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febuxostat 80 mg Tablet, 1,000-count — NDC 72578-0137-10 package photo

febuxostat 80 mg Tablet, 1,000-count

by Viona Pharmaceuticals Inc · 1000 TABLET in 1 BOTTLE (72578-137-10)
NDC 72578-0137-10
🏷️ FDA NDC (as labeled) 72578-137-10 billing pads the product segment with a zero
This package
Contains1,000-count Pack sizes6 compare ↓
Also priced by: Part D plans $0.7479/unit — full pricing hub ↓
Also comes in: 30 tablets 72578-0137-06 90 tablets 72578-0137-16 100 tablets 72578-0137-01 100 tablets 72578-0137-77 500 tablets 72578-0137-05
Rx only Generic 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

⚠️
Other active recalls for Febuxostat (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 4, 2024 — CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0369-2024
Class II · Mar 4, 2024 — CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0368-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 72578-137-10
Product NDC 72578-137
11-digit billing NDC 72578013710
RxCUI 834235, 834241
UNII 101V0R1N2E
UPC 0372578137069, 0372578136062
Application # ANDA205443
SPL Set ID b2aeb900-d792-48b2-b678-94f82d68be32
Established class (EPC) Xanthine Oxidase Inhibitor
Mechanism of action Xanthine Oxidase Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-03-31
Route ORAL
Dosage form TABLET
Substance FEBUXOSTAT
GPI-14 68000030000330
GCN Seq No 064830
GCN 16809
HICL code 036106
Ingredient (HICL) Febuxostat
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C7
Therapeutic class — intermediate (HIC2) Metabolic Inhibitors And Stimulants
HIC3 code C7A
Therapeutic class — specific (HIC3) Hyperuricemia Tx - Xanthine Oxidase Inhibitors
AHFS code 92:16.00.00
AHFS class Antigout Agents
FDB label name FEBUXOSTAT 80 MG TABLET
FDB brand name Febuxostat
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 72578-137-10 — 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 → 72578-0137-10. 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 Xanthine Oxidase Inhibitor class.

Pharmacologic class Xanthine Oxidase Inhibitor
Drug family (ATC) Preparations inhibiting uric acid production
How it works Xanthine Oxidase 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

LabelerViona Pharmaceuticals Inc
Application holderZYDUS LIFESCIENCES LTD
FDA applicationANDA205443 (ANDA)
Labeler code72578
First marketedMar 2023
Product typeHuman Prescription Drug
Portfolio94 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 FEBUXOSTAT 80 MG TABLET Ingredient Febuxostat
📗 Our plain-language guide HelloPharmacist
  • You're right that allopurinol is typically tried first for gout. Febuxostat is specifically approved for people who haven't responded well enough to allopurinol at the highest tole...
  • Why am I on febuxostat instead of allopurinol — isn't allopurinol the usual gout medicine?
  • This is actually very common and completely expected in the early weeks. When febuxostat starts lowering your uric acid, it stirs up deposits that have built up in your joints, whi...
  • My gout attacks are actually getting worse since I started this medicine. Is something wrong?
📖 Read our full Febuxostat 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 White
ShapeRound
Imprint402
Size12 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 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 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 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 FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 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 7CV7WJK4UI
    Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
  • 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.

