Pazopanib Hydrochloride (Votrient)

Trade Name : VOTRIENT

Novartis Pharmaceuticals Corporation

TABLET, FILM COATED

Strength 200 mg/1

PAZOPANIB HYDROCHLORIDE Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Pazopanib Hydrochloride (Votrient) which is also known as VOTRIENT and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 200 mg/1 per ml. Read more

Pazopanib Hydrochloride (Votrient) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

Warnings and Precautions, Embryo-Fetal Toxicity ()nttu00a0u00a0u00a0u00a0u00a0nt 5/2017

See full prescribing information for complete boxed warning.

VOTRIENT is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).
VOTRIENT is indicated for the treatment of patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy.
Limitationn- sn- of Use
VOTRIENTu00a0is au00a0kinase inhibitor indicated for the treatment of patients with:u00a0

advanced renal cell carcinoma. ()n
advanced soft tissue sarcoma who have received prior chemotherapy. ()

No data

800 mg orally once daily without food (at least 1 hour before or 2 hours after a meal). ()n
Baseline moderateu00a0hepatic impairment u2013 200u00a0mg orally once daily. Not recommended in patients with severe hepatic impairment. ()

200-mg tabletsu00a0of VOTRIENT u2014 modified capsule-shaped, gray, film-coated with GSu00a0JT debossed on one side. Each tablet contains 216.7u00a0mg of pazopanib hydrochloride equivalent to 200u00a0mg of pazopanib.
200u00a0mg tablets ()

nttu00a0u00a0u00a0u00a0u00a0ntNone.
None ()

No data

Increases in serum transaminase levels and bilirubin were observed. Severe and fatal hepatotoxicity hasu00a0occurred. Measure liver chemistries before the initiation of treatment and regularly during treatment. ()n
Prolonged QT intervals and torsades de pointes have been observed. Use with caution in patients at higher risk of developing QT interval prolongation. Monitoring electrocardiograms (ECGs) and electrolytes should be considered. ()n
Cardiac dysfunction such as congestive heart failure and decreased left ventricular ejection fraction (LVEF) have occurred. Monitor blood pressure and manage hypertension promptly. Baseline and periodic evaluation of LVEF is recommended in patients at risk of cardiac dysfunction. ()n
Fatal hemorrhagic events have been reported. VOTRIENTu00a0has not been studied in patients who have a history of hemoptysis, cerebral, or clinically significant gastrointestinal hemorrhage in the past 6u00a0months and should not be used in those patients. ()n
Arterial thromboembolic events have been observed and can be fatal. Use with caution in patients who are at increased risk for these events. ()n
Venous thromboembolic events (VTE) have been observed, including fatal pulmonary emboli (PE). Monitor for signs and symptoms of VTE and PE. ()n
Thrombotic microangiopathy (TMA),u00a0including thrombotic thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS)u00a0has been observed. Permanently discontinue VOTRIENT if TMA occurs. ()n
Gastrointestinal perforation or fistula has occurred. Fatal perforation events have occurred. Use with caution in patients at risk for gastrointestinal perforation or fistula. ()n
Interstitial lung disease (ILD)/pneumonitis have been observed and can be fatal. Discontinue VOTRIENT in patients developing ILD or pneumonitis. ()n
Reversible Posterior Leukoencephalopathy Syndrome (RPLS) has been observed and can be fatal. Permanently discontinue VOTRIENT in patients developing RPLS. ()n
Hypertension including hypertensive crisis has been observed.u00a0Blood pressure should be wellu00a0controlled prior to initiating VOTRIENT. Monitor blood pressure within one week after starting VOTRIENT and frequently thereafter.u00a0()n
Interruption of therapy with VOTRIENT is recommended in patients undergoing surgical procedures. ()n
Hypothyroidism may occur. Monitoring of thyroid function tests is recommended. ()n
Proteinuria: Monitor urine protein. Interrupt treatment for 24-hour urine protein greater than or equal tou00a03 grams and discontinue for repeat episodes despite dose reductions. ()n
Infection: Serious infections (with or without neutropenia), some with fatal outcome, have been reported. Monitor for signs and symptoms and treat active infection promptly. Interrupt or discontinue VOTRIENT. ()n
Animal studies have demonstrated VOTRIENT can severely affect organ growth and maturation during early postnatal development. The safety and effectiveness in pediatric patients have not been established. ()n
Embryo-Fetal Toxicity:u00a0VOTRIENT can cause fetal harm when administered to a pregnant woman. Advise femalesu00a0of reproductiveu00a0potential of the potential risk to the fetus and advise females and malesu00a0to use effective contraception. (, , )

