ZYTUX™

Description

Zytux™ is a biosimilar product with the generic name of Rituximab. It is a genetically engineered human-mouse chimeric monoclonal antibody produced by Chinese Hamster Ovary (CHO) cells in suspension. It is a fusion of the light and heavy chain variable domains of a murine monoclonal anti-CD20 antibody and human kappa light-chain and gamma 1 heavy-chain constant regions. Rituximab is a chimeric monoclonal antibody against CD20 antigens presents on surface of lymphocyte cells. Rituximab binds to the target CD20 antigen via the variable murine regions, while the remainder of the antibody interacts with human immune-effector mechanisms to kill the target cells.

Indication

Zytux™ is used for treatment of:

• Non-Hodgkin’s Lymphoma (NHL)
• Chronic Lymphocytic Leukemia (CLL)
• Rheumatoid Arthritis (RA)
• Granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)

ZytuxTM is supplied as a sterile, clear and colorless concentrate for solution for infusion. It is provided in vials of 10 milliliter and 50 milliliter containing 100 mg and 500 mg Rituximab, respectively. Zytux™ should be administered as intravenous infusion after dilution.