Rituximab and hyaluronidase human (Rituxan Hycela)
Class/mechanism: Anti-CD20 antibody, chimeric murine/human monoclonal IgG1 kappa, which binds to CD20 (human B-lymphocyte-restricted differentiation antigen, Bp35), which is expressed on B-cells. The Fc domain recruits immune effector functions to mediate B-cell lysis. Possible mechanisms of cell lysis include complement-dependent cytotoxicity (CDC) and antibody-dependent cell mediated cytotoxicity (ADCC).
Route: SC* (Rituxan Hycela treatment should be initiated only after patients have received at least one full dose of a rituximab product by intravenous infusion)
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Diseases for which it is used
Patient drug information
To be completed
History of changes in FDA indication
- 6/22/2017: FDA approved for adult patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia, as follows:
- Relapsed or refractory, follicular lymphoma (FL) as a single agent.
- Previously untreated FL in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy.
- Non-progressing (including stable disease), FL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
- Previously untreated diffuse large B-cell lymphoma (DLBCL) in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens.
- Previously untreated and previously treated CLL in combination with fludarabine and cyclophosphamide (FC).
- Rituxan Hycela is not indicated for the treatment of non-malignant conditions.