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Votrient/ Pazopanib by GlaxoSmithKline is used for advanced renal cell carcinoma (RCC); kidney cancer. It is also used for advanced soft tissue sarcoma (STS).

Indications

Pazopanib / Votrient is indicated for the treatment of patients with advanced renal cell carcinoma (RCC); kidney cancer. Pazopanib is also used to treat patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy.

Therapeutic Class

Targeted Cancer Therapy

Pharmacology

Pazopanib / Votrient is a multi-tyrosine kinase inhibitor of vascular endothelial growth factorreceptor (VEGFR)- 1, VEGFR-2, VEGFR-3, platelet-derived growth factor receptor (PDGFR)-α and -β, fibroblast growth factor receptor (FGFR)-1 and -3, cytokinereceptor (Kit), interleukin-2 receptor-inducible T-cell kinase (Itk), leukocyte-specific protein tyrosine kinase (Lck), and transmembrane glycoprotein receptor tyrosine kinase (c-Fms).

In vitro, pazopanib / Votrient 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.

Dosage & Administration

Recommended Dosing: The recommended starting dose of Pazopanib is 800 mg orally once daily without food (at least 1 hour before or 2 hours after a meal). The dose of Pazopanib 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.

Dose Modification Guidelines:

• In advanced renal cell carcinoma, the initial dose reduction should be 400 mg, and additional dose decrease, or increase should be in 200-mg steps based on individual tolerability.
• In advanced soft tissue sarcoma, a decrease or increase should be in 200-mg steps based on individual tolerability.

Hepatic Impairment: No dose adjustment is required in patients with mild hepatic impairment. In patients with moderate hepatic impairment, alternatives to Pazopanib / Votrient should be considered.

If Pazopanib is used in patients with moderate hepatic impairment, the dose should be reduced to 200 mg per day. Pazopanib is not recommended in patients with severe hepatic impairment

Interaction

Co-administration with CYP3A4 (e.g., itraconazole, clarithromycin, atazanavir, idinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit juice), P-gp & BCRP inhibitors, high-/low-fat food increases exposure & cone of pazopanib.

Co-administration with CYP3A4 (e.g., rifampicin) inducers may decrease plasma pazopanib cone. P-gp & BCRP inducers may alter exposure & distribution of pazopanib.

Pazopanib / Votrient may alter exposure & distribution of CYP3A4 substrates (e.g., midazolam), CYP2C8 substrates (e.g., paclitaxel) & UGT1A1 substrates (e.g., irinotecan & its active metabolite SN-38). Pazopanib may increase the ratio of dextrometrophan to dextrophan cone after administration of dextrometrophan.

Proton-pump inhibitors (e.g., esomeprazole) & other agents that increase gastric pH may decrease bioavailability of pazopanib. Concomitant use with simvastatin & other statins may lead to ALT elevations.

Contraindications

Hypersensitivity.

Side Effects

Common side effects of Pazopanib include:

headache, loss of appetite, weight loss, altered sense of taste, nausea and vomiting (may be severe), diarrhea, numbness/tingling/redness in hands/feet, changes in hair or skin color, joint or muscle pain, or, feeling tired/weak.

Pregnancy & Lactation

Pazopanib can cause fetal harm when administered to a pregnant woman. Based on its mechanism of action, Pazopanib is expected to result in adverse reproductive effects. In pre-clinical studies in rats and rabbits, pazopanib was teratogenic, embryotoxic, fetotoxic, and abortifacient.

There are no adequate and well-controlled studies of Pazopanib in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant while taking Pazopanib

Precautions & Warnings

Hepatic Toxicity and Hepatic Impairment, QT Prolongation, Cardiac Dysfunction, Hemorrhagic Events, Thromboembolic Events, Gastrointestinal Perforation and Fistula, Hypertension, Hypothyroidism, Pregnancy.

Overdose Effects

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 Pazopanib should consist of general supportive measures. There is no specific antidote for overdosage of Pazopanib.

Hemodialysis is not expected to enhance the elimination of Pazopanib because pazopanib is not significantly renally excreted and is highly bound to plasma proteins.