Gefitinib

Gefitinib is a cancer medicine that affects how cancer cells grow and spread 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 areas of the body.

Gefitinib may also be used for reasons not mentioned in this medication guide.

Your doctor will do blood tests to confirm that you have the right type of tumor to be treated with gefitinib.

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

You can take gefitinib with or without food.

To make it easier to swallow:

• Put 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 it for later.
• 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 can also be given through a nasogastric (NG) tube. Ask your healthcare provider for instructions.

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

Store at room temperature away from moisture and heat.

Follow all instructions on your medicine label and package. Inform each of your healthcare providers about all your medical conditions, allergies, and all medicines you are taking.

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 or 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.

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 right away 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 that are more sensitive to light;
• liver problems--nausea, upper stomach pain, itching, feeling very tired, 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.

Usual Adult Dose for Non-Small Cell Lung Cancer:

250 mg orally once a day until disease progression or unacceptable toxicityNOTE: 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.

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.

Do not take 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.

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.