How to know If Gleevec is Working Learn About Our Support Program How to Take Gleevec

Important Information

Gleevec is available only by prescription.

Indication

GLEEVEC^® (imatinib mesylate) tablets are indicated for the treatment of newly diagnosed adult patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Follow-up is limited to 5 years.

Gleevec is also indicated for the treatment of patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.

Who should NOT take Gleevec

• Women who are or could be pregnant. Fetal harm can occur when administered to a pregnant woman, therefore, women should not become pregnant, as well as be advised of the potential risk to the unborn child if Gleevec is used during pregnancy
• Women who are breast-feeding, because of the potential for serious adverse reactions in nursing infants
• Sexually active females should use adequate contraception while taking Gleevec

Be sure to talk to your doctor and/or nurse about these issues before taking Gleevec.

Important safety information

The following serious side effects have been reported in patients taking Gleevec:

• Severe fluid retention, which can be seen in swelling around the eyes or swelling of the lower legs, lungs and heart
• Low levels of certain blood cells
• Heart failure
• Liver problems
• Muscle or bone pain
• Abnormal bleeding (including gastrointestinal bleeding)
• Skin blistering

Your doctor will check you closely for any side effects reactions to stop more serious complications from occurring. Patients with heart disease or risk factors for heart failure should also be monitored carefully.

Gleevec is sometimes associated with stomach or intestinal irritation. Gleevec should be taken with food and a large glass of water to minimize this problem. There have been rare reports, including deaths, of stomach or intestinal perforation.

Common side effects of Gleevec

A majority of patients with Ph+ CML experience side effects at some time. Most side effects are mild to moderate in severity. Some common side effects you may experience include:

• Fluid retention
• Vomiting
• Muscle cramps
• Muscle or bone pain
• Diarrhea
• Fatigue
• Nausea
• Rash
• Abdominal pain
• Hemorrhage (Abnormal bleeding)

Some mild to moderate side effects can be managed with the help of other medicines and advice from your doctor. However in some cases, your dose of Gleevec may be stopped for a while or may be changed.

Be sure to tell your doctor and nurse if you have any side effects during Gleevec therapy. Some signs or symptoms of side effects include sudden weight gain, fatigue, fever, shortness of breath, blood in stools or yellowing of the skin or eyes. Also tell your doctor if you have a history of heart disease or risk factors for heart disease.

Talk to your doctor and/or nurse about other medications you may be taking. Taking Gleevec with medicines such as ketoconazole; Tylenol^® (acetaminophen); Coumadin^® (warfarin); rifampin, St. John's wort (hypericum perforatum); erythromycin and Dilantin^® (phenytoin) may have an effect on how these drugs work, and these drugs may affect how Gleevec works.

Patients should also avoid grapefruit juice and other foods that may have an effect on how Gleevec works. Tell your doctor if you are taking or plan on taking iron supplements.

Take Gleevec exactly as prescribed. Do not change your dose or stop taking Gleevec unless you are told to do so by your doctor. If you miss a dose, take your dose as soon as possible, unless it is almost time for your next dose. In this case, your missed dose should not be taken. A double dose should not be taken to make up for any missed dose. You should take Gleevec with a meal and a large glass of water.

Please see complete Prescribing Information.

Tylenol (acetaminophen) is a registered trademark of McNeil Consumer & Specialty Pharmaceuticals, a division of McNeil PPC, Inc.; Coumadin (warfarin) is a registered trademark of Bristol-Meyers Squibb Company; Dilantin (phenytoin) is a registered trademark of Parke-Davis, a division of Pfizer Inc.