gefitinib

Generic Name: gefitinib (ge FI ti nib)Brand Names: Iressa

What is gefitinib?

Gefitinib is a cancer chemotherapy medication. Gefitinib interferes with the growth of cancer cells and slows their growth and spread in the body.

Gefitinib is used in the treatment of non-small cell lung cancer.

Gefitinib may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about gefitinib?

Gefitinib should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of gefitinib including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); lung problems; liver problems; eye problems; severe nausea, vomiting, loss of appetite, or diarrhea; and others. Talk to your doctor about the possible side effects from treatment with gefitinib.

What should I discuss with my healthcare provider before taking gefitinib?

Do not use gefitinib without first talking to your doctor if you have

• liver disease; or

• lung or breathing problems (other than lung cancer).

You may not be able to take gefitinib, or you may require a dosage adjustment or special monitoring if you have any of the conditions listed above.

Gefitinib is in the FDA pregnancy category D. This means that it is known to be harmful to an unborn baby. Do not use gefitinib without first talking to your doctor if you are pregnant or could become pregnant during treatment. Birth control should be used during treatment with gefitinib. It is not known whether gefitinib passes into breast milk. Do not take gefitinib without first talking to your doctor if you are breast-feeding a baby.

How should I use gefitinib?

Gefitinib should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Take each dose of gefitinib with a full glass of water.

Gefitinib can be taken with or without food.

Your doctor will determine the correct amount and frequency of treatment with gefitinib depending upon the type of cancer being treated and other factors. Talk to your doctor if you have any questions or concerns regarding the treatment schedule.

It is important to take gefitinib regularly to get the most benefit.

Your doctor may want you to have blood tests and other medical evaluations during treatment with gefitinib to monitor progress and side effects.

Your healthcare provider will store gefitinib as directed by the manufacturer. If you are storing gefitinib at home, follow the directions provided by your healthcare provider.

What happens if I miss a dose?

Contact your doctor if you miss a dose of gefitinib.

What happens if I overdose?

If an overdose of gefitinib is suspected, seek emergency medical attention or contact your healthcare provider immediately.

Symptoms of a gefitinib overdose tend to be similar to side effects caused by the medication, although often more severe.

What should I avoid while using gefitinib?

There are no restrictions on food, beverages, or activity during treatment with gefitinib unless otherwise directed by your doctor.

Gefitinib side effects

If you experience any of the following serious side effects from gefitinib, contact your doctor immediately:

• an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

• lung problems (difficulty breathing, shortness of breath, increased coughing, fever, or chest pain);

• severe or persistent nausea, vomiting, loss of appetite, or diarrhea; or

• eye pain or irritation.

Other, less serious side effects may be more likely to occur. Continue taking gefitinib and talk to your doctor if you experience:

• mild to moderate nausea, vomiting, loss of appetite, or diarrhea;

• skin rash, dryness, itching, or acne; or

• weakness.

Other side effects have also been reported. Discuss with your doctor any side effect that occurs during treatment with gefitinib. You may report side effects to FDA at 1-800-FDA-1088.

Gefitinib Dosing Information

Usual Adult Dose for Non-Small Cell Lung Cancer:

250 mg orally with or without food

What other drugs will affect gefitinib?

Before taking gefitinib, tell your doctor if you are taking any other medicines, especially any of the following:

• warfarin (Coumadin);

• rifampin (Rifadin, Rimactane);

• phenytoin (Dilantin, Phenytek);

• ketoconazole (Nizoral);

• itraconazole (Sporanox); or

• a stomach acid reducer such as cimetidine (Tagamet, Tagamet HB), ranitidine (Zantac, Zantac 75), esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), and others.

You may not be able to take gefitinib, or you may require a dosage adjustment or special monitoring if you are taking any of the medicines listed above.

Many other drugs may interact with gefitinib. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

Where can I get more information?

• Your healthcare provider may have additional information about gefitinib that you may read.

• 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.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.05. Revision Date: 4/12/2009 4:45:08 PM.