INDICATIONS AND USAGE（适应症）

Gastrointestinal Stromal Tumor

Sunitinib malate capsules are indicated for the treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate.

Advanced Renal Cell Carcinoma

Sunitinib malate capsules are indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC).

Adjuvant Treatment of Renal Cell Carcinoma

Sunitinib malate capsules are indicated for the adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy.

Advanced Pancreatic Neuroendocrine Tumors

Sunitinib malate capsules are indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease.

DOSAGE（服用剂量）

Recommended Dosage for GIST and Advanced RCC

The recommended dosage of sunitinib malate capsules for gastrointestinal stromal tumor (GIST) and advanced renal cell carcinoma (RCC) is 50 mg taken orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off (Schedule 4/2) until disease progression or unacceptable toxicity. Sunitinib malate capsules may be taken with or without food.

Recommended Dosage for Adjuvant Treatment of RCC

The recommended dosage of sunitinib malate capsules for the adjuvant treatment of RCC is 50 mg taken orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off (Schedule 4/2), for nine 6-week cycles. Sunitinib malate capsules may be taken with or without food.

Recommended Dosage for pNET

The recommended dosage of sunitinib malate capsules for pancreatic neuroendocrine tumors (pNET) is 37.5 mg taken orally once daily until disease progression or unacceptable toxicity. Sunitinib malate capsules may be taken with or without food.

ADVERSE REACTIONS（不良反应）

Hepatotoxicity

Cardiovascular Events

QT Interval Prolongation and Torsade de Pointes

Hypertension

Hemorrhagic Events

Tumor Lysis Syndrome

Thrombotic Microangiopathy

Proteinuria

Dermatologic Toxicities

Reversible Posterior Leukoencephalopathy Syndrome

Thyroid Dysfunction

Hypoglycemia

Osteonecrosis of the Jaw

Impaired Wound Healing

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/06e0ad28-6637-4f54-879c-2c194aece5fd/spl-doc?hl=sunitinib

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