17.2 Skin Effects
Skin discoloration possibly due to the drug color (yellow) occurred in approximately one third of patients. Patients should be advised that depigmentation of the hair or skin may occur during treatment with SUTENT. Other possible dermatologic effects may include dryness, thickness or cracking of skin, blister or rash on the palms of the hands and soles of the feet.

17.3 Other Common Events
Other commonly reported adverse events included fatigue, high blood pressure, bleeding, swelling, mouth pain/irritation and taste disturbance.

17.4 Concomitant Medications
Patients should be advised to inform their health care providers of all concomitant medications, including over-the-counter medications and dietary supplements (see 7 DRUG INTERACTIONS).

Rev: [July/2006]

Sutent (sunitinib malate) 
PRODUCT INFO
Product Code 0069-0550 Dosage Form CAPSULE
Route Of Administration ORAL DEA Schedule 
 
INGREDIENTS
Name (Active Moiety) Type Strength
sunitinib malate (sunitinib)  Active 12.5 MILLIGRAM  In 1 CAPSULE
mannitol Inactive  
croscarmellose sodium Inactive  
povidone (K-25) Inactive  
magnesium stearate Inactive  
gelatin Inactive  
titanium dioxide Inactive  
red iron oxide Inactive  
shellac Inactive  
propylene glycol Inactive  
sodium hydroxide Inactive  
povidone Inactive  
 
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color ORANGE Score 1
Shape CAPSULE Symbol false
Imprint Code Pfizer;STN;12.5;mg Coating false
Size 14mm
 
PACKAGING
# NDC Package Description Multilevel Packaging
1 0069-0550-38 28 CAPSULE In 1 BOTTLE None
2 0069-0550-30 30 CAPSULE In 1 BOTTLE None
 

Sutent (sunitinib malate) 
PRODUCT INFO
Product Code 0069-0770 Dosage Form CAPSULE
Route Of Administration ORAL DEA Schedule 
 
INGREDIENTS
Name (Active Moiety) Type Strength
sunitinib malate (sunitinib)  Active 25 MILLIGRAM  In 1 CAPSULE
mannitol Inactive  
croscarmellose sodium Inactive  
povidone (K-25) Inactive  
magnesium stearate Inactive  
gelatin Inactive  
titanium dioxide Inactive  
red iron oxide Inactive  
yellow iron oxide Inactive  
black iron oxide Inactive  
shellac Inactive  
propylene glycol Inactive  
sodium hydroxide Inactive  
povidone Inactive  
 
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color ORANGE, BROWN (caramel)  Score 1
Shape CAPSULE Symbol false
Imprint Code Pfizer;STN;25;mg Coating false
Size 16mm
 
PACKAGING
# NDC Package Description Multilevel Packaging
1 0069-0770-38 28 CAPSULE In 1 BOTTLE None
2 0069-0770-30 30 CAPSULE In 1 BOTTLE None
 

Sutent (sunitinib malate) 
PRODUCT INFO
Product Code