In a subanalysis of patients with PSA-matched cohorts,
African American men lived longer than Caucasian menc,d
cThe PROCEED registry evaluated the expected safety and survival profile of PROVENGE received by patients in a real-world setting in which there was no control group. The study was conducted to quantify the risk of cerebrovascular events and survival. Patients may have received subsequent anti-cancer interventions per the local investigator's standard of care.
dThis subgroup analysis of the PROCEED registry was exploratory and results need careful interpretation.
PROVENGE® (sipuleucel-T) is a prescription medicine used to treat certain men with advanced prostate cancer. PROVENGE is an established cellular immunotherapy and is customized to each individual by using his own immune cells.
Before receiving PROVENGE®, tell your doctor about any medical conditions, including heart or lung problems, or if you have had a stroke.
Tell your doctor about any medicines you take, including prescription and nonprescription drugs, vitamins, or dietary supplements.
The most common side effects of PROVENGE include chills, fatigue, fever, back pain, nausea, joint ache, and headache. These are not all the possible side effects of PROVENGE treatment.
PROVENGE is made from your own immune cells, which are collected during a process called leukapheresis. The cells are processed, returned, and then infused back into the patient through an IV (intravenous) infusion about 3 days later. This process is completed in 3 cycles, about 2 weeks apart. Each infusion takes approximately 1 hour and requires 30 minutes of post-infusion monitoring.
PROVENGE infusion can cause serious reactions. Tell your doctor right away if you:
• Have signs of a heart attack or lung problems, such as trouble breathing, chest pains, racing or irregular heartbeats, high or low blood pressure, dizziness, fainting, nausea, or vomiting
• Have signs of a stroke, such as numbness or weakness on one side of the body, decreased vision in one eye, or difficulty speaking
• Develop symptoms of thrombosis which may include: pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, shortness of breath, chest pain that worsens or deep breathing
• Have signs of infection such as a fever over 100°F, redness or pain at the infusion or collection sites
Tell your doctor about any side effect(s) that concerns you or does not go away. For more information, talk with your doctor.
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