Gleevec is a medication used to treat Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia, also known as Ph+ CML. People with Ph+ CML have an overproduction of their body's white blood cells, which also live longer than normal cells. A specific genetic abnormality is the cause of Ph+ CML. The goals of treating Ph+ CML are to reduce the number of white blood cells to normal, to relieve the symptoms associated with Ph+ CML, and to eliminate white blood cells that have the specific genetic abnormality. Gleevec is different from other medications that are used to treat Ph+ CML. The white blood cells that are the hallmark of the disease are made to grow by an abnormal protein, called the Bcr-Abl tyrosine kinase. Most chemotherapies act by killing all fast-growing cells—both abnormal and normal. Gleevec works by specifically blocking this abnormal protein, thereby preventing the growth and reducing the number of abnormal white blood cells (Gleevec is also known to inhibit other receptors in the body that may affect non-CML-related cells.)*

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Gleevec should be taken only under the close direction and supervision of your doctor. Gleevec is a medicine for patients with Ph+ CML, which is a disease with multiple stages.

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
• 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. 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 should not be taken by patients who have an allergy to imatinib mesylate or to any other component of Gleevec. In addition, Gleevec should not be taken by individuals who have not been thoroughly evaluated and counseled by their physician or by women who are pregnant or breastfeeding. Gleevec should be used with caution in patients with a history of liver disease.

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Gleevec comes as 100 mg and scored 400 mg tablets. In general, the recommended daily dose requires taking multiple tablets per day. Your doctor will prescribe your dose based on the specifics of your disease.

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Gleevec should be taken with food and a large glass of water to minimize the risk of stomach upset. In general, Gleevec is taken by mouth every day, but your physician will advise you of your exact regimen. Gleevec should not be taken with grapefruit juice.

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Gleevec is occasionally associated with serious side effects, including severe fluid retention in different parts of the body including the lungs and heart, low levels of certain blood cells, liver problems, abnormal bleeding, muscle or bone pain, 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. Gleevec should not be used in patients with a known allergic reaction to Gleevec or any of its ingredients.

Of the approximately 1700 patients in clinical studies for Gleevec, the most common side effects were fluid retention (usually swelling around the eyes or legs) (54%-76%), diarrhea (30%-60%), nausea (43%-73%), vomiting (15%-58%), fatigue (30%-48%), muscle cramps (28%-62%), muscle or bone pain (11%-49%), abdominal pain (23%-37%), and rash (26%-47%)^†. In most 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 4% to 8% of patients.

Gleevec should not be given to women who are or could be pregnant, or who are breastfeeding.

For more information, see "Side Effects And Safety Information".

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Gleevec may affect other drugs when taken at the same time, and some drugs may affect Gleevec. You should inform your doctor about other medications you are taking or when there is a change in your medications. In particular, Tylenol^®† (acetaminophen), birth control pills (oral contraceptives), blood thinners (especially warfarin, Coumadin^®+), herbal products (e.g., St. John's Wort), erythromycin and phenytoin e.g., Dilantin^®‡) are all broken down by the same enzymes that metabolize Gleevec. Drug-drug interactions may therefore occur with these medications.

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Gleevec can cause abnormalities in blood tests. For this reason, regular complete blood counts and blood tests, including liver function tests, should be performed and followed closely during treatment. Patients should be weighed and monitored regularly for signs and symptoms of fluid retention.

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Women of childbearing age should avoid becoming pregnant if they are on Gleevec, and Gleevec should not be used during pregnancy due to the harm it can cause to an unborn fetus. There are no well-controlled studies in pregnancy, and the risk to the unborn child is not known. However, Gleevec has been shown to cause fetal deformity in animals, so Gleevec should not be taken by pregnant women unless it is clearly necessary. If you are of childbearing age, it is important that you use effective birth control during the course of your treatment. Additionally, women taking Gleevec should not breastfeed.

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Gleevec safety and efficacy have been demonstrated in children with Ph+ chronic phase CML that is newly diagnosed or that has recurred after stem cell transplantation or resistance to interferon alpha therapy. There are no data in children under 3 years of age. There was no difference in the safety profile in patients older than 65 years as compared with younger patients, with the exception of more common mild or moderate superficial swelling. The efficacy of Gleevec was similar in all age groups.

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If you have questions or problems, talk with your doctor or other healthcare provider. You can ask your doctor or pharmacist for more information about Gleevec. Do not use Gleevec for any condition for which it was not prescribed, and do not share your medications with other people.

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