Advice
Product overview
Mode of action
Rituximab (MabThera, Roche Products Limited) is a monoclonal antibody that targets the CD20 surface antigen, which is expressed on normal and malignant B cells. Rituximab binds to the CD20 surface antigen on B cells mediating cell lysis and inducing cell death by apoptosis (summary of product characteristics).
Regulatory status
Rituximab concentrate for solution for intravenous infusion (MabThera, Roche Products Limited) is licensed in adults for treating non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, and granulomatosis with polyangiitis and microscopic polyangiitis. It is administered as an intravenous infusion.
Rituximab is also available as a solution for subcutaneous injection (MabThera, Roche Products Limited), which is licensed for non-Hodgkin's lymphoma. This evidence summary does not consider this formulation of rituximab.
Rituximab is not licensed for treating systemic sclerosis (or localised scleroderma) and use for this indication is off‑label.
In line with the guidance from the General Medical Council (GMC) on prescribing unlicensed medicines, the prescriber should take full responsibility for determining the needs of the person and whether using rituximab is suitable outside its authorised indications. Supporting information and advice is also available from the GMC.
Dosing information
Dosing information varies for rituximab depending on the indication it is being used for. The recommended dose is 375 mg/m2 body surface area for non-Hodgkin's lymphoma and granulomatosis with polyangiitis and microscopic polyangiitis, and 500 mg/m2 for chronic lymphocytic leukaemia (after 1 dose of 375 mg/m2). The recommended treatment intervals and durations differ across these conditions. For rheumatoid arthritis, the recommended dosage is 2×1,000 mg doses of rituximab administered 2 weeks apart, with dosing repeated at no less than 6‑month intervals. More information on dosage regimens for the licensed indications can be found in the summary of product characteristics.
Dosing information for rituximab for systemic sclerosis (an off‑label indication) is discussed in the evidence review within this evidence summary.
Cost
Rituximab 10 mg/ml concentrate for solution for intravenous infusion costs £349.25 for 2×10 ml vials and £873.15 for 1×50 ml vial (excluding VAT; MIMS, January 2017).