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rituximab (Mabthera)

Advice

following a full submission:

rituximab (MabThera®) is accepted for restricted use within NHS Scotland.

Indication under review: In combination with glucocorticoids for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA).

SMC restriction: to use in patients who have relapsed following treatment with cyclophosphamide or
who are intolerant to or unable to receive cyclophosphamide.

One course of rituximab (an intravenous infusion weekly for four weeks) was non-inferior to three to six months of oral cyclophosphamide for the proportion of patients achieving remission at six months. The study was conducted in patients with severe proteinase 3- or myeloperoxidase-antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis who were treatment-naïve or previously treated.

Drug Details

Drug Name: rituximab (Mabthera)
SMC Drug ID: 894/13
Manufacturer: Roche
Indication: In combination with glucocorticoids for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA).
BNF Category:
Sub Category: 8.2 Drugs affecting the immune response
Submission Type: Full submission
Status: Restricted
Date Advice Published: 9 September 2013

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