Gefitinib Oral tablet

What is this medicine?

GEFITINIB (ge FI ti nib) is a chemotherapy drug. It targets a specific enzyme within cancer cells and stops the cancer cells from growing. It is used to treat advanced non-small cell lung cancer. To receive this medicine, you will be enrolled in the Iressa Access Program. The medicine will be provided by a special mail-order pharmacy.

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

What should I tell my health care provider before I take this medicine?

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

• liver disease
• lung fibrosis
• recent or ongoing radiation therapy
• an unusual or allergic reaction to gefitinib, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a full glass of water. Follow the directions on the prescription label. You can take it with or without food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

If you have difficulty swallowing the tablets, let your doctor, pharmacist or health care professional know. They can help you with advice.

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?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose and skip your missed dose. Do not take double or extra doses.

What may interact with this medicine?

• antiviral medicines for HIV or AIDS
• bosentan
• carbamazepine
• ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine
• medicines for fungal infections like ketoconazole and itraconazole
• phenobarbital
• phenytoin
• rifabutin
• rifampin
• St. John's wort
• stomach acid blockers like cimetidine, famotidine, ranitidine, or omeprazole
• vinorelbine
• warfarin

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 medicine?

Visit your doctor for checks on your progress. You will need to have regular blood tests while on this medicine.

Report any new symptoms promptly. Let your doctor know if you have severe or persistent diarrhea, nausea, loss of appetite, or vomiting, as these side effects may cause dehydration. This drug may cause severe lung problems. Call your doctor if your breathing gets worse and/or you develop a cough or fever.

Do not become pregnant while taking this medicine. 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 health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

What side effects may I notice from receiving this medicine?

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
• breathing problems like cough, shortness of breath
• changes in vision
• dark urine
• eye irritation
• eye pain
• fever
• general ill feeling or flu-like symptoms
• light-colored stools
• loss of appetite
• mouth sores
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• right upper belly pain
• unusually weak or tired
• vomiting
• yellowing of the eyes or skin

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

• acne
• decreased appetite
• diarrhea
• dry skin
• nausea
• 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 medicine?

Keep out of the reach of children.

Store at room temperature 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.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.