SUTENT® Principal Display Panel (sunitinib malate) | Pfizer Medical Information - US

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

PRINCIPAL DISPLAY PANEL - 12.5 mg Capsule Bottle Label

ALWAYS DISPENSE WITH MEDICATION GUIDE

NDC 0069-0550-38

Pfizer

Sutent®
(sunitinib malate)

12.5 mg*

Capsules

28 Capsules
Rx only

PRINCIPAL DISPLAY PANEL - 12.5 mg Capsule Bottle Label

PRINCIPAL DISPLAY PANEL - 25 mg Capsule Bottle Label

ALWAYS DISPENSE WITH MEDICATION GUIDE

NDC 0069-0770-38

Pfizer

Sutent®
(sunitinib malate)

25 mg*

Capsules

28 Capsules
Rx only

PRINCIPAL DISPLAY PANEL - 25 mg Capsule Bottle Label

PRINCIPAL DISPLAY PANEL - 50 mg Capsule Bottle Label

ALWAYS DISPENSE WITH MEDICATION GUIDE

NDC 0069-0980-38

Pfizer

Sutent®
(sunitinib malate)

50 mg*

Capsules

28 Capsules
Rx only

PRINCIPAL DISPLAY PANEL - 50 mg Capsule Bottle Label

PRINCIPAL DISPLAY PANEL - 37.5 mg Capsule Bottle Label

ALWAYS DISPENSE WITH MEDICATION GUIDE

NDC 0069-0830-38

Pfizer

Sutent®
(sunitinib malate)

37.5 mg*

Capsules

28 Capsules
Rx only

PRINCIPAL DISPLAY PANEL - 37.5 mg Capsule Bottle Label

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

SUTENT® Quick Finder

Pfizer samples (for eligible HCPs)

Requests for samples of prescription medications can be made by contacting Pfizer for Professionals at 1-800-505-4426 or by visiting the PfizerPro website www.pfizerpro.com.
Report an adverse event or concern about the quality of a Pfizer product

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), 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 or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.
If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly by visiting www.fda.gov/medwatch or by calling (800)-332-1088.
Assistance programs (for eligible patients)

Pfizer RxPathways connects eligible patients to a range of assistance programs that offer insurance support, co-pay help, and medicines for free or at a savings. Patients and physicians can contact RxPathways at (866) 706-2400 or visit the website for more information on these programs www.pfizerrxpathways.com.
Resources

Show All Hide All

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...

Read more

Did you find an answer to your question? Yes No

WARNING: HEPATOTOXICITY

Hepatotoxicity may be severe, and in some cases, fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue SUTENT as recommended [see...

Read more

Did you find an answer to your question? Yes No

1 INDICATIONS AND USAGE

1.1 Gastrointestinal Stromal Tumor

SUTENT is indicated for the treatment of adult patients with gastrointestinal stromal tumor (GIST) after...

Read more

Did you find an answer to your question? Yes No

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...

Read more

Did you find an answer to your question? Yes No

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:...

Read more

Did you find an answer to your question? Yes No

4 CONTRAINDICATIONS

None.

Read more

Did you find an answer to your question? Yes No

5 WARNINGS AND PRECAUTIONS

5.1 Hepatotoxicity

SUTENT can cause severe hepatotoxicity, resulting in liver failure or death. In the pooled safety population, liver...

Read more

Did you find an answer to your question? Yes No

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling.

Hepatotoxicity [see Warnings and Precautions (...

Read more

Did you find an answer to your question? Yes No

7 DRUG INTERACTIONS

7.1 Effect of Other Drugs on SUTENT

Strong CYP3A4 Inhibitors

...

Read more

Did you find an answer to your question? Yes No

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on animal...

Read more

Did you find an answer to your question? Yes No

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...

Read more

Did you find an answer to your question? Yes No

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 ...

Read more

Did you find an answer to your question? Yes No

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...

Read more

Did you find an answer to your question? Yes No

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

The carcinogenic potential of sunitinib has been evaluated in 2 species: rasH2...

Read more

Did you find an answer to your question? Yes No

14 CLINICAL STUDIES

14.1 Gastrointestinal Stromal Tumor

Study 1

Study 1 (NCT#...

Read more

Did you find an answer to your question? Yes No

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:

...

Read more

Did you find an answer to your question? Yes No

This Medication Guide has been approved by the U.S. Food and Drug Administration.			Revised: August 2021
MEDICATION GUIDE...

Read more

Did you find an answer to your question? Yes No

This product's labeling may have been updated. For the most recent prescribing information, please visit http://www.pfizer.com.

...

Read more

Did you find an answer to your question? Yes No

Did you find an answer to your question? Yes No

Resources

website

Sutent Website for Healthcare Professionals

website

Sutent Website for Consumers and Patients

website

Pfizer Oncology together

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985^*

*Contact Medical Information.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

Report Adverse Event

Pfizer Safety

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), 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 or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety 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.