GILOTRIF is a trademark of and used under license from Boehringer Ingelheim International GmbH.

The other brands listed are trademarks of their respective owners and are not trademarks of Boehringer Ingelheim Pharmaceuticals, Inc.

Copyright 2013 Boehringer Ingelheim International GmbH
ALL RIGHTS RESERVED

IT5562BG172013
302972-01

Patient Information

GILOTRIF™ (JEE-loh-trif)
(afatinib)
tablets
Read this Patient Information before you start taking GILOTRIF and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.

What is GILOTRIF?

     GILOTRIF is a prescription medicine used to treat people with non-small cell lung cancer (NSCLC),

◦that has certain types of abnormal epidermal growth factor receptor (EGFR) genes, and
◦who have not had previous treatment for cancer that has spread to other parts of the body
It is not known if GILOTRIF is safe and effective in children.
What should I tell my doctor before taking GILOTRIF?

 Before you take GILOTRIF, tell your doctor if you:

◦have kidney or liver problems
◦have lung or breathing problems other than lung cancer
◦have a history of severe dry eye or any other eye problems. Tell your doctor if you wear contact lenses.
◦have heart problems
◦have any other medical conditions
◦are pregnant or plan to become pregnant. GILOTRIF can harm your unborn baby. You should not become pregnant while taking GILOTRIF.
◦Women who are able to become pregnant should use effective birth control during treatment with GILOTRIF and for at least 2 weeks after your last dose of GILOTRIF. Talk to your doctor about birth control methods that may be right for you.
◦Tell your doctor right away if you become pregnant while taking GILOTRIF.
◦are breastfeeding or plan to breastfeed. It is not known if GILOTRIF passes into your breast milk. You and your doctor should decide if you will take GILOTRIF or breastfeed. You should not do both.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. GILOTRIF may affect the way other medicines work, and other medicines may affect the way GILOTRIF works.
Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.
How should I take GILOTRIF?

◦Take GILOTRIF exactly as your doctor tells you to take it.
◦Your doctor will tell you how many GILOTRIF tablets to take and when to take them. Do not change your dose or stop GILOTRIF unless your doctor tells you to.
◦Take GILOTRIF on an empty stomach at least 1 hour before a meal or 2 hours after a meal.
◦If you miss a dose of GILOTRIF, take it as soon as you remember. If it is within 12 hours of your next dose, skip the dose and just take your next dose at your regular time.
◦Do not take 2 doses of GILOTRIF at the same time.
◦If you take too much GILOTRIF, call your doctor or go to the nearest hospital emergency room right away.
What should I avoid while taking GILOTRIF?
Limit your time in the sun. GILOTRIF can make your skin sensitive to the sun. You could get or have worsening rash or acne. You could get a severe sunburn. Use sunscreen and wear a hat and clothes that cover you