurring clinically at the recommended dose (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 2-4% and 15-20%, respectively. Data Animal Data In an embryo-fetal development study in pregnant rats, daily oral administration of cabozantinib throughout organogenesis caused increased embryo-fetal lethality compared to controls at a dose of 0.03 mg/kg (approximately 0.12-fold of human area under the curve [AUC] at the recommended dose).

Findings included delayed ossification and skeletal variations at a dose of 0.01 mg/kg/day (approximately 0.04-fold of human AUC at the recommended dose). In pregnant rabbits, daily oral administration of cabozantinib throughout organogenesis resulted in findings of visceral malformations and variations including reduced spleen size and missing lung lobe at 3 mg/kg (approximately 1.1-fold of the human AUC at the recommended dose). In a pre- and postnatal study in rats, cabozantinib was administered orally from gestation day 10 through postnatal day 20.

Cabozantinib did not produce adverse maternal toxicity or affect pregnancy, parturition or lactation of female rats, and did not affect the survival, growth or postnatal development of the offspring at doses up to 0.3 mg/kg/day (0.05-fold of the maximum recommended clinical dose).

8.2Lactation Risk Summary There is no information regarding the presence of cabozantinib or its metabolites in human milk, or their effects on the breastfed child or milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with CABOMETYX and for 4 months after the final dose.

8.3Females and Males of Reproductive Potential Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating CABOMETYX [see Use in Specific Populations (8.1) ] . Contraception CABOMETYX can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] . Females Advise females of reproductive potential to use effective contraception during treatment with CABOMETYX and for 4 months after the final dose.

Infertility Females and Males Based on findings in animals, CABOMETYX may impair fertility in females and males of reproductive potential [see Nonclinical Toxicology (13.1) ] .

8.4Pediatric Use The safety and effectiveness of CABOMETYX for the treatment of differentiated thyroid cancer (DTC) and neuroendocrine tumors (NETs) have been established in pediatric patients aged 12 years and older. Use of CABOMETYX in pediatric patients aged 12 years and older with DTC and NETs is supported by evidence from adequate and well-controlled studies of CABOMETYX in adults with additional population pharmacokinetic data demonstrating that cabozantinib exposure is within the same range between adults and pediatric patients aged 12 years and older at the recommended dosages [see Dosage and Administration (2.2 , 2.3 ), Ad…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1) ] , CABOMETYX can cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk. In animal developmental and reproductive toxicology studies administration of cabozantinib to pregnant rats and rabbits during organogenesis resulted in embryofetal lethality and structural anomalies at exposures that were below those occurring clinically at the recommended dose (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 2-4% and 15-20%, respectively. Data Animal Data In an embryo-fetal development study in pregnant rats, daily oral administration of cabozantinib throughout organogenesis caused increased embryo-fetal lethality compared to controls at a dose of 0.03 mg/kg (approximately 0.12-fold of human area under the curve [AUC] at the recommended dose).

Findings included delayed ossification and skeletal variations at a dose of 0.01 mg/kg/day (approximately 0.04-fold of human AUC at the recommended dose). In pregnant rabbits, daily oral administration of cabozantinib throughout organogenesis resulted in findings of visceral malformations and variations including reduced spleen size and missing lung lobe at 3 mg/kg (approximately 1.1-fold of the human AUC at the recommended dose). In a pre- and postnatal study in rats, cabozantinib was administered orally from gestation day 10 through postnatal day 20.

Cabozantinib did not produce adverse maternal toxicity or affect pregnancy, parturition or lactation of female rats, and did not affect the survival, growth or postnatal development of the offspring at doses up to 0.3 mg/kg/day (0.05-fold of the maximum recommended clinical dose).

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness of CABOMETYX for the treatment of differentiated thyroid cancer (DTC) and neuroendocrine tumors (NETs) have been established in pediatric patients aged 12 years and older. Use of CABOMETYX in pediatric patients aged 12 years and older with DTC and NETs is supported by evidence from adequate and well-controlled studies of CABOMETYX in adults with additional population pharmacokinetic data demonstrating that cabozantinib exposure is within the same range between adults and pediatric patients aged 12 years and older at the recommended dosages [see Dosage and Administration (2.2 , 2.3 ), Adverse Reactions (6.1) , Clinical Pharmacology (12.3) and Clinical Studies (14.3 , 14.4) ] .

