Optimal Dosing for Optimal Results1,2

• Considering the results of all clinical trials of Gleevec®:

– The recommended starting dose for chronic phase CML is 400mg.

– For accelerated phase and blast crisis, the recommended starting dose is 600mg.

• Patients should be monitored every 3–6 months for a cytogenetic and hematologic response.

• Dose adjustment for body surface area is not necessary, and flat dosing is appropriate.

– Dosing below recommendations should generally be avoided, as this may result in subtherapeutic

drug concentrations.

• Dose escalation (from 400mg to 600mg in chronic phase, from 600mg to 800mg in advanced

phases) may be appropriate in the absence of severe adverse drug reactions or severe

hematologic abnormalities for:

– Failure to achieve complete hematologic response after 3 months

– Failure to achieve a cytogenetic response after 6–12 months

– Loss of a previous hematologic or cytogenetic response

– Disease progression (at any time)

References

1. Gleevec® (imatinib mesylate) Prescribing Information. East Hanover, NJ: Novartis Pharmaceuticals

Corporation; 2003.

2. Data on file. Novartis Pharmaceuticals Corporation, East Hanover, NJ.