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VOTRIENT pazopanib hydrochloride 200 mg Tablet, Film Coated, 120-count

by Novartis Pharmaceuticals Corporation · 120 TABLET, FILM COATED in 1 BOTTLE (0078-1077-66)

NDC 00078-1077-66

🏷️ FDA NDC (as labeled) 0078-1077-66 billing pads the labeler segment with a zero

Rx only Brand On market Non-controlled

🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

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

Past resolved recalls for this product (1)

Class III · Nov 20, 2023 · Completed — Failed Dissolution Specifications (Siegfried Barbera, SL) · FDA recall D-0149-2024

🆔 Identity & classification

FDA NDC (as labeled) 0078-1077-66

Product NDC 0078-1077

11-digit billing NDC 00078107766

NCPDP billing unit EA — each (per item)

RxCUI 867502, 867506

UNII 33Y9ANM545

Application # NDA022465

SPL Set ID eeaaaf38-fb86-4d9f-a19d-0f61daac2fd7

Established class (EPC) Kinase Inhibitor

Mechanism of action Cytochrome P450 2C8 Inhibitors; Cytochrome P450 2D6 Inhibitors; Cytochrome P450 3A4 Inhibitors; Protein Kinase Inhibitors

DEA schedule Non-controlled

Marketing category NDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2016-07-12

Route ORAL

Dosage form TABLET, FILM COATED

Substance PAZOPANIB HYDROCHLORIDE

GPI-14 21533042100320

GPI class Votrient

GCN Seq No 065777

GCN 27829

HICL code 036709

Ingredient (HICL) Pazopanib Hcl

HIC1 code V

Therapeutic class — broad (HIC1) Neoplasms

HIC2 code V1

Therapeutic class — intermediate (HIC2) Antineoplastic Drugs

HIC3 code V1Q

Therapeutic class — specific (HIC3) Antineoplastic Systemic Enzyme Inhibitors

AHFS code 10:00.00.00

AHFS class Antineoplastic Agents

FDB label name VOTRIENT 200 MG TABLET

FDB brand name Votrient

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 0078-1077-66 — a 4-4-2 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 labeler segment → 00078-1077-66. 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, Cytochrome P450 2D6 Inhibitors, Cytochrome P450 3A4 Inhibitors, Cytochrome P450 2C8 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

LabelerNovartis Pharmaceuticals Corporation

Application holderNOVARTIS PHARMACEUTICALS CORP

FDA applicationNDA022465 (NDA)

Labeler code00078

First marketedJul 2016

Product typeHuman Prescription Drug

Portfolio209 products on file

🔎 All NDCs from Novartis Pharmaceuticals Corporation

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 VOTRIENT 200 MG TABLET Ingredient Pazopanib Hcl

📖 What it is MedlinePlus · NLM

Pazopanib is used to treat advanced renal cell carcinoma (RCC, a type of cancer that begins in the cells of the kidneys) in adults. Pazopanib is in a class of medications called kinase inhibitors. It works by slowing or stopping the spread of cancer cells.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

Pazopanib targets the signals that allow cancer cells and the blood vessels feeding them to grow. By blocking these signals, it can slow or stop the growth of advanced kidney cance...
What exactly is pazopanib treating in my body?
Yes, it matters a lot. You should take pazopanib on an empty stomach — at least 1 hour before or 2 hours after eating. Even a light meal can roughly double how much drug gets into...
Does it matter if I eat before taking my tablet?

📖 Read our full Pazopanib guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

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

💊 What it looks like

Color Pink

ShapeFreeform

ImprintGS;JT

Size14 mm

ScoringNot scored

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

Where does this data come from?

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

🧪 Inactive Ingredients / Excipients

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

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

UNII 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 XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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 B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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.

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

Where does this data come from?

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

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

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

Why might an inactive ingredient be missing?

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

Can inactive ingredients matter?

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

💲 Pricing

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

Price system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	$147.80	$17,735.52 / 120 tablets
Medicare drug plans payPart D · Q2 2026	$145.99	$17,519.30 / 120 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Votrient 200 mgthis 00078-1077-66	Novartis	120 tablets	—	AB	FDA listed	—
Pazopanib 200 mg 00480-4184-89	Teva	120 tablets	—	AB	FDA listed	—
Pazopanib 200 mg 42291-0939-12	AvKARE	120 tablets	—	AB	FDA listed	—
Pazopanib 200 mg 51407-0872-12	Golden	120 tablets	—	AB	FDA listed	—
Pazopanib 200 mg 59651-0582-08	Aurobindo	120 tablets	—	AB	FDA listed	—
Pazopanib 200 mg 60505-4779-05	Apotex	500 tablets	—	AB	FDA listed	—
Pazopanib 200 mg 63304-0116-13	SUN	120 tablets	—	AB	FDA listed	—
pazopanib 200 mg 82293-0022-10	Novugen	120 tablets	—	AB	FDA listed	—

About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.

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

On the market since

Jul 2016

📍

2026

Currently FDA-listed

10 years listed

🔒

Generic approved (availability unconfirmed)

see note

🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

Where does this data come from?

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

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00078-1077-66, not the drug overall. Other pack sizes report separately.

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

📅 Q1 2025 – Q4 2025 · 4 quarters of data

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

Prescriptions last 4 qtrs

382

Units reimbursed last 4 qtrs

37.2K

Gross reimbursed last 4 qtrs

$5.5M

Avg / prescription

$14,391.54

Avg / unit

$147.80

Latest quarter Q4 2025

91Rx

Fee-for-service vs managed care ⓘ

77% FFS 23% MCO

Fee-for-service · 295 Rx Managed care · 87 Rx

State Medicaid map

Units reimbursed · per 100k residents

21.864.0

gray = no data reported ⓘ

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

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 New York 64.0 /100k

2 Connecticut 55.6 /100k

3 California 36.5 /100k

4 Florida 25.8 /100k

5 Ohio 21.8 /100k

National units — by quarter

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

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

Medicare Part D (outpatient prescription) spending for Votrient — 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 Votrient. 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

$1.13M

Claims incl. refills

Beneficiaries

Spend / beneficiary

$27,519.25

Spend / claim

$12,398.79

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 NDC	Description	Marketing start	Status
00078-1077-66 You're viewing this	120 TABLET, FILM COATED in 1 BOTTLE (0078-1077-66)	2021-12-13	Active

🧭 About this NDC listing & data coverage

Finished prescription product

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

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

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

Questions about this listing

Why is there no price listed?

