Difference between revisions of "Bortezomib (Velcade)"

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Also known as PS-341.
 
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==General information==
 
==General information==
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Class/mechanism: Reversible inhibitor of the 26S proteasome, interfering with degradation of ubiquitinated proteins. This disrupts normal homeostatic mechansims, leading to cell death.<ref name="insert">[http://www.millennium.com/pdf/VelcadePrescribingInformation.pdf Bortezomib (Velcade) package insert]</ref><ref>[[Media:Bortezomib.pdf | Bortezomib (Velcade) package insert (locally hosted backup)]]</ref><ref>[http://www.velcade.com Velcade manufacturer's website]</ref>  
+
Class/mechanism: Reversible inhibitor of the 26S proteasome, interfering with degradation of ubiquitinated proteins. This disrupts normal homeostatic mechansims, leading to cell death.<ref name="insert">[https://www.velcade.com/files/pdfs/VELCADE_PRESCRIBING_INFORMATION.pdf Bortezomib (Velcade) package insert]</ref><ref>[[:File:Bortezomib.pdf | Bortezomib (Velcade) package insert (locally hosted backup)]]</ref><ref>[http://www.velcade.com Velcade manufacturer's website]</ref>  
 
<br>Route: IV, SC
 
<br>Route: IV, SC
 
<br>Extravasation: [[irritant]]
 
<br>Extravasation: [[irritant]]
  
−
*Use antiviral prophylaxis (such as with acyclovir (Zovirax) 400 mg PO daily or valacyclovir (Valtrex) 250-500 mg PO daily) to decrease risk of reactivating herpes zoster in patients treated with Bortezomib (Velcade)<ref>Vickrey E, Allen S, Mehta J, Singhal S. Acyclovir to prevent reactivation of varicella zoster virus (herpes zoster) in multiple myeloma patients receiving bortezomib therapy. Cancer. 2009 Jan 1;115(1):229-32. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.24006/full link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/19090004 PubMed]</ref>
+
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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://reference.medscape.com/drug/velcade-bortezomib-342256 Medscape], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref>
  
−
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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://reference.medscape.com/drug/velcade-bortezomib-342256 Medscape],[http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref>
+
==Diseases for which it is established ''(work in progress)''==
 +
*[[Follicular lymphoma]]
 +
*[[Mantle cell lymphoma]]
 +
*[[Multiple myeloma]]
  
 
==Diseases for which it is used==
 
==Diseases for which it is used==
−
*[[Multiple myeloma]]
+
*[[B-cell lymphoma of mucosa-associated lymphoid tissue]]
−
*[[Non-Hodgkin lymphoma]]
+
*[[Castleman disease]]
 +
*[[Light-chain (AL) amyloidosis]]
 +
*[[Peripheral T-cell lymphoma]]
 +
*[[Plasma cell leukemia]]
 +
*[[Waldenström macroglobulinemia]]
 +
 
 +
==Diseases for which it was used==
 +
*[[Diffuse large B-cell lymphoma - historical|Diffuse large B-cell lymphoma]]
 +
 
 +
==Notable side effects==
 +
*HSV reactivation <ref>Chanan-Khan A, Sonneveld P, Schuster MW, Stadtmauer EA, Facon T, Harousseau JL, Ben-Yehuda D, Lonial S, Goldschmidt H, Reece D, Neuwirth R, Anderson KC, Richardson PG. Analysis of herpes zoster events among bortezomib-treated patients in the phase III APEX study. J Clin Oncol. 2008 Oct 10;26(29):4784-90. Epub 2008 Aug 18. [https://doi.org/10.1200/JCO.2007.14.9641 link to original article] [https://pubmed.ncbi.nlm.nih.gov/18711175/ PubMed]</ref><ref>Vickrey E, Allen S, Mehta J, Singhal S. Acyclovir to prevent reactivation of varicella zoster virus (herpes zoster) in multiple myeloma patients receiving bortezomib therapy. Cancer. 2009 Jan 1;115(1):229-32. [https://doi.org/10.1002/cncr.24006 link to original article] [https://pubmed.ncbi.nlm.nih.gov/19090004/ PubMed]</ref>
 +
**Use antiviral prophylaxis (such as with [[acyclovir (Zovirax)]] 400 mg PO once per day or [[valacyclovir (Valtrex)]] 250 to 500 mg PO once per day) to decrease risk of reactivating herpes zoster in patients treated with bortezomib
 +
*Neuropathy <ref>Broyl A, Corthals SL, Jongen JL, van der Holt B, Kuiper R, de Knegt Y, van Duin M, el Jarari L, Bertsch U, Lokhorst HM, Durie BG, Goldschmidt H, Sonneveld P. Mechanisms of peripheral neuropathy associated with bortezomib and vincristine in patients with newly diagnosed multiple myeloma: a prospective analysis of data from the HOVON-65/GMMG-HD4 trial. Lancet Oncol. 2010 Nov;11(11):1057-65. Epub 2010 Sep 21. [https://doi.org/10.1016/S1470-2045%2810%2970206-0 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/20864405/ PubMed]</ref>
  
