Pronunciation:

ge-FI-ti-nib

Brand Names:

• Iressa

Dosage Forms:

• Tablet

Classifications:

Therapeutic

Antineoplastic Agent

Pharmacologic

Tyrosine Kinase Inhibitor

Uses of This Medicine:

Gefitinib 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.

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast-feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Vinorelbine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Itraconazole
• Ketoconazole
• Phenytoin
• Ranitidine
• Rifampin
• Warfarin

Other interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of this medicine. 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 this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• 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.

Check with your doctor immediately if any of the following side effects occur:

Less common

bloating or swelling of face, arms, hands, lower legs, or feet

burning, dry or itching eyes

change in vision

difficult or labored breathing

eye discharge or excessive tearing

redness, pain, swelling of eye, eyelid, or inner lining of eyelid

shortness of breath

tightness in chest

tingling of hands or feet

unusual weight gain or loss

wheezing

Incidence unknown

abnormal eyelash growth

blistering, peeling, loosening of skin

bloating of stomach

blood in urine

bloody nose

chills

constipation

cough

darkened urine

diarrhea

fainting or loss of consciousness

fast heartbeat

fast or irregular breathing

fever

indigestion

joint or muscle pain

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs

loss of appetite

nausea

pains in stomach, side, or abdomen, possibly radiating to the back

redness, tenderness, itching, or burning of skin

seeing floating spots before the eyes

severe stinging of the eye

skin rash

sore throat

sores, ulcers, or white spots in mouth or on lips

unusual tiredness or weakness

vomiting

yellow eyes or skin

Symptoms of Overdose

Get emergency help immediately if any of the following symptoms of overdose occur:

Diarrhea

skin rash

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

blemishes on the skin, pimples

lack or loss of strength

dry skin

Less common

irritation or soreness of mouth

blisters under the skin, large, hard skin blisters

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.