The most common adverse reactions in patients with advanced renal cell carcinoma (greater than or equal to 20%) are diarrhea, hypertension, hair color changes (depigmentation), nausea, anorexia, and vomiting. ()
The most common adverse reactions in patients with advanced soft tissue sarcoma (greater than or equal to 20%) are fatigue, diarrhea, nausea, decreased weight, hypertension, decreased appetite, hair color changes, vomiting, tumor pain, dysgeusia,u00a0headache, musculoskeletal pain, myalgia, gastrointestinal pain, and dyspnea. ()

No data

CYP3A4 Inhibitors: Avoid use of strongu00a0CYP3A4u00a0inhibitors. If coadministration is warranted, reduce the dose of VOTRIENT to 400 mg. ()n
CYP3A4 Inducers: Consider an alternate concomitant medication with no or minimal enzyme induction potential or avoid VOTRIENT. ()n
CYP Substrates: Concomitant use of VOTRIENTu00a0with agents with narrow therapeutic windows that are metabolized by CYP3A4, CYP2D6, or CYP2C8 is not recommended. ()n
Concomitant use of VOTRIENT and simvastatin increases the risk of alanine aminotransferase (ALT) elevations and should be undertaken with caution and close monitoring. ()n
Drugs that Raise Gastric pH: Avoid concomitant use of VOTRIENT with drugs that raise gastric pH. Consider short-acting antacids in place of proton pump inhibitors (PPIs) and H2 receptor antagonists. Separate antacid and pazopanib dosing by several hours. ()

No data

Lactation: Advise not to breastfeed. ()

Pazopanib doses up to 2,000u00a0mg have been evaluated in clinical trials.u00a0Dose-limiting toxicity (Grade 3 fatigue) and Grade 3 hypertension wereu00a0each observed in 1 of 3 patients dosed at 2,000u00a0mg daily and 1,000u00a0mg daily, respectively.
Treatment of overdose with VOTRIENT should consist of general supportive measures. There is no specific antidote for overdosage of VOTRIENT.u00a0
Hemodialysis is not expected to enhance the elimination of VOTRIENT because pazopanib is not significantly renally excreted and is highly bound to plasma proteins.

VOTRIENT (pazopanib) is a tyrosine kinase inhibitor (TKI). 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 CHNOSu2022HCl and a molecular weight of 473.99. Pazopanib hydrochloride has the following chemical structure:
Pazopanib hydrochloride is a white to slightly yellow solid.u00a0It is very slightly soluble at pH 1 and practically insoluble above pH 4 in aqueous media.
Tablets of VOTRIENT are for oral administration. Each 200-mg tablet of VOTRIENT contains 216.7u00a0mg of pazopanib hydrochloride, equivalent to 200u00a0mg of pazopanib free base.
The inactive ingredients of VOTRIENT are: Magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate. Gray film-coat: Hypromellose, iron oxide black, macrogol/polyethylene glycol 400 (PEGu00a0400), polysorbate 80, titanium dioxide.u00a0

