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
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Warnings and Precautions, Cardiovascular Events (5.3) |
4/2015 |
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Warnings and Precautions, Thrombotic Microangiopathy (5.8) |
4/2015 |
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Warnings and Precautions, Proteinuria (5.9) |
6/2014 |
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Warnings and Precautions, Dermatologic Toxicities (5.10) |
6/2014 |
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Warnings and Precautions, Hypoglycemia (5.12) |
12/2014 |
INDICATIONS AND USAGE
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)
DOSAGE AND ADMINISTRATION
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)
DOSAGE FORMS AND STRENGTHS
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Capsules: 12.5 mg, 25 mg, 37.5 mg, 50 mg (3)
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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)
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Hypertension may occur. Monitor blood pressure and treat as needed. (5.5)
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Hemorrhagic events including tumor-related hemorrhage have occurred. Perform serial complete blood counts and physical examinations. (5.6)
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Cases of Tumor Lysis Syndrome (TLS) have been reported primarily in patients with RCC and GIST with high tumor burden. Monitor these patients closely and treat as clinically indicated. (5.7)
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Thrombotic microangiopathy, including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, sometimes leading to renal failure or a fatal outcome, has been reported in clinical trials and in post-marketing experience of SUTENT. (5.8)
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Proteinuria: Monitor urine protein. Interrupt treatment for 24-hour urine protein ≥3 grams. Discontinue for repeat episodes of protein ≥3 grams despite dose reductions or nephrotic syndrome. (5.9)
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Discontinue SUTENT if necrotizing fasciitis, erythema multiforme, Stevens-Johnson Syndrome or toxic epidermal necrolysis occurs. (5.10).
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Thyroid dysfunction may occur. Patients with signs and/or symptoms suggestive of hypothyroidism or hyperthyroidism should have laboratory monitoring of thyroid function performed and be treated as per standard medical practice. (5.11)
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Hypoglycemia may occur. Check blood glucose levels regularly and assess if anti-diabetic drug dose modifications are required. (5.12)
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Osteonecrosis of the jaw has been reported. Consider preventive dentistry prior to treatment with SUTENT. If possible, avoid invasive dental procedures, particularly in patients receiving intravenous bisphosphonate therapy. (5.13)
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Wound Healing: Impaired wound healing has occurred with SUTENT. Temporary interruption of therapy with SUTENT is recommended in patients undergoing major surgical procedures. (5.14)
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Adrenal hemorrhage was observed in animal studies. Monitor adrenal function in case of stress such as surgery, trauma or severe infection. (5.15)
ADVERSE REACTIONS
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The most common adverse reactions (≥20%) are fatigue, asthenia, fever, diarrhea, nausea, mucositis/stomatitis, vomiting, dyspepsia, abdominal pain, constipation, hypertension, peripheral edema, rash, hand-foot syndrome, skin discoloration, dry skin, hair color changes, altered taste, headache, back pain, arthralgia, extremity pain, cough, dyspnea, anorexia, and bleeding. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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CYP3A4 Inhibitors: Consider dose reduction of SUTENT when administered with strong CYP3A4 inhibitors. (7.1)
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CYP3A4 Inducers: Consider dose increase of SUTENT when administered with CYP3A4 inducers. (7.2)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 4/2015
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