Drugs of interest to pathologists
Drugs related to clinical pathology

Topic Completed: 1 January 2012

Minor changes: 22 August 2019

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PubMed Search: Provenge [title]

Him G. Kwee, M.D.
Page views in 2019: 47
Page views in 2020 to date: 53
Cite this page: Kwee HG. Sipuleucel-T. PathologyOutlines.com website. http://www.pathologyoutlines.com/topic/drugsprovenge.html. Accessed August 14th, 2020.
Definition / general
  • Autologous cellular immunotherapy agent (vaccine)
Trade name
  • Provenge®
Clinical information
  • Approved by U.S. Food and Drug Administration for asymptomatic or minimally symptomatic metastatic hormone refractory prostatic carcinoma
  • Cost is $93,000 for 3 infusions
  • Medicare may provide full coverage
Proposed mechanism of action
  • The precise mechanism of action is unknown
  • Developed based on concept of antigen presenting cells (APCs), which include dendritic cells, macrophages and B lymphocytes
  • APCs can internalize, process and present antigens on their cell surface, where they are recognized by T cell receptors
  • APCs express major histocompatibility (MHC) class II molecules, which can stimulate CD4+ T helper cells and MHC class I molecules, which can stimulate CD8+ T cytotoxic cells
  • APCs from patients blood are harvested by leukapheresis, sent to drug company (Dendreon), where they are incubated with recombinant fusion protein antigen containing PAP (prostatic acid phosphatase) and GM CSF (granulocyte macrophage colony stimulating factor)
  • These antigen loaded APCs are infused into patient and may prime a T cell mediated immune response against prostatic cancer cells (J Clin Oncol 2006;24:3089)
Diagrams / tables

Images hosted on other servers:

Proposed mechanism
of action (from
manufacturer's website)

Drug administration features
  • Complete process takes up to four days from leukapheresis
  • Course of therapy consists of 3 complete doses given at 2 week intervals
  • Maximum dosing interval has not been established
  • If patient is unable to receive a scheduled infusion, an additional leukapheresis procedure is necessary to continue the course of treatment
  • Each dose contains a minimum of 50 million autologous CD54+ cells containing PAP GM CSF suspended in 250 ml lactated Ringer solution USP; is infused within 60 minutes
  • Patient identifiers and expiration date must be checked before infusion
  • Product is tested by manufacturer by Gram stain, endotoxin content and in process sterility with two day incubation but final sterility tests are not available at time of infusion
  • Manufacturer notifies treating physician if sterility results become positive after the drug has been approved for infusion (P T 2010;35:345)
  • Bag content is normally slightly cloudy with a cream to pink color; small clumps should disperse with gentle mixing; do NOT use if lumps do not disperse after gentle mixing or if bag has a leak
  • Insulate the bag in polyurethane until time of infusion
  • Discard if bag is left at room temperature for > 3 hours (www.provengehcp.com: Prescribing Information [Accessed 14 December 2018])
  • Use universal precautions during handling of leukapheresis material and sipuleucel-T, since they product is not routinely tested for transmissible infectious diseases
  • Most common adverse effects are acute infusion reactions of fever, chills, dyspnea
  • If acute infusion reaction occurs, can decrease / stop infusion, depending on severity of the reaction
  • Can premedicate with acetaminophen and antihistamines 30 minutes before infusion to prevent some of these reactions (N Engl J Med 2010;363:411)
  • No studies of drug interactions with sipuleucel-T have been performed (P T 2011;32:197)
  • The use of chemotherapy (e.g. docetaxel) or immunosuppressive agents (e.g. corticosteroids) given concurrently with sipuleucel-T has not been studied
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