 
==Patient drug information==
 
==Patient drug information==
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*[http://chemocare.com/chemotherapy/drug-info/bortezomib.aspx Bortezomib (Velcade) patient drug information (Chemocare)]<ref>[http://chemocare.com/chemotherapy/drug-info/bortezomib.aspx Bortezomib (Velcade) patient drug information (Chemocare)]</ref>
+
*[https://chemocare.com/druginfo/bortezomib.aspx Bortezomib (Velcade) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/bortezomib.aspx Bortezomib (Velcade) patient drug information (Chemocare)]</ref>
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*Patient counseling information can be found on [http://www.velcade.com/Files/PDFs/VELCADE_PRESCRIBING_INFORMATION.pdf#page=35 page 35 of the package insert]<ref name="insert"></ref>
+
*Patient counseling information can be found in the [https://www.velcade.com/files/pdfs/VELCADE_PRESCRIBING_INFORMATION.pdf package insert]<ref name="insert"></ref>
 
*[http://www.uptodate.com/contents/bortezomib-patient-drug-information Bortezomib (Velcade) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/bortezomib-patient-drug-information Bortezomib (Velcade) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/bortezomib-patient-drug-information Bortezomib (Velcade) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/bortezomib-patient-drug-information Bortezomib (Velcade) patient drug information (UpToDate)]</ref>
 +
 +
==History of changes in FDA indication==
 +
===[[Mantle cell lymphoma]]===
 +
*2006-12-08: [http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm094929.htm Approved] for the treatment of patients with [[Mantle cell lymphoma | mantle cell lymphoma]] who have received at least one prior therapy. ''(New disease entity; based on PINNACLE)''
 +
*2014-10-08: [http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021602Orig1s040ltr.pdf Approved] for treatment of patients with [[Mantle cell lymphoma | mantle cell lymphoma]]. ''(including first-line therapy for untreated patients; previously was only approved for patients who had received at least one prior treatment; based on LYM-3002)''
 +
===[[Multiple myeloma]]===
 +
*2003-05-13: Initial [http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021602lbl.pdf accelerated approval] for the treatment of [[Multiple myeloma | multiple myeloma]] patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. ''(Based on SUMMIT)''
 +
*2005-03-25: Converted to regular approval for the treatment of [[Multiple myeloma | multiple myeloma]] patients who have received at least 1 prior therapy. ''(Based on APEX)''
 +
*2008-06-23: [http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm094633.htm Approved] for the treatment of patients with [[multiple myeloma]]. ''(previously was only approved for patients who had received prior therapy; based on VISTA)''
 +
*2012-01-23: Approved for subcutaneous administration of patients with [[multiple myeloma]]. ''(Based on MMY-3021)''
 +
*2014-08-11: Approved for retreatment of patients with [[multiple myeloma]]. ''(Based on RETRIEVE)''
 +
 +
==History of changes in EMA indication==
 +
*2004-04-26: Initial marketing authorization as Velcade.
 +
*2013-07-31: Velcade in combination with dexamethasone is indicated for the induction treatment of adult patients with previously untreated [[multiple myeloma]] who are eligible for high dose chemotherapy with haematopoietic stem cell transplantation.
 +
*2013-07-31: Velcade in combination with dexamethasone and thalidomide is indicated for the induction treatment of adult patients with previously untreated [[multiple myeloma]] who are eligible for high dose chemotherapy with haematopoietic stem cell transplantation.
 +
*2013-12-18: Extension of indication for Velcade in combination with pegylated liposomal doxorubicin in patients with relapsed and /or progressive [[multiple myeloma]] who have received at least 1 prior therapy.
 +
*2013-12-18: Extension of indication for Velcade in combination with dexamethasone in patients with relapsed and /or progressive [[multiple myeloma]] who have received at least 1 prior therapy.
 +
*2015-01-30: Extension of indication for the use of VELCADE in combination with rituximab, cyclophosphamide, doxorubicin and prednisone for the treatment of adult patients with previously untreated [[mantle cell lymphoma]].
 +
*Uncertain date: Velcade as monotherapy is indicated for the treatment of adult patients with progressive [[multiple myeloma]] who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.
 +
*Uncertain date: Velcade in combination with pegylated liposomal doxorubicin is indicated for the treatment of adult patients with progressive [[multiple myeloma]] who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.
 +
*Uncertain date: Velcade in combination with dexamethasone is indicated for the treatment of adult patients with progressive [[multiple myeloma]] who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.
 +
*Uncertain date: Velcade in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated [[multiple myeloma]] who are not eligible for high dose chemotherapy with haematopoietic stem cell transplantation.
 +
*Uncertain date: Velcade in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated [[mantle cell lymphoma]] who are unsuitable for haematopoietic stem cell transplantation.
 +
 +
==History of changes in Health Canada indication==
 +
*2005-01-27: Initial notice of compliance with conditions
 +
*2007-09-11: Conditions were met
 +
==History of changes in PMDA indication==
 +
*2006-10-20: Initial approval for treatment of relapsed or refractory [[multiple myeloma]].
 +
*2011-09-16: New indication and a new dosage for the treatment of [[multiple myeloma]].
 +
*2012-12-21: New route of administration indicated for the treatment of [[multiple myeloma]].
 +
*2015-06-26: New additional indication and a new dosage for the treatment of patients with [[mantle cell lymphoma]].
 +
*2018-03-23: New additional indication and a new dosage indicated for the treatment of [[Waldenström macroglobulinemia|Waldenström's macroglobulinemia]] and lymphoplasmacytic lymphoma.
 +
*2021-08-25: New indication and a new dosage for the treatment of [[Light-chain (AL) amyloidosis|systemic AL amyloidosis]].
 +
 +
==Also known as==
 +
*'''Code names:''' LDP-341, MLN-341, PS-341
 +
*'''Brand names:''' Biocure, Borater, Bortecad, Bortemib, Bortenat, Bortetrust, Bortrac, Borvex, Borviz, Botepar, Bromadene, Egybort, Mibor, Myezom, Norvelzo, Ortez, Velcade, Zomib, Zuricade
  
