Difference between revisions of "Rituximab and hyaluronidase human (Rituxan Hycela)"

Revision as of 23:51, 8 June 2022

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)

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. (Based on SABRINA)
- 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). (Based on SAWYER)
- Rituxan Hycela is not indicated for the treatment of non-malignant conditions.

Also known as

Brand name: Rituxan Hycela

References

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 *6/22/2017: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm564235.htm FDA approved] for adult patients with [[follicular lymphoma]], [[diffuse large B-cell lymphoma]], and [[Chronic lymphocytic leukemia|chronic lymphocytic leukemia]], as follows:
 **Relapsed or refractory, [[Follicular lymphoma|follicular lymphoma (FL)]] as a single agent.
-**Previously untreated [[Follicular lymphoma|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.
+**Previously untreated [[Follicular lymphoma|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)''
 **Non-progressing (including stable disease), [[Follicular lymphoma|FL]] as a single agent after first-line [[Follicular_lymphoma#CVP|cyclophosphamide, vincristine, and prednisone (CVP)]] chemotherapy.
 **Previously untreated [[Diffuse large B-cell lymphoma|diffuse large B-cell lymphoma (DLBCL)]] in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens.