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)capsule for oral use
Initial U.S. Approval: 2006
RECENT MAJOR CHANGES
Indications and Usage ( 1.2)  7/2006
Warnings and Precautions, Left Ventricular Function ( 5.2)  7/2006
Warnings and Precautions, QT Interval Prolongation ( 5.3)  7/2006
Warnings and Precautions, Hemorrhagic Events ( 5.4)  7/2006
Warnings and Precautions, Hypertension ( 5.5)  7/2006
INDICATIONS AND USAGE
SUTENT is a multi-kinase inhibitor indicated for
the treatment of gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate.
the treatment of advanced renal cell carcinoma (RCC).
DOSAGE AND ADMINISTRATION
One 50-mg oral capsule taken once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off (Schedule 4/2). SUTENT may be taken with or without food. Dose increase or reduction of 12.5-mg increments is recommended based on individual safety and tolerability.
DOSAGE FORMS AND STRENGTHS
12.5-mg capsules
25-mg capsules
50-mg capsules
 CONTRAINDICATIONS
None
WARNINGS AND PRECAUTIONS
Pregnancy Category D: There are no adequate and well-controlled studies of SUTENT in pregnant women. If the drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with SUTENT.
Left Ventricular Dysfunction: Left ventricular ejection fraction (LVEF) declines have been observed below the lower limit of normal in both GIST and MRCC patients. It is unknown whether patients with concomitant cardiac conditions may be at a higher risk of developing drug-related left ventricular dysfunction. Physicians are advised to weigh this risk against the potential benefits of the drug. These patients should be carefully monitored for clinical signs and symptoms of CHF while receiving SUTENT. Baseline and periodic eva luations of LVEF should also be considered while the patient is receiving SUTENT. In patients without cardiac risk factors, a baseline eva luation of ejection fraction should be considered. In the presence of clinical manifestations of CHF, discontinuation of SUTENT is recommended. The dose of SUTENT should be interrupted and/or reduced in patients without clinical evidence of CHF but with an ejection fraction <50% and >20% below baseline.
QT Interval Prolongation: At approximately twice therapeutic concentrations, SUTENT has been shown to prolong the QTcF interval. Torsade de pointe has been observed in <0.1% of SUTENT-exposed patients. SUTENT should be used with caution in patients with a known history of QT interval prolongation, patients who are taking antiarrhythmics, or patients with relevant pre-existing cardiac disease, bradycardia, or electrolyte disturbances. Concomitant treatment with strong CYP3A4 inhibitors, which may increase sunitinib plasma concentrations, should be used with caution and dose reduction of SUTENT should be considered.
Hemorrhagic Events: Tumor-related hemorrhage has been observed in patients treated with SUTENT as early as cycle 1 and as late as cycle 6. These events may occur sud