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Prescribing Glivec® (imatinib)
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Glivec (imatinib) Dosage Information
Glivec (imatinib) Safety Information
Before the molecular era, the outlook for patients with CML was bleak. Diagnosis was poor and tended to occur at later disease stages2. Prognosis was poor. Available treatment options promised only limited efficacy and were often associated with difficult side effects.
Glivec® (imatinib) is the first protein-tyrosine kinase inhibitor to reach the clinic and is thus the most established molecularly targeted agent of its class. It differs from interferon alfa (IFN-α) and chemotherapeutic agents in having a well-characterised mechanism of action and in exerting its effects on a particular abnormal protein within the leukaemic cell. In clinical trials, Glivec demonstrated efficacy in CML superior to that achieved with previous systemic therapies, and it has been well tolerated by patients in all studies.
Efficacy of Glivec (imatinib)
Glivec is the standard of care in Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) with proven efficacy and longevity. With more than 5 years of follow-up data in the IRIS study, Glivec has consistently achieved and maintained exceptional rates of response. No other drug for CML has established as proven and durable a track record of efficacy and safety as Glivec.
Few drugs have succeeded to the extent that Glivec has in fundamentally changing the natural history of a disease.
Glivec is confirmed as the standard first-line therapy for all CML patients by clinical studies with 5-year follow-up 4-7.
- An 89% overall survival rate at 5 years with Glivec exceeds that of all other CML therapies, with <5% of deaths related to CML.
- An estimated 98% of patients in chronic-phase CML have had a best response of CHR, and an estimated 92% of patients have had a best response of major cytogenetic response with Glivec
- Late responses to Glivec occur and responses are durable.
- Annual risk of progression is decreasing with time.
- The annual rate of progression to advanced phases of CML (accelerated phase/blast crisis) at year 5 declined to 0.6% (from 1.5% in year 1).
- Increasing the daily dose of Glivec to 600 or 800 mg may be considered for patients in the absence of severe adverse drug reaction and severe non-leukaemia-related neutropaenia or thrombocytopaenia in certain circumstances, including disease progression, failure to achieve response within prespecified time points, or loss of response (refer to SmPC for further details)4.
- Overall risk of progression to advanced phase is low and is associated with the degree of response, regardless of when achieved.
Treatment with Glivec in newly diagnosed and untreated paediatric patients with chronic-phase CML is tolerated well and produces cytogenetic response rates comparable to the results observed in adults4, 75.
Dosage
Glivec (imatinib) Dosage Information
Glivec is supplied as 100-mg and 400-mg film-coated tablets. The recommended starting doses for adult patients in whom Glivec therapy is indicated are 400 mg/d for chronic-phase CML and 600 mg/d for accelerated-phase or blast-crisis disease. The recommended starting dosages for children with CML in whom Glivec therapy is indicated is 340 mg/m2/d for chronic-phase CML and advanced-phase CML (not to exceed the total dose of 800 mg)4.
Dose increases from 400 mg to 600 mg or 800 mg in adult patients with chronic-phase disease, or from 600 mg to a maximum of 800 mg (given as 400 mg twice daily) in patients in accelerated phase or blast crisis, may be considered in the absence of severe adverse drug reaction and severe non-leukaemia-related neutropaenia or thrombocytopaenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response4.
Please refer to local prescribing information for specific indications.
Glivec (imatinib) Safety Information
Safety and TolerabilityRead about emerging recommendations for Ongoing Management of CML.
