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SUTENT® (sunitinib malate)

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Download Prescribing Information
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HIGHLIGHTS OF PRESCRIBING INFORMATION

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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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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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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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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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4 CONTRAINDICATIONS

None.

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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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7 DRUG INTERACTIONS

7.1 Effect of Other Drugs on SUTENT

Strong CYP3A4 Inhibitors

...
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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on animal...

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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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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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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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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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14 CLINICAL STUDIES

14.1 Gastrointestinal Stromal Tumor

Study 1

Study 1 (NCT#...

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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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This Medication Guide has been approved by the U.S. Food and Drug Administration.Revised: August 2021  
MEDICATION GUIDE...
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This product's labeling may have been updated. For the most recent prescribing information, please visit http://www.pfizer.com.

...

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Resources

Pfizer Oncology Together
For questions regarding the Pfizer Oncology Together program, please call (877) 744-5675.
website
Sutent Website for Consumers and Patients
 
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Call (800) 438-1985

Contact Pfizer Medical Information to speak with a professional regarding your medical question on a Pfizer prescription product: (800) 438-1985

Report Adverse Event
Pfizer Safety

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.

FDA Medwatch
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.