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Glivec

Active Ingredient:
Imatinib
Origin:
EU

Glivec (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.

Manufacturer / TM Owner

Novartis Europharm Limited

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Indications & Clinical Uses

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.

Side Effects

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.

Precautions & Warnings

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.

Avoid Interactions

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

Glivec is a prescription drug classified as a tyrosine‑kinase inhibitor; its active ingredient is imatinib.

Imatinib blocks the activity of BCR‑ABL, c‑KIT, and PDGFR tyrosine kinases, interrupting signaling pathways that promote uncontrolled cell proliferation.

Approved indications include chronic myeloid leukemia (CML), Philadelphia chromosome‑positive acute lymphoblastic leukemia (Ph+ ALL), gastrointestinal stromal tumor (GIST), dermatofibrosarcoma protuberans (DFSP), and systemic mastocytosis.

Yes, Glivec is indicated for CML in chronic, accelerated, and blast phases, providing therapeutic options across disease stages.

Common adverse events include nausea, vomiting, loss of appetite, diarrhea, abdominal discomfort, peripheral edema, fatigue, and mild skin rash or itching.

Serious reactions such as severe neutropenia or leukopenia, significant liver enzyme elevations indicating hepatotoxicity, and signs of cardiac dysfunction like congestive heart failure should prompt urgent evaluation.

Baseline complete blood count, liver function tests, and assessment of cardiac status are recommended prior to initiating treatment.

Patients with hepatic impairment may require closer monitoring of liver enzymes and dose adjustments, as the drug is metabolized primarily by the liver.

Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) and potent CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) should be avoided because they can significantly alter imatinib concentrations.

Live attenuated vaccines should be used with caution or avoided, as Glivec may suppress immune function; inactivated vaccines are generally considered safe.

The safety of Glivec during pregnancy has not been established; it may pose risks to the fetus, so pregnancy testing and contraception are advised for women of childbearing potential.

Glivec is taken orally, usually in tablet form, and is prescribed for use under the supervision of a qualified healthcare professional.

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GNH India Pharmaceuticals Limited

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