When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to afatinib, or if you are pregnant.

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Take this medicine on an empty stomach at least 1 hour before or 2 hours after a meal.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If your next dose is more than 12 hours away, take your medicine as soon as you can. If your next dose is less than 12 hours away, skip the missed dose and take a dose at the regular time. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how afatinib works. Tell your doctor if you are also using amiodarone, carbamazepine, cyclosporine, erythromycin, itraconazole, ketoconazole, nelfinavir, phenobarbital, phenytoin, quinidine, rifampicin, ritonavir, saquinavir, St John's wort, tacrolimus, or verapamil.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Keep using birth control during treatment and for at least 2 weeks after your last dose.
• Tell your doctor if you have kidney disease, liver disease, heart disease, or other lung problems. Tell your doctor if you wear contact lenses or have a history of eye problems, such as keratitis or severe dry eyes.
• Do not breastfeed during treatment and for 2 weeks after your last dose of this medicine.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine may cause the following problems:
  
  • Diarrhea, which can lead to dehydration or kidney damage if not treated
  • Heart, liver, or lung problems
  • Eye or vision problems
  • Severe skin reaction
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Blurred vision, eye redness, irritation, swelling, or pain
• Change in how much or how often you urinate, bloody or cloudy urine, painful urination
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Rapid weight gain, swelling in your ankles, feet, or legs
• Severe diarrhea or diarrhea that does not stop
• Trouble breathing, chest pain, cough, fever

If you notice these less serious side effects, talk with your doctor:

• Acne, mild rash, itching
• Sores or white patches on your lips, mouth, or throat

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088