All Names: pazopanib,Votrient
Indications:1. Renal Cell Carcinomal 2. Soft Tissue Sarcoma
Manufacturer:Novartis, Switzerland
Customs Clearance Procedure:If the customs requires the package for customs clearance, please pay the customs clearance fee according to the content of EMS SMS and customs regulations.
INDICATIONS AND USAGE(适应症)
Renal Cell Carcinoma
VOTRIENT® is indicated for the treatment of adults with advanced renal cell carcinoma (RCC).
Soft 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(服用剂量)
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. The dosage should be modified for hepatic impairment and in patients taking certain concomitant drugs.
Swallow tablets whole. 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 < 12 hours until the next dose.
ADVERSE REACTIONS(不良反应)
Hepatic Toxicity
QT Prolongation and Torsades de Pointes
Cardiac Dysfunction
Hemorrhagic Events
Arterial Thromboembolic Events
Venous Thromboembolic Events
Thrombotic Microangiopathy (TMA)
Gastrointestinal Perforation and Fistula
Interstitial Lung Disease (ILD)/Pneumonitis
Posterior Reversible Encephalopathy Syndrome (PRES)
Hypertension
Hypothyroidism
Proteinuria
Tumor Lysis Syndrome
Infection
For full information, please refer to:
https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/eeaaaf38-fb86-4d9f-a19d-0f61daac2fd7/spl-doc?hl=pazopanib
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