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 $0.7479 $747.90 / 1000 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
Febuxostat 80 mg 00054-0414-13 Hikma 30 tablets $0.281 AB Availability likely —
Febuxostat 80 mg 00527-2248-32 Lannett 30 tablets $0.281 AB Availability likely —
Febuxostat 80 mg 00904-7396-46 MAJOR 30 tablets $0.281 AB Availability likely —
Febuxostat 80 mg 00904-7485-03 Major 30 tablets $0.281 AB Discontinued —
Febuxostat 80 mg 16714-0060-01 NorthStar 30 tablets $0.281 AB Availability likely —
Febuxostat 80 mg 27808-0207-01 Tris 30 tablets $0.281 AB Availability likely —
Febuxostat 80 mg 33342-0275-07 Macleods 30 films $0.281 AB Availability likely —
Febuxostat 80 mg 43547-0296-03 Solco 30 tablets $0.281 AB Availability likely —
Febuxostat 80 mg 72205-0029-30 Novadoz 30 tablets $0.281 AB Availability likely —
Febuxostat 80 mg 46708-0191-06 Alembic 60 tablets — AB FDA listed —
Febuxostat 80 mg 47335-0722-18 Sun 1000 tablets — AB FDA listed —
Febuxostat 80 mg 51407-0294-30 Golden 30 tablets — AB FDA listed —
Febuxostat 80 mg 55111-0797-01 DR 100 tablets — AB FDA listed —
Febuxostat 80 mg 59651-0114-01 Aurobindo 100 tablets — AB FDA listed —
Febuxostat 80 mg 62332-0191-06 Alembic 60 tablets — AB FDA listed —
Uloric 80 mg 64764-0677-11 Takeda 100 tablets — AB FDA listed —
Febuxostat 80 mg 67877-0669-01 Ascend 100 tablets — AB FDA listed —
Febuxostat 80 mg 68071-3761-09 NuCare 90 tablets — AB FDA listed —
febuxostat 80 mg 70771-1553-00 Zydus 1000 tablets — AB FDA listed —
Febuxostat 80 mg 72303-0856-01 HEC 30 tablets — AB FDA listed —
febuxostat 80 mgthis 72578-0137-10 Viona 1000 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2023
On the market since
Mar 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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 tablets72578-0137-06 232 Rx · $6,145
100 tablets72578-0137-01 No Medicaid data
500 tablets72578-0137-05 No Medicaid data
1000 tablets this page72578-0137-10 No Medicaid data
90 tablets72578-0137-16 No Medicaid data
10 tablets72578-0137-77 No Medicaid data
Drug total (last 4 qtrs): 232 Rx · 8,395 units · $6,145 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 Febuxostat — the program that covers self-administered drugs. 13 manufacturers.
⚠️ 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 Febuxostat. 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
$5.54M
Claims incl. refills
87.2K
Beneficiaries
60.3K
Spend / beneficiary
$92.00
Spend / claim
$63.59
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 Febuxostat — the ingredient across all brands.

Top reported reactions

Diarrhoea881
Acute Kidney Injury857
Nausea857
Rash800
Gout699
Dyspnoea640
Fatigue619

Age at onset

Neonate1
Child2
Adolescent4
Adult1,113
Elderly2,196

Reporter sex

16,669 reports
Male · 67%
Female · 32%
Unknown · 1%

Serious outcomes

Hospitalization7,176
Death2,180
Life-threatening1,050
Disabling623
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,668 0
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 Per unit Per pack Marketing startStatus
72578-0137-01 100 TABLET in 1 BOTTLE (72578-137-01) — — 2023-03-31 Active
72578-0137-05 500 TABLET in 1 BOTTLE (72578-137-05) — — 2023-03-31 Active
72578-0137-06 30 TABLET in 1 BOTTLE (72578-137-06) $0.2810 / ea $8.43 2023-03-31 Active
72578-0137-10 You're viewing this 1000 TABLET in 1 BOTTLE (72578-137-10) — — 2023-03-31 Active
72578-0137-16 90 TABLET in 1 BOTTLE (72578-137-16) — — 2023-03-31 Active
72578-0137-77 10 BLISTER PACK in 1 CARTON (72578-137-77) / 10 TABLET in 1 BLISTER PACK — — 2023-03-31 Active

This pack shows little to no recent Medicaid volume — the 30 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 72578-0137-10?
NDC 72578-0137-10 is a 1,000-count package — 1000 tablet in 1 bottle.
What is the difference between NDC 72578-0137-10 and NDC 72578-0137-06?
Both are febuxostat 80 mg Tablet — the drug itself is identical. NDC 72578-0137-10 is the 1,000-count package, while NDC 72578-0137-06 is the 30 tablets package.
What NDC number is used to bill for this package of febuxostat 80 mg Tablet?
Bill NDC 72578-0137-10 — the 11-digit billing format is 72578013710. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 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 72578-137-10, 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: 72578-0137-10, written without dashes as 72578013710. 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 72578-0137-10, the first segment (72578) is the labeler code FDA assigned to Viona Pharmaceuticals Inc; the middle segment (0137) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) 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 Viona Pharmaceuticals 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 5 other package presentations of this same product, including 30 tablets (72578-0137-06), 90 tablets (72578-0137-16), 100 tablets (72578-0137-01). 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?
Viona Pharmaceuticals 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.
🚨 Boxed Warning 🎯 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 💬 Medication Guide
🚨 Boxed Warning 190 words ▾

WARNING: CARDIOVASCULAR DEATH Gout patients with established cardiovascular (CV) disease treated with febuxostat had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study [see Warnings and Precautions ( 5.1 )] . Consider the risks and benefits of febuxostat when deciding to prescribe or continue patients on febuxostat. Febuxostat should only be used in patients who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable [see Indications and Usage ( 1 )] .

WARNING: CARDIOVASCULAR DEATH See full prescribing information for complete boxed warning. Gout patients with established cardiovascular (CV) disease treated with febuxostat had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study. ( 5.1 ) Consider the risks and benefits of febuxostat when deciding to prescribe or continue patients on febuxostat.

