Difference between revisions of "Rituximab-pvvr (Ruxience)"

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==Diseases for which it is used==
 
==Diseases for which it is used==
 
<div style="column-count:3;-moz-column-count:3;-webkit-column-count:3">
 
<div style="column-count:3;-moz-column-count:3;-webkit-column-count:3">
−
*[[Acquired coagulopathy]]
+
*[[Acquired hemophilia A]]
 
*[[Immune thrombocytopenia (ITP)]]
 
*[[Immune thrombocytopenia (ITP)]]
 
*[[B-cell acute lymphoblastic leukemia]]
 
*[[B-cell acute lymphoblastic leukemia]]
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*[[Hairy cell leukemia]]
 
*[[Hairy cell leukemia]]
 
*[[HIV-associated lymphoma]]
 
*[[HIV-associated lymphoma]]
−
*[[Hodgkin lymphoma]]
+
*[[Classical Hodgkin lymphoma]]
 
*[[Hodgkin lymphoma, nodular lymphocyte-predominant]]
 
*[[Hodgkin lymphoma, nodular lymphocyte-predominant]]
 
*[[Inherited coagulopathy|Inherited coagulopathy with inhibitor]]
 
*[[Inherited coagulopathy|Inherited coagulopathy with inhibitor]]
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*[[Post-transplant lymphoproliferative disorder]]
 
*[[Post-transplant lymphoproliferative disorder]]
 
*[[Primary mediastinal B-cell lymphoma]]
 
*[[Primary mediastinal B-cell lymphoma]]
−
*[[Thrombotic thrombocytopenic purpura]]
+
*[[Acquired thrombotic thrombocytopenic purpura]]
 
*[[Transformed lymphoma]]
 
*[[Transformed lymphoma]]
 
*[[Waldenström macroglobulinemia]]
 
*[[Waldenström macroglobulinemia]]
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==Patient drug information==
 
==Patient drug information==
 
*[http://www.gene.com/gene/products/information/pdf/rituxan-prescribing.pdf Rituximab (Rituxan) package insert]
 
*[http://www.gene.com/gene/products/information/pdf/rituxan-prescribing.pdf Rituximab (Rituxan) package insert]
−
*[http://chemocare.com/chemotherapy/drug-info/Rituximab.aspx Rituximab (Rituxan) patient drug information (Chemocare)]<ref>[http://chemocare.com/chemotherapy/drug-info/Rituximab.aspx Rituximab (Rituxan) patient drug information (Chemocare)]</ref>
+
*[https://chemocare.com/druginfo/Rituximab.aspx Rituximab (Rituxan) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/Rituximab.aspx Rituximab (Rituxan) patient drug information (Chemocare)]</ref>
 
*[http://www.uptodate.com/contents/rituximab-patient-drug-information Rituximab (Rituxan) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/rituximab-patient-drug-information Rituximab (Rituxan) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/rituximab-patient-drug-information Rituximab (Rituxan) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/rituximab-patient-drug-information Rituximab (Rituxan) patient drug information (UpToDate)]</ref>
  
