Difference between revisions of "Bortezomib (Velcade)"

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==History of changes in FDA indication==
 
==History of changes in FDA indication==
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*5/13/2003: [http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021602lbl.pdf FDA approved] "for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy."
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*5/13/2003: [http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021602lbl.pdf FDA approved] "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."
−
*3/25/2005: [http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021602s006lbl.pdf FDA approved] "for the treatment of multiple myeloma patients who have received at least 1 prior therapy."
+
*3/25/2005: [http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021602s006lbl.pdf FDA approved] "for the treatment of [[Multiple myeloma | multiple myeloma]] patients who have received at least 1 prior therapy."
−
*12/8/2006: [http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm094929.htm FDA approved] "for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy."
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*12/8/2006: [http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm094929.htm FDA approved] "for the treatment of patients with [[Mantle cell lymphoma | mantle cell lymphoma]] who have received at least one prior therapy."
−
*6/23/2008: [http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm094633.htm FDA approved] "for the treatment of patients with multiple myeloma" (previously was only approved for patients who had received prior therapy).  
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*6/23/2008: [http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm094633.htm FDA approved] "for the treatment of patients with [[Multiple myeloma | multiple myeloma]]" (previously was only approved for patients who had received prior therapy).  
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*10/8/2014: [http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021602Orig1s040ltr.pdf FDA 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).
+
*10/8/2014: [http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021602Orig1s040ltr.pdf FDA 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).
  
 
==Also known as==
 
==Also known as==
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[[Category:Irritant chemotherapy]]
 
[[Category:Irritant chemotherapy]]
 
[[Category:Proteasome inhibitors]]
 
[[Category:Proteasome inhibitors]]
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[[Category:Aggressive Non-Hodgkin lymphoma medications]]
 
[[Category:Aggressive Non-Hodgkin lymphoma medications]]
 
[[Category:Follicular lymphoma medications]]
 
[[Category:Follicular lymphoma medications]]
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[[Category:Transplant medications]]
 
[[Category:Transplant medications]]
 
[[Category:Waldenström macroglobulinemia medications]]
 
[[Category:Waldenström macroglobulinemia medications]]
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 +
[[Category:Drugs FDA approved in 2003]]

Revision as of 20:23, 25 October 2014

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

  • 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)[4]

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

  • 5/13/2003: FDA approved "for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy."
  • 3/25/2005: FDA approved "for the treatment of multiple myeloma patients who have received at least 1 prior therapy."
  • 12/8/2006: FDA approved "for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy."
  • 6/23/2008: FDA approved "for the treatment of patients with multiple myeloma" (previously was only approved for patients who had received prior therapy).
  • 10/8/2014: FDA 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).

Also known as

PS-341.

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. ↑ 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
  5. ↑ Bortezomib (Velcade) patient drug information (Chemocare)
  6. ↑ Bortezomib (Velcade) patient drug information (UpToDate)
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