Bortezomib (Velcade)

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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

  • 12/8/2006: Approved for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. (New disease entity; based on PINNACLE)
  • 10/8/2014: 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

  • 5/13/2003: 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)
  • 3/25/2005: Approved for the treatment of multiple myeloma patients who have received at least 1 prior therapy. (Based on APEX)
  • 6/23/2008: Approved for the treatment of patients with multiple myeloma. (previously was only approved for patients who had received prior therapy; based on VISTA)
  • Uncertain date: Approved for subcutaneous administration of patients with multiple myeloma. (Based on MMY-3021)
  • Uncertain date: Approved for retreatment of patients with multiple myeloma. (Based on RETRIEVE)

History of changes in EMA indication

  • 4/26/2004: Initial marketing authorization as Velcade.

Also known as

  • Code names: LDP 341, MLN341, 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)