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

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

Yes, they identify this exact package in different formats. The FDA registers it as 0078-1077-66, 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: 00078-1077-66, written without dashes as 00078107766. 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 00078-1077-66, the first segment (00078) is the labeler code FDA assigned to Novartis Pharmaceuticals Corporation; the middle segment (1077) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (66) 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 Novartis Pharmaceuticals Corporation. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Novartis Pharmaceuticals Corporation 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 62 words ▾

WARNING: HEPATOTOXICITY Severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended [see Warnings and Precautions (5.1)]. WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning.

Severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended. ( 5.1 )

🎯 Indications and Usage 129 words ▾

1 INDICATIONS AND USAGE VOTRIENT is a kinase inhibitor indicated for the treatment of adults with: advanced renal cell carcinoma (RCC). ( 1.1 ) advanced soft tissue sarcoma (STS) who have received prior chemotherapy. ( 1.2 ) Limitations of Use : The efficacy of VOTRIENT for the treatment of patients with adipocytic soft tissue sarcoma or gastrointestinal stromal tumors has not been demonstrated.

1.1Renal Cell Carcinoma VOTRIENT ® is indicated for the treatment of adults with advanced renal cell carcinoma (RCC).

1.2Soft Tissue Sarcoma VOTRIENT is indicated for the treatment of adults with advanced soft tissue sarcoma (STS) who have received prior chemotherapy. Limitations of Use : The efficacy of VOTRIENT for the treatment of patients with adipocytic STS or gastrointestinal stromal tumors has not been demonstrated.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Recommended Dosage : 800 mg orally once daily without food (at least 1 hour before or 2 hours after a meal). ( 2.1 ) Moderate Hepatic Impairment : 200 mg orally once daily. ( 2.2 )

2.1Recommended Dosage The recommended dosage of VOTRIENT is 800 mg (four 200 mg tablets) orally once daily without food (at least 1 hour before or 2 hours after a meal) until disease progression or unacceptable toxicity [see Clinical Pharmacology (12.3)] . The dosage should be modified for hepatic impairment and in patients taking certain concomitant drugs [see Dosage and Administration (2.3, 2.4)] . Swallow tablets whole.

Do not crush tablets due to the potential for increased rate of absorption, which may affect systemic exposure [see Clinical Pharmacology (12.3)] . If a dose is missed, it should not be taken if it is < 12 hours until the next dose.

2.2Dosage Modifications for Adverse Reactions Table 1 summarizes the recommended dose reductions. Table 1. Recommended Dose Reductions of VOTRIENT for Adverse Reactions Dose reduction For renal cell carcinoma For soft tissue sarcoma First 400 mg orally once daily 600 mg orally once daily Second 200 mg orally once daily 400 mg orally once daily Permanently discontinue VOTRIENT in patients unable to tolerate the second dose reduction.

Table 2 summarizes the recommended dosage modifications for adverse reactions. Table 2. Recommended Dosage Modifications of VOTRIENT for Adverse Reactions Abbreviations: ALT, alanine aminotransferase; ULN, upper limit of normal. a National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.

Adverse reaction Severity a Dosage modification Hepatic Toxicity [see Warnings and Precautions (5.1)] Isolated ALT elevations between 3 × ULN and 8 × ULN Continue and monitor liver function weekly until ALT returns to Grade 1 or baseline. Isolated ALT elevations of > 8 × ULN Withhold until improvement to Grade 1 or baseline. If the potential benefit for resuming treatment with VOTRIENT is considered to outweigh the risk for hepatotoxicity, then resume at a reduced dose of no more than 400 mg once daily and measure serum liver tests weekly for 8 weeks.

Permanently discontinue if ALT elevations > 3 × ULN recur despite dose reduction(s). ALT elevations > 3 × ULN occur concurrently with bilirubin elevations > 2 × ULN Permanently discontinue and continue to monitor until resolution. Patients with only a mild, indirect (unconjugated) hyperbilirubinemia, known as Gilbert’s syndrome, and ALT elevations > 3 × ULN should be managed per the recommendations outlined for isolated ALT elevations.

Left Ventricular Systolic Dysfunction [see Warnings and Precautions (5.3)] Symptomatic or Grade 3 Withhold until improvement to Grade < 3. Resume treatment based on medical judgement. Grade 4 Permanently discontinue.

Hemorrhagic Events [see Warnings and Precautions (5.4)] Grade 2 Withhold until improvement to Grade ≤ 1. Resume at reduced dose (see Table 1). Permanently discontinue if Grade 2 recurs after dose interruption and reduction.

Grade 3 or 4 Permanently discontinue. Arterial Thromboembolic Events [see Warnings and Precautions (5.5)] Any grade Permanently discontinue. Venous Thromboembolic Events [see Warnings and Precautions (5.6)] Grade 3 Withhold VOTRIENT and resume at same dose if managed with appropriate therapy for at least one week.

Grade 4 Permanently discontinue. Thrombotic Microangiopathy [see Warnings and Precautions (5.7)] Any grade Permanently discontinue. Gastrointestinal Perforation [see Warnings and Precautions (5.8)] Any grade Permanently discontinue.

Gastrointestinal Fistula [see Warnings and Precautions (5.8)] Grade 2 or 3 Withhold and resume based on medical judgement. Grade 4 Permanently discontinue. Interstitial Lung Disease / Pneumonitis [see Warnings and Precautions (5.9)] Any grade Permanently discontinue.

Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions (5.10)] Any grade Permanently discontinue. Hy…

💊 Dosage Forms and Strengths 27 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 200 mg, modified capsule-shaped, gray or pink, film-coated with ‘GS JT’ debossed on one side. Tablets: 200 mg ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hepatic Toxicity : Severe and fatal hepatotoxicity has occurred. Monitor liver tests at baseline, regularly during treatment and as clinically indicated. Withhold VOTRIENT and resume at reduced dose with continued weekly monitoring for 8 weeks, or permanently discontinue with weekly monitoring until resolution based on severity of hepatotoxicity.

( 2.2 , 5.1 ) QT Prolongation and Torsades de Pointes : Monitor patients who are at significant risk of developing QT interval prolongation. Monitor electrocardiograms (ECGs) and electrolytes at baseline and as clinically indicated. Correct hypokalemia, hypomagnesemia, and hypocalcemia prior to initiating VOTRIENT and during treatment.

( 5.2 , 12.2 ) Cardiac Dysfunction : Cardiac dysfunction, including decreased left ventricular ejection fraction (LVEF) and congestive heart failure, have occurred. Monitor blood pressure and manage as appropriate. Monitor for clinical signs or symptoms of congestive heart failure.

Conduct baseline and periodic evaluation of LVEF in patients at risk of cardiac dysfunction. Withhold or permanently discontinue VOTRIENT based on severity of cardiac dysfunction. ( 2.2 , 5.3 ) Hemorrhagic Events : Fatal hemorrhagic events have occurred.

VOTRIENT has not been studied in patients who have a history of hemoptysis, cerebral hemorrhage, or clinically significant gastrointestinal hemorrhage in the past 6 months. Withhold VOTRIENT and resume at reduced dose or permanently discontinue based on severity of hemorrhagic events. ( 2.2 , 5.4 ) Arterial Thromboembolic Events : Arterial thromboembolic events have been observed and can be fatal.

VOTRIENT has not been studied in patients who have had an arterial thromboembolic event within the previous 6 months. Permanently discontinue VOTRIENT in case of an arterial thromboembolic event. ( 2.2 , 5.5 ) Venous Thromboembolic Events : Venous thromboembolic events (VTEs) have been observed, including fatal pulmonary emboli (PE).

Monitor for signs and symptoms of VTE and PE. Withhold VOTRIENT and then resume at same dose or permanently discontinue based on severity of VTE. ( 2.2 , 5.6 ) Thrombotic Microangiopathy : Thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS), has been observed.

Permanently discontinue VOTRIENT if TMA occurs. ( 2.2 , 5.7 ) Gastrointestinal Perforation and Fistula : Fatal perforation events have occurred. Monitor for signs and symptoms of gastrointestinal perforation or fistula.

Withhold VOTRIENT in case of Grade 2 or 3 gastrointestinal fistula and resume based on medical judgement. Permanently discontinue VOTRIENT in case of gastrointestinal perforation or Grade 4 gastrointestinal fistula. ( 2.2 , 5.8 ) Interstitial Lung Disease/Pneumonitis : Can be fatal.

Monitor patients for pulmonary symptoms. Permanently discontinue VOTRIENT in patients who develop interstitial lung disease (ILD) or pneumonitis. ( 2.2 , 5.9 ) Posterior Reversible Encephalopathy Syndrome : Can be fatal.

Permanently discontinue VOTRIENT in patients who develop posterior reversible encephalopathy syndrome (PRES). ( 2.2 , 5.10 ) Hypertension : Hypertension, including hypertensive crisis, has been observed. Do not initiate VOTRIENT in patients with uncontrolled hypertension.

Optimize blood pressure prior to initiating VOTRIENT. Monitor blood pressure as clinically indicated and initiate and adjust antihypertensive therapy as appropriate. Withhold and then dose reduce VOTRIENT or permanently discontinue based on severity of hypertension.

( 2.2 , 5.11 ) Risk of Impaired Wound Healing : Withhold VOTRIENT for at least 1 week prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of VOTRIENT after resolution of wound healing complications has not been established.

( 5.12 ) Hypothyroidism : Monitor thyroid tests at baseline, during treatment and as clinicall…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are elsewhere in the labeling: Hepatic Toxicity [see Warnings and Precautions (5.1)] QT Prolongation and Torsades de Pointes [see Warnings and Precautions (5.2)] Cardiac Dysfunction [see Warnings and Precautions (5.3)] Hemorrhagic Events [see Warnings and Precautions (5.4)] Arterial Thromboembolic Events [see Warnings and Precautions (5.5)] Venous Thromboembolic Events [see Warnings and Precautions (5.6)] Thrombotic Microangiopathy (TMA) [see Warnings and Precautions (5.7)] Gastrointestinal Perforation and Fistula [see Warnings and Precautions (5.8)] Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions (5.9)] Posterior Reversible Encephalopathy Syndrome (PRES) [see Warnings and Precautions (5.10)] Hypertension [see Warnings and Precautions (5.11)] Hypothyroidism [see Warnings and Precautions (5.13)] Proteinuria [see Warnings and Precautions (5.14)] Tumor Lysis Syndrome [see Warnings and Precautions (5.15)] Infection [see Warnings and Precautions (5.16)] The most common adverse reactions in patients with RCC (≥ 20%) are diarrhea, hypertension, hair color changes (depigmentation), nausea, anorexia, and vomiting.

( 6.1 ) The most common adverse reactions in patients with STS (≥ 20%) are fatigue, diarrhea, nausea, decreased weight, hypertension, decreased appetite, vomiting, tumor pain, hair color changes, musculoskeletal pain, headache, dysgeusia, dyspnea, and skin hypopigmentation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 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 with 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 reflect exposure of 977 patients who received VOTRIENT as a single agent, including 586 VOTRIENT-treated patients with RCC. With a median duration of treatment of 7.4 months (range, 0.1 to 27.6) in these 977 patients, the most common adverse reactions (≥ 20%) in these 586 patients were diarrhea, hypertension, hair color change, nausea, fatigue, anorexia, and vomiting.

