Gleevec 100 mg tablets provide you with a simple way to get the therapy your doctor prescribed.

Taking Gleevec Therapy

• The recommended dosage of Gleevec is based on body size for children*
• If you are taking Gleevec 100 mg tablets, talk to your doctor to see if switching to the scored 400 mg tablets is right for you
• Gleevec 400 mg tablets are designed to offer patients the convenience of taking fewer tablets each day
• You can help achieve the best results with Gleevec by taking it exactly as directed by your doctor and pharmacist

Because there is iron in the coating of Gleevec tablets, if you are taking 800 mg (or more) of Gleevec daily, be sure to take 2 of the 400 mg tablets (as opposed to taking 8 of the 100 mg tablets) to lower your iron exposure.

*Gleevec is indicated for the treatment of newly diagnosed adult and pediatric patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Follow-up is limited. Gleevec is also indicated for the treatment of pediatric patients with Ph+ chronic phase CML whose disease has recurred after stem cell transplant or who are resistant to interferon-alpha therapy. There are no controlled trials in pediatric patients demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.

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Gleevec scored 400 mg tablets provide you with a simple way to get the therapy your doctor prescribed, and are designed to offer you the convenience of taking fewer tablets each day. If you are taking 6 Gleevec 100 mg tablets, talk to your doctor to see if switching to 400 mg scored tablets is right for you. With the scored 400 mg tablets, you would need to take just 1 ½ tablets a day.

• If your doctor prescribed a dose of 400 mg daily, you take just 1 tablet a day
• If your doctor prescribed a dose of 600 mg daily, you can take just 1 ½ tablets a day
• If your doctor prescribed a dose of 800 mg daily, you take just 1 tablet twice a day
• You can help achieve the best results with Gleevec by taking it exactly as directed by your doctor and pharmacist

Because there is iron in the coating of Gleevec tablets, if you are taking 800 mg (or more) of Gleevec daily, be sure to take 2 of the 400 mg tablets (as opposed to taking 8 of the 100 mg tablets) to lower your iron exposure.

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All Patients Taking Gleevec Need to Remember:

• DO take the exact dose of Gleevec that your doctor has prescribed
• DO take Gleevec with a meal and a large glass of water
• DO tell your doctor if you have any side effects during Gleevec therapy. Some signs of side effects include fever, weight gain, fatigue, shortness of breath, blood in stools, or yellowing of skin or eyes.
• DO NOT stop taking Gleevec or change the dose on your own
• DO NOT take any other medications, including over-the-counter medications such as acetaminophen (e.g., Tylenol^®*) or herbal products (e.g., St. Johns Wort) without talking to your doctor or pharmacist first. Examples of other medications that should be used with caution with Gleevec are warfarin (e.g., Coumadin^®+), erythromycin, and phenytoin (e.g., Dilantin^®‡). Also, be sure to tell your doctor if you are taking or plan to take iron supplements.

Gleevec may cause side effects. Gleevec is occasionally associated with serious side effects, including severe fluid retention in different parts of the body including the lungs and heart, heart failure, low levels of certain blood cells (including children), liver problems, abnormal bleeding, or skin blistering. There have also been reports, including deaths, from increased pressure on the heart or brain, swelling of the brain, swelling inside the eye, and holes in the walls of the intestinal tract. Your doctor will monitor you closely for these reactions to prevent more serious complications from occurring. Patients with heart failure or risk factors for heart failure should also be monitored carefully. Gleevec should not be used in patients with a known allergic reaction to Gleevec or any of its ingredients. The majority of patients who received Gleevec in clinical studies experienced side effects, but they were usually mild or moderate.

Of the approximately 1700 adult patients who received Gleevec in clinical studies, the most common side effects were fluid retention (usually swelling around the eyes or legs) (59%-81%), diarrhea (39%-70%), nausea (47%-74%), vomiting (21%-58%), fatigue (30%-53%), muscle cramps (28%-62%), muscle or bone pain (30%-49%), abdominal pain (30%-40%), and rash (36%-53%)^†. In some cases, these side effects were managed with other medications without having to reduce the dose of Gleevec or stop treatment. In a small percentage of patients with side effects, the dose of Gleevec was reduced or treatment was stopped temporarily. Discontinuation of Gleevec therapy because of side effects occurred in 3%-5% of patients.

Side effects in children were similar to the side effects in adults except muscle pain was less frequent and there was no fluid retention. The most common side effects were nausea and vomiting.

Gleevec should not be given to women who are or could be pregnant, or who are breastfeeding. Women should avoid becoming pregnant and be aware of the potential risk to the unborn child if Gleevec is used during pregnancy.

*Tylenol^® (acetaminophen) is a registered trademark of McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
⁺Coumadin^® (warfarin sodium) is a registered trademark of Bristol-Myers Squibb
^‡Dilantin^® (phenytoin) is a registered trademark of Parke-Davis, a Division of Pfizer, Inc.
^†Numbers are given as ranges because they include side effects from 5 distinct studies. For more detailed study information, please see the full prescribing information.

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