U.S. License Holder:
Amgen / Allergan
Date of License:
December-17-2020
Last Update:
Nov-15-2024
FDA-Approved Indications
RIABNI (rituximab-arrx) is a CD20-directed cytolytic antibody indicated for the treatment of:
Adult patients with Non-Hodgkin's Lymphoma (NHL): Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent; Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy; Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy; Previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens;
Adult patients with Chronic Lymphocytic Leukemia (CLL): Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC);
Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA who have inadequate response to one or more TNF antagonist therapies;
Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids.