The data described in the WARNINGS AND PRECAUTIONS also reflects exposure of 382 patients with advanced soft tissue sarcoma who received VOTRIENT as a single agent, with a median duration of treatment of 3.6 months (range, 0 to 53). The most common adverse reactions (≥ 20%) in these 382 patients were fatigue, diarrhea, nausea, decreased weight, hypertension, decreased appetite, vomiting, tumor pain, hair color changes, musculoskeletal pain, headache, dysgeusia, dyspnea, and skin hypopigmentation. Renal Cell Carcinoma The safety of VOTRIENT was evaluated in 290 patients with RCC who participated in VEG105192, a randomized, double-blind, placebo-controlled trial [see Clinical Studies (14.1)] .

The median duration of treatment was 7.4 months (range, 0 to 23) for patients who received VOTRIENT. Forty-two percent of patients on VOTRIENT required a dose interruption and 36% required a dose reduction. Table 3 presents adverse reactions in VEG105192.

Table 3. Adverse Reactions (≥ 10%) in Patients with RCC Who Received VOTRIENT in VEG105192 Abbreviation: RCC, renal cell carcinoma. a National Cancer Institute Common Terminology Criteria for Adverse Events, version 3. VOTRIENT (N = 290) Placebo (N = 145) All Grades a Grade 3 Grade 4 All Grades a Grade 3 Grade 4 Adverse reactions % % % % % % Diarrhea 52 3 < 1 9 < 1 0 Hypertension 40 4 0 10 < 1 0 Hair color changes 38 < 1 0 3 0 0 Nausea 26 < 1 0 9 0 0 Anorexia 22 2 0 10 < 1 0 Vomiting 21 2 < 1 8 2 0 Fatigue 19 2 0 8 1 1 Asthenia 14 3 0 8 0 0 Abdominal pain 11 2 0 1 0 0 Headache 10 0 0 5 0 0 Other adverse reactions observed more commonly in patients…

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS Strong CYP3A4 Inhibitors : Avoid coadministration of VOTRIENT with strong CYP3A4 inhibitors. If coadministration cannot be avoided, reduce the dose of VOTRIENT. ( 2.4 , 7.1 ) Strong CYP3A4 Inducers : Consider an alternate concomitant medication with no or minimal enzyme induction potential.

VOTRIENT is not recommended if chronic use of strong CYP3A4 inducers cannot be avoided. ( 2.4 , 7.1 ) CYP Substrates : Coadministration of VOTRIENT with agents with narrow therapeutic windows that are metabolized by CYP3A4, CYP2D6, or CYP2C8 is not recommended. ( 7.2 ) Concomitant Use With Simvastatin : Concomitant use of VOTRIENT with simvastatin increases the risk of alanine aminotransferase (ALT) elevations.

Increase to weekly monitoring of liver function as recommended. Withhold VOTRIENT and resume at reduced dose, or permanently discontinue based on severity of hepatotoxicity. ( 7.3 ) Concomitant Use With Gastric Acid-Reducing Agents : Avoid concomitant use of VOTRIENT with gastric acid-reducing agents.

Consider short-acting antacids in place of proton pump inhibitors (PPIs) and H2-receptor antagonists. Separate antacid and pazopanib dosing by several hours. ( 2.4 , 7.4 )

7.1Effect of Other Drugs on VOTRIENT Strong CYP3A4 Inhibitors Coadministration of pazopanib with strong inhibitors of CYP3A4 increases pazopanib concentrations [see Clinical Pharmacology (12.3)] . Avoid coadministration of VOTRIENT with strong CYP3A4 inhibitors and consider an alternate concomitant medication with no or minimal enzyme inhibition potential. If coadministration of a strong CYP3A4 inhibitor cannot be avoided, reduce the dose of VOTRIENT [see Dosage and Administration (2.4)] .

Strong CYP3A4 Inducers Coadministration of strong CYP3A4 inducers may decrease plasma pazopanib concentrations. Consider an alternate concomitant medication with no or minimal enzyme induction potential. VOTRIENT is not recommended if chronic use of strong CYP3A4 inducers cannot be avoided [see Dosage and Administration (2.4)] .

Transporters Coadministration of strong inhibitors of P-gp or BCRP may increase pazopanib concentrations. Avoid concomitant use of VOTRIENT with strong inhibitors of P-gp or BCRP. Consider selection of alternative concomitant medicinal products with no or minimal potential to inhibit P-gp or BCRP.

7.2Effects of VOTRIENT on Other Drugs CYP Substrates Coadministration of VOTRIENT with agents with narrow therapeutic windows that are metabolized by CYP3A4, CYP2D6, or CYP2C8 may result in inhibition of the metabolism of these products and create the potential for serious adverse reactions. The concomitant use of VOTRIENT with agents with narrow therapeutic windows that are metabolized by CYP3A4, CYP2D6, or CYP2C8 is not recommended [see Clinical Pharmacology (12.3)] .

7.3Concomitant Use With Simvastatin Concomitant use of VOTRIENT with simvastatin increases the incidence of ALT elevations. Across clinical trials of VOTRIENT as a single agent, ALT > 3 × ULN was reported in 126/895 (14%) of patients who did not use statins compared with 11/41 (27%) of patients who had concomitant use of simvastatin. If a patient receiving concomitant simvastatin develops ALT elevations, increase to weekly monitoring of liver function as recommended.

Withhold VOTRIENT and resume at reduced dose, or permanently discontinue based on severity of hepatotoxicity [see Dosage and Administration (2.2), Warnings and Precautions (5.1)] . Insufficient data are available to assess the risk of concomitant administration of alternative statins and VOTRIENT.

