GLEEVEC (imatinib mesylate) Capsules FACT SHEET

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1 Health Canada Santé Canada GLEEVEC (imatinib mesylate) Capsules FACT SHEET CONDITIONAL APPROVAL OF GLEEVEC This fact sheet notifies the Canadian public that Health Canada has issued a conditional marketing authorization under the Notice of Compliance with Conditions policy to reflect the promising nature of the clinical evidence and the need for confirmatory studies to verify the clinical benefit. The longterm safety data are not available and drug interaction data are limited. For more information, patients are advised to contact their health care provider. What is Gleevec? GLEEVEC (also known as imatinib mesylate, STI571) is a drug that has been specifically developed to treat cancer by blocking an enzyme that causes cells to become cancerous and multiply. Health Canada has issued a conditional marketing authorization under a policy called the "Notice of Compliance with Conditions" (NOC/c) for the treatment of adult patients with newly diagnosed chronic myeloid leukemia (CML). This approval was based on the promising nature of the clinical evidence which must be confirmed and extended with further studies. The long-term benefits of therapy with GLEEVEC are not known

2 What is GLEEVEC used for? This current conditional approval for GLEEVEC is for adult patients with newly diagnosed CML. Previous Conditional approvals for GLEEVEC are for adult patients with: a) CML in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy b) unresectable and/or metastatic gastrointestinal stromal tumors (GIST) What is CML? What are the symptoms of CML? CML is a type of cancer in which the bone marrow produces an excessive number of abnormal (leukemic) white blood cells. These abnormal cells suppress the production of normal white blood cells, which act to protect the body against infection. In the early stage, patients may only be diagnosed through routine blood tests that show an increase in white blood cells. In later stages, patients experience infections, bleeding, fever, chills, sweats, weakness, fatigue and headaches

3 What are the phases of CML? The three phases are: Chronic phase: This phase may last for about 4 to 5 years. Initially, patients in this phase usually have minor symptoms and their cancer is usually detected by routine blood tests. Traditionally, most patients have received interferon therapy alone or with other drugs. Patients can also be treated with bone marrow transplants. Accelerated phase: This phase may last from 6 to 18 months. The white blood cell count increases and the disease is harder to control with conventional treatments. Myeloid blast crisis: This phase is the final phase of the disease and may last about 3 to 6 months. CML worsens as it progresses from the chronic phase to the accelerated phase and the final phase called the blast crisis. The three phases are characterized by steadily increasing numbers of abnormal cells within the bone marrow and by spread of abnormal cells to sites outside of the bone marrow. How does GLEEVEC work? What other treatments have been used to treat CML? GLEEVEC inhibits the growth of abnormal white blood cells by blocking an enzyme that is necessary for the development of CML. Several drugs are used to treat CML including busulfan, hydroxyurea, and cytosine arabinoside (Ara-C) and interferon. Current therapy for the chronic phase of CML generally includes interferon with or without other drugs. Bone marrow transplantation may be an option for some patients

4 What do patients need to know about using GLEEVEC? Monitoring If patients experience swelling or weight gain from water retention, they should inform their doctor as soon as possible and should be closely monitored. Patients will need to be regularly monitored to determine whether GLEEVEC is having the desired effect. Patient s body weight and blood will also need to be monitored regularly while taking this medication. Drug interactions GLEEVEC interacts with many other medications, including over-the-counter medications (medications that can be purchased without a prescription, e.g. acetaminophen) or herbal products (e.g. St. John s Wort). Patients should inform their doctors as to all drugs that they are taking. GLEEVEC may increase or decrease blood levels of certain drugs, which may increase side efects or decrease the effectiveness of treatment

5 What are the side effects of GLEEVEC and how serious are they? GLEEVEC can have some side effects which are usually mild to moderate. During treatment with GLEEVEC, the patient s body may retain water (fluid retention) and this may result in rapid weight gain. Tell the doctor immediately if the patient experiences swelling or sudden weight gain. Treatment with GLEEVEC may reduce the number of white cells in the patient s blood, which may lead to infection. If the patient experiences signs of fever, severe chills, sore throat or mouth ulcers the doctor should be contacted immediately. GLEEVEC can also affect the patient s liver. The doctor should be informed immediately if the patient experiences jaundice (yellow skin and eyes, or dark urine). Other very common side effects that can occur during treatment with GLEEVEC are weight gain, headache, nausea, vomiting, diarrhea, indigestion, rash, muscle spasms and cramps, pain in the muscles and bones, and joint swelling. Other possible side effects of GLEEVEC are anorexia, dizziness, taste disturbance, numbness of the hands or feet, difficulty sleeping (insomnia), red eye (conjunctivitis), increased tear production, chest pain on deep breathing (pleurisy), nose bleeds, abdominal pain or distension, gas (flatulence), constipation, dry mouth, itching, dry skin, unusual hair loss or thinning, night sweats, fatigue, weakness, and increased muscle tension. Tell the doctor if the patient experiences any of the events listed above

6 Who can be treated with GLEEVEC? How is GLEEVEC taken? GLEEVEC is indicated for the treatment of adult patients with newly diagnosed chronic myeloid leukemia (CML). It is also indicated for the treatment of adult patients in all phases of chronic myeloid leukemia (CML) who may have failed other therapies. GLEEVEC is also indicated for the treatment of adult patients with unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). GLEEVEC should only be prescribed to the patient by a doctor who is experienced in the use of medicines to treat CML. GLEEVEC should be taken with food and a large glass of water to minimize the risk of stomach and gastrointestinal irritation. Grapefruit juice should be avoided during treatment with GLEEVEC because it could affect GLEEVEC blood levels. The doctor will tell the patient how many capsules of GLEEVEC to take. For further information Should the patient have medical enquiries regarding GLEEVEC, kindly contact our Medical Information department at This document including the GLEEVEC Prescribing Information and Patient Information can be found on our Website ( October