Precautions (5.4)].
•Keratitis
Advise patients to immediately report eye problems (e.g., eye pain, swelling, redness, blurred vision, or other vision changes) [see Warnings and Precautions (5.5)].
•Left Ventricular Dysfunction
Advise patients to contact a healthcare professional immediately for any of the following: new onset or worsening shortness of breath or exercise intolerance, cough, fatigue, swelling of the ankles/legs, palpitations, or sudden weight gain [see Dosage and Administration (2.3) and Adverse Reactions (6.1)].
•Instructions for Taking Gilotrif
Advise patients to take Gilotrif on an empty stomach at least 1 hour before or 2 hours after eating [see Dosage and Administration (2.2)]. Advise patients not to take a missed dose within 12 hours of the next dose.
•Embryofetal Toxicity
Counsel patients on pregnancy planning and prevention. Advise females of reproductive potential to use highly effective contraception during treatment, and for at least 2 weeks after taking the last dose of Gilotrif [see Warnings and Precautions (5.6) and Use in Specific Populations (8.1)].
•Nursing Mothers
Advise patients to discontinue nursing while taking Gilotrif [see Use in Specific Populations (8.3)].
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.
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 b |
