Safety information
MabThera has more than 10 years of clinical experience and more than 1,000,000 patients have been treated to date. The majority of patients experience mild to moderate infusion-related reactions (IRRs) during the first administration of rituximab, but the incidence decreases markedly with subsequent infusions. Rituximab induces a rapid depletion of normal CD20-expressing B-cells in the peripheral blood, and levels remain low or undetectable for 2-6 months before returning to pretreatment levels, generally within 12 months. T-cells are unaffected by rituximab and consequently opportunistic infections rarely occur in association with rituximab therapy. When used in combination with a variety of chemotherapeutic regimens, rituximab does not add to the toxicity of chemotherapy, with the exception of a higher rate of neutropenia, although this does not translate into a higher infection rate. For the great majority of patients, rituximab is safe and well tolerated.
The European Summary of Product Characteristics (ESPC) provides comprehensive clinical, pharmacological and prescribing information about MabThera. Detailed information about the safety experience with MabThera can be found in the ESPC.
The Brief Prescribing Information document details the indications and usage of MabThera, together with a brief summary of the clinical, pharmacological and safety information.