Physeal widening has been observed in children with open growth plates when treated with CABOMETYX. Based on the limited available data of the effects of CABOMETYX on longitudinal growth, physeal and longitudinal growth monitoring is recommended in children with open growth plates. The safety and effectiveness of CABOMETYX in pediatric patients less than 12 years of age have not been established.

Juvenile Animal Toxicity Data Juvenile rats were administered cabozantinib at doses of 1 or 2 mg/kg/day from Postnatal Day 12 (comparable to less than 2 years in humans) through Postnatal Day 35 or 70. Mortalities occurred at doses ≥1 mg/kg/day (approximately 0.16 times the clinical dose of 60 mg/day based on body surface area). Hypoactivity was observed at both doses tested on Postnatal Day 22.

Targets were generally similar to those seen in adult animals, occurred at both doses, and included the kidney (nephropathy, glomerulonephritis), reproductive organs, gastrointestinal tract (cystic dilatation and hyperplasia in Brunner’s gland and inflammation of duodenum; and epithelial hyperplasia of colon and cecum), bone marrow (hypocellularity and lymphoid depletion), and liver. Tooth abnormalities and whitening as well as effects on bones including reduced bone mineral content and density, physeal hypertrophy, and decreased cortical bone also occurred at all dose levels.

Recovery was not assessed at a dose of 2 mg/kg (approximately 0.32 times the clinical dose of 60 mg based on body surface area) due to high levels of mortality. At the low dose level, effects on bone parameters were partially resolved but effects on the kidney and epididymis/testis persisted after treatment ceased.

🧓 Geriatric Use 194 words ▾

8.5Geriatric Use In CABOSUN and METEOR, 41% of 409 patients treated with CABOMETYX were age 65 years and older, and 8% were 75 years and older. In CELESTIAL, 49% of 467 patients treated with CABOMETYX were age 65 years and older, and 15% were 75 years and older. In COSMIC-311, 50% of 125 patients treated with CABOMETYX were age 65 years and older, and 12% were 75 years and older.

In CABINET, 38% of 63 patients treated with CABOMETYX were age 65 years and older, and 5% were 75 years and older in the pNET cohort, and 55% of 132 patients treated with CABOMETYX were age 65 years and older, and 13% were 75 years and older in the epNET cohort [see Clinical Studies (14) ] . No overall differences in safety or effectiveness were observed between these patients and younger patients. Of the 320 patients with RCC treated with CABOMETYX in combination with nivolumab in CHECKMATE-9ER, 41% were 65 years or older and 9% were 75 years or older [see Clinical Studies (14.1) ] .

No overall difference in safety was reported between older and younger patients receiving both CABOMETYX and nivolumab.

🆘 Overdosage 59 words ▾

10 OVERDOSAGE One case of overdosage was reported following administration of another formulation of cabozantinib; a patient inadvertently took twice the intended dose for 9 days. The patient suffered Grade 3 memory impairment, Grade 3 mental status changes, Grade 3 cognitive disturbance, Grade 2 weight loss, and Grade 1 increase in BUN. The extent of recovery was not documented.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action In vitro biochemical and/or cellular assays have shown that cabozantinib inhibits the tyrosine kinase activity of MET, VEGFR-1, -2 and -3, AXL, RET, ROS1, TYRO3, MER, KIT, TRKB, FLT-3, and TIE-2. These receptor tyrosine kinases are involved in both normal cellular function and pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, drug resistance, and maintenance of the tumor microenvironment.

12.2Pharmacodynamics The exposure-response or safety relationship for cabozantinib is not fully characterized. Cardiac Electrophysiology The effect of cabozantinib on QTc interval was evaluated in a randomized, double-blinded, placebo-controlled trial in patients with medullary thyroid cancer administered a cabozantinib capsule formulation. A mean increase in QTcF of 10 - 15 ms was observed at 4 weeks after initiation.

A concentration-QTc relationship could not be definitively established. Changes in cardiac wave form morphology or new rhythms were not observed. No patients in this study had a confirmed QTcF > 500 ms nor did any patients in METEOR, CABOSUN, CELESTIAL, CHECKMATE-9ER, COSMIC-311, or CABINET.

