Product image of Glivec (Imatinib) supplied by GNH India

Glivec

Active Ingredient:
Imatinib
Origin:
EU

Glivec (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.

Manufacturer / TM Owner

Novartis Europharm Limited

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Indications & Clinical Uses

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.

Side Effects

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.

Precautions & Warnings

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.

Avoid Interactions

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.

Frequently Asked Questions

Glivec is a prescription drug whose active ingredient is imatinib, a tyrosine‑kinase inhibitor administered orally.

In the EU, Glivec is approved for chronic myeloid leukemia (CML), Philadelphia chromosome‑positive acute lymphoblastic leukemia (Ph+ ALL), gastrointestinal stromal tumor (GIST) with KIT or PDGFRA mutations, dermatofibrosarcoma protuberans (DFSP), and systemic mastocytosis with an activating KIT mutation.

Imatinib inhibits the BCR‑ABL, c‑KIT, and PDGFR tyrosine kinases, blocking the signaling pathways that drive proliferation of certain cancer cells.

Common side effects include nausea, vomiting, diarrhea, peripheral edema, fatigue, and skin rash or itching.

Serious reactions can include liver toxicity, severe neutropenia or thrombocytopenia, and cardiac dysfunction such as left ventricular failure.

Baseline liver function tests and complete blood counts are recommended, with periodic monitoring during therapy.

Safety data are limited; the medication should only be used during pregnancy or lactation if the potential benefit justifies the potential risk, after consulting a healthcare professional.

Strong CYP3A4 inhibitors such as ketoconazole or clarithromycin should be avoided because they can increase imatinib concentrations.

CYP3A4 inducers (e.g., rifampin, phenytoin) may lower imatinib levels, and anticoagulants like warfarin may need INR monitoring.

If a dose is missed, patients should take it as soon as they remember on the same day, but should not double the next dose; they should follow the guidance of their prescribing clinician.

Dose adjustments may be necessary for patients with significant hepatic or renal dysfunction; clinicians should assess organ function before prescribing.

Patients with pre‑existing heart disease should have baseline cardiac evaluation and periodic follow‑up, especially if they develop symptoms of heart failure.

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GNH India Pharmaceuticals Limited

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