 
==References==
 
==References==
 
<references/>
 
<references/>
  
−
[[Category:Drug index]]
+
[[Category:Drugs]]
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[[Category:Chemotherapy]]
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[[Category:Intravenous medications]]
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[[Category:Irritant chemotherapy]]
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[[Category:Subcutaneous medications]]
 +
 
 +
[[Category:Irritant]]
 
[[Category:Proteasome inhibitors]]
 
[[Category:Proteasome inhibitors]]
 +
 +
[[Category:Castleman disease medications]]
 +
[[Category:Follicular lymphoma medications]]
 +
[[Category:Light-chain (AL) amyloidosis medications]]
 +
[[Category:MALT lymphoma medications]]
 +
[[Category:Mantle cell lymphoma medications]]
 
[[Category:Multiple myeloma medications]]
 
[[Category:Multiple myeloma medications]]
−
[[Category:Non-Hodgkin lymphoma medications]]
+
[[Category:Peripheral T-cell lymphoma medications]]
 +
[[Category:Plasma cell leukemia medications]]
 +
[[Category:Waldenström macroglobulinemia medications]]
 +
 
 +
[[Category:Diffuse large B-cell lymphoma medications (historic)]]
 +
 
 +
[[Category:EMA approved in 2004]]
 +
[[Category:FDA approved in 2003]]
 +
[[Category:Health Canada approved in 2005]]
 +
[[Category:PMDA approved in 2006]]
 +
 
 +
[[Category:WHO Essential Cancer Medicine]]

Latest revision as of 00:15, 4 March 2024

General information

Class/mechanism: Reversible inhibitor of the 26S proteasome, interfering with degradation of ubiquitinated proteins. This disrupts normal homeostatic mechansims, leading to cell death.[1][2][3]
Route: IV, SC
Extravasation: irritant

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 established (work in progress)

Diseases for which it is used

Diseases for which it was used

Notable side effects

  • HSV reactivation [4][5]
    • Use antiviral prophylaxis (such as with acyclovir (Zovirax) 400 mg PO once per day or valacyclovir (Valtrex) 250 to 500 mg PO once per day) to decrease risk of reactivating herpes zoster in patients treated with bortezomib
  • Neuropathy [6]