7.4Concomitant Use With Gastric Acid-Reducing Agents Concomitant use of VOTRIENT with esomeprazole, a PPI, decreased the exposure of pazopanib. Avoid concomitant use of VOTRIENT with gastric acid-reducing agents. If concomitant administration with a gastric acid-reducing agent cannot be avoided, consider short-acting antacids in place of PPIs and H2-receptor antagonists. Separate short-acting antacid and pazopanib dosin…

👥 Use in Specific Populations ~3 min read ▾

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

8.1Pregnancy Risk Summary Based on animal reproduction studies and its mechanism of action [see Clinical Pharmacology (12.1)] , VOTRIENT can cause fetal harm when administered to a pregnant woman. There are no available data on VOTRIENT use in pregnant women to evaluate for a drug-associated risk. In animal developmental and reproductive toxicology studies, oral administration of pazopanib to pregnant rats and rabbits throughout organogenesis resulted in teratogenicity, and abortion at systemic exposures lower than that observed at the MRHD of 800 mg/day (based on AUC) ( see Data ).

Advise pregnant women of the potential risk to a fetus. 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 U.S. general population, the estimated background risk of major birth defects in clinically recognized pregnancies and miscarriage is 2% to 4% and 15% to 20%, respectively. Data Animal Data In a female fertility and early embryonic development study, female rats were administered oral pazopanib at least 15 days prior to mating and for 6 days after mating, which resulted in increased pre-implantation loss and early resorptions at dosages greater than or equal to 30 mg/kg/day (approximately 0.4-fold the AUC at the MRHD of 800 mg/day).

Total litter resorption was seen at 300 mg/kg/day (approximately 0.8-fold the AUC at the MRHD of 800 mg/day). Postimplantation loss, embryolethality, and decreased fetal body weights were noted in females administered doses greater than or equal to 10 mg/kg/day (approximately 0.3-fold the AUC at the MRHD of 800 mg/day). In embryo-fetal developmental toxicity studies in rats and rabbits, oral pazopanib was administered to pregnant animals during organogenesis.

In rats, dose levels of greater than or equal to 3 mg/kg/day (approximately 0.1-fold the AUC at the MRHD of 800 mg/day) resulted in teratogenic effects, including cardiovascular malformations (retroesophageal subclavian artery, missing innominate artery, changes in the aortic arch), incomplete or absent ossification, increases in postimplantation loss, embryolethality and reduced fetal body weight. In rabbits, maternal toxicity, increased postimplantation loss and abortion were observed at doses greater than or equal to 30 mg/kg/day (approximately 0.007-fold the AUC at the MRHD of 800 mg/day).

In addition, severe maternal body weight loss and 100% litter loss were observed at doses greater than or equal to 100 mg/kg/day (0.02-fold the AUC at the MRHD of 800 mg/day), while fetal weight was reduced at doses greater than or equal to 3 mg/kg/day (AUC not calculated).

8.2Lactation Risk Summary There is no data on the presence of pazopanib or its metabolites in human milk or their effects on the breastfed infant or milk production. Because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with VOTRIENT and for 2 weeks after the final dose.

8.3Females and Males of Reproductive Potential VOTRIENT can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)] . Pregnancy Testing Verify pregnancy status of females of reproductive potential prior to starting treatment with VOTRIENT. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with VOTRIENT and for at least 2 weeks after the last dose.

Males Advise males (including those who have had vasectomies) with female partners of reproductive potential to use condoms during treatment with VOTRIENT and for at least 2 weeks after the last dose. Infertility Based on findings from animal studies, VOTRIENT may impair fertility in females and males of reproductive potential while receiving treatment [see Nonclinical Toxicology (13.1)].

8.4 Pe…

🤰 Pregnancy ~2 min read ▾

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use The safety and effectiveness of VOTRIENT in pediatric patients have not been established. VOTRIENT is not indicated for use in pediatric patients [see Warnings and Precautions (5.18)] . Based on its mechanism of action, pazopanib may have severe effects on organ growth and maturation during early postnatal development.

Administration of pazopanib to juvenile rats < 21 days old resulted in toxicity to the lungs, liver, heart, and kidney and in death at doses significantly lower than the clinically recommended dose or doses tolerated in older animals (see Juvenile Animal Toxicity Data) . The safety and efficacy of VOTRIENT or an unapproved pazopanib formulation were investigated but not established in two open-label studies: a study in 37 pediatric patients 2 to < 17 years with recurrent or refractory solid tumors [NCT00929903] and a study in 46 pediatric patients 1 year to < 17 years with refractory solid tumors, including sarcoma [NCT01956669].

Meaningful anti-tumor activity was not observed in these studies. Juvenile Animal Toxicity Data In rats, weaning occurs at Day 21 postpartum which approximately equates to a human pediatric age of 2 years. In a juvenile animal toxicology study performed in rats, when animals were dosed from Day 9 through Day 14 postpartum (pre-weaning), pazopanib caused abnormal organ growth/maturation in the kidney, lung, liver, and heart at approximately 0.1-fold the AUC in adults at the MRHD of 800 mg/day of VOTRIENT.

At approximately 0.4-fold the AUC in adults at the MRHD of 800 mg/day, pazopanib administration resulted in mortality. In repeat-dose toxicology studies in rats, including 4-week, 13-week, and 26-week administration, toxicities in bone, teeth, and nail beds were observed at doses greater than or equal to 3 mg/kg/day (approximately 0.07-fold the AUC at the MRHD of 800 mg/day). Doses of 300 mg/kg/day (approximately 0.8-fold the AUC at the MRHD of 800 mg/day) were not tolerated in 13- and 26-week studies and animals required dose reductions due to body weight loss and morbidity.

Hypertrophy of epiphyseal growth plates, nail abnormalities (including broken, overgrown, or absent nails) and tooth abnormalities in growing incisor teeth (including excessively long, brittle, broken, and missing teeth, and dentine and enamel degeneration and thinning) were observed in rats at doses greater than or equal to 30 mg/kg/day (approximately 0.35-fold the AUC at the MRHD of 800 mg/day) at 26 weeks, with the onset of tooth and nail bed alterations noted clinically after 4 to 6 weeks. Similar findings were noted in repeat-dose studies in juvenile rats dosed with pazopanib beginning Day 21 postpartum (post-weaning).

