Europe — EMA
Glivec
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, presented in oral tablet form; specific strength information is not disclosed in this summary. It belongs to the tyrosine‑kinase inhibitor class and is marketed in the European Union. The drug works by blocking several tyrosine kinases that drive abnormal cell growth, making it a targeted therapy for certain cancers. It is administered under medical supervision and requires a prescription.
What is Imatinib used for?
Glivec (imatinib) is indicated for several malignancies where abnormal tyrosine‑kinase activity drives disease progression.
- Chronic myeloid leukemia (CML) across chronic, accelerated, and blast phases, as first‑line therapy. - Philadelphia chromosome‑positive acute lymphoblastic leukemia (Ph+ ALL) in adult patients. - Gastrointestinal stromal tumor (GIST) that is unresectable, metastatic, or recurrent after surgery. - Dermatofibrosarcoma protuberans (DFSP) as adjuvant treatment following complete surgical excision. - Systemic mastocytosis with symptomatic disease, including organ involvement. - Additional investigational indications evaluated in clinical trials.
What are the side effects of Imatinib?
The safety profile of Glivec includes a range of adverse events that vary in frequency and severity.
Common: - Nausea, vomiting, or loss of appetite, often mild to moderate. - Diarrhea or abdominal discomfort, which may be intermittent. - Edema, particularly peripheral swelling of the ankles or hands. - Fatigue or generalized weakness that can affect daily activities. - Skin rash or mild pruritus, sometimes accompanied by dry skin.
Serious: - Severe neutropenia or leukopenia, which can increase the risk of serious infections. - Hepatotoxicity, indicated by markedly elevated liver enzymes or jaundice. - Cardiac dysfunction such as congestive heart failure, though it occurs rarely.
What precautions apply to Imatinib?
When prescribing Glivec, clinicians consider several precautionary measures to minimize risks and optimize therapy.
- Baseline and periodic complete blood counts to monitor for cytopenias. - Liver function tests before initiation and regularly during treatment. - Assessment of cardiac function in patients with pre‑existing heart disease. - Evaluation of pregnancy status; drug may pose risks to the fetus. - Monitoring for signs of fluid retention or edema, especially in the lower extremities. - Adjustments may be needed in patients with severe renal impairment. - Caution in elderly patients due to increased susceptibility to adverse effects.
What does Imatinib interact with?
Glivec can interact with other medicines, altering its effectiveness or increasing toxicity.
Avoid: - Strong CYP3A4 inducers such as rifampin, carbamazepine, or phenytoin, which may reduce imatinib levels. - Concomitant use with potent CYP3A4 inhibitors like ketoconazole or clarithromycin, which can raise drug concentrations.
Use with caution: - Antacids or proton‑pump inhibitors that may affect gastric pH and absorption. - Warfarin, as imatinib may enhance anticoagulant effects and require INR monitoring. - Vaccines, particularly live attenuated vaccines, due to potential immunosuppression. - Herbal supplements containing St. John’s wort, a CYP3A4 inducer.
Frequently asked questions
What type of medication is Glivec and what is its active ingredient?+
How does imatinib work as a tyrosine‑kinase inhibitor?+
Which cancers are approved for treatment with Glivec in the European Union?+
Can Glivec be used in patients with chronic myeloid leukemia who have progressed to blast phase?+
What are the most frequently reported side effects of Glivec?+
Which serious adverse reactions require immediate medical attention while on Glivec?+
What laboratory tests should be performed before starting Glivec therapy?+
How does liver impairment affect the use of Glivec?+
Which medications should be avoided when taking Glivec?+
Is it safe to receive vaccinations while being treated with Glivec?+
Does Glivec have any known effects on pregnancy or fertility?+
How is Glivec administered and what is the typical route of administration?+
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