Clinical Experience in Granulomatosis with polyangiitis (Wegener’s) (GPA) and Microscopic polyangiitis (MPA) In the RAVE 99 patients were treated with rituximab (375 mg/m2, once weekly for 4 weeks) and glucocorticoids (see CLINICAL TRIALS). The ADRs listed in 21 were all adverse events which occurred at an incidence of 5% in ≥ the rituximab-treated group. The safety profile from long-term use of rituximab to treat GPA/MPA has not been established. Table 21: Adverse drug reactions occurring in 5% of patients receiving rituximab, and at a ≥ higher frequency than cyclophosphamide, in the pivotal study at 6-months* Rituximab CYC Adverse reactions (n=99) (n=98) Blood and lymphatic system disorders Thrombocytopenia 7% 3% Gastrointestinal disorders Diarrhoea 18% 12% Dyspepsia 6% 5% Constipation 5% 1% General disorders and administration site conditions Peripheral oedema 16% 9% Immune system disorders Infusion related reactions 5% 2% Infections and infestations Urinary tract infection 7% 3% Bronchitis 5% 2% Herpes zoster 5% 2% Nasopharyngitis 5% 4% Investigations Decreased haemoglobin 6% 4% Metabolism and nutrition disorders Hypokalaemia 5% 2% Musculoskeletal and connective tissue disorders Muscle spasm 18% 17% Arthralgia 15% 10% Back pain 10% 6% Muscle weakness 5% 4% Musculoskeletal pain 5% 0% Pain in extremities 5% 3% Nervous system disorders Dizziness 10% 9% Tremor 10% 6% Psychiatric disorders Insomnia 14% 13%
Clinical Experience in Granulomatosis with polyangiitis (Wegener’s) (GPA) and Microscopic polyangiitis (MPA) In the RAVE 99 patients were treated with rituximab (375 mg/m2, once weekly for 4 weeks) and glucocorticoids (see CLINICAL TRIALS). The ADRs listed in 21 were all adverse events which occurred at an incidence of ≥ 5% in the rituximab-treated group. The safety profile from long-term use of rituximab to treat GPA/MPA has not been established. Table 21: Adverse drug reactions occurring in ≥ 5% of patients receiving rituximab, and at a higher frequency than cyclophosphamide, in the pivotal study at 6-months* Adverse reactions Rituximab (n=99) CYC (n=98) Blood and lymphatic system disorders Thrombocytopenia 7% 3% Gastrointestinal disorders Diarrhoea Dyspepsia Constipation 18% 6% 5% 12% 5% 1% General disorders and administration site conditions Peripheral oedema 16% 9% Immune system disorders Infusion related reactions 5% 2% Infections and infestations Urinary tract infection Bronchitis Herpes zoster Nasopharyngitis 7% 5% 5% 5% 3% 2% 2% 4% Investigations Decreased haemoglobin 6% 4% Metabolism and nutrition disorders Hypokalaemia 5% 2% Musculoskeletal and connective tissue disorders Muscle spasm Arthralgia Back pain Muscle weakness Musculoskeletal pain Pain in extremities 18% 15% 10% 5% 5% 5% 17% 10% 6% 4% 0% 3% Nervous system disorders Dizziness Tremor 10% 10% 9% 6% Psychiatric disorders Insomnia 14% 13%