HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use SUTENT safely and effectively. See full prescribing information for SUTENT.

SUTENT® (sunitinib malate) capsules, oral
Initial U.S. Approval: 2006
 
WARNING: HEPATOTOXICITY

See full prescribing information for complete boxed warning.

Hepatotoxicity has been observed in clinical trials and post-marketing experience. This hepatotoxicity may be severe, and deaths have been reported. [See Warnings and Precautions (5.1)]
 
RECENT MAJOR CHANGES
Boxed Warning 7/2010
Indications and Usage, Advanced Pancreatic Neuroendocrine Tumors (1.3)  5/2011
Dosage and Administration, Recommended Dose for pNET (2.2) 5/2011
Dosage and Administration, Dose Modification (2.3) 5/2011
Warnings and Precautions, Hepatotoxicity (5.1) 7/2010
Warnings and Precautions, Pregnancy (5.2) 5/2011
Warnings and Precautions, Left Ventricular Dysfunction (5.3) 5/2011
Warnings and Precautions, Hypertension (5.5) 5/2011
Warnings and Precautions, Hemorrhagic Events (5.6) 5/2011
Warnings and Precautions, Thyroid Dysfunction (5.7) 5/2011
Warnings and Precautions, Wound Healing (5.8) 5/2011
INDICATIONS AND USAGE
SUTENT is a kinase inhibitor indicated for the treatment of:

Gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1)
Advanced renal cell carcinoma (RCC). (1.2)
Progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in patients with unresectable locally advanced or metastatic disease. (1.3)
DOSAGE AND ADMINISTRATION
GIST and RCC:
50 mg orally once daily, with or without food, 4 weeks on treatment followed by 2 weeks off. (2.1)
pNET:
37.5 mg orally once daily, with or without food, continuously without a scheduled off-treatment period. (2.2)
Dose Modification:
Dose interruptions and/or dose adjustments of 12.5 mg recommended based on individual safety and tolerability. (2.3)
DOSAGE FORMS AND STRENGTHS
Capsules: 12.5 mg, 25 mg, 50 mg (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Hepatotoxicity, including liver failure, has been observed. Monitor liver function tests before initiation of treatment, during each cycle of treatment, and as clinically indicated. SUTENT should be interrupted for Grade 3 or 4 drug-related hepatic adverse events and discontinued if there is no resolution. Do not restart SUTENT if patients subsequently experience severe changes in liver function tests or have other signs and symptoms of liver failure. (5.1)
Women of childbearing potential should be advised of the potential hazard to the fetus and to avoid becoming pregnant. (5.2)
Cardiac toxicity including left ventricular ejection fraction declines to below the lower limit of normal and cardiac failure including death have occurred. Monitor patients for signs and symptoms of congestive heart failure. (5.3)
Prolonged QT intervals and Torsade de Pointes have been observed. Use with caution in patients at higher risk for developing QT interval prolongation. When using SUTENT, monitoring with on-treatment electrocardiograms and electrolytes should be considered. (5.4)
Hypertension may occur. Monitor blood pressure and treat as needed. (5.5)
Hemorrhagic events including tumor-related hemorrhage have occurred. Perform serial