t use GILOTRIF for a condition for which it was not prescribed. Do not give GILOTRIF to other people, even if they have the same symptoms you have. It may harm them.
This Patient Information summarizes the most important information about GILOTRIF. If you would like more information about GILOTRIF, talk with your doctor. You can ask your doctor or pharmacist for information about GILOTRIF that is written for health professionals.
For more information, go to www.gilotrif.com or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 or (TTY) 1-800-459-9906, or scan the code below to go to www.gilotrif.com.
What are the ingredients in GILOTRIF?
Active ingredient: afatinib
Inactive ingredients: Tablet Core: lactose monohydrate, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate.
Tablet Coating: hypromellose, polyethylene glycol, titanium dioxide, talc, polysorbate 80, FD&C Blue No. 2 (40 mg and 30 mg tablets only).
This Patient Information has been approved by the U.S. Food and Drug Administration.
Distributed by:
Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT 06877 USA
Licensed from:
Boehringer Ingelheim International GmbH
GILOTRIF is a trademark of and used under license from Boehringer Ingelheim International GmbH.
Copyright 2013 Boehringer Ingelheim International GmbH
ALL RIGHTS RESERVED
Issued: July 2013
IT5562BG172013
302972-01
Gilotrif™ 20 mg TabletsNDC: 0597-0141-30
(click image for full-size original) Gilotrif™ 30 mg TabletsNDC: 0597-0137-30
(click image for full-size original) Gilotrif™ 40 mg TabletsNDC: 0597-0138-30
(click image for full-size original) GILOTRIF afatinib tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0597-0141
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
afatinib (afatinib) afatinib 20 mg
Product Characteristics
Color WHITE (Slightly yellowish) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code T20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0597-0141-30 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (0597-0141-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA201292 07/12/2013
GILOTRIF afatinib tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0597-0137
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
afatinib (afatinib) afatinib 30 mg
Product Characteristics
Color BLUE (Dark Blue) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code T30
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0597-0137-30 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (0597-0137-30)
Market
