Rituximab-pvvr (Ruxience)

Note: this is an FDA-approved biosimilar. The information below is reproduced from the Rituximab (Rituxan) page, except for the details of FDA indication.

General information

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: IV
Extravasation: neutral

• Rituximab (Rituxan) desensitization protocol

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 hemophilia A
• 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
• Classical 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
• Acquired thrombotic thrombocytopenic purpura
• Transformed lymphoma
• Waldenström macroglobulinemia

Patient drug information

• Rituximab (Rituxan) package insert
• Rituximab (Rituxan) patient drug information (Chemocare)
• Rituximab (Rituxan) patient drug information (UpToDate)

History of changes in FDA indication

Note: all initial approvals were granted simultaneously on 7/23/2019.

Chronic lymphocytic leukemia

• 2019-07-23: Approved for previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC).

Diffuse large B-cell lymphoma

• 2019-07-23: Approved for previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens.

Follicular lymphoma

• 2019-07-23: Approved for follicular, CD20-positive B-cell NHL as a single agent. (Based on REFLECTIONS B328-06)
• 2019-07-23: Approved for 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

Indolent lymphomas

• 2019-07-23: Approved for low grade CD20-positive B-cell NHL as a single agent.
• 2019-07-23: Approved for 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.

Also known as

• Code name: PF-05280586
• Brand name: Ruxience