DrugindexOnline^{2nd edition}

Generic Name: Gefitinib (geh-FIT-in-ib)
Brand Name: Iressa

Gefitinib is used for:

Treating non-small cell lung cancer after other cancer chemotherapy treatments have not been successful. It may also be used for other conditions as determined by your doctor.

Gefitinib is a cancer chemotherapy agent. It works by blocking a certain protein (an enzyme called tyrosine kinase). This helps to stop the cancer from growing and spreading.

Do NOT use Gefitinib if:

• you are allergic to any ingredient in Gefitinib

Contact your doctor or health care provider right away if any of these apply to you.

Before using Gefitinib :

Some medical conditions may interact with Gefitinib . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have lung disease (eg, pulmonary fibrosis), heart problems, severe kidney problems, or liver problems
• if you have had a stroke

Some MEDICINES MAY INTERACT with Gefitinib . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Antacids (eg, sodium bicarbonate, calcium carbonate), histamine H₂-receptor blockers (eg, famotidine), hydantoins (eg, phenytoin), or rifampin because the effectiveness of Gefitinib may be decreased
• Imidazoles (eg, ketoconazole) because the side effects of Gefitinib may be increased
• Anticoagulants (eg, warfarin) because the risk of bleeding may be increased
• Vinorelbine because the risk of low white blood cell counts may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Gefitinib may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Gefitinib :

Use Gefitinib as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Gefitinib may be taken with or without food.
• If you have difficulty swallowing the tablet, it can be added to half a glass of water (non-carbonated). Do not use other liquids. Drop the tablet into the water, without crushing it, and stir until it dissolves (about 10 minutes). Then drink the liquid immediately. Rinse the glass with half a glass of water and drink it.
• Take Gefitinib regularly to receive the most benefit from it.
• Taking Gefitinib at the same time each day will help you remember to take it.
• If you miss a dose of Gefitinib , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Gefitinib .

Important safety information:

• Additional monitoring of your dose or condition may be needed if you are taking erythromycin, clarithromycin, or St. John's wort.
• Gefitinib may cause changes in vision. Contact your doctor if eye irritation occurs. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Gefitinib .
• LAB TESTS, including liver function tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Gefitinib is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not become pregnant while taking Gefitinib . Gefitinib may cause harm to the fetus. If you become pregnant, discuss with your doctor the benefits and risks of using Gefitinib during pregnancy. It is unknown if Gefitinib is excreted in breast milk. Do not breast-feed while taking Gefitinib .

Possible side effects of Gefitinib :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; diarrhea; dry skin; loss of appetite; mouth ulcers; nausea; unusual weakness; vision problems; vomiting; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the eyelids, mouth, face, lips, or tongue); cough; dark urine; dizziness; eye irritation or pain; extreme fatigue; fever; persistent diarrhea; stomach pain; swelling of the ankles or feet; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include severe or persistent diarrhea; severe skin rash.

Proper storage of Gefitinib :

Store Gefitinib at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Gefitinib out of the reach of children and away from pets.

General information:

• If you have any questions about Gefitinib , please talk with your doctor, pharmacist, or other health care provider.
• Gefitinib is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Gefitinib . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.