Febuxostat should only be used in patients who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. ( 1 )

🎯 Indications and Usage 128 words ▾

1 INDICATIONS AND USAGE Febuxostat tablets are xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. ( 1 ) Limitations of Use: Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. ( 1 ) Febuxostat tablets are xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable.

Limitations of Use: Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Recommended dosage is 40 mg or 80 mg once daily. The recommended starting dosage is 40 mg once daily. For patients who do not achieve a serum uric acid (sUA) less than 6 mg/dL after 2 weeks, the recommended dosage is 80 mg once daily.

( 2.1 ) Patients with severe renal impairment: Limit the dosage to 40 mg once daily. ( 2.2 , 8.6 ) Flare prophylaxis is recommended upon initiation of febuxostat. ( 2.4 ) Can be administered without regard to food or antacid use.

( 2.1 )

2.1Recommended Dosage The recommended febuxostat dosage is 40 mg or 80 mg once daily. The recommended starting dosage of febuxostat tablet is 40 mg once daily. For patients who do not achieve a serum uric acid (sUA) less than 6 mg/dL after two weeks, the recommended febuxostat dosage is 80 mg once daily.

Febuxostat tablets can be taken without regard to food or antacid use [see Clinical Pharmacology ( 12.3 )]. Concurrent prophylactic treatment with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended [see Dosage and Administration (2.4) and Warnings and Precautions ( 5.2 )].

2.2Dosage Recommendations in Patients with Renal Impairment and Hepatic Impairment The recommended dosage of febuxostat is limited to 40 mg once daily in patients with severe renal impairment. No dose modification is necessary when administering febuxostat in patients with mild or moderate renal impairment [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )]. No dosage modification is necessary in patients with mild to moderate hepatic impairment [see Use in Specific Populations ( 8.7 ) and Clinical Pharmacology ( 12.3 )] .

2.3Serum Uric Acid Level Monitoring Testing for the target serum uric acid level of less than 6 mg/dL may be performed as early as two weeks after initiating febuxostat therapy.

2.4Recommended Prophylaxis for Gout Flares Gout flares may occur after initiation of febuxostat due to changing serum uric acid levels resulting in mobilization of urate from tissue deposits. Flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended upon initiation of febuxostat tablets. Prophylactic therapy may be beneficial for up to six months [see Clinical Studies ( 14.1 )] .

If a gout flare occurs during febuxostat tablets treatment, febuxostat tablets need not be discontinued. The gout flare should be managed concurrently, as appropriate for the individual patient [see Warnings and Precautions ( 5.2 )] .

💊 Dosage Forms and Strengths 55 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablet: 40 mg, 80 mg. ( 3 ) 40 mg tablets, white to off-white, beveled-edge, oval-shaped tablets debossed with "401" on one side and plain on the other side. 80 mg tablets, white to off-white, beveled-edge, round-shaped tablets debossed with "402" on one side and plain on the other side.

⛔ Contraindications 34 words ▾

4 CONTRAINDICATIONS Febuxostat is contraindicated in patients being treated with azathioprine or mercaptopurine. ( 4 ) Febuxostat is contraindicated in patients being treated with azathioprine or mercaptopurine [see Drug Interactions ( 7 )] .

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Gout Flares: An increase in gout flares is frequently observed after initiation of febuxostat. If a gout flare occurs during treatment, febuxostat need not be discontinued. Prophylactic therapy (i.e., non-steroidal anti-inflammatory drug or colchicine) upon initiation of treatment may be beneficial for up to six months.

( 2.4 , 5.2 ) Hepatic Effects: Cases of hepatic failure, some fatal, have been reported. If liver injury is detected, promptly interrupt febuxostat and treat cause, if possible, to resolution or stabilization. Permanently discontinue febuxostat if liver injury is confirmed, and no alternate etiology can be found.

( 5.3 ) Serious Skin Reactions: Serious skin and hypersensitivity reactions, including Stevens-Johnson Syndrome, drug reaction with eosinophilia and systemic symptoms and toxic epidermal necrolysis have been reported in patients taking febuxostat. Discontinue febuxostat if serious skin reactions are suspected. ( 5.4 )

5.1Cardiovascular Death In a cardiovascular (CV) outcome study, gout patients with established CV disease treated with febuxostat had a higher rate of CV death compared to those treated with allopurinol. Sudden cardiac death was the most common cause of adjudicated CV deaths, 2.7% in the febuxostat group (83 of 3,098) as compared to 1.8% in the allopurinol group (56 of 3,092). Febuxostat was similar to allopurinol for nonfatal myocardial infarction (MI), nonfatal stroke and unstable angina with urgent coronary revascularization [see Clinical Studies ( 14.2 )] .

