What is Imatinib Accord - imatinib used for?
Imatinib Accord is a cancer medicine that contains the active substance imatinib . It is used for the treatment of the following diseases:
- chronic myeloid leukemia (CML) in children, a cancer of white blood cells in which granulocytes (a type of white blood cell) begin to grow out of control. Imatinib Accord is used in patients with "Philadelphia positive chromosome" (Ph +). This means that some of their genes have reorganized to form a special chromosome, called the "Philadelphia chromosome". Imatinib Accord is used in children with newly diagnosed Ph + CML not subject to bone marrow transplantation. It is also used in children in the "chronic phase" of the disease, after the failure of interferon-alpha therapy (another anticancer medicine), and in more advanced stages of the disease ("accelerated phase" and "blast crisis");
- Ph + CML in "blast crisis" in adults;
- acute lymphoblastic leukemia (ALL) with Ph +, a type of tumor in which lymphocytes (another type of white blood cells) multiply too quickly. Imatinib Accord is used in combination with other anticancer medicines in adults with newly diagnosed Ph + ALL. It is also used in monotherapy (alone) for the treatment of Ph + ALL if the disease recurs after previous treatment or if the patient does not respond to treatment with other drugs;
- myelodysplastic or myeloproliferative syndromes (MD / MPD), a group of diseases in which the body produces large amounts of abnormal blood cells. Imatinib Accord is used in the treatment of platelet origin (PDGFR);
- advanced hypereosinophilic syndrome (HES) or chronic eosinophilic leukemia (CEL), diseases in which eosinophils (another type of white blood cells) begin to grow out of control. Imatinib Accord is used to treat adults with HES or CEL in which a specific reorganization of two genes is observed, called FIP1L1 and PDGFRα;
- dermatofibrosarcoma protuberans (DFSP), a type of tumor (sarcoma) in which cells in the subcutaneous tissue divide uncontrollably. Imatinib Accord is used for the treatment of adults with non-surgically removable DFSP and adults in whom surgery is not recommended because the tumor has returned after treatment or has spread to other parts of the body.
Imatinib Accord is a "generic medicine". This means that Imatinib Accord is similar to a 'reference medicine' already authorized in the European Union (EU) called Glivec. For more information on generic medicines, see the questions and answers by clicking here.
How is Imatinib Accord used - imatinib?
Imatinib Accord is available as tablets (100 and 400 mg). The medicine can only be obtained with a prescription and treatment should be started by a doctor experienced in treating patients with blood cancer or solid tumors. Imatinib Accord is given by mouth during a meal, with a large glass of water to reduce the risk of stomach and bowel irritation. The dose depends on the disease being treated, the age and condition of the patient as well as the response to treatment, but should not exceed 800 mg a day. For more information, see the package leaflet.
How does Imatinib Accord - imatinib work?
The active substance in Imatinib Accord, imatinib, is a protein-tyrosine kinase inhibitor, which means that it blocks some specific enzymes known as tyrosine kinases. It is possible to find these enzymes in some receptors on the surface of tumor cells, including the receptors that help to stimulate cells to divide uncontrollably. By blocking these receptors, Imatinib Accord helps control cell division.
What studies have been performed on Imatinib Accord - imatinib
Because Imatinib Accord is a generic medicine, studies in patients have been limited to tests to determine its bioequivalence to the reference medicine, Glivec. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body
What are the benefits and risks of Imatinib Accord - imatinib?
Because Imatinib Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.
Why has Imatinib Accord - imatinib been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Imatinib Accord has been shown to have comparable quality and to be bioequivalent to Glivec. Therefore, the CHMP considered that, as in the case of Glivec, the benefits outweigh the identified risks and recommended to approve the use of Imatinib Accord in the EU
What measures are being taken to ensure the safe and effective use of Imatinib Accord - imatinib?
A risk management plan has been developed to ensure that Imatinib Accord is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Imatinib Accord, including the appropriate precautions to be followed by healthcare professionals and patients.
Other information on Imatinib Accord - imatinib
On 1 July 2013, the European Commission issued a marketing authorization for Imatinib Accord, valid throughout the European Union. For more information about treatment with Imatinib Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. The full EPAR for the reference medicine can also be found on the Agency's website. Last update of this summary: 07-2013.
