Systemic Therapy
Imatinib - Management of Adverse Events
Although Glivec is generally well tolerated, several common hematologic and nonhematologic adverse events may occur and need to be monitored and managed. Occasionally, dose reduction or brief dose interruption may be necessary.1
Hematologic adverse events
Dose reduction or treatment interruption for severe neutropenia and thrombocytopenia is recommended (Table 1).1
Nonhematologic adverse events
If a severe nonhematologic adverse reaction develops with Glivec use, treatment must be withheld until the event has resolved. Thereafter, treatment can be resumed as appropriate depending on the initial severity of the event. Edemas may be managed with diuretics, with other supportive measures, or by reducing the dose of Glivec.
Fluid retention can usually be managed by withholding Glivec temporarily and with diuretics and other appropriate supportive care measures.1
| Chronic-phase CML and GIST (starting dose 400 mg)* |
ANC <1.0 × 109/L or platelets <50 × 109/L |
|
| Accelerated-phase CML and blast crisis (starting dose 600 mg)‡ |
ANC <0.5 × 109/L§ or platelets <10 × 109/L |
|
*Or 260 mg/m2 in children.
†Or 200 mg/m2 in children.
‡Or 340 mg/m2 in children.
§ Occurring after at least 1 month of treatment. ANC, absolute neutrophil count; CML, chronic myeloid leukemia; GIST, gastrointestinal stromal tumor.
Liver toxicity
If elevations in bilirubin >3× institutional upper limit of normal (IULN) or if liver transaminases >5× IULN occur, Glivec should be withheld until bilirubin levels have returned to <1.5× IULN and transaminase levels to <2.5× IULN. Treatment with Glivec may then be continued at a reduced daily dose. In adults, the dose should be reduced from 400 mg to 300 mg or from 600 mg to 400 mg; in children, the dose should be reduced from 260 mg to 200 mg/m2/d or from 340 mg to 260 mg/m2/d.
References:
1. Glivec summary of product characteristics [SMPC]. Basel, Switzerland: Novartis Pharma AG; 2006.