Because of the increased risk of CV death, febuxostat should only be used in patients who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable [see Indications and Usage ( 1 )] . Consider the risks and benefits of febuxostat when deciding to prescribe or continue patients on febuxostat. Consider use of prophylactic low-dose aspirin therapy in patients with a history of CV disease.

Monitor patients for the development of CV events. Inform patients about the symptoms of serious CV events and the steps to take if they occur.

5.2Gout Flares After initiation of febuxostat, an increase in gout flares is frequently observed. This increase is due to reduction in serum uric acid levels, resulting in mobilization of urate from tissue deposits. In order to prevent gout flares when febuxostat is initiated, concurrent prophylactic treatment with an NSAID or colchicine is recommended [see Dosage and Administration ( 2.4 )].

5.3Hepatic Effects Cases of fatal and nonfatal hepatic failure in patients taking febuxostat, have been reported. During randomized controlled studies, transaminase elevations greater than three times the upper limit of normal (ULN) were observed (AST: 2%, 2%, and ALT: 3%, 2% in febuxostat and allopurinol-treated patients, respectively). No dose-effect relationship for these transaminase elevations was noted [see Clinical Pharmacology ( 12.3 )] .

Obtain a liver test panel (serum alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase, and total bilirubin) as a baseline before initiating febuxostat. Measure liver tests promptly in patients who report symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice. In this clinical context, if the patient presents abnormal liver tests (ALT or AST greater than three times the upper limit of the reference range), interrupt febuxostat treatment while investigating the probable cause.

Permanently discontinue febuxostat if liver injury is confirmed, and no alternate etiology can be found. Permanently discontinue febuxostat in patients who have serum ALT or AST greater than three times the reference range with serum total bilirubin greater than two times the reference range without alternative etiologies because they are at risk for severe drug-induced…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the prescribing information: Cardiovascular Death [see Warnings and Precautions ( 5.1 )] Hepatic Effects [see Warnings and Precautions ( 5.3 )] Serious Skin Reactions [see Warnings and Precautions ( 5.4 )] Adverse reactions in ≥ 1% of patients treated with febuxostat are liver function abnormalities, nausea, arthralgia, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viona Pharmaceuticals Inc. at 1-888-304-5011 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. In Phase 2 and 3 clinical studies, a total of 2,757 patients with hyperuricemia and gout were treated with febuxostat 40 mg or 80 mg daily. For febuxostat 40 mg, 559 patients were treated for ≥ 6 months.

For febuxostat 80 mg, 1,377 patients were treated for ≥ 6 months, 674 patients were treated for ≥ 1 year and 515 patients were treated for ≥ 2 years. In the CARES study, a total of 3098 patients were treated with febuxostat 40 mg or 80 mg daily; of these, 2155 patients were treated for ≥ 1 year and 1539 were treated for ≥ 2 years [see Clinical Studies ( 14.2 )] . Most Common Adverse Reactions In three randomized, controlled clinical studies (Studies 1, 2 and 3), which were 6 to 12 months in duration, the following adverse reactions were reported by the treating physician as related to study drug.

Table 1 summarizes adverse reactions reported at a rate of at least 1% in febuxostat treatment groups and at least 0.5% greater than placebo. Table 1 Adverse Reactions Occurring in ≥ 1% of Patients Treated with Febuxostat and at Least 0.5% Greater than in Patients Receiving Placebo in Controlled Studies * Of the patients who received allopurinol, 10 received 100 mg, 145 received 200 mg, and 1122 received 300 mg, based on level of renal impairment. Adverse Reactions Placebo Febuxostat Allopurinol* (N=134) 40 mg daily (N=757) 80 mg daily (N=1,279) (N=1,277) Liver Function Abnormalities 0.7% 6.6% 4.6% 4.2% Nausea 0.7% 1.1% 1.3% 0.8% Arthralgia 0% 1.1% 0.7% 0.7% Rash 0.7% 0.5% 1.6% 1.6% The most common adverse reaction leading to discontinuation from therapy was liver function abnormalities in 1.8% of febuxostat 40 mg, 1.2% of febuxostat 80 mg, and in 0.9% of patients treated with allopurinol.

In addition to the adverse reactions presented in Table 1, dizziness was reported in more than 1% of patients treated with febuxostat although not at a rate more than 0.5% greater than placebo. In the CARES study, liver function abnormalities and diarrhea were reported in more than 1% of patients treated with febuxostat, although not at a rate more than 0.5% greater than allopurinol. Less Common Adverse Reactions In clinical studies the following adverse reactions occurred in less than 1% of patients and in more than one subject treated with doses ranging from 40 mg to 240 mg of febuxostat.

