Difference between revisions of "Rituximab (Rituxan)"

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==History of changes in FDA indication==
 
==History of changes in FDA indication==
−
*11/26/1997: Initial FDA approval for the treatment of patients with relapsed or refractory low-grade or follicular, CD20 positive, B-cell non-Hodgkin’s lymphoma.
+
*11/26/1997: Initial FDA approval for the treatment of patients with relapsed or refractory [[Follicular lymphoma |low-grade or follicular, CD20 positive, B-cell non-Hodgkin’s lymphoma]].
 +
*2/10/2006: FDA approved for use in the first‑line treatment of patients with [[Diffuse large B-cell lymphoma|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)''
 +
*9/29/2006: FDA approved for the first-line treatment of patients with [[Follicular lymphoma |low grade or follicular, CD20-positive B-cell non-Hodgkin’s lymphoma]]. ''(scope expanded to first-line treatment)''
 
*10/19/2012: FDA approved for 90-minute infusion in previously untreated [[Follicular lymphoma | follicular Non-Hodgkin lymphoma (NHL)]] and [[Aggressive Non-Hodgkin lymphoma | diffuse large B-cell lymphoma (DLBCL)]] starting with cycle 2:<ref>[http://www.hematology.org/News/2012/9119.aspx FDA Approves New Dosing and Administration Information for Rituximab (10/19/2012)] Hematology.org, accessed 10/19/2012</ref>
 
*10/19/2012: FDA approved for 90-minute infusion in previously untreated [[Follicular lymphoma | follicular Non-Hodgkin lymphoma (NHL)]] and [[Aggressive Non-Hodgkin lymphoma | diffuse large B-cell lymphoma (DLBCL)]] starting with cycle 2:<ref>[http://www.hematology.org/News/2012/9119.aspx FDA Approves New Dosing and Administration Information for Rituximab (10/19/2012)] Hematology.org, accessed 10/19/2012</ref>
 
**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.<ref name="insert"></ref><ref>Atmar J. Review of the safety and feasibility of rapid infusion of rituximab. J Oncol Pract. 2010 Mar;6(2):91-3. [http://jop.ascopubs.org/content/6/2/91.full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20592783 PubMed]</ref><ref>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. [http://bloodjournal.hematologylibrary.org/content/109/10/4171.full.html link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/17244675 PubMed]</ref><ref>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. [https://www.ncbi.nlm.nih.gov/pubmed/24471908 PubMed]</ref>
 
**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.<ref name="insert"></ref><ref>Atmar J. Review of the safety and feasibility of rapid infusion of rituximab. J Oncol Pract. 2010 Mar;6(2):91-3. [http://jop.ascopubs.org/content/6/2/91.full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20592783 PubMed]</ref><ref>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. [http://bloodjournal.hematologylibrary.org/content/109/10/4171.full.html link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/17244675 PubMed]</ref><ref>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. [https://www.ncbi.nlm.nih.gov/pubmed/24471908 PubMed]</ref>

Revision as of 03:34, 26 November 2018

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 used

Patient drug information

History of changes in FDA indication

Also known as

  • Code names: BI 695500, CT-P10, IDEC-102, IDEC-C2B8, PF-05280586, RTXM83
  • Brand names: Ikgdar, Mabtas, MabThera, Reditux, Ristova, Rituxan, Rituxim, Transera-Kit, Truxima

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 (10/19/2012) Hematology.org, accessed 10/19/2012
  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 verified protocol 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 verified protocol 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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