Rituximab and hyaluronidase human (Rituxan Hycela)

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: SC* (Rituxan Hycela treatment should be initiated only after patients have received at least one full dose of a rituximab product by intravenous infusion)

• 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 established (work in progress)

• Chronic lymphocytic leukemia
• Diffuse large B-cell lymphoma
• Follicular lymphoma

Diseases for which it is used

• Waldenström macroglobulinemia

Patient drug information

To be completed

History of changes in FDA indication

• 2017-06-22: Approved for relapsed or refractory follicular lymphoma (FL) as a single agent. (No supporting studies are cited)
• 2017-06-22: Approved for 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. (Based on SABRINA)
• 2017-06-22: Approved for non-progressing (including stable disease), FL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. (No supporting studies are cited)
• 2017-06-22: Approved for previously untreated diffuse large B-cell lymphoma (DLBCL) in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens. (Based on MabEase)
• 2017-06-22: Approved for previously untreated and previously treated CLL in combination with fludarabine and cyclophosphamide (FC). (Based on SAWYER)

Also known as

• Brand name: Rituxan Hycela