oms of a heart problem which may include:
◦new or worsening shortness of breath while at rest or with activity
◦cough
◦tiredness
◦swelling of your ankles, feet, or legs
◦feeling that your heart is pounding or racing (palpitations)
◦sudden weight gain
The most common side effects of Gilotrif include:
•diarrhea
•rash
•mouth sores
•nail infection
•dry skin
•acne
•decreased appetite
•itching
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of Gilotrif. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Gilotrif?
•Store Gilotrif at room temperature between 68°F to 77°F (20°C to 25°C).
•Keep Gilotrif in the original container and keep the container tightly closed.
•Keep Gilotrif away from moisture and light.
•Safely throw away (discard) any Gilotrif that is out of date or no longer needed.
Keep Gilotrif and all medicines out of the reach of children.
General information about Gilotrif
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not 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 Tablets
NDC: 0597-0141-30
Gilotrif™ 30 mg Tablets
NDC: 0597-0137-30
Gilotrif™ 40 mg Tablets
NDC: 0597-0138-30
Gilotrif
afatinib tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL 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 (Slig