In the post-weaning animals, the occurrence of changes in teeth and bones occurred earlier and with greater severity than in older animals. There was evidence of tooth degeneration and decreased bone growth at doses greater than or equal to 30 mg/kg (approximately 0.1- to 0.2-fold the AUC at the MRHD of 800 mg/day). Pazopanib exposure in juvenile rats was lower than that seen at the same dose levels in adult animals, based on comparative AUC values.

At pazopanib doses approximately 0.5- to 0.7-fold the AUC at the MRHD of 800 mg/day, decreased bone growth in juvenile rats persisted even after the end of the dosing period. Finally, despite lower pazopanib exposures than those reported in adult animals or adult humans, juvenile animals administered 300 mg/kg/dose pazopanib required dose reduction within 4 weeks of dosing initiation due to significant toxicity, although adult animals could tolerate this same dose for at least 3 times as long [see Warnings and Precautions (5.18)].

🧓 Geriatric Use 156 words ▾

8.5Geriatric Use In pooled clinical trials with VOTRIENT, 30% of 2080 patients were aged ≥ 65 years. More patients ≥ 65 years had ALT elevations > 3 × ULN compared to patients < 65 years (23% versus 18%) [see Warnings and Precautions (5.1)] . In the RCC trials, 33% of 586 patients were aged ≥ 65 years.

No overall differences in safety or effectiveness of VOTRIENT were observed between these patients and younger patients. In the STS trials, 24% of 382 patients were aged ≥ 65 years. Patients aged ≥ 65 years had a higher incidence of Grade 3 or 4 fatigue (19% versus 12% for patients aged < 65 years), hypertension (10% versus 6%), decreased appetite (11% versus 2%), ALT elevations (3% versus 2%) and AST elevations (4% versus 1%).

In the randomized STS trial (VEG110727), no overall differences in effectiveness of VOTRIENT were observed between patients aged ≥ 65 years and younger patients.

🆘 Overdosage 71 words ▾

10 OVERDOSAGE Dose-limiting toxicity (Grade 3 fatigue) and Grade 3 hypertension were each observed in 1 of 3 patients dosed at 2,000 mg daily (2.5 times the recommended dose) and 1,000 mg daily (1.25 times the recommended dose), respectively. Provide general supportive measures to manage an overdose. Hemodialysis is not expected to enhance the elimination of VOTRIENT because pazopanib is not significantly renally excreted and is highly bound to plasma proteins.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Pazopanib is a multi-tyrosine kinase inhibitor of vascular endothelial growth factor receptor (VEGFR)-1, VEGFR-2, VEGFR-3, platelet-derived growth factor receptor (PDGFR)-α and -β, fibroblast growth factor receptor (FGFR)-1 and -3, cytokine receptor (Kit), interleukin-2 receptor-inducible T-cell kinase (Itk), lymphocyte-specific protein tyrosine kinase (Lck), and transmembrane glycoprotein receptor tyrosine kinase (c-Fms). In vitro, pazopanib inhibited ligand-induced autophosphorylation of VEGFR-2, Kit, and PDGFR-β receptors.

In vivo, pazopanib inhibited VEGF-induced VEGFR-2 phosphorylation in mouse lungs, angiogenesis in a mouse model, and the growth of some human tumor xenografts in mice.

12.2Pharmacodynamics Increases in blood pressure have been observed and are related to steady-state trough plasma pazopanib concentrations. Cardiac Electrophysiology The QT prolongation potential of pazopanib was assessed in a randomized, blinded, parallel trial (N = 96) using moxifloxacin as a positive control. VOTRIENT 800 mg orally under fasting conditions was administered on Days 2 to 8 and 1,600 mg was administered on Day 9 after a meal in order to increase exposure to pazopanib and its metabolites.

No large changes (i.e., > 20 msec) in QTc interval following exposure to pazopanib were detected in this QT trial. The trial was not able to exclude small changes (< 10 msec) in QTc interval, because assay sensitivity below this threshold (< 10 msec) was not established in this trial [see Warnings and Precautions (5.2)] .

12.3Pharmacokinetics The recommended dosage of 800 mg once daily results in mean AUC of 1,037 mcg•h/mL and C max of 58.1 mcg/mL. There was no consistent increase in AUC or C max at pazopanib doses above 800 mg. Administration of a single 400-mg crushed tablet increased AUC 0-72h by 46% and C max by approximately 2-fold and decreased T max by approximately 2 hours compared with administration of the whole tablet [see Dosage and Administration (2.1)] .

Absorption The median time to achieve peak concentrations was 2 to 4 hours after a dose. Effect of Food Systemic exposure to pazopanib is increased when administered with food. Administration of pazopanib with a high-fat (approximately 50% fat) or low-fat (approximately 5% fat) meal results in an approximately 2-fold increase in AUC and C max .

Distribution Binding of pazopanib to human plasma protein in vivo was > 99% with no concentration dependence over the range of 10 to 100 mcg/mL. In vitro studies suggest that pazopanib is a substrate for P-gp and BCRP. Elimination Pazopanib has a mean half-life of 31 hours after administration of the recommended dose of 800 mg.

Metabolism In vitro studies demonstrated that pazopanib is metabolized by CYP3A4 with a minor contribution from CYP1A2 and CYP2C8. Excretion Elimination is primarily via feces with renal elimination accounting for < 4% of the administered dose. Specific Populations Patients with Hepatic Impairment Table 7 presents a comparison of the median steady-state C max and the median AUC 0-24h values for patients with normal, mild, moderate and severe hepatic impairment.

The median steady-state of pazopanib C max and AUC 0-24h after a once-daily dose of 800 mg in patients with mild impairment were in a similar range as the median steady-state C max and median AUC 0-24h in patients with no hepatic impairment. The maximum tolerated pazopanib dose in patients with moderate hepatic impairment was 200 mg once daily. The median steady-state C max and the median AUC 0-24h were approximately 43% and 29%, respectively, of the corresponding median values after administration of 800 mg once daily in patients with no hepatic impairment.

