Approximately 1 Month of PROVENGE Immunotherapy
PROVENGE is administered in three 1-hour infusions, each preceded by a standard leukapheresis procedure (a standard cell-collection procedure performed at a blood center).
26 Weeks of Sustained Immune Response
26weeks
A sustained immune response to PROVENGE was seen out to 26 weeks in the pivotal study (the last time point measured).1
PSA and PROVENGE
Changes in PSA responses may not reflect treatment response to PROVENGE.2
As opposed to cytotoxic therapies, which have their greatest effects soon after initiation of therapy, immunotherapies such as PROVENGE require time to generate an immune response, and evidence of activity may be delayed.3,4
Administering PROVENGE
- At least 1 week prior to the first leukapheresis procedure, the prescribing physician or infusion staff should initiate venous assessment. The apheresis center will be available for consultation
- Infusions can be administered through a peripheral line or a central venous catheter (23% of patients received central venous catheters in the pivotal trial)
- To help minimize infusion reactions such as chills and fever, pretreat patients orally with acetaminophen and an antihistamine such as diphenhydramine approximately 30 minutes prior to infusion with PROVENGE
- Each infusion takes approximately 1 hour
- Use primary intravenous tubing with no cell filter for the infusion
To learn more about how to infuse PROVENGE, watch How to Infuse PROVENGE here.
sample schedule
- The dosing interval ranged from 1 to 15 weeks in controlled clinical trials1
- Leukapheresis and PROVENGE infusions are scheduled 2 to 3 days apart and can start on various days of the week
- Prior to the first leukapheresis procedure, a venous assessment must be done by the prescribing practitioner
REFERENCES:
- PROVENGE [package insert]. Dendreon Corporation; June 2011.
- Data on file. Dendreon Corporation.
- Madan RA et al. Oncologist. 2010;15:969-975.
- Guidance for industry: clinical considerations for therapeutic cancer vaccines.
www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm182443.htm.