This list also includes adverse reactions (less than 1% of patients) associated with organ systems from Warnings and Precautions. Blood and Lymphatic System Disorders : anemia, idiopathic thrombocytopenic purpura, leukocytosis/leukopenia, neutropenia, pancytopenia, splenomegaly, thrombocytopenia. Cardiac Disorders : angina pectoris, atrial fibrillation/flutter, cardiac murmur, ECG abnormal, palpitations, sinus bradycardia, tachycardia.

Ear and Labyrinth Disorders : deafness, tinnitus, vertigo. Eye Disorders : vision blurred. Gastrointestinal Disorders : abdominal distention, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, frequent stools, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gingival pain, hematemesis, hyperchlorhydria, hematochezia, mouth ulceration, pancreatitis,…

🔄 Drug Interactions 176 words ▾

7 DRUG INTERACTIONS Concomitant administration of febuxostat with XO substrate drugs, azathioprine or mercaptopurine could increase plasma concentrations of these drugs resulting in severe toxicity. ( 7 )

7.1Xanthine Oxidase Substrate Drugs Febuxostat is an XO inhibitor. A drug interaction study of febuxostat and azathioprine, also metabolized by XO, showed an increase in exposure of 6-mercaptopurine which may lead to toxicity [see Clinical Pharmacology ( 12.3 )] . Drug interaction studies of febuxostat with other drugs that are metabolized by XO (e.g., mercaptopurine) have not been conducted.

Febuxostat is contraindicated in patients being treated with azathioprine or mercaptopurine [see Contraindications ( 4 )].

7.2Cytotoxic Chemotherapy Drugs Drug interaction studies of febuxostat with cytotoxic chemotherapy have not been conducted. No data are available regarding the safety of febuxostat during cytotoxic chemotherapy.

7.3In Vivo Drug Interaction Studies Based on drug interaction studies in healthy patients, febuxostat does not have clinically significant interactions with colchicine, naproxen, indomethacin, hydrochlorothiazide, warfarin or desipramine [see Clinical Pharmacology ( 12.3 )]. Therefore, febuxostat may be used concomitantly with these medications.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Patients with severe hepatic impairment: No studies have been conducted in this patient population. Caution should be exercised in these patients. ( 8.7 ) Patients with secondary hyperuricemia (including patients being treated for Lesch-Nyhan syndrome or malignant disease, or in organ transplant recipients): febuxostat is not recommended for use as no studies have been conducted in this patient population. ( 8.8 )

8.1Pregnancy Risk Summary Limited available data with febuxostat use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. No adverse developmental effects were observed in embryo-fetal development studies with oral administration of febuxostat to pregnant rats and rabbits during organogenesis at doses that produced maternal exposures up to 40 and 51 times, respectively, the exposure at the maximum recommended human dose (MRHD). No adverse developmental effects were observed in a pre-and postnatal development study with administration of febuxostat to pregnant rats from organogenesis through lactation at an exposure approximately 11 times the MRHD (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US 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 in pregnant rats dosed during the period of organogenesis from gestation Days 7 - 17, febuxostat was not teratogenic and did not affect fetal development or survival at exposures up to approximately 40 times the MRHD (on an AUC basis at maternal oral doses up to 48 mg/kg/day). In an embryo-fetal development study in pregnant rabbits dosed during the period of organogenesis from gestation Days 6 – 18, febuxostat was not teratogenic and did not affect fetal development at exposures up to approximately 51 times the MRHD (on an AUC basis at maternal oral doses up to 48 mg/kg/day).

In a pre-and postnatal development study in pregnant female rats dosed orally from gestation Day 7 through lactation Day 20, febuxostat had no effects on delivery or growth and development of offspring at a dose approximately 11 times the MRHD (on an AUC basis at a maternal oral dose of 12 mg/kg/day). However, increased neonatal mortality and a reduction in neonatal body weight gain were observed in the presence of maternal toxicity at a dose approximately 40 times the MRHD (on an AUC basis at a maternal oral dose of 48 mg/kg/day).

Febuxostat crossed the placental barrier following oral administration to pregnant rats and was detected in fetal tissues.

8.2Lactation Risk Summary There are no data on the presence of febuxostat in human milk, the effects on the breastfed infant, or the effects on milk production. Febuxostat is present in rat milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for febuxostat and any potential adverse effects on the breastfed child from febuxostat or from the underlying maternal condition.

