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pazopanib hydrochloride
Overview
What is VOTRIENT?
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 CHNOS•HCl and a molecular weight of 473.99. 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.
Tablets of VOTRIENT are for oral administration. Each 200-mg tablet of VOTRIENT contains 216.7 mg of pazopanib hydrochloride, equivalent to 200 mg 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 (PEG 400), polysorbate 80, titanium dioxide.
What does VOTRIENT look like?
What are the available doses of VOTRIENT?
200 mg tablets ()
What should I talk to my health care provider before I take VOTRIENT?
How should I use VOTRIENT?
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.
Limitation
s
of Use
The recommended starting dose of VOTRIENT is 800 mg orally once daily without food (at least 1 hour before or 2 hours after a meal) . The dose of VOTRIENT should not exceed 800 mg.
Do not crush tablets due to the potential for increased rate of absorption which may affect systemic exposure
.
If a dose is missed, it should not be taken if it is less than 12 hours until the next dose.
What interacts with VOTRIENT?
Sorry No Records found
What are the warnings of VOTRIENT?
Sorry No Records found
What are the precautions of VOTRIENT?
Sorry No Records found
What are the side effects of VOTRIENT?
Sorry No records found
What should I look out for while using VOTRIENT?
None.
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)].
What might happen if I take too much VOTRIENT?
Pazopanib doses up to 2,000 mg have been evaluated in clinical trials. Dose-limiting toxicity (Grade 3 fatigue) and Grade 3 hypertension were each observed in 1 of 3 patients dosed at 2,000 mg daily and 1,000 mg daily, respectively.
Treatment of overdose with VOTRIENT should consist of general supportive measures. There is no specific antidote for overdosage of VOTRIENT.
Hemodialysis is not expected to enhance the elimination of VOTRIENT because pazopanib is not significantly renally excreted and is highly bound to plasma proteins.
How should I store and handle VOTRIENT?
Store at 20°C to 25°C (68°F to 77°F) [See USP controlled room temperature]. Protect from moisture.The 200-mg tablets of VOTRIENT are modified capsule-shaped, gray, film-coated with GS JT debossed on one side and are available in:Bottles of 120 tablets: NDC 0078-0670-66Store at room temperature between 20ºC and 25ºC (68ºF to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature].The 200-mg tablets of VOTRIENT are modified capsule-shaped, gray, film-coated with GS JT debossed on one side and are available in:Bottles of 120 tablets: NDC 0078-0670-66Store at room temperature between 20ºC and 25ºC (68ºF to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature].The 200-mg tablets of VOTRIENT are modified capsule-shaped, gray, film-coated with GS JT debossed on one side and are available in:Bottles of 120 tablets: NDC 0078-0670-66Store at room temperature between 20ºC and 25ºC (68ºF to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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.
Non-Clinical Toxicology
None.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)].
Results of preliminary studies in humans and rats suggest that nonabsorbable antacids given concurrently with lactulose may inhibit the desired lactulose-induced drop in colonic pH. Therefore, a possible lack of desired effect of treatment should be taken into consideration before such drugs are given concomitantly with lactulose solution.
In clinical trials with VOTRIENT, hepatotoxicity, manifested as increases in serum transaminases (alanine transferase (ALT), aspartate aminotransferase (AST)) and bilirubin, was observed. This hepatotoxicity can be severe and fatal. Patients older than 65 years are at greater risk for hepatotoxicity . Transaminase elevations occur early in the course of treatment (92.5% of all transaminase elevations of any grade occurred in the first 18 weeks) .
In the randomized RCC trial, ALT greater than 3 X upper limit of normal (ULN) was reported in 18% and 3% of the groups receiving VOTRIENT and placebo, respectively. ALT greater than 10 X ULN was reported in 4% of patients who received VOTRIENT and in less than 1% of patients who received placebo. Concurrent elevation in ALT greater than 3 X ULN and bilirubin greater than 2 X ULN in the absence of significant alkaline phosphatase greater than 3 X ULN occurred in 2% (5/290) of patients on VOTRIENT and 1% (2/145) on placebo.
In the randomized STS trial, ALT greater than 3 X ULN was reported in 18% and 5% of the groups receiving VOTRIENT and placebo, respectively. ALT greater than 8 X ULN was reported in 5% and 2% of the groups receiving VOTRIENT and placebo, respectively. Concurrent elevation in ALT greater than 3 X ULN and bilirubin greater than 2 X ULN in the absence of significant alkaline phosphatase greater than 3 X ULN occurred in 2% (4/240) of patients on VOTRIENT and less than 1% (1/123) on placebo.
Two-tenths percent of the patients (2/977) from trials that supported the RCC indication died with disease progression and hepatic failure and 0.4% of patients (1/240) in the randomized STS trial died of hepatic failure.
Concomitant use of VOTRIENT and simvastatin increases the risk of ALT elevations and should be undertaken with caution and close monitoring Insufficient data are available to assess the risk of concomitant administration of alternative statins and VOTRIENT.
In patients with preexisting moderate hepatic impairment, the starting dose of VOTRIENT should be reduced or alternatives to VOTRIENT should be considered. Treatment with VOTRIENT is not recommended in patients with preexisting severe hepatic impairment, defined as total bilirubin greater than 3 X ULN with any level of ALT
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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