Recelbia^®

Rituximab

Description
The Rituximab antibody is a genetically engineered chimeric murine/human monoclonal antibody. It is directed against the CD20 antigen which found on the surface of normal and malignant B lymphocytes. The antibody is an IgG kappa immunoglobulin containing murine light- and heavy chain variable region sequences and human constant region sequences. Rituximab is composed of two heavy chains of 451 amino acids and two light chains of 213 amino acids (based on cDNA analysis) and has an approximate molecular weight of 145 kD. Rituximab has a binding affinity for the CD20 antigen approximately 8.0 nM. Rituximab is a sterile, clear, colorless, preservative-free liquid concentrate for intravenous (IV) administration.

Indications
Recelbia® is indicated for the treatment of 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 Recelbia® in combination with chemotherapy, as single-agent maintenance therapy.
- Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a singleagent after first-line CVP chemotherapy
- Previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracycline-based chemotherapy regimens
Chronic Lymphocytic Leukemia (CLL)
In combination with fludarabine and cyclophosphamide (FC), for the treatment of patients with previously untreated and previously treated CD20-positive CLL.
Rheumatoid Arthritis (RA)
In combination with methotrexate is indicated for the treatment of adult patients with moderately- to severely- active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.
Wegener's Granulomatosis (WG) and Microscopic Polyangiitis (MPA)
In combination with glucocorticoids, is indicated for the treatment of adult patients with Wegener's Granulomatosis (WG) and Microscopic Polyangiitis (MPA).

Supply
Recelbia® 100 mg Injection: Each commercial box contains 1 vial of Rituximab INN 100 mg.
Recelbia® 500 mg Injection: Each commercial box contains 1 vial of Rituximab INN 500 mg.