Europe — EMA
Glivec (Imatinib)
Glivec (imatinib) is an oral tyrosine‑kinase inhibitor used for CML, Ph+ ALL, GIST, DFSP, and systemic mastocytosis. Learn indications, side effects, and precautions.
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What is Imatinib?
Glivec is a prescription medication whose active ingredient is imatinib, supplied in oral tablet form at strengths that vary by market; the specific strength for this EU product is not disclosed. It belongs to the tyrosine‑kinase inhibitor class and is used as an antineoplastic agent. Imatinib works by blocking specific cellular enzymes that drive the growth of certain cancers, including chronic myeloid leukemia and gastrointestinal stromal tumors.
What is Imatinib used for?
Glivec (imatinib) is indicated for several malignancies that involve abnormal tyrosine‑kinase activity and is prescribed as part of targeted therapy regimens.
- Chronic myeloid leukemia (CML), particularly in newly diagnosed patients or those with resistance to prior therapy. - Philadelphia chromosome‑positive acute lymphoblastic leukemia (Ph+ ALL) in adults and eligible pediatric patients. - Gastrointestinal stromal tumor (GIST) that harbors KIT or PDGFRA activating mutations. - Dermatofibrosarcoma protuberans (DFSP) when surgical options are limited. - Systemic mastocytosis with an activating KIT mutation, as part of disease‑modifying treatment.
What are the side effects of Imatinib?
Adverse reactions to Glivec vary in frequency and severity; they are documented in clinical studies and post‑marketing reports.
Common: - Nausea, vomiting, or loss of appetite. - Diarrhea or abdominal discomfort. - Edema, especially peripheral swelling. - Fatigue or generalized weakness. - Skin rash or pruritus.
Serious: - Hepatotoxicity manifested by elevated liver enzymes. - Severe neutropenia or thrombocytopenia increasing infection or bleeding risk. - Cardiac dysfunction such as left ventricular failure.
What precautions apply to Imatinib?
Before initiating Glivec, clinicians consider several safety factors to minimize risk.
- Baseline and periodic liver function tests to monitor for hepatotoxicity. - Complete blood counts to detect myelosuppression early. - Assessment of cardiac function in patients with pre‑existing heart disease. - Caution in patients with renal impairment; dose adjustment may be required. - Pregnancy and lactation status should be evaluated, as safety data are limited. - Patients should be advised to report signs of infection, bleeding, or severe rash promptly.
What does Imatinib interact with?
Glivec can interact with other medicines, affecting its concentration or toxicity.
Avoid: - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) that may raise imatinib levels. - Concurrent use with other tyrosine‑kinase inhibitors due to overlapping toxicity.
Use with caution: - CYP3A4 inducers (e.g., rifampin, phenytoin) that may reduce efficacy. - Anticoagulants such as warfarin, which may have altered INR. - Proton‑pump inhibitors that could affect gastric pH and absorption. - Vaccines, especially live attenuated, due to potential immunosuppression.



