Difference between revisions of "Brentuximab vedotin (Adcetris)"

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(FDA approval)
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==General information==
 
==General information==
Class/mechanism: Anti-CD30 antibody (brentuximab) with protease-cleavable linker to chemotherapeutic agent (monomethyl auristatin E (MMAE, vedotin)).  The antibody-drug complex binds to CD30 expressing cells and is internalized, where the active chemotherapeutic agent MMAE is released via proteolytic cleavage of the antibody-drug linker.  MMAE is a microtubule disrupting agent that interferes with mitosis, causes cell cycle arrest, and eventual apoptosis.<ref name="insert">[http://www.adcetris.com/_pdf/Final_Adcetris_USPI_Jan12_2012.pdf Brentuximab vedotin (Adcetris) package insert]</ref><ref>[[Media:Brentuximabvedotin.pdf | Brentuximab vedotin (Adcetris) package insert (locally hosted backup)]]</ref><ref>[http://www.adcetris.com Adcetris manufacturer's website]</ref>
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Class/mechanism: Anti-CD30 antibody (brentuximab) with protease-cleavable linker to chemotherapeutic agent (monomethyl auristatin E (MMAE, vedotin)).  The antibody-drug complex binds to CD30 expressing cells and is internalized, where the active chemotherapeutic agent MMAE is released via proteolytic cleavage of the antibody-drug linker.  MMAE is a microtubule disrupting agent that interferes with mitosis, causes cell cycle arrest, and eventual apoptosis.<ref name="insert">[http://www.adcetrisconsolidation.com/doc/adcetris-pi-with-aethera-data.pdf Brentuximab vedotin (Adcetris) package insert]</ref><ref>[[Media:Brentuximabvedotin.pdf | Brentuximab vedotin (Adcetris) package insert (locally hosted backup)]]</ref><ref>[http://www.adcetris.com Adcetris manufacturer's website]</ref>
 
<br>Route: IV
 
<br>Route: IV
 
<br>Extravasation: no information
 
<br>Extravasation: no information
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==Patient drug information==
 
==Patient drug information==
 
*[http://chemocare.com/chemotherapy/drug-info/brentuximab-vedotin.aspx Brentuximab vedotin (Adcetris) patient drug information (Chemocare)]<ref>[http://chemocare.com/chemotherapy/drug-info/brentuximab-vedotin.aspx Brentuximab vedotin (Adcetris) patient drug information (Chemocare)]</ref>
 
*[http://chemocare.com/chemotherapy/drug-info/brentuximab-vedotin.aspx Brentuximab vedotin (Adcetris) patient drug information (Chemocare)]<ref>[http://chemocare.com/chemotherapy/drug-info/brentuximab-vedotin.aspx Brentuximab vedotin (Adcetris) patient drug information (Chemocare)]</ref>
*Brief patient counseling information can be found on [http://www.adcetris.com/_pdf/Final_Adcetris_USPI_Jan12_2012.pdf#page=15 page 15 of the package insert]<ref name="insert"></ref>
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*Brief patient counseling information can be found in the [http://www.adcetrisconsolidation.com/doc/adcetris-pi-with-aethera-data.pdf Brentuximab vedotin (Adcetris) package insert]<ref name="insert"></ref>
 
*[http://www.uptodate.com/contents/brentuximab-vedotin-patient-drug-information Brentuximab vedotin (Adcetris) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/brentuximab-vedotin-patient-drug-information Brentuximab vedotin (Adcetris) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/brentuximab-vedotin-patient-drug-information Brentuximab vedotin (Adcetris) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/brentuximab-vedotin-patient-drug-information Brentuximab vedotin (Adcetris) patient drug information (UpToDate)]</ref>
  
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# Treatment of patients with [[Hodgkin lymphoma | Hodgkin lymphoma]] after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates.
 
# Treatment of patients with [[Hodgkin lymphoma | Hodgkin lymphoma]] after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates.
 
# Treatment of patients with [[Anaplastic large cell lymphoma | systemic anaplastic large cell lymphoma (sALCL)]] after failure of at least one prior multi-agent chemotherapy regimen.
 
# Treatment of patients with [[Anaplastic large cell lymphoma | systemic anaplastic large cell lymphoma (sALCL)]] after failure of at least one prior multi-agent chemotherapy regimen.
*8/17/2015: FDA approval expanded for the post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation treatment of patients with [[Hodgkin lymphoma |classical Hodgkin lymphoma (HL)]] at high risk of relapse or progression.
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*8/17/2015: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm458815.htm FDA approval expanded] "for the post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation treatment of patients with [[Hodgkin lymphoma |classical Hodgkin lymphoma (HL)]] at high risk of relapse or progression."
  
 
==Also known as==
 
==Also known as==

Revision as of 07:55, 19 August 2015

General information

Class/mechanism: Anti-CD30 antibody (brentuximab) with protease-cleavable linker to chemotherapeutic agent (monomethyl auristatin E (MMAE, vedotin)). The antibody-drug complex binds to CD30 expressing cells and is internalized, where the active chemotherapeutic agent MMAE is released via proteolytic cleavage of the antibody-drug linker. MMAE is a microtubule disrupting agent that interferes with mitosis, causes cell cycle arrest, and eventual apoptosis.[1][2][3]
Route: IV
Extravasation: no information

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, Medscape,UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

Diseases for which it is used

Patient drug information

History of changes in FDA indication

  1. Treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates.
  2. Treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.

Also known as

SGN-35 and cAC10-vcMMAE.

References