*A sustained immune response was seen out to 26 weeks in the pivotal study (the last time point measured).1
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INDICATION
PROVENGE® (sipuleucel-T) is approved by the FDA as an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
IMPORTANT SAFETY INFORMATION
PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.
In controlled clinical trials, serious adverse events reported in the PROVENGE group included acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. Severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.
The most common adverse events (incidence ≥ 15%) reported in the PROVENGE group were chills, fatigue, fever, back pain, nausea, joint ache, and headache.
Please see the Full Prescribing Information.
REFERENCES:
- PROVENGE [package insert]. Dendreon Corporation; June 2011.
- Kantoff PW, Higano CS, Shore ND, et al; for the IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010;363:411-422.
- NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer. V.1.2013. National Comprehensive Cancer Network Web site. www.nccn.org. Accessed December 13, 2012.