Afatinib tablets

What is this medication?

AFATINIB (a FA ti nib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat non-small cell lung cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): GILOTRIF

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• eye disease, vision problems, or if you wear contact lenses
• heart disease
• kidney disease
• liver disease
• lung or breathing disease
• stomach or intestine problems
• an unusual or allergic reaction to afatinib, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine on an empty stomach, at least 1 hour before or 2 hours after food. Do not take with food. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Take your missed dose as soon as you remember. If your next dose is to be taken in less than 12 hours, then do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

What may interact with this medication?

• amiodarone
• carbamazepine
• certain medicines for fungal infections like ketoconazole and itraconazole
• cyclosporine A
• erythromycin
• grapefruit juice
• nelfinavir
• phenobarbital
• phenytoin
• quinidine
• rifampicin
• ritonavir
• saquinavir
• St. John's wort
• tacrolimus
• verapamil

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your doctor for regular check ups. Report any side effects. Continue your course of treatment unless your doctor tells you to stop. You will need blood work done while you are taking this medicine.

If you experience any of the following, contact your healthcare provider: eye irritation; rash; severe or continuing diarrhea, nausea, decreased appetite, or vomiting; or if your breathing gets worse or you develop shortness of breath or cough.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your healthcare provider right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

Do not become pregnant while taking this medicine or for 2 weeks after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your healthcare provider or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for 2 weeks after the last dose.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• bloody or black tarry stools
• eye irritation
• eye pain
• fever
• mouth sores
• problems related to breathing including shortness of breath or cough
• redness, blistering, peeling, or loosening of the skin, including inside the mouth
• severe or persistent diarrhea, nausea, vomiting, or loss of appetite
• severe stomach pain
• spitting up blood or brown material that looks like coffee grounds
• unusual bleeding or bruising

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• acne
• diarrhea
• dry skin
• itching
• loss of appetite
• nausea
• vomiting
• weak or tired
• weight loss

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.