me symptoms you have. It may harm them.
This Patient Information leaflet summarizes the most important information about BOSULIF. If you would like more information, talk with your doctor. You may ask your doctor or pharmacist for information about BOSULIF that is written for healthcare professionals.
For more information, go to www.Bosulif.com or www.pfizermedicalinformation.com or call 1-800-438-1985.
What are the ingredients in BOSULIF?
Active ingredient: bosutinib.
Inactive ingredients: microcrystalline cellulose, croscarmellose sodium, poloxamer, povidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and iron oxide yellow (for 100 mg tablet) and iron oxide red (for 500 mg tablet).
This Patient Information has been approved by the U.S. Food and Drug Administration.
LAB-0639-1.0
September 2012
PRINCIPAL DISPLAY PANEL - 100 mg Bottle Label
Pfizer
NDC 0069-0135-01
Bosulif®
(bosutinib) tablets
100 mg*
Do not crush or cut tablet
For Oncology Use Only
120 Tablets
Rx only
PRINCIPAL DISPLAY PANEL - 500 mg Bottle Label
Pfizer
NDC 0069-0136-01
Bosulif®
(bosutinib) tablets
500 mg*
Do not crush or cut tablet
For Oncology Use Only
30 Tablets
Rx only
BOSULIF
bosutinib monohydrate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-0135
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Bosutinib monohydrate (Bosutinib) Bosutinib 100 mg
Inactive Ingredients
Ingredient Name Strength
cellulose, microcrystalline
croscarmellose sodium
POVIDONE K25
magnesium stearate
polyvinyl alcohol
titanium dioxide
POLYETHYLENE GLYCOL 3350
talc
ferric oxide yellow
POLOXAMER 188
Product Characteristics
Color YELLOW Score no score
Shape OVAL (biconvex) Size 11mm
Flavor Imprint Code Pfizer;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0069-0135-01 120 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203341 09/04/2012
BOSULIF
bosutinib monohydrate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-0136
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Bosutinib monohydrate (Bosutinib) Bosutinib 500 mg
Inactive Ingredients
Ingredient Name Strength
cellulose, microcrystalline
croscarmellose sodium
POVIDONE K25
magnesium stearate
polyvinyl alcohol
titanium dioxide
POLYETHYLENE GLYCOL 3350
talc
ferric oxide red
POLOXAM
