GNH USA

Europe — EMA

Glivec (Imatinib)

Glivec (imatinib) is an oral tyrosine kinase inhibitor used for CML, GIST, Ph+ ALL, and other BCR‑ABL positive cancers in the EU.

Imatinib

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What is Imatinib?

Glivec is a prescription oral medication whose active ingredient is imatinib. The product is marketed in the European Union and is classified as a tyrosine kinase inhibitor used in oncology. While the exact strength and dosage form are not specified, Glivec is administered by mouth and belongs to the antineoplastic therapeutic class.

What is Imatinib used for?

Glivec is indicated for several BCR‑ABL positive malignancies and related cancers. It is commonly prescribed in the following clinical situations:

- Chronic myeloid leukemia (CML) - Philadelphia chromosome‑positive acute lymphoblastic leukemia (Ph+ ALL) - Gastrointestinal stromal tumor (GIST) - Other BCR‑ABL positive hematologic malignancies - Off‑label use in select solid tumors under specialist supervision

What are the side effects of Imatinib?

Side effects of Glivec vary in frequency and severity. Patients should be aware of both common and serious reactions.

Common: - Nausea and vomiting - Diarrhea or constipation - Fatigue or weakness - Edema, especially peripheral swelling - Muscle cramps or joint pain

Serious: - Severe liver enzyme elevation - Cardiac dysfunction or heart failure - Severe neutropenia or thrombocytopenia - Pulmonary arterial hypertension - Life‑threatening allergic reactions

What precautions apply to Imatinib?

Glivec requires careful monitoring and specific precautions before and during therapy. Important considerations include: - Baseline and periodic liver function tests - Regular complete blood counts to detect cytopenias - Cardiac evaluation for patients with pre‑existing heart disease - Pregnancy avoidance; the drug is category D and may cause fetal harm - Contraception for both male and female patients of reproductive potential - Monitoring for signs of fluid retention or pulmonary hypertension

What does Imatinib interact with?

Glivec can interact with several drug classes, affecting its efficacy or safety profile.

Avoid: - Strong CYP3A4 inhibitors such as ketoconazole, clarithromycin, or ritonavir - Certain antacids containing aluminum or magnesium that may reduce absorption

Use with caution: - CYP3A4 inducers like rifampin, phenytoin, or St. John's wort - Concomitant anticoagulants (e.g., warfarin) due to bleeding risk - Other myelosuppressive agents that may increase cytopenia risk - Medications that prolong QT interval

Frequently asked questions

What type of medication is Glivec and how is it taken?+
Glivec is an oral prescription drug containing the active ingredient imatinib. It is taken by mouth in tablet form as directed by a healthcare professional.
Which cancers are approved for treatment with Glivec in the European Union?+
Glivec is approved for chronic myeloid leukemia (CML), Philadelphia chromosome‑positive acute lymphoblastic leukemia (Ph+ ALL), gastrointestinal stromal tumor (GIST), and other BCR‑ABL positive hematologic malignancies.
How does imatinib work to control cancer growth?+
Imatinib inhibits the BCR‑ABL tyrosine kinase as well as c‑KIT and PDGFR, blocking signaling pathways that promote uncontrolled cell proliferation in certain cancers.
What are the most frequently reported side effects of Glivec?+
Common side effects include nausea, diarrhea or constipation, fatigue, peripheral edema, and muscle or joint pain.
What serious adverse reactions should patients monitor while on Glivec?+
Serious reactions can include severe liver enzyme elevation, heart failure, significant drops in blood cell counts, pulmonary arterial hypertension, and severe allergic responses.
Is Glivec safe to use during pregnancy?+
Glivec is classified as pregnancy category D, indicating potential risk to the fetus. It should be avoided during pregnancy and effective contraception is recommended.
What laboratory tests are required before starting Glivec therapy?+
Baseline liver function tests, complete blood count, and cardiac assessment are typically performed to evaluate suitability and monitor for toxicity.
Can Glivec be taken with antacids or supplements?+
Strong antacids containing aluminum or magnesium may reduce imatinib absorption and should be avoided or spaced several hours apart from Glivec.
Which medications should be avoided because they reduce Glivec effectiveness?+
Potent CYP3A4 inhibitors such as ketoconazole, clarithromycin, and ritonavir can increase imatinib levels and should be avoided.
What should patients discuss with their doctor before starting Glivec?+
Patients should inform their physician about existing liver or heart conditions, current medications, pregnancy plans, and any history of allergic reactions.
How often should blood counts be monitored during Glivec treatment?+
Blood counts are usually checked at baseline and then regularly (e.g., monthly) during the first few months, with frequency adjusted based on clinical response.
Is there a need for dose adjustments of Glivec in patients with liver impairment?+
Dose adjustments may be required for patients with moderate to severe hepatic impairment; the prescribing physician will determine the appropriate regimen.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.
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Product details

Drug
Imatinib
Route
Oral Use
Manufacturer
Novartis Europharm Limited
Origin
EU

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