cluding diarrhea, nausea, vomiting, mouth sores, upset stomach, abdominal pain, and constipation. Talk with your healthcare provider about ways to handle these problems.
rash or other skin changes, including drier, thicker, or cracking skin.
blisters or a rash on the palms of your hands and soles of your feet.
taste changes
loss of appetite
pain or swelling in your arms or legs
cough
shortness of breath
bleeding, such as nosebleeds or bleeding from cuts.
Call your healthcare provider if you have any swelling or bleeding during treatment with SUTENT.
These are not all the possible side effects of SUTENT. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How do I store SUTENT?
Store SUTENT at room temperature, between 59°F and 86°F (15°C to 30°C).
Keep SUTENT and all medicines out of the reach of children.
General information about SUTENT
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SUTENT for a condition for which it was not prescribed. Do not give SUTENT to other people, even if they have the same symptoms you have. It may harm them.
This Medication Guide gives the most important information about SUTENT. For more information about SUTENT, talk with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for information about SUTENT that is written for health professionals.
For more information go to www.SUTENT.com or call 1-877-5-SUTENT.
What are the ingredients in SUTENT?
Active ingredient: sunitinib malate
Inactive ingredients: mannitol, croscarmellose sodium, povidone (K-25), magnesium stearate Orange gelatin capsule shell: titanium dioxide, red iron oxide Caramel gelatin capsule shell: titanium dioxide, red iron oxide, yellow iron oxide, black iron oxide White printing ink: shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Gleevec® is a registered trademark of Novartis Pharmaceuticals Corp
LAB-0361-4
May 2011
PRINCIPAL DISPLAY PANEL - 12.5 mg Bottle Label
ALWAYS DISPENSE WITH MEDICATION GUIDE
NDC 0069-0550-38
28 Capsules
Rx only
Sutent®
(sunitinib malate)
12.5 mg*
Distributed by
Pfizer Labs
Division of Pfizer Inc, NY, NY 10017
PRINCIPAL DISPLAY PANEL - 25 mg Bottle Label
ALWAYS DISPENSE WITH MEDICATION GUIDE
NDC 0069-0770-38
28 Capsules
Rx only
Sutent®
(sunitinib malate)
25 mg*
Distributed by
Pfizer Labs
Division of Pfizer Inc, NY, NY 10017
PRINCIPAL DISPLAY PANEL - 50 mg Bottle Label
ALWAYS DISPENSE WITH MEDICATION GUIDE
NDC 0069-0980-38
28 Capsules
Rx only
Sutent®
(sunitinib malate)
50 mg*
Distributed by
Pfizer Labs
Division of Pfizer Inc, NY, NY 10017
SUTENT
sunitinib malate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0069-0550
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sunitinib malate(Sunitinib) Sunitinib 12.5mg
