Rituximab (Rituxan)

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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).[1][2][3]
Route: IV
Extravasation: neutral

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.[1]

Diseases for which it is established (work in progress)

Diseases for which it is used

Patient drug information

History of changes in FDA dosing recommendations

  • 2012-10-19: Approved for 90-minute infusion in previously untreated diffuse large B-cell lymphoma (DLBCL) and follicular Non-Hodgkin lymphoma (NHL) starting with cycle 2:[6]
    • Patients who do not experience a grade 3 or 4 infusion related adverse event during cycle 1 may undergo a 90-minute infusion when used as part of a glucocorticoid-containing chemotherapy regimen. In cycle 2, 20% of the total dose is to be given over the first 30 minutes, and the remaining 80% of the total dose is to be given over the last 60 minutes. If this 90-minute infusion is tolerated, the same rate can be used for remaining cycles of the treatment.[1][7][8][9]

History of changes in FDA indication

Note: there is a gap in FDA labels between 1997 and 2006 on the FDA website; there are likely missing indications issued during that time period.

Chronic lymphocytic leukemia

  • 2010-02-18: Approved in combination with fludarabine and cyclophosphamide (FC), for the treatment of previously untreated and previously treated patients with chronic lymphocytic leukemia (CLL). (New disease entity; based on GCLLSG CLL8 & REACH)

Diffuse large B-cell lymphoma

  • 2006-02-10: Approved for use in the first-line treatment of patients with diffuse large B-cell, CD20-positive, non-Hodgkin's lymphoma in combination with CHOP or other anthracycline-based chemotherapy regimens. (new disease entity added; scope expanded to first-line treatment; combination therapy required; based on ECOG E4494, LNH 98-5, NCIC-CTG LY.9)

Follicular lymphoma

  • 1997-11-26: Initial FDA approval for the treatment of patients with relapsed or refractory follicular, CD20 positive, B-cell non-Hodgkin’s lymphoma. (Based on Maloney et al. 1997a & McLaughlin et al. 1998)
  • 2006-09-29: Approved for the first-line treatment of patients with follicular, CD20-positive B-cell non-Hodgkin’s lymphoma. (scope expanded to first-line treatment; based on M39021)
  • 2011-01-28: Approved for maintenance therapy for patients with previously untreated follicular, CD-20 positive, B-cell non-Hodgkin lymphoma who achieve a response to rituximab in combination with chemotherapy. (Approval extended to maintenance setting; based on ECOG E1496 & PRIMAFL)

Indolent (Low grade) lymphoma

  • 1997-11-26: Initial FDA approval for the treatment of patients with relapsed or refractory low-grade, CD20 positive, B-cell non-Hodgkin’s lymphoma. (Based on Maloney et al. 1997a & McLaughlin et al. 1998)
  • 2006-09-29: Approved for the first-line treatment of patients with low grade, CD20-positive B-cell non-Hodgkin’s lymphoma. (scope expanded to first-line treatment; based on M39021)

Pediatric lymphoma/leukemia

History of changes in EMA indication

  • 1998-06-02: Initial marketing authorization as MabThera.

History of changes in PMDA indication

Also known as

  • Code names: BI-695500, IDEC-102, IDEC-C2B8, PF-05280586, RTXM-83
  • Brand names: Ikgdar, Mabtas, MabThera, Reditux, Ristova, Rituxan, Rituxim, Transera-Kit

References

  1. ↑ 1.0 1.1 1.2 1.3 Rituximab (Rituxan) package insert
  2. ↑ Rituximab (Rituxan) package insert (locally hosted backup)
  3. ↑ Rituxan manufacturer's site
  4. ↑ Rituximab (Rituxan) patient drug information (Chemocare)
  5. ↑ Rituximab (Rituxan) patient drug information (UpToDate)
  6. ↑ FDA Approves New Dosing and Administration Information for Rituximab (2012-10-19) Hematology.org, accessed 2012-10-19
  7. ↑ Atmar J. Review of the safety and feasibility of rapid infusion of rituximab. J Oncol Pract. 2010 Mar;6(2):91-3. link to original article contains dosing details in manuscript link to PMC article PubMed
  8. ↑ Sehn LH, Donaldson J, Filewich A, Fitzgerald C, Gill KK, Runzer N, Searle B, Souliere S, Spinelli JJ, Sutherland J, Connors JM. Rapid infusion rituximab in combination with corticosteroid-containing chemotherapy or as maintenance therapy is well tolerated and can safely be delivered in the community setting. Blood. 2007 May 15;109(10):4171-3. Epub 2007 Jan 23. link to original article contains dosing details in manuscript PubMed
  9. ↑ Dakhil S, Hermann R, Schreeder MT, Gregory SA, Monte M, Windsor KS, Hurst D, Chai A, Brewster M, Richards P. Phase III safety study of rituximab administered as a 90-minute infusion in patients with previously untreated diffuse large B-cell and follicular lymphoma. Leuk Lymphoma. 2014 Oct;55(10):2335-40. Epub 2014 Mar 7. PubMed
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