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

Gefitinib is used to treat non-small cell lung cancer.

Gefitinib is sometimes used to treat cancer that has spread to other parts of the body.

Gefitinib may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Your doctor will perform blood tests to make sure you have the correct tumor type to be treated with gefitinib.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

You may take gefitinib with or without food.

To make swallowing easier:

• Place the tablet into a glass of water (4 to 8 ounces) and stir for about 15 minutes.

• Do not use any liquid other than water.

• Stir and drink this mixture right away. Do not save for later use.

• To make sure you get the entire dose, add 4 to 8 more ounces of water to the same glass, swirl gently and drink right away.

• This mixture may also be given through a nasogastric (NG) tube. Ask your healthcare provider for instructions.

While using gefitinib, you may need frequent blood tests to check your liver function.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Non-Small Cell Lung Cancer:

250 mg orally once a day until disease progression or unacceptable toxicity

NOTE: For patients who have difficulty swallowing tablets immerse the tablet in 4 to 8 ounces of water (noncarbonated) and stir until dispersed (about 15 minutes). Drink the liquid or administer through a nasogastric tube. Rinse the container with 4 to 8 ounces of water and drink or administer through nasogastric tube.

Comments:
-Select patients for the first-line treatment of metastatic NSCLC with this drug based on the presence of EGFR exon 19 deletions or exon 21 L858R mutations in their tumor or plasma specimens.

Use: For first-line treatment of metastatic non-small cell lung cancer (NSCLC) in patients whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.

You should not use gefitinib if you are allergic to it.

To make sure gefitinib is safe for you, tell your doctor if you have:

• liver disease;

• kidney disease;

• vision problems;

• breathing problems, lung disease other than lung cancer; or

• if you take a blood thinner (warfarin, Coumadin, Jantoven).

Do not use gefitinib if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using gefitinib and for at least 2 weeks after your treatment ends.

This medicine may affect fertility (the ability to have children) in women. Tell your doctor if you plan to become pregnant.

It is not known whether gefitinib passes into breast milk or if it could harm a nursing baby. Do not breast-feed while taking gefitinib.

Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 12 hours away. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

Avoid taking an antacid or stomach acid reducer (Nexium, Pepcid, Prevacid, Prilosec, Zantac, and others) within 6 hours before or 6 hours after you take gefitinib. These other medicines can make gefitinib much less effective when taken at the same time.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Gefitinib may cause serious side effects. Call your doctor at once if you have:

• severe or ongoing diarrhea;

• sudden chest pain or discomfort, new or worsening cough with fever, trouble breathing;

• blurred vision, watery eyes, eye pain or redness, eyes being more sensitive to light;

• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• signs of stomach bleeding--severe stomach pain, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects of gefitinib may include:

• diarrhea;

• acne;

• dry skin; or

• itching or skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with gefitinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to gefitinib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.