complete blood counts and physical examinations. (5.6)
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. (5.7)
Temporary interruption of therapy with SUTENT is recommended in patients undergoing major surgical procedures. (5.8)
Adrenal hemorrhage was observed in animal studies. Monitor adrenal function in case of stress such as surgery, trauma or severe infection. (5.9)
ADVERSE REACTIONS
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
CYP3A4 Inhibitors: Consider dose reduction of SUTENT when administered with strong CYP3A4 inhibitors. (7.1)
CYP3A4 Inducers: Consider dose increase of SUTENT when administered with CYP3A4 inducers. (7.2)
See 17 for PATIENT COUNSELING INFORMATION and the FDA-approved Medication Guide
Revised: 05/2011
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Back to Highlights and TabsFULL PRESCRIBING INFORMATION: CONTENTS*
*Sections or subsections omitted from the full prescribing information are not listed
WARNING: HEPATOTOXICITY
1INDICATIONS AND USAGE
1.1Gastrointestinal Stromal Tumor (GIST)
1.2Advanced Renal Cell Carcinoma (RCC)
1.3Advanced Pancreatic Neuroendocrine Tumors (pNET)
2DOSAGE AND ADMINISTRATION
2.1Recommended Dose for GIST and RCC
2.2Recommended Dose for pNET
2.3Dose Modification
3DOSAGE FORMS AND STRENGTHS
4CONTRAINDICATIONS
5WARNINGS AND PRECAUTIONS
5.1Hepatotoxicity
5.2Pregnancy
5.3Left Ventricular Dysfunction
5.4QT Interval Prolongation and Torsade de Pointes
5.5Hypertension
5.6Hemorrhagic Events
5.7 Thyroid Dysfunction
5.8 Wound Healing
5.9 Adrenal Function
5.10 Laboratory Tests
6ADVERSE REACTIONS
6.1Adverse Reactions in GIST Study A
6.2Adverse Reactions in the Treatment-Naïve RCC Study
6.3Adverse Reactions in the Phase 3 pNET Study
6.4Venous Thromboembolic Events
6.5Reversible Posterior Leukoencephalopathy Syndrome
6.6Pancreatic and Hepatic Function
6.7Post-marketing Experience
7DRUG INTERACTIONS
7.1CYP3A4 Inhibitors
7.2CYP3A4 Inducers
7.3In Vitro Studies of CYP Inhibition and Induction
8USE IN SPECIFIC POPULATIONS
8.1Pregnancy
8.3Nursing Mothers
8.4Pediatric Use
8.5Geriatric Use
8.6Hepatic Impairment
8.7Renal Impairment
10OVERDOSAGE
11DESCRIPTION
12CLINICAL PHARMACOLOGY
12.1Mechanism of Action
12.3Pharmacokinetics
12.4 Cardiac Electrophysiology
13NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility
14CLINICAL STUDIES
14.1Gastrointestinal Stromal Tumor
14.2Renal Cell Carcinoma
14.3 Pancreatic Neuroendocrine Tumors
16HOW SUPPLIED/STORAGE AND HANDLING
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