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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
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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)]
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RECENT MAJOR CHANGES
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Boxed Warning |
7/2010 |
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Indications and Usage, Advanced Pancreatic Neuroendocrine Tumors (1.3) |
5/2011 |
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Dosage and Administration, Recommended Dose for pNET (2.2) |
5/2011 |
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Dosage and Administration, Dose Modification (2.3) |
5/2011 |
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Warnings and Precautions, Hepatotoxicity (5.1) |
7/2010 |
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Warnings and Precautions, Pregnancy (5.2) |
5/2011 |
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Warnings and Precautions, Left Ventricular Dysfunction (5.3) |
5/2011 |
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Warnings and Precautions, Hypertension (5.5) |
5/2011 |
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Warnings and Precautions, Hemorrhagic Events (5.6) |
5/2011 |
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Warnings and Precautions, Thyroid Dysfunction (5.7) |
5/2011 |
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Warnings and Precautions, Wound Healing (5.8) |
5/2011 |
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INDICATIONS AND USAGE
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SUTENT is a kinase inhibitor indicated for the treatment of:
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Gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1)
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Advanced renal cell carcinoma (RCC). (1.2)
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Progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in patients with unresectable locally advanced or metastatic disease. (1.3)
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DOSAGE AND ADMINISTRATION
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GIST and RCC:
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50 mg orally once daily, with or without food, 4 weeks on treatment followed by 2 weeks off. (2.1)
pNET:
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37.5 mg orally once daily, with or without food, continuously without a scheduled off-treatment period. (2.2)
Dose Modification:
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Dose interruptions and/or dose adjustments of 12.5 mg recommended based on individual safety and tolerability. (2.3)
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DOSAGE FORMS AND STRENGTHS
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Capsules: 12.5 mg, 25 mg, 50 m
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