Note: this is an FDA-approved biosimilar. The information below is reproduced from the Rituximab (Rituxan) page, except for the details of FDA indication.
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).
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.
Diseases for which it is used
- Acquired coagulopathy
- Immune thrombocytopenia (ITP)
- B-cell acute lymphoblastic leukemia
- Burkitt lymphoma
- Castleman disease
- Chronic lymphocytic leukemia
- CNS lymphoma
- Cold agglutinin disease
- Diffuse large B-cell lymphoma
- Follicular lymphoma
- Hairy cell leukemia
- HIV-associated lymphoma
- Hodgkin lymphoma
- Hodgkin lymphoma, nodular lymphocyte-predominant
- Inherited coagulopathy with inhibitor
- Mantle cell lymphoma
- Marginal zone lymphoma
- Mediastinal gray-zone lymphoma
- Post-transplant lymphoproliferative disorder
- Primary mediastinal B-cell lymphoma
- Thrombotic thrombocytopenic purpura
- Transformed lymphoma
- Waldenström macroglobulinemia
Patient drug information
History of changes in FDA indication
- 7/2019: Initial FDA approval for the treatment of adult patients with:
- 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; and
- 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.
- Previously untreated and previously treated CD20‑positive CLL in combination with fludarabine and cyclophosphamide (FC).
Also known as
- Brand names: Ruxience