Sunday, July 21, 2019

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PRESCRIBING INFORMATION

PROVENGE^® (sipuleucel-T)

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INDICATION & IMPORTANT SAFETY INFORMATION

INDICATION

PROVENGE^® (sipuleucel-T) is an autologous cellular immunotherapy indicated 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 include 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 are chills, fatigue, fever, back pain, nausea, joint ache, and headache.

Please see the Full Prescribing Information.

P-A-04.12-087.00