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SUTENT®Index Section (sunitinib malate)

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: HEPATOTOXICITY

1 INDICATIONS AND USAGE

1.1 Gastrointestinal Stromal Tumor

1.2 Advanced Renal Cell Carcinoma

1.3 Adjuvant Treatment of Renal Cell Carcinoma

1.4 Advanced Pancreatic Neuroendocrine Tumors

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage for GIST and Advanced RCC

2.2 Recommended Dosage for Adjuvant Treatment of RCC

2.3 Recommended Dosage for pNET

2.4 Dosage Modifications for Adverse Reactions

2.5 Dosage Modification for Drug Interactions

2.6 Dosage Modification for End-Stage Renal Disease Patients on Hemodialysis

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Hepatotoxicity

5.2 Cardiovascular Events

5.3 QT Interval Prolongation and Torsade de Pointes

5.4 Hypertension

5.5 Hemorrhagic Events and Viscus Perforation

5.6 Tumor Lysis Syndrome

5.7 Thrombotic Microangiopathy

5.8 Proteinuria

5.9 Dermatologic Toxicities

5.10 Reversible Posterior Leukoencephalopathy Syndrome

5.11 Thyroid Dysfunction

5.12 Hypoglycemia

5.13 Osteonecrosis of the Jaw

5.14 Impaired Wound Healing

5.15 Embryo-Fetal Toxicity

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Effect of Other Drugs on SUTENT

7.2 Drugs that Prolong QT Interval

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.3 Females and Males of Reproductive Potential

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Hepatic Impairment

8.7 Renal Impairment

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Gastrointestinal Stromal Tumor

14.2 Renal Cell Carcinoma

14.3 Pancreatic Neuroendocrine Tumors

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.
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