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RUXIENCE (Pfizer Australia Pty Ltd)
Product name
RUXIENCE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
188 (255 working days)
Active ingredients
rituximab
Registration type
NCE/NBE
Indication
Non-Hodgkin's Lymphoma
RUXIENCE (concentrated solution for injection) is indicated for treatment of patients with:
- CD20 positive, previously untreated, Stage III/IV follicular, B-cell non-Hodgkin's lymphoma,
- CD20 positive, relapsed or refractory low grade or follicular, B-cell non-Hodgkin's lymphoma,
- CD20 positive, diffuse large B-cell non-Hodgkin's lymphoma, in combination with chemotherapy.
Chronic Lymphocytic Leukaemia
RUXIENCE is indicated for the treatment of patients with CD20 positive chronic lymphocytic leukaemia (CLL) in combination with chemotherapy.
Rheumatoid Arthritis
RUXIENCE in combination with methotrexate is indicated for the treatment of adult patients with severe, active rheumatoid arthritis who have had an inadequate response or intolerance to at least one tumour necrosis factor (TNF) inhibitor therapy.
RUXIENCE has been shown to reduce the rate of progression of joint damage as measured by x-ray when given in combination with methotrexate.
Granulomatosis with polyangiitis (Wegener's) (GPA) and Microscopic polyangiitis (MPA)
RUXIENCE in combination with glucocorticoids is indicated for the induction of remission in patients with severely active Granulomatosis with polyangiitis (GPA, also known as Wegener's granulomatosis) and Microscopic polyangiitis (MPA). The efficacy and safety of retreatment with RUXIENCE have not been established.