2 Adverse Events in GIST Study A
6.3 Adverse Events in MRCC Studies
6.4 Cardiovascular Events
6.5 Venous Thromboembolic Events
6.6 Seizures
6.7 Laboratory Abnormalities/Testing
7 DRUG INTERACTIONS
7.1 In Vitro Studies of CYP Inhibition and Induction
7.2 CYP3A4 Inhibitors
7.3 CYP3A4 Inducers
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism Of Action
12.3 Pharmacokinetics
12.4 Cardiac Electrophysiology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Gastrointestinal Stromal Tumor
14.2 Renal Cell Carcinoma
15 REFERENCE
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 12.5-mg Capsules
16.2 25-mg Capsules
16.3 50-mg Capsules
16.4 Storage
17 PATIENT COUNSELING INFORMATION
17.1 Gastrointestinal Disorders
17.2 Skin Effects
17.3 Other Common Events
17.4 Concomitant Medications
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
1.1 Gastrointestinal Stromal Tumor
SUTENT is indicated for the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate.
1.2 Advanced Renal Cell Carcinoma
SUTENT is indicated for the treatment of advanced renal cell carcinoma.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose
The recommended dose of SUTENT for GIST and advanced renal cell carcinoma (RCC) is one 50-mg oral dose taken once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off. SUTENT may be taken with or without food.
2.2 Dose Modification
Dose increase or reduction of 12.5-mg increments is recommended based on individual safety and tolerability.
Strong CYP3A4 inhibitors such as ketoconazole may increase SUTENT plasma concentrations (see 7 DRUG INTERACTIONS). Selection of an alternate concomitant medication with no or minimal enzyme inhibition potential is recommended. A dose reduction for SUTENT to a minimum of 37.5 mg daily should be considered if SUTENT must be co-administered with a strong CYP3A4 inhibitor.
CYP3A4 inducers such as rifampin may decrease SUTENT plasma concentrations (see 7 DRUG INTERACTIONS). Selection of an alternate concomitant medication with no or minimal enzyme induction potential is recommended. A dose increase for SUTENT to a maximum of 87.5 mg daily should be considered if SUTENT must be co-administered with a CYP3A4 inducer. If dose is increased, the patient should be monitored carefully for toxicity. St. John's Wort may decrease SUTENT plasma concentrations unpredictably. Patients receiving SUTENT should not take St. John's Wort concomitantly.
3 DOSAGE FORMS AND STRENGTHS
12.5-mg capsules
25-mg capsules
50-mg capsules
4 CONTRAINDICATIONS
None
5 WARNINGS AND PRECAUTIONS
5.1 Pregnancy Category D
Sunitinib was eva luated in pregnant rats (0.3, 1.5, 3.0, 5.0 mg/kg/day) and rabbits (0.5, 1, 5, 20 mg/kg/day) for effects on the embryo. Significant increases in the incidence of embryolethality and structural abnormalities were observed in rats at the dose of 5 mg/kg/day (approximately 5.5 times the syste
