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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