Data Animal Data Orally administered febuxostat was detected in the milk of lactating rats at up to approximately 7 times the plasma concentration.

8.4Pediatric Use Safety and effectiveness of febuxostat in pediatric patients have not been established.

8.5Geriatric Use No dose adjustment is necessary in elderly patients. Of the total number of patients in Studies 1, 2, and 3 (clinical studies of febuxostat in the treatment of gout) [see Clinical Studies ( 14.1 )] , 16 % were 65 and over, while 4 % were 75 and over. Comparing patients in different age groups, no clinically significant differences in safety or effectiveness were observed but greater sensitivity of some older individuals cannot be ruled out.

T…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Limited available data with febuxostat use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. No adverse developmental effects were observed in embryo-fetal development studies with oral administration of febuxostat to pregnant rats and rabbits during organogenesis at doses that produced maternal exposures up to 40 and 51 times, respectively, the exposure at the maximum recommended human dose (MRHD). No adverse developmental effects were observed in a pre-and postnatal development study with administration of febuxostat to pregnant rats from organogenesis through lactation at an exposure approximately 11 times the MRHD (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US 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 in pregnant rats dosed during the period of organogenesis from gestation Days 7 - 17, febuxostat was not teratogenic and did not affect fetal development or survival at exposures up to approximately 40 times the MRHD (on an AUC basis at maternal oral doses up to 48 mg/kg/day). In an embryo-fetal development study in pregnant rabbits dosed during the period of organogenesis from gestation Days 6 – 18, febuxostat was not teratogenic and did not affect fetal development at exposures up to approximately 51 times the MRHD (on an AUC basis at maternal oral doses up to 48 mg/kg/day).

In a pre-and postnatal development study in pregnant female rats dosed orally from gestation Day 7 through lactation Day 20, febuxostat had no effects on delivery or growth and development of offspring at a dose approximately 11 times the MRHD (on an AUC basis at a maternal oral dose of 12 mg/kg/day). However, increased neonatal mortality and a reduction in neonatal body weight gain were observed in the presence of maternal toxicity at a dose approximately 40 times the MRHD (on an AUC basis at a maternal oral dose of 48 mg/kg/day).

Febuxostat crossed the placental barrier following oral administration to pregnant rats and was detected in fetal tissues.

🧒 Pediatric Use 15 words ▾

8.4Pediatric Use Safety and effectiveness of febuxostat in pediatric patients have not been established.

🧓 Geriatric Use 116 words ▾

8.5Geriatric Use No dose adjustment is necessary in elderly patients. Of the total number of patients in Studies 1, 2, and 3 (clinical studies of febuxostat in the treatment of gout) [see Clinical Studies ( 14.1 )] , 16 % were 65 and over, while 4 % were 75 and over. Comparing patients in different age groups, no clinically significant differences in safety or effectiveness were observed but greater sensitivity of some older individuals cannot be ruled out.

The C max and AUC 24 of febuxostat following multiple oral doses of febuxostat in geriatric patients (≥ 65 years) were similar to those in younger patients (18 to 40 years) [see Clinical Pharmacology ( 12.3 )].

🆘 Overdosage 48 words ▾

10 OVERDOSAGE Febuxostat tablets were studied in healthy patients in doses up to 300 mg daily for seven days without evidence of dose-limiting toxicities. No overdose of febuxostat tablet was reported in clinical studies. Patients should be managed by symptomatic and supportive care should there be an overdose.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Febuxostat, a xanthine oxidase inhibitor, achieves its therapeutic effect by decreasing serum uric acid. Febuxostat is not expected to inhibit other enzymes involved in purine and pyrimidine synthesis and metabolism at therapeutic concentrations.

12.2Pharmacodynamics Effect on Uric Acid and Xanthine Concentrations In healthy patients, febuxostat resulted in a dose dependent decrease in 24 hours mean serum uric acid concentrations and an increase in 24 hours mean serum xanthine concentrations. In addition, there was a decrease in the total daily urinary uric acid excretion. Also, there was an increase in total daily urinary xanthine excretion.

Percent reduction in 24 hours mean serum uric acid concentrations was between 40% and 55% at the exposure levels of 40 mg and 80 mg daily doses. Effect on Cardiac Repolarization The effect of febuxostat on cardiac repolarization as assessed by the QTc interval was evaluated in normal healthy patients and in patients with gout. Febuxostat in doses up to 300 mg daily (3.75 times the maximum recommended daily dosage), at steady-state, did not demonstrate an effect on the QTc interval.