12.3Pharmacokinetics Repeat daily dosing of a cabozantinib capsule formulation for 19 days resulted in 4- to 5-fold mean cabozantinib accumulation (based on AUC) compared to a single dose administration; steady state was achieved by Day 15. Absorption Median time to peak cabozantinib concentrations (T max ) ranged from 3 to 4 hours post-dose. A 19% increase in the C max of CABOMETYX compared to a cabozantinib capsule formulation was observed following a single 140 mg dose.

A less than 10% difference in the AUC was observed between CABOMETYX and a cabozantinib capsule formulation [see Dosage and Administration (2.1) ] . Food Effect Cabozantinib C max and AUC increased by 41% and 57%, respectively, following a high-fat meal relative to fasted conditions in healthy subjects administered a single oral dose of a cabozantinib capsule formulation. Distribution The oral volume of distribution (V z /F) of cabozantinib is approximately 319 L.

Cabozantinib is highly protein bound in human plasma (≥99.7%). Elimination The predicted terminal half-life is approximately 99 hours and the clearance (CL/F) at steady-state is estimated to be

2.2L/hr. Metabolism Cabozantinib is a substrate of CYP3A4 in vitro. Excretion Approximately 81% of the total administered radioactivity was recovered within a 48-day collection period following a single dose of radiolabeled 14 C-cabozantinib in healthy subjects.

Approximately 54% was recovered in feces and 27% in urine. Unchanged cabozantinib accounted for 43% of the total radioactivity in feces and was not detectable in urine following a 72-hour collection. Specific Populations The following patient characteristics did not result in a clinically relevant difference in the pharmacokinetics of cabozantinib: age (32-86 years), sex, race (Whites and non-Whites), or mild to moderate renal impairment (eGFR ≥30 mL/min/1.73 m 2 as estimated by MDRD (modification of diet in renal disease equation)).

The pharmacokinetics of cabozantinib is unknown in patients with eGFR <29 mL/min/1.73m 2 as estimated by MDRD equation or requiring dialysis. Pediatric Patients The systemic exposures to cabozantinib in pediatric patients 12 years and older at the recommended dosages are expected to be comparable to the exposure in adults at the dose of CABOMETYX 60 mg once daily. Patients with Hepatic Impairment Based on a population pharmacokinetic analysis of cabozantinib in healthy subjects and patients with cancer, no clinically significant differences in the mean cabozantinib exposure were observed between subjects with normal liver function (total bilirubin and AST ≤ULN) and those with mild hepatic impairment (total bilirubin ≤ULN and AST >ULN or total bilirubin >1 to 1.5x ULN and any AST value).

In a dedicated pharmacokinetic study, cabozantinib exposure (AUC 0-INF )…

🧬 Mechanism of Action 63 words ▾

12.1Mechanism of Action In vitro biochemical and/or cellular assays have shown that cabozantinib inhibits the tyrosine kinase activity of MET, VEGFR-1, -2 and -3, AXL, RET, ROS1, TYRO3, MER, KIT, TRKB, FLT-3, and TIE-2. These receptor tyrosine kinases are involved in both normal cellular function and pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, drug resistance, and maintenance of the tumor microenvironment.

📦 How Supplied / Storage and Handling 167 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING CABOMETYX tablets are supplied as follows: 60 mg tables are yellow film-coated, oval shaped with no score, debossed with "XL" on one side and "60" on the other side of the tablet; available in: bottle of 30 tablets: NDC 42388-023-26 bottle of 30 tablets packaged in a carton: NDC 42388-023-46 40 mg tablets are yellow film-coated, triangle shaped with no score, debossed with "XL" on one side and "40" on the other side of the tablet; available in: bottle of 30 tablets: NDC 42388-025-26 bottle of 30 tablets packaged in a carton: NDC 42388-025-46 20 mg tablets are yellow film-coated, round shaped with no score, debossed with "XL" on one side and "20" on the other side of the tablet; available in: bottle of 30 tablets: NDC 42388-024-26 bottle of 30 tablets packaged in a carton: NDC 42388-024-46 Store CABOMETYX at 20°C to 25°C (68°F to 77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

📋 Description 156 words ▾

11 DESCRIPTION CABOMETYX is the ( S )-malate salt of cabozantinib, a kinase inhibitor. Cabozantinib ( S )-malate is described chemically as N -(4-(6,7-dimethoxyquinolin-4-yloxy)phenyl)- N' -(4-fluorophenyl)cyclopropane-1,1-dicarboxamide, (2 S )-hydroxybutanedioate. The molecular formula is C 28 H 24 FN 3 O 5 •C 4 H 6 O 5 and the molecular weight is 635.6 Daltons as malate salt.

