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SUTENT®(sunitinib malate)
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SUTENT® Quick Finder
Highlights
Boxed Warning
WARNING: HEPATOTOXICITY
Hepatotoxicity may be severe, and in some cases, fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue SUTENT as recommended [see...
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Indications and Usage
1 INDICATIONS AND USAGE
1.1 Gastrointestinal Stromal Tumor
SUTENT is indicated for the treatment of adult patients with gastrointestinal stromal tumor (GIST) after...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage for GIST and Advanced RCC
The recommended dosage of SUTENT for gastrointestinal stromal tumor (GIST) and advanced...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Capsules, hard gelatin:
- 12.5 mg sunitinib: orange cap and orange body, printed with white ink "Pfizer" on the cap and "STN 12.5 mg" on the body.
- 25 mg sunitinib:...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Hepatotoxicity
SUTENT can cause severe hepatotoxicity, resulting in liver failure or death. In the pooled safety population, liver...
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Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling.
- Hepatotoxicity [see Warnings and Precautions (...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Effect of Other Drugs on SUTENT
Strong CYP3A4 Inhibitors
...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on animal...
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Overdosage
10 OVERDOSAGE
Treatment of overdose with SUTENT should consist of general supportive measures. There is no specific antidote for overdosage with SUTENT. If indicated, elimination of unabsorbed drug should be achieved by...
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Description
11 DESCRIPTION
Sunitinib is a kinase inhibitor present in SUTENT capsules as the malate salt. Sunitinib malate is described chemically as (2S)-2-hydroxybutanedoic acid with ...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Sunitinib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs), some of which are implicated...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
The carcinogenic potential of sunitinib has been evaluated in 2 species: rasH2...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Gastrointestinal Stromal Tumor
Study 1
Study 1 (NCT#...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
SUTENT 12.5 mg capsules are supplied as hard gelatin capsule with orange cap and orange body, printed with white ink "Pfizer" on the cap, "STN 12.5 mg" on the body:
...
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Medication Guide
| This Medication Guide has been approved by the U.S. Food and Drug Administration. | Revised: August 2021 | ||
| MEDICATION GUIDE... | |||
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Resources
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