No data

The carcinogenic potential of pazopanibu00a0was evaluated in CD-1 mice, and Sprague-Dawley rats. Administration of pazopanib to mice for 2 years did not result in increased incidence of neoplasms at doses up to 100 mg/kg/dayu00a0(approximately 1.4u00a0-fold the AUC at the maximum recommended human dose (MRHD) of 800 mg/day).u00a0Administration of pazopanib to rats for 2 years resulted in findings of duodenal adenocarcinoma in males at 30 mg/kg/day (approximately 0.3 -fold the AUC at the MRHD of 800 mg/day) and in females at greater than or equal to 10 mg/kg/day (approximately 0.3 -fold the AUC at the MRHD of 800 mg/day). The human relevance of these neoplastic findings is unclear.u00a0u00a0
Pazopanib did not induce mutations in the microbial mutagenesis (Ames) assay and was not clastogenic in both the in vitro cytogenetic assay using primary human lymphocytes and in the in vivo rat micronucleus assay.u00a0
In an oral female fertility and early embryonic development study, female rats were administered pazopanib at least 15 days prior to mating, and for 6 days after mating.u00a0Pazopanib did affect fertility in female rats. Reduced fertility including increased pre-implantation lossu00a0and early resorptions were noted at dosages greater than or equal to 30u00a0mg/kg/day (approximately 0.4 -fold the AUC at the MRHD of 800 mg/day). Decreased corpora lutea and increased cysts were noted in mice given greater than or equal to 100u00a0mg/kg/day for 13u00a0weeks and ovarian atrophy was noted in rats given greater than or equal to 300u00a0mg/kg/day for 26u00a0weeksu00a0(approximately 1.3 and 0.85u00a0-fold the AUC at the MRHD of 800 mg/day). Decreased corpora lutea was also noted in monkeys given 500u00a0mg/kg/day for up to 34u00a0weeks (approximately 0.4 -fold the AUC at the MRHD of 800 mg/day).
Pazopanib did not affect mating or fertility in male rats. However,u00a0there were reductions in sperm production rates and testicular sperm concentrations at doses greater than or equal to 3 mg/kg/day, epididymal sperm concentrations at doses greater than or equal to 30u00a0mg/kg/day, and sperm motility at greater than or equal to 100u00a0mg/kg/dayu00a0following 15u00a0weeks of dosing. Following 15 and 26u00a0weeks of dosing, there wereu00a0decreased testicular and epididymal weights at doses of greater than or equal to 30u00a0mg/kg/day (approximately 0.35 -fold the AUC at the MRHD of 800 mg/day); atrophy and degeneration of the testes with aspermia, hypospermia and cribiform change in the epididymis was also observed at this dose in the 6-month toxicity studies in male rats.

No data

The 200-mg tablets of VOTRIENT are modified capsule-shaped, gray, film-coated with GSu00a0JT debossed on one side and are available in:
Bottles of 120 tablets: NDCu00a00078-0670-66
Store at room temperature between 20u00baC and 25u00baC (68u00baF to 77u00baF); excursions permitted to 15u00baC to 30u00baC (59u00baF to 86u00baF) [see USP Controlled Room Temperature].

Advise the patient to read the FDA-approved patient labeling (Medication Guide). The Medication Guide is contained in a separate leaflet that accompanies the product.u00a0
However, inform patients of the following:
Distributed by: Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
u00a9 Novartis
T2017-66May 2017

This Medication Guide has been approved by the U.S. Food and Drug Administration.nttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0nt Revised: May 2017

PRINCIPAL DISPLAY PANEL
NDC 0078-0670-66
Votrientn
(pazopanib)
Tablets
Arrayn- 200 mg
120 Tablets
R only
Each tablet contains 216.7 mg of pazopanib hydrochloride, equivalent to 200 mg of pazopanib free base.
Dispense the Medication Guide, attached or provided separately, to each patient pursuant to Federal Law.
Store at room temperature between 20u00b0C and 25u00b0C (68u00b0F to 77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [See USP Controlled Room Temperature].
Do not use if printed safety seal under cap is broken or missing.
Dosage:

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Pazopanib Hydrochloride (Votrient)

Trade Name : VOTRIENT

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Pazopanib Hydrochloride (Votrient)

Trade Name : VOTRIENT

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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NZ Drugs

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