The median steady-state C max and the median AUC 0-24h were approximately 18% and 15%, respectively, of the corresponding median values after administration of 800 mg once daily in patients with no hepatic impairment. Table 7. Pharmacokinetic Paramete…

🧬 Mechanism of Action 90 words ▾

In vivo, pazopanib inhibited VEGF-induced VEGFR-2 phosphorylation in mouse lungs, angiogenesis in a mouse model, and the growth of some human tumor xenografts in mice.

📦 How Supplied / Storage and Handling 63 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING VOTRIENT 200 mg tablets are supplied as modified capsule-shaped, gray or pink, film-coated with ‘GS JT’ debossed on one side and are available in: Bottles of 120 tablets: NDC 0078-0670-66 (gray tablets), NDC 0078-1077-66 (pink tablets) Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

📋 Description 138 words ▾

11 DESCRIPTION Pazopanib is a kinase inhibitor. Pazopanib is presented as the hydrochloride salt, with the chemical name 5-[[4-[(2,3-dimethyl-2H-indazol-6-yl)methylamino]-2-pyrimidinyl]amino]-2-methylbenzenesulfonamide monohydrochloride. It has the molecular formula C 21 H 23 N 7 O 2 S•HCl and a molecular weight of 473.99 g/mol.

Pazopanib hydrochloride has the following chemical structure: Pazopanib hydrochloride is a white to slightly yellow solid. It is very slightly soluble at pH 1 and practically insoluble above pH 4 in aqueous media. VOTRIENT tablets are for oral use.

Each 200-mg tablet of VOTRIENT contains 200 mg of pazopanib equivalent to 216.7 mg of pazopanib hydrochloride. The inactive ingredients of VOTRIENT are: Tablet Core: magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. Coating: Gray or pink film-coat: hypromellose, iron oxide black, macrogol/polyethylene glycol 400 (PEG 400), polysorbate 80, and titanium dioxide. chemical structure for VOTRIENT (pazopanib)

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Hepatic Toxicity : Inform patients that periodic laboratory testing will be performed. Advise patients to report signs and symptoms of liver dysfunction to their healthcare provider right away [see Warnings and Precautions (5.1)].

QT Prolongation and Torsades de Pointes : Inform patients that ECG monitoring may be performed. Advise patients to inform their physicians of concomitant medications [see Warnings and Precautions (5.2)]. Interstitial Lung Disease/Pneumonitis : Advise patients to report pulmonary signs or symptoms indicative of interstitial lung disease (ILD) or pneumonitis [see Warnings and Precautions (5.9)] .

Cardiac Dysfunction : Advise patients to report hypertension or signs and symptoms of congestive heart failure [see Warnings and Precautions (5.3)] . Hemorrhagic Events : Advise patients to report unusual bleeding [see Warnings and Precautions (5.4)] . Arterial Thromboembolic Events : Advise patients to report signs or symptoms of an arterial thrombosis [see Warnings and Precautions (5.5)] .

Pneumothorax and Venous Thromboembolic Events : Advise patients to report new onset of dyspnea, chest pain, or localized limb edema [see Warnings and Precautions (5.6), Adverse Reactions (6.1)] . Posterior Reversible Encephalopathy Syndrome : Advise patients to inform their doctor if they have worsening of neurological function consistent with PRES (headache, seizure, lethargy, confusion, blindness, and other visual and neurologic disturbances) [see Warnings and Precautions (5.10)] . Hypertension : Advise patients to monitor blood pressure early in the course of therapy and frequently thereafter and report increases of blood pressure or symptoms, such as blurred vision, confusion, severe headache, or nausea and vomiting [see Warnings and Precautions (5.11)] .

Gastrointestinal Perforation and Fistula : Advise patients to report signs and symptoms of a GI perforation or fistula [see Warnings and Precautions (5.8)] . Risk of Impaired Wound Healing : Advise patients that VOTRIENT may impair wound healing. Advise patients to inform their healthcare provider of any scheduled surgical procedure [see Warnings and Precautions (5.12)] .

Hypothyroidism and Proteinuria : Inform patients that thyroid function testing and urinalysis will be performed during treatment [see Warnings and Precautions (5.13, 5.14)] . Tumor Lysis Syndrome : Advise patients to contact their healthcare provider promptly to report any signs and symptoms of TLS, such as abnormal heart rhythm, seizure, confusion, muscle cramps or spasms, or a decrease in urine output [see Warnings and Precautions (5.15)] . Infection : Advise patients to promptly report any signs or symptoms of infection [see Warnings and Precautions (5.16)] .

Embryo-Fetal Toxicity : Advise female patients to inform their healthcare provider of a known or suspected pregnancy during treatment with VOTRIENT. Inform female patients of the risk to a fetus and the potential loss of the pregnancy [see Warnings and Precautions (5.19), Use in Specific Populations (8.1)] . Advise females of reproductive potential to use effective contraception during treatment and for at least 2 weeks after the last dose of VOTRIENT.

Advise male patients with female partners of reproductive potential to use condoms during treatment with VOTRIENT and for at least 2 weeks after the last dose [see Warnings and Precautions (5.19), Use in Specific Populations (8.3)] . Lactation : Advise women not to breastfeed during treatment with VOTRIENT and for 2 weeks after the last dose [see Use in Specific Populations (8.2)] . Infertility : Advise males and females of reproductive potential that VOTRIENT may impair fertility [see Use in Specific Populations (8.3)] .

Gastrointestinal Adverse Reactions : Advise patients on how to manage nausea, vomiting, and diarrhea and to notify their healthcare provider if moderate-to-severe…

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: December 2021 MEDICATION GUIDE VOTRIENT ® (VO-tree-ent) (pazopanib) tablets What is the most important information I should know about VOTRIENT?

VOTRIENT can cause severe liver problems, including death. Your healthcare provider will do blood tests to check your liver before you start and while you take VOTRIENT. Tell your healthcare provider right away if you get any of these signs of liver problems during treatment with VOTRIENT: ○ yellowing of your skin or the whites of your eyes (jaundice) ○ loss of appetite ○ dark urine ○ pain on the right side of your stomach area (abdomen) ○ tiredness ○ bruise easily ○ nausea or vomiting Your healthcare provider may need to prescribe a lower dose of VOTRIENT for you or tell you to stop taking VOTRIENT if you develop liver problems during treatment.

