Bortezomib (Velcade)

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.
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.

Diseases for which it is used

• Aggressive Non-Hodgkin lymphoma
• Castleman disease
• Follicular lymphoma
• Light-chain (AL) amyloidosis
• Mantle cell lymphoma
• Marginal zone lymphoma
• Multiple myeloma
• Peripheral T-cell lymphoma
• Plasma cell leukemia
• Waldenström macroglobulinemia

Diseases for which it was used

• Diffuse large B-cell lymphoma

Notable side effects

• HSV reactivation 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
  • 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

Patient drug information

• Bortezomib (Velcade) patient drug information (Chemocare)
• Patient counseling information can be found in the package insert
• Bortezomib (Velcade) patient drug information (UpToDate)

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

• 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