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|Iressa

GEFITINIB (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Iressa

† Not commercially available in Canada.

Category

• Antineoplastic

Description

Gefitinib ((ge-FI-tye-nib)) belongs to the group of medicines called antineoplastics. It is used to treat non-small cell lung cancer after the failure of other chemotherapy treatment.

Before you begin treatment with gefitinib, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

This medicine is available only with your doctor"s prescription, in the following dosage forms:

• Oral
• Tablets (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For gefitinib, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to gefitinib. Also tell your doctor and pharmacist if you are allergic to any other substances such as food, preservatives, or dyes.

Pregnancy—Gefitinib has been shown to cause miscarriages and death of the fetus in animals. However, this medicine may be needed in serious diseases or other situations that threaten the mother"s life. Be sure you have discussed this with your doctor.

It is best to use some kind of birth control while you are receiving gefitinib. Tell your doctor right away if you think you have become pregnant while receiving gefitinib.

Breast-feeding—It is not known whether gefitinib passes into the breast milk. However, gefitinib is not recommended during breast-feeding, because it may cause unwanted effects in nursing babies.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of gefitinib in children with use in other age groups.

Older adults—This medicine has been tested in elderly patients and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking gefitinib, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• CYP3A4 inducers such as
• Phenytoin (e.g., Dilantin), or
• Rifampin (e.g., Rifadin)—May decreases the effectiveness of gefitinib.

• Histamine H₂ -receptor antagonist (medicine for ulcers), such as
• Cimetidine (e.g., Tagamet), or
• Ranitidine (e.g., Zantac )—May decrease the effectiveness of gefitinib.

• Itraconazole (e.g., Sporanox) or
• Ketoconazole (e.g., Nizoral)—Higher blood levels of gefitinib may occur, increasing the chance of serious side effects.

• Metoprolol (e.g., Toprol-XL, Lopressor)—Higher blood levels of metoprolol may occur.

• Vinorelbine (e.g., Navelbine)—Use with gefitinib may increase the side effects of vinorelbine.

• Warfarin (e.g., Coumadin)—Bleeding may occur.

Other medical problems—The presence of other medical problems may affect the use of gefitinib. Make sure you tell your doctor if you have any other medical problems, especially:

• Idiopathic pulmonary fibrosis—Condition may worsen while receiving gefitinib therapy

• Kidney disease or
• Liver disease—The chance of serious side effects is greatly increased.

Proper Use of This Medicine

Dosing—The dose of gefitinib will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of gefitinib. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form:
  • For lung cancer, non-small cell:
    • Adults—250 milligrams (mg) daily.
    • Children—Use and dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Precautions While Using This Medicine

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

It is very important to check with your doctor if you have diarrhea, nausea or anorexia.

It is very important to check with your doctor if you have problems breathing.

It is very important to check with your doctor if you have any new eye problems.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 12/3/2003
Revised: 07/14/2005

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