12.3Pharmacokinetics In healthy patients, maximum plasma concentrations (C max ) and AUC of febuxostat increased in a dose proportional manner following single and multiple doses of 10 mg (0.25 times the lowest recommended dosage) to 120 mg (1.5 times the maximum recommended dosage). There is no accumulation when therapeutic doses are administered every 24 hours. Febuxostat has an apparent mean terminal elimination half-life (t 1/2 ) of approximately 5 hours to 8 hours.

Febuxostat pharmacokinetic parameters for patients with hyperuricemia and gout estimated by population pharmacokinetic analyses were similar to those estimated in healthy patients. Absorption The absorption of radiolabeled febuxostat following oral dose administration was estimated to be at least 49% (based on total radioactivity recovered in urine). Maximum plasma concentrations of febuxostat occurred between 1 hour and 1.5 hours postdose.

After multiple oral 40 mg and 80 mg once daily doses, C max is approximately 1.6 ± 0.6 mcg/mL (N=30), and 2.6 ± 1.7 mcg/mL (N=227), respectively. Absolute bioavailability of the febuxostat tablet has not been studied. Following multiple 80 mg once daily doses with a high fat meal, there was a 49% decrease in C max and an 18% decrease in AUC, respectively.

However, no clinically significant change in the percent decrease in serum uric acid concentration was observed (58% fed vs. 51% fasting). Thus, febuxostat may be taken without regard to food.

Concomitant ingestion of an antacid containing magnesium hydroxide and aluminum hydroxide with an 80 mg single dose of febuxostat has been shown to delay absorption of febuxostat (approximately one hour) and to cause a 31% decrease in C max and a 15% decrease in AUC ∞ . As AUC rather than C max was related to drug effect, change observed in AUC was not considered clinically significant. Therefore, febuxostat may be taken without regard to antacid use.

Distribution The mean apparent steady-state volume of distribution (V ss /F) of febuxostat was approximately 50 L (CV ~40%). The plasma protein binding of febuxostat is approximately 99.2% (primarily to albumin), and is constant over the concentration range achieved with 40 mg and 80 mg doses. Metabolism Febuxostat is extensively metabolized by both conjugation via uridine diphosphate glucuronosyltransferase (UGT) enzymes including UGT1A1, UGT1A3, UGT1A9, and UGT2B7 and oxidation via cytochrome P450 (CYP) enzymes including CYP1A2, 2C8 and 2C9 and non-P450 enzymes.

The relative contribution of each enzyme isoform in the metabolism of febuxostat is not clear. The oxidation of the isobutyl side chain leads to the formation of four pharmacologically active hydroxy metabolites, all of which occur in plasma of humans at a much lower extent than febuxostat. In urine and feces,…

🧬 Mechanism of Action 37 words ▾

12.1Mechanism of Action Febuxostat, a xanthine oxidase inhibitor, achieves its therapeutic effect by decreasing serum uric acid. Febuxostat is not expected to inhibit other enzymes involved in purine and pyrimidine synthesis and metabolism at therapeutic concentrations.

📦 How Supplied / Storage and Handling 186 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Febuxostat Tablets, 40 mg are white to off-white, beveled-edge, oval-shaped tablets debossed with "401" on one side and plain on the other side and are supplied as follows: NDC 72578-136-06 in bottle of 30 tablets with child-resistant closure. NDC 72578-136-16 in bottle of 90 tablets with child-resistant closure. NDC 72578-136-01 in bottle of 100 tablets NDC 72578-136-05 in bottle of 500 tablets NDC 72578-136-10 in bottle of 1,000 tablets NDC 72578-136-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Febuxostat Tablets, 80 mg are white to off-white, beveled-edge, round-shaped tablets debossed with "402" on one side and plain on the other side and are supplied as follows: NDC 72578-137-06 in bottle of 30 tablets with child-resistant closure.

NDC 72578-137-16 in bottle of 90 tablets with child-resistant closure. NDC 72578-137-01 in bottle of 100 tablets NDC 72578-137-05 in bottle of 500 tablets NDC 72578-137-10 in bottle of 1,000 tablets NDC 72578-137-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light.

📋 Description 130 words ▾

11 DESCRIPTION Febuxostat is a xanthine oxidase inhibitor. The active ingredient in febuxostat tablet is 2-[3-cyano-4-(2-methylpropoxy) phenyl]-4-methylthiazole-5-carboxylic acid, with a molecular weight of 316.37. The molecular formula is C 16 H 16 N 2 O 3 S.

The chemical structure is: Febuxostat is a non-hygroscopic, white to off-white colored powder that is freely soluble in dimethylformamide; soluble in dimethylsulfoxide; sparingly soluble in ethanol; slightly soluble in methanol and acetonitrile; and practically insoluble in water. The melting range is 205°C to 208°C. Each febuxostat tablet intended for oral administration contains 40 mg and 80 mg of febuxostat.