The chemical structure of cabozantinib ( S )-malate salt is: Cabozantinib ( S )-malate salt is a white to off-white solid that is practically insoluble in aqueous media. CABOMETYX (cabozantinib) tablets for oral use are supplied as film-coated tablets containing 20 mg, 40 mg, or 60 mg of cabozantinib, which is equivalent to 25 mg, 51 mg, or 76 mg of cabozantinib ( S )-malate, respectively. CABOMETYX also contains the following inactive ingredients: microcrystalline cellulose, lactose anhydrous, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate.

The film coating contains hypromellose, titanium dioxide, triacetin, and iron oxide yellow.

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Hemorrhage : Instruct patients to contact their healthcare provider to seek immediate medical attention for signs or symptoms of unusual severe bleeding or hemorrhage [see Warnings and Precautions (5.1) ] . Perforations and fistulas : Advise patients that gastrointestinal disorders such as diarrhea, nausea, vomiting, and constipation may develop during CABOMETYX treatment and to seek immediate medical attention if they experience persistent or severe abdominal pain because cases of gastrointestinal perforation and fistula have been reported in patients taking CABOMETYX [see Warnings and Precautions (5.2) ] .

Thromboembolic Events : Venous and arterial thromboembolic events have been reported. Advise patients to report signs or symptoms of an arterial thrombosis. Venous thromboembolic events including pulmonary embolus have been reported.

Advise patients to contact their health care provider if new onset of dyspnea, chest pain, or localized limb edema occurs [see Warnings and Precautions (5.3) ] . Hypertension and hypertensive crisis : Inform patients of the signs and symptoms of hypertension. Advise patients to undergo routine blood pressure monitoring and to contact their health care provider if blood pressure is elevated or if they experience signs or symptoms of hypertension [see Warnings and Precautions (5.4) ] .

Cardiac Failure : Advise patients that CABOMETYX can cause cardiac failure. Advise patients to immediately contact their healthcare provider for signs or symptoms of cardiac failure [see Warnings and Precautions (5.5) ] . Diarrhea : Advise patients to notify their healthcare provider at the first signs of poorly formed or loose stool or an increased frequency of bowel movements [see Warnings and Precautions (5.6) ] .

Palmar-plantar erythrodysesthesia : Advise patients to contact their healthcare provider for progressive or intolerable rash [see Warnings and Precautions (5.7) ] . Hepatotoxicity : Advise patients to contact their healthcare provider immediately for jaundice, severe nausea or vomiting, or easy bruising or bleeding [see Warnings and Precautions (5.8) ] . Adrenal insufficiency : Advise patients receiving with nivolumab to contact their healthcare provider immediately for signs or symptoms of adrenal insufficiency [see Warnings and Precautions (5.9) ] .

Proteinuria : Advise patients to contact their healthcare provider for signs or symptoms of proteinuria [see Warnings and Precautions (5.10) ] . Osteonecrosis of the jaw : Advise patients regarding good oral hygiene practices. Advise patients to immediately contact their healthcare provider for signs or symptoms associated with osteonecrosis of the jaw [see Warnings and Precautions (5.11) ] .

Impaired wound healing : Advise patients that CABOMETYX may impair wound healing. Advise patients to inform their healthcare provider of any planned surgical procedure [see Dosage and Administration (2.1) , Warnings and Precautions (5.12) ] . Reversible posterior leukoencephalopathy syndrome : Advise patients to immediately contact their health care provider for new onset or worsening neurological function [see Warnings and Precautions (5.13) ] .

Thyroid dysfunction : Advise patients that CABOMETYX can cause thyroid dysfunction and that their thyroid function should be monitored regularly during treatment. Advise patients to immediately contact their healthcare provider for signs or symptoms of thyroid dysfunction [see Warnings and Precautions (5.14) ] . Hypocalcemia : Advise patients that CABOMETYX can cause low calcium levels and that their serum calcium levels should be monitored regularly during treatment.

Advise patients to immediately contact their healthcare provider for signs or symptoms of hypocalcemia [see Warnings and Precautions (5.15) ] . Embryo-fetal toxicity : Advise females of reproductive potential of the potential risk to a fetus.…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 42388-0024-26 · Exelixis, 42389-0001-01 · Carepro →
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.