 
==History of changes in FDA indication==
 
==History of changes in FDA indication==
−
*7/2019: Initial FDA approval for the treatment of adult patients with:
+
''Note: all initial approvals were granted simultaneously on 7/23/2019.''
−
**Relapsed or refractory, [[Follicular lymphoma|low grade or follicular]], [[Biomarkers#CD20|CD20]]‑[[Biomarkers#Expression|positive]] B-cell NHL as a single agent;
+
===[[Chronic lymphocytic leukemia]]===
−
**Previously untreated [[Follicular lymphoma|follicular]], [[Biomarkers#CD20|CD20]]‑[[Biomarkers#Expression|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; and
+
*2019-07-23: Approved for previously untreated and previously treated [[Biomarkers#CD20|CD20]]-[[Biomarkers#Expression|positive]] [[Chronic lymphocytic leukemia|CLL]] in combination with fludarabine and cyclophosphamide (FC).
−
**Non-progressing (including stable disease), low-grade, [[Biomarkers#CD20|CD20]]‑[[Biomarkers#Expression|positive]], B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
+
===[[Diffuse large B-cell lymphoma]]===
−
**Previously untreated [[Diffuse large B-cell lymphoma|diffuse large B-cell]], [[Biomarkers#CD20|CD20]]‑[[Biomarkers#Expression|positive]] NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens.
+
*2019-07-23: Approved for previously untreated [[Diffuse large B-cell lymphoma|diffuse large B-cell]], [[Biomarkers#CD20|CD20]]-[[Biomarkers#Expression|positive]] NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens.
−
**Previously untreated and previously treated [[Biomarkers#CD20|CD20]]‑[[Biomarkers#Expression|positive]] [[Chronic lymphocytic leukemia|CLL]] in combination with fludarabine and cyclophosphamide (FC).
+
===[[Follicular lymphoma]]===
 +
*2019-07-23: Approved for [[Follicular lymphoma|follicular]], [[Biomarkers#CD20|CD20]]-[[Biomarkers#Expression|positive]] B-cell NHL as a single agent. ''(Based on REFLECTIONS B328-06)''
 +
*2019-07-23: Approved for previously untreated [[Follicular lymphoma|follicular]], [[Biomarkers#CD20|CD20]]-[[Biomarkers#Expression|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
 +
 
 +
===[[:Category:Indolent lymphomas|Indolent lymphomas]]===
 +
*2019-07-23: Approved for [[:Category:Indolent lymphomas|low grade]] [[Biomarkers#CD20|CD20]]-[[Biomarkers#Expression|positive]] B-cell NHL as a single agent.
 +
*2019-07-23: Approved for non-progressing (including stable disease), [[:Category:Indolent lymphomas|low-grade]], [[Biomarkers#CD20|CD20]]-[[Biomarkers#Expression|positive]], B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
  
 
==Also known as==
 
==Also known as==
−
*'''Brand names:''' Ruxience
+
*'''Code name:''' PF-05280586
 +
*'''Brand name:''' Ruxience
  
 
==References==
 
==References==
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[[Category:Anti-CD20 antibodies]]
 
[[Category:Anti-CD20 antibodies]]
  
−
[[Category:Acquired coagulopathy medications]]
+
[[Category:Acquired hemophilia A medications]]
 
[[Category:B-cell acute lymphoblastic leukemia medications]]
 
[[Category:B-cell acute lymphoblastic leukemia medications]]
 
[[Category:Burkitt lymphoma medications]]
 
[[Category:Burkitt lymphoma medications]]
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[[Category:Hairy cell leukemia medications]]
 
[[Category:Hairy cell leukemia medications]]
 
[[Category:HIV-associated lymphoma medications]]
 
[[Category:HIV-associated lymphoma medications]]
−
[[Category:Hodgkin lymphoma medications]]
+
[[Category:Classical Hodgkin lymphoma medications]]
 
[[Category:Hodgkin lymphoma, nodular lymphocyte-predominant medications]]
 
[[Category:Hodgkin lymphoma, nodular lymphocyte-predominant medications]]
 
[[Category:Immune thrombocytopenia medications]]
 
[[Category:Immune thrombocytopenia medications]]
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[[Category:Post-transplant lymphoproliferative disorder medications]]
 
[[Category:Post-transplant lymphoproliferative disorder medications]]
 
[[Category:Primary mediastinal B-cell lymphoma medications]]
 
[[Category:Primary mediastinal B-cell lymphoma medications]]
−
[[Category:Thrombotic thrombocytopenic purpura medications]]
+
[[Category:Acquired thrombotic thrombocytopenic purpura medications]]
 
[[Category:Transformed lymphoma medications]]
 
[[Category:Transformed lymphoma medications]]
 
[[Category:Waldenström macroglobulinemia medications]]
 
[[Category:Waldenström macroglobulinemia medications]]

Revision as of 12:57, 26 May 2024

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

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

Patient drug information

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

References

  1. ↑ Rituximab (Rituxan) patient drug information (Chemocare)
  2. ↑ Rituximab (Rituxan) patient drug information (UpToDate)
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