Gleevec - Imatinib Tablets

What is this medication?

IMATINIB (i MAT in ib) treats some types of cancer. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Gleevec

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bleeding disorder
• Infection, especially a viral infection, such as chickenpox, cold sores, herpes
• Heart disease
• Heart failure
• Kidney disease
• Liver disease
• Lung disease
• Stomach or intestine problems
• An unusual or allergic reaction to imatinib, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a full glass of water. Take it as directed on the prescription label at the same time every day. Take it with food. Keep taking it unless your care team tells you to stop.

Do not take this medication with grapefruit juice.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 1 year for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Flibanserin
• Lomitapide

This medication may also interact with the following:

• Acetaminophen
• Alfentanil
• Certain antibiotics, such as clarithromycin
• Certain antivirals for HIV or hepatitis
• Certain medications for cholesterol, such as simvastatin
• Certain medications for fungal infections, such as ketoconazole, itraconazole, voriconazole
• Certain medications for seizures, such as carbamazepine, phenytoin, phenobarbital
• Cisapride
• Cyclosporine
• Ergot alkaloids, such as ergotamine
• Fentanyl
• Grapefruit or grapefruit juice
• Nefazodone
• Pimozide
• Rifampin
• Sirolimus
• St. John's wort
• Tacrolimus
• Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work while taking this medication.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. You may also notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

This medication may increase your risk to bruise or bleed. Call your care team if you notice any unusual bleeding.

This medication may affect your coordination, reaction time, or judgement. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects if taken during pregnancy or for 14 days after stopping treatment. Talk to your care team about reliable forms of contraception.

Do not breast-feed while taking this medication and for 1 month after stopping therapy.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Infection—fever, chills, cough, or sore throat
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Shortness of breath or trouble breathing
• Stomach bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds
• Stomach pain that is severe, does not go away, or gets worse
• Sudden weight gain
• Swelling of the ankles, hands, or feet
• Tumor lysis syndrome (TLS)—nausea, vomiting, diarrhea, decrease in the amount of urine, dark urine, unusual weakness or fatigue, confusion, muscle pain or cramps, fast or irregular heartbeat, joint pain
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Blurry vision
• Diarrhea
• Dizziness
• Fatigue
• Muscle pain or cramps
• Nausea
• Stomach pain
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from moisture. Keep the container tightly closed. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.