Pazopanib film-coated Votrient 200mg

[Drug Name]

Generic Name: Pazopanib

Brand Name: Pazopanib

English Name: Pazopanib

Pinyin: PaZuoPaNi

[Main Ingredient] Pazopanib.

[Composition] Molecular Formula: C21H23N7O2S

[Indications/Therapeutic Uses] Pazopanib is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma.

[Specification/Model] 200 mg × 30 tablets

[Dosage and Administration] 800 mg orally once daily, taken without food (at least 1 hour before or 2 hours after a meal). Moderate hepatic impairment at baseline – 200 mg orally once daily. Use is not recommended in patients with severe hepatic impairment.

[Adverse Reactions] Common adverse reactions include fatigue, diarrhea, nausea, vomiting, decreased appetite, weight loss, hypertension, tumor-site and musculoskeletal pain, hair color changes, headache, altered taste, dyspnea, and skin discoloration.

[Contraindications] Not yet established.

[Precautions] 1) Elevated serum transaminase and bilirubin levels have been observed. Severe and fatal hepatotoxicity has occurred. Liver chemistry tests should be performed prior to initiating treatment and periodically during treatment. 2) QT interval prolongation and *torsades de pointes* have been observed. Use with caution in patients at higher risk for QT interval prolongation. ECG and electrolyte monitoring should be considered. 3) Fatal hemorrhagic events have been reported. VOTRIENT has not been studied in patients with a history of hemoptysis, cerebral hemorrhage, or clinically significant gastrointestinal bleeding within the past 6 months; therefore, it should not be used in these patients. 4) Arterial thrombotic events, including fatal events, have been observed. Use with caution in patients at increased risk for these events. 5) Gastrointestinal perforation or fistula formation has occurred. Fatal perforation events have occurred. Use with caution in patients at increased risk for gastrointestinal perforation or fistula formation. 6) Hypertension has been observed. Blood pressure should be well-controlled prior to initiating treatment with VOTRIENT. Monitor and treat hypertension as needed. 7) Discontinuation of VOTRIENT treatment is recommended in patients undergoing surgery. 8) Hypothyroidism may occur. Monitoring of thyroid function is recommended. 9) Proteinuria: Monitor for urinary protein. Discontinue the drug in cases of Grade 4 proteinuria. 10) VOTRIENT may cause fetal harm when administered to pregnant women. Women of childbearing potential should be advised of the potential hazard to the fetus and to avoid pregnancy while taking the medication. Please read the package insert carefully and use strictly according to physician's instructions.

[Drug Interactions] Pazopanib is a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor; it acts by selectively inhibiting VEGFR-1, VEGFR-2, and VEGFR-3 through competitive binding with ATP at the intracellular ligand-binding sites, thereby blocking intramolecular tyrosine autophosphorylation, inhibiting VEGFR activation, and consequently accelerating apoptosis, inhibiting angiogenesis, and suppressing tumor infiltration and metastasis. In in vitro studies, Pazopanib effectively inhibited vascular endothelial growth factor-induced VEGFR phosphorylation and angiogenesis in mouse lungs. Additionally, Pazopanib specifically targets platelet-derived growth factor receptors (PDGFR)-α and PDGFR-β, fibroblast growth factor receptors (FGFR)-1 and -3, stem cell factor receptor (Kit), inducible T-cell kinase (Itk), lymphocyte-specific protein tyrosine kinase (Lck), and transmembrane glycoprotein receptor tyrosine kinase (c-Fms).

[Packaging] 200 mg × 30 tablets/box. Product Specifications

Product Name: Novartis Votrient (Pazopanib Tablets) 200 mg × 30 Tablets

Common Name: Pazopanib

Active Ingredient: Pazopanib

Dosage Form: Tablets

Specification: 200 mg × 30 tablets per box

Manufacturer: Novartis Pharmaceuticals

Indications: Pazopanib is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma.

Dosage and Administration: 800 mg orally once daily, taken without food (at least 1 hour before or 2 hours after a meal). For patients with baseline moderate hepatic impairment: 200 mg orally once daily. Use is not recommended for patients with severe hepatic impairment.