Indications : התוויות

4.1   Therapeutic indications

Ruxience is indicated for the following indications:

Non-Hodgkin’s lymphoma (NHL)
Ruxience is indicated for the treatment of patients with relapsed or refractory low-grade or follicular, B-cell non-hodgkin's lymphoma.

Ruxience is indicated for the treatment of previously untreated patients with low-grade or follicular lymphoma in combination with chemotherapy.


Ruxience is indicated for the treatment of patients with CD20 positive diffuse large B- cell non-Hodgkin’s lymphoma in combination with CHOP chemotherapy.

Ruxience maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.

Chronic lymphocytic leukaemia (CLL)

Ruxience in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including Ruxience or patients refractory to previous Ruxience plus chemotherapy.

See section 5.1 for further information.

Rheumatoid arthritis
Ruxience is indicated, in combination with methotrexate, to reduce signs and symptoms in adult patients with moderately to severely active rheumatoid arthritis who had an inadequate response or intolerance to one or more TNF antagonist therapies.

Granulomatosis with polyangiitis and microscopic polyangiitis

Ruxience, in combination with glucocorticoids, is indicated for the treatment of adult patients with granulomatosis with polyangiitis (GPA) (Wegener's Granulomatosis (WG)) and microscopic polyangiitis (MPA).


Pemphigus vulgaris
Ruxience is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris (PV).