Patient drug information

History of changes in FDA indication

Mantle cell lymphoma

  • 2006-12-08: Approved for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. (New disease entity; based on PINNACLE)
  • 2014-10-08: Approved for treatment of patients with mantle cell lymphoma. (including first-line therapy for untreated patients; previously was only approved for patients who had received at least one prior treatment; based on LYM-3002)

Multiple myeloma

  • 2003-05-13: Initial accelerated approval for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. (Based on SUMMIT)
  • 2005-03-25: Converted to regular approval for the treatment of multiple myeloma patients who have received at least 1 prior therapy. (Based on APEX)
  • 2008-06-23: Approved for the treatment of patients with multiple myeloma. (previously was only approved for patients who had received prior therapy; based on VISTA)
  • 2012-01-23: Approved for subcutaneous administration of patients with multiple myeloma. (Based on MMY-3021)
  • 2014-08-11: Approved for retreatment of patients with multiple myeloma. (Based on RETRIEVE)

History of changes in EMA indication

  • 2004-04-26: Initial marketing authorization as Velcade.
  • 2013-07-31: Velcade in combination with dexamethasone is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high dose chemotherapy with haematopoietic stem cell transplantation.
  • 2013-07-31: Velcade in combination with dexamethasone and thalidomide is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high dose chemotherapy with haematopoietic stem cell transplantation.
  • 2013-12-18: Extension of indication for Velcade in combination with pegylated liposomal doxorubicin in patients with relapsed and /or progressive multiple myeloma who have received at least 1 prior therapy.
  • 2013-12-18: Extension of indication for Velcade in combination with dexamethasone in patients with relapsed and /or progressive multiple myeloma who have received at least 1 prior therapy.
  • 2015-01-30: Extension of indication for the use of VELCADE in combination with rituximab, cyclophosphamide, doxorubicin and prednisone for the treatment of adult patients with previously untreated mantle cell lymphoma.
  • Uncertain date: Velcade as monotherapy is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.
  • Uncertain date: Velcade in combination with pegylated liposomal doxorubicin is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.
  • Uncertain date: Velcade in combination with dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.
  • Uncertain date: Velcade in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high dose chemotherapy with haematopoietic stem cell transplantation.
  • Uncertain date: Velcade in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.

History of changes in Health Canada indication

  • 2005-01-27: Initial notice of compliance with conditions
  • 2007-09-11: Conditions were met

History of changes in PMDA indication

Also known as

  • Code names: LDP-341, MLN-341, PS-341
  • Brand names: Biocure, Borater, Bortecad, Bortemib, Bortenat, Bortetrust, Bortrac, Borvex, Borviz, Botepar, Bromadene, Egybort, Mibor, Myezom, Norvelzo, Ortez, Velcade, Zomib, Zuricade

References

  1. ↑ 1.0 1.1 1.2 Bortezomib (Velcade) package insert
  2. ↑ Bortezomib (Velcade) package insert (locally hosted backup)
  3. ↑ Velcade manufacturer's website
  4. ↑ Chanan-Khan A, Sonneveld P, Schuster MW, Stadtmauer EA, Facon T, Harousseau JL, Ben-Yehuda D, Lonial S, Goldschmidt H, Reece D, Neuwirth R, Anderson KC, Richardson PG. Analysis of herpes zoster events among bortezomib-treated patients in the phase III APEX study. J Clin Oncol. 2008 Oct 10;26(29):4784-90. Epub 2008 Aug 18. link to original article PubMed
  5. ↑ Vickrey E, Allen S, Mehta J, Singhal S. Acyclovir to prevent reactivation of varicella zoster virus (herpes zoster) in multiple myeloma patients receiving bortezomib therapy. Cancer. 2009 Jan 1;115(1):229-32. link to original article PubMed
  6. ↑ Broyl A, Corthals SL, Jongen JL, van der Holt B, Kuiper R, de Knegt Y, van Duin M, el Jarari L, Bertsch U, Lokhorst HM, Durie BG, Goldschmidt H, Sonneveld P. Mechanisms of peripheral neuropathy associated with bortezomib and vincristine in patients with newly diagnosed multiple myeloma: a prospective analysis of data from the HOVON-65/GMMG-HD4 trial. Lancet Oncol. 2010 Nov;11(11):1057-65. Epub 2010 Sep 21. link to original article contains dosing details in manuscript PubMed
  7. ↑ Bortezomib (Velcade) patient drug information (Chemocare)
  8. ↑ Bortezomib (Velcade) patient drug information (UpToDate)
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