denly, and in the case of pulmonary tumors may present as severe and life-threatening hemoptysis or pulmonary hemorrhage. Clinical assessment of these events should include serial complete blood counts (CBCs) and physical examinations.
Hypertension: Severe hypertension (>200 mmHg systolic or 110 mmHg diastolic) occurred in 4% of GIST patients on SUTENT and 1% of GIST patients on placebo, 5% of treatment-naïve MRCC patients on SUTENT and 1% on interferon-α (IFN-α), and 6% of cytokine-refractory MRCC patients. Patients should be monitored for hypertension and treated as needed with standard antihypertensive therapy. In cases of severe hypertension, temporary suspension of SUTENT is recommended until hypertension is controlled.
ADVERSE REACTIONS
Most common all-causality adverse reactions (≥ 20%) are Constitutional (fatigue), Gastrointestinal (diarrhea, nausea, mucositis/stomatitis, vomiting, constipation, and abdominal pain), Cardiac (hypertension), Dermatology (rash, skin discoloration), Neurology (altered taste, headache), Musculoskeletal (arthralgia, myalgia/limb pain), Metabolism/Nutrition (anorexia, asthenia), Hemorrhage/bleeding (bleeding, all sites).
Elevated liver function tests, pancreatic enzymes, creatinine, and myelosuppression were more common in GIST patients treated with SUTENT than placebo. Acquired hypothyroidism was noted in 8 patients (4%) on SUTENT versus 1 (1%) on placebo. Common treatment emergent laboratory abnormalities also observed in the MRCC studies included hypophosphatemia, hyperuricemia and increased lipase.
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
CYP3A4 Inhibitors: Concurrent administration of sunitinib malate with the strong CYP3A4 inhibitor, ketoconazole, resulted in an increase in exposure after a single dose of sunitinib malate. A dose reduction for SUTENT should be considered when it must be co-administered with strong CYP3A4 inhibitors.
CYP3A4 Inducers: Concurrent administration of SUTENT with the strong CYP3A4 inducer, rifampin, resulted in a reduction in exposure after a single dose of SUTENT. A dose increase for SUTENT should be considered when it must be co-administered with CYP3A4 inducers.
USE IN SPECIFIC POPULATIONS
Nursing Mothers: It is not known whether sunitinib or its primary active metabolite is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, women should be advised against breastfeeding while taking SUTENT.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 02/2007
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FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
1 INDICATIONS AND USAGE
1.1 Gastrointestinal Stromal Tumor
1.2 Advanced Renal Cell Carcinoma
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose
2.2 Dose Modification
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Pregnancy Category D
5.2 Left Ventricular Dysfunction
5.3 QT Interval Prolongation
5.4 Hemorrhagic Events
5.5 Hypertension
5.6 Adrenal Function
5.7 Laboratory Tests
6 ADVERSE REACTIONS
6.1 Overview
6. |
