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GLEEVEC is a brand name for Imatinib, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
, General for more information on gastrointestinal hemorrhage. 4 Abnormal Laboratory Findings). Complete blood counts should be performed weekly for the first month, biweekly for the second month, and periodically thereafter as clinically indicated (for example every 2-3 months).
The occurrence of these cytopenias is dependent on the stage of disease and is more frequent in patients with accelerated phase CML or blast crisis than in patients with chronic phase CML. In pediatric CML patients the most frequent toxicities observed were Grade 3 or 4 cytopenias involving neutropenia (31%), thrombocytopenia (16%) and anemia (14%).
2 Recommended Dose and Dosage Adjustment - Hematologic adverse drug reactions). An increased rate of opportunistic infections was observed in a monkey study with chronic imatinib treatment. In a 39-week monkey study, treatment with imatinib resulted in worsening of normally suppressed malarial infections in these animals.
3% patients). Hepatic/Biliary/Pancreatic Liver Failure There have been cases of cytolytic and cholestatic hepatitis and hepatic failure; in some cases the outcome was fatal. 4 Drug-Drug Interactions). 2 Clinical Trial Adverse Reactions).
Liver function (transaminases, bilirubin, and alkaline phosphatase) should be monitored before initiation of treatment and monthly or as clinically indicated. 2 Recommended Dose and Dosage Adjustment – Hepatic Impairment). Patients with hepatic impairment should be closely monitored.
Although pharmacokinetic analysis results showed there is considerable inter-subject variation, the mean exposure to imatinib did not differ significantly between patients with mild and moderate liver dysfunction (as measured by dose normalized AUC) and patients with normal liver function.
Patients with severe liver dysfunction demonstrated increased exposure to imatinib and its active metabolite CGP 74588. 3 Pharmacokinetics – Hepatic Insufficiency). 2 Clinical Trial Adverse Reactions). Hepatotoxicity has been observed in patients treated with GLEEVEC.
2% for unresectable and/or metastatic malignant GIST patients. Immune Hepatitis B virus Reactivation GLEEVEC® (imatinib) Product Monograph Page 14 of 70 Reactivation of hepatitis B virus (HBV) has occurred in patients who are chronic carriers of this virus after receiving a Bcr-Abl tyrosine kinase inhibitor (TKI), including GLEEVEC.
Some cases resulted in acute hepatic failure or fulminant hepatitis leading to liver transplantation or death. Patients should be tested for HBV infection before initiating treatment with GLEEVEC. Patients currently on GLEEVEC should have baseline testing for HBV infection in order to identify chronic carriers of the virus.
Experts in liver disease and in the treatment of hepatitis B should be consulted before treatment is initiated in patients with positive HBV serology (including those with active disease) and for patients who test positive for HBV infection during treatment.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Carriers of HBV who require treatment with GLEEVEC should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy. Monitoring and Laboratory Tests Patients with known cardiac disease or risk factors for cardiac failure should be monitored carefully and those with symptoms or signs consistent with CHF should be evaluated and treated.
In patients with history of cardiac disease or in elderly patients, a baseline evaluation of LVEF is recommended prior to initiation of GLEEVEC therapy (see 7 Warnings and Precautions - Cardiovascular). 2 Dosage and Dosage Adjustment – Hematologic adverse drug reactions).
2 Recommended Dose and Dosage Adjustment – Hepatic Impairment). Patients should be weighed and monitored regularly for signs and symptoms of fluid retention as fluid retention can occur after months of treatment with GLEEVEC (see 7 WARNINGS AND PRECAUTIONS - General).
Thyroid-Stimulating Hormone (TSH) levels should be closely monitored in thyroidectomy patients undergoing levothyroxine replacement during treatment with GLEEVEC (see 7 Warnings and Precautions – Endocrine and Metabolism). , hyperuricemia, hyperkalemia, hypocalcemia, hyperphosphatemia, acute renal failure, elevated LDH, high fevers) should be monitored at baseline and during initial […]