What is VOTRIENT? VOTRIENT is a prescription medicine used to treat adults with: advanced renal cell cancer (RCC) advanced soft tissue sarcoma (STS) who have received chemotherapy in the past It is not known if VOTRIENT is effective in treating certain soft tissue sarcomas or certain gastrointestinal tumors. It is not known if VOTRIENT is safe and effective in children under 18 years of age.

What should I tell my healthcare provider before taking VOTRIENT? Before taking VOTRIENT, tell your healthcare provider about all of your medical conditions, including if you: have or had liver problems. You may need a lower dose of VOTRIENT, or your healthcare provider may prescribe a different medicine to treat your advanced renal cell cancer or advanced soft tissue sarcoma. have high blood pressure have heart problems or an irregular heartbeat, including QT prolongation have a history of a stroke have headaches, seizures, or vision problems have coughed up blood in the last 6 months had bleeding of your stomach or intestines in the last 6 months have a history of a tear (perforation) in your stomach or intestine, or an abnormal connection between two parts of your gastrointestinal tract (fistula) have had blood clots in a vein or in the lung have thyroid problems had recent surgery or are going to have surgery.

You should stop taking VOTRIENT at least 1 week before scheduled surgery because VOTRIENT may affect healing after surgery. Do not take VOTRIENT for at least 2 weeks following major surgery and until your wound heals adequately. Your healthcare provider should tell you when you may start taking VOTRIENT again after surgery. have problems with your kidney function are pregnant or plan to become pregnant.

VOTRIENT can harm your unborn baby. Your healthcare provider should check to see if you are pregnant before you start taking VOTRIENT. You should not become pregnant while you are taking VOTRIENT.

You should use effective birth control during treatment with VOTRIENT and for at least 2 weeks after your final dose of VOTRIENT. Talk to your healthcare provider about types of birth control that may be right for you during this time. are a male (including one who has had a vasectomy) with a sexual partner who is pregnant, think that they may be pregnant, or who could become pregnant (including those who use other forms of birth control). You should use condoms during sexual intercourse during treatment with VOTRIENT and for at least 2 weeks after the last dose of VOTRIENT. are breastfeeding or plan to breastfeed.

It is not known if VOTRIENT passes into your breast milk. Do not breastfeed during treatment with VOTRIENT and for 2 weeks after the final dose. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

VOTRIENT may affect the way other medicines work and other medicines may affect how VOTRIENT works. Especially, tell your healthcare provider if you: take medicines that can affect how your liver enzymes work, such as: ○ certain antibiotics (used to treat infec…

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

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

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

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

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

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

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

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

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

anorexia: Loss of appetite, or not feeling hungry (on a drug label this means reduced appetite, not the eating disorder).

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

asthenia: Unusual weakness or lack of physical strength and energy.

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

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

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

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

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

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

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

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

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

CYP1A2: A liver enzyme that breaks down certain medicines and whose activity can be changed by cigarette smoke.

CYP2D6: A liver enzyme that breaks down many medicines; people inherit different versions, so it works faster in some and slower in others.

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

diarrhea: Loose, watery bowel movements that happen more often than normal.

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

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

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

dose-limiting toxicity: A side effect severe enough that it prevents giving a higher dose of a medicine.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dysgeusia: A changed or unpleasant sense of taste, such as a metallic taste.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

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

efficacy: How well a treatment works under the controlled conditions of a clinical study.

ejection fraction: The share of blood in the heart's main pumping chamber that gets pushed out with each beat, given as a percentage.

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

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

encephalopathy: Any condition that affects how the brain works, causing confusion, memory problems, or changes in alertness.

enzyme induction: When a substance makes the body produce more of an enzyme, speeding up how fast certain drugs are removed.

enzyme inhibition: When a substance slows or blocks an enzyme, causing certain drugs to build up to higher levels.

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

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

fertility: The natural ability to become pregnant or to father a child.

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

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

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

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

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

hemoptysis: Coughing up blood or bloody mucus from the lungs or airways.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

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

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

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

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

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypertensive crisis: A dangerous, sudden rise in blood pressure to very high levels.

hypocalcemia: A lower-than-normal level of calcium, a mineral, in the blood.

hypokalemia: A lower-than-normal level of potassium, an important mineral, in the blood.

hypomagnesemia: A lower-than-normal level of magnesium, a mineral, in the blood.

hypothyroidism: A condition where the thyroid gland makes too little thyroid hormone, which can slow the body down.

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

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

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

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

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

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

lethargy: A state of tiredness and sluggishness, often with slowed thinking or movement.

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

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

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

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

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

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

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

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

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

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

perforation: A hole that forms all the way through the wall of the stomach or intestine.

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

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

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

postpartum: The period of time right after a woman gives birth.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

proteinuria: Protein leaking into the urine, which can be a sign that the kidneys' filters are damaged.

purpura: Purple spots or patches on the skin caused by bleeding just under the surface.

QT prolongation: A longer-than-normal electrical recovery time between heartbeats, seen on a heart tracing (ECG), which can raise the chance of a dangerous heart rhythm.

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

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

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

refractory: Describing a disease that does not respond to, or improve with, treatment.

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

seizure: A sudden burst of abnormal electrical activity in the brain that can cause shaking, staring, confusion, or loss of awareness.

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

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

thrombosis: The forming of a blood clot inside a blood vessel, which can block normal blood flow.

torsades de pointes: A rare but dangerous fast heart rhythm that can cause fainting and, in the worst cases, become life-threatening.

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

tumor lysis syndrome: A serious condition where many cancer cells break apart quickly, releasing their contents and upsetting the body's balance of salts and waste products.

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

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

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

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

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

← 00078-1070-68 · Novartis 00078-1091-20 · Novartis →

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.

VOTRIENT pazopanib hydrochloride 200 mg Tablet, Film Coated, 120-count

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