Difference between revisions of "Rituximab-abbs (Truxima)"

Latest revision as of 13:13, 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

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 used

Patient drug information

History of changes in FDA indication

2018-11-28: Initial approval for the treatment of adult patients with relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent.
2018-11-28: Initial approval for the treatment of adult patients with previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy.
2018-11-28: Initial approval as single-agent maintenance therapy for the treatment of adult patients with follicular, CD20-positive, B-cell NHL achieving a complete or partial response to a rituximab product in combination with chemotherapy.
2018-11-28: Initial approval for the treatment of adult patients with 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: CT-P10
Brand name: Truxima

References

[1] Rituximab (Rituxan) patient drug information (Chemocare)

[2] Rituximab (Rituxan) patient drug information (UpToDate)

[1]

[2]

@@ Line 10: / Line 10: @@
 ==Diseases for which it is used==
 <div style="column-count:3;-moz-column-count:3;-webkit-column-count:3">
-*[[Acquired coagulopathy]]
+*[[Acquired hemophilia A]]
 *[[Immune thrombocytopenia (ITP)]]
 *[[B-cell acute lymphoblastic leukemia]]
@@ Line 22: / Line 22: @@
 *[[Hairy cell leukemia]]
 *[[HIV-associated lymphoma]]
-*[[Hodgkin lymphoma]]
+*[[Classical Hodgkin lymphoma]]
 *[[Hodgkin lymphoma, nodular lymphocyte-predominant]]
 *[[Inherited coagulopathy|Inherited coagulopathy with inhibitor]]
@@ Line 30: / Line 30: @@
 *[[Post-transplant lymphoproliferative disorder]]
 *[[Primary mediastinal B-cell lymphoma]]
-*[[Thrombotic thrombocytopenic purpura]]
+*[[Acquired thrombotic thrombocytopenic purpura]]
 *[[Transformed lymphoma]]
 *[[Waldenström macroglobulinemia]]
@@ Line 36: / Line 36: @@
 ==Patient drug information==
 *[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>
 ==History of changes in FDA indication==
-*11/28/2018: Initial FDA approval for the treatment of adult patients with:
+*2018-11-28: Initial approval for the treatment of adult patients with relapsed or refractory, [[:Category:Indolent_lymphomas|low grade]] or [[Follicular lymphoma|follicular]], [[Biomarkers#CD20|CD20]]-[[Biomarkers#Expression|positive]] B-cell NHL as a single agent.
-**Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent;
+*2018-11-28: Initial approval for the treatment of adult patients with previously untreated [[Follicular lymphoma|follicular]], [[Biomarkers#CD20|CD20]]-[[Biomarkers#Expression|positive]], B-cell NHL in combination with first line chemotherapy.
-**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; and
+*2018-11-28: Initial approval as single-agent maintenance therapy for the treatment of adult patients with [[Follicular lymphoma|follicular]], [[Biomarkers#CD20|CD20]]-[[Biomarkers#Expression|positive]], B-cell NHL achieving a complete or partial response to a rituximab product in combination with chemotherapy.
-**Non-progressing (including stable disease), low-grade, CD20positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
+*2018-11-28: Initial approval for the treatment of adult patients with 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==
-*'''Brand names:''' Truxima
+*'''Code name:''' CT-P10
+*'''Brand name:''' Truxima
 ==References==
@@ Line 54: / Line 55: @@
 [[Category:Protein expression-specific medications]]
-[[Category:Antibody medications]]
 [[Category:Anti-CD20 antibodies]]
-[[Category:Acquired coagulopathy medications]]
+[[Category:Acquired hemophilia A medications]]
 [[Category:B-cell acute lymphoblastic leukemia medications]]
 [[Category:Burkitt lymphoma medications]]
@@ Line 68: / Line 69: @@
 [[Category:Hairy cell leukemia medications]]
 [[Category:HIV-associated lymphoma medications]]
-[[Category:Hodgkin lymphoma medications]]
+[[Category:Classical Hodgkin lymphoma medications]]
 [[Category:Hodgkin lymphoma, nodular lymphocyte-predominant medications]]
 [[Category:Immune thrombocytopenia medications]]
@@ Line 77: / Line 78: @@
 [[Category:Post-transplant lymphoproliferative disorder medications]]
 [[Category:Primary mediastinal B-cell lymphoma medications]]
-[[Category:Thrombotic thrombocytopenic purpura medications]]
+[[Category:Acquired thrombotic thrombocytopenic purpura medications]]
 [[Category:Transformed lymphoma medications]]
 [[Category:Waldenström macroglobulinemia medications]]