In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, povidone, sodium stearyl fumarate, talc and titanium dioxide. Structured product formula for febuxostat

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). CV Death Inform patients that gout patients with established CV disease treated with febuxostat had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study. Inform all patients of the higher rate of CV death with febuxostat compared to allopurinol.

Alert all patients (those with and without CV disease) for the development of signs and symptoms of CV events and to seek medical care promptly should they occur [see Warnings and Precautions ( 5.1 )] . Gout Flares Inform patients that after initiation of febuxostat an increase in gout flares can occur and that is not reason to stop taking the medication. Instruct patients that it is recommended to initiate and continue gout prophylaxis therapy for six months while taking febuxostat [see Warnings and Precautions ( 5.2 )] .

Hepatic Effects Inform patients that hepatic effects, including fatal ones, have occurred in patients treated with febuxostat. Instruct them to inform their healthcare provider if they experience liver injury symptoms [see Warnings and Precautions ( 5.3 )] . Serious Skin Reactions Inform patients that serious skin and hypersensitivity reactions have occurred in patients treated with febuxostat.

Instruct patients to discontinue febuxostat if they develop symptoms of these reactions [see Warnings and Precautions ( 5.4 )] . Medication Guide available at www.vionausa.com/medguides or call 1-888-304-5011.

💬 Medication Guide ~3 min read ▾

SPL MEDGUIDE MEDICATION GUIDE Febuxostat (fe buxʹ oh stat) Tablets, for oral use Read the Medication Guide that comes with febuxostat tablets before you start taking it and each time you get a refill. There may be new information. The Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information that I should know about Febuxostat Tablets? Febuxostat tablets may cause serious side effects, including: Heart-related deaths. Call your doctor or get emergency medical help right away if you have any of the following symptoms, especially if they are new, worse, or worry you: chest pain numbness or weakness on one side of your body shortness of breath or trouble breathing slurring of speech dizziness, fainting or feeling lightheaded sudden blurry vision or sudden severe headache rapid or irregular heartbeat What are Febuxostat Tablets?

Febuxostat tablet is a prescription medicine called a xanthine oxidase (XO) inhibitor used to lower blood uric acid levels in adult patients with gout when allopurinol has not worked well enough or when allopurinol is not right for you. Febuxostat tablets are not for use in people who do not have symptoms of high blood uric acid levels. It is not known if febuxostat tablets are safe and effective in children.

Who should not take Febuxostat Tablets? Do not take febuxostat tablets if you: take Azathioprine (Azasan ®$ , Imuran ®$ ) take Mercaptopurine (Purinethol ®$ , Purixan ®$ ) What should I tell my doctor before taking Febuxostat Tablets? Before taking febuxostat tablets tell your doctor about all of your medical conditions, including if you: have taken allopurinol and what happened to you while you were taking it. have a history of heart disease or stroke. have liver or kidney problems. are pregnant or plan to become pregnant.

It is not known if febuxostat tablets will harm your unborn baby. Talk with your doctor if you are pregnant or plan to become pregnant. are breastfeeding or plan to breastfeed. It is not known if febuxostat passes into your breast milk.

You and your doctor should decide if you should take febuxostat tablets while breastfeeding. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Febuxostat tablets may affect the way other medicines work, and other medicines may affect how febuxostat tablets works.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. How should I take Febuxostat Tablets?

Take febuxostat tablets exactly as your doctor tells you to take it. Febuxostat tablets can be taken with or without food. Febuxostat tablets can be taken with antacids.

Your gout may get worse (flare) when you start taking febuxostat tablets. Do not stop taking febuxostat tablets because you have a flare. Your doctor may do certain tests while you take febuxostat tablets.

What are the possible side effects of Febuxostat Tablets? Febuxostat tablets may cause serious side effects, including: Heart problems. See "What is the most important information I should know about Febuxostat Tablets?".

Gout Flares. Gout flares can happen when you start taking febuxostat tablets. Your doctor may give you other medicines to help prevent your gout flares.

Liver problems. Liver problems can happen in people who take febuxostat tablets. Your doctor may do blood tests to check how well your liver is working before and during your treatment with febuxostat tablets.

Tell your doctor if you get any of the following signs or symptoms of liver problems: fatigue dark or "tea-colored" urine loss of appetite for several days or longer your skin or the white part of your eyes turns yellow (jaundice) pain, aching, or tenderness on the right side of your stomach-area Severe skin and allergic reactions. Serious skin and allergic reactions that may affect different parts of the body such…

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