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Limited experience with doses higher than the approved intravenous doses of MabThera is available from clinical trials in humans. The highest IV dose tested in humans to date is 5000 mg (2250 mg/m2), tested in a dose escalation study in patients with chronic lymphocytic leukaemia. No additional safety signals were identified. Patients who experience overdose should have immediate interruption of their infusion and be closely monitored.
Three patients in the MabThera/Rituxan SC trial SABRINA (BO22334) study were inadvertently administered the SC formulation through the IV route up to a maximum rituximab dose of 2780 mg, with no untoward effect. Patients who experience overdose or medication error with MabThera SC should be closely monitored.
Consideration should be given to the need for regular monitoring of blood cell count and for increased risk of infections while patients are B cell-depleted.
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