Infuser Site Web Site Language
About PROVENGE Language:
PROVENGE® (sipuleucel-T) is the first and only FDA-approved immunotherapy for advanced
prostate cancer
PROVENGE is the only personalized treatment that is clinically proven to help extend life in certain
men with advanced prostate cancer. PROVENGE is an immunotherapy that takes your own immune
cells and reprograms them to attack your advanced prostate cancer. This process delivers a
treatment designed just for you.
PROVENGE® (sipuleucel-T) has proven results as an advanced prostate cancer
immunotherapy
In the clinical trial (IMPACT) that supported FDA approval, more men treated with PROVENGE
lived longer than men not treated with PROVENGE.
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More men in the PROVENGE group were alive 3 years after the start of the study than men
not treated with PROVENGE
PROVENGE reduced the risk of death by 22.5% for patients in the PROVENGE group
Only 1.5% of men discontinued treatment with PROVENGE due to side effects
For additional information about PROVENGE, visit www.PROVENGE.com.
(Must also include Indication and Important Safety Information language found at the end of
this document when mentioning PROVENGE)
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PROVENGE Announcement Language:
PROVENGE® (sipuleucel-T) is now available for the treatment of certain types of advanced prostate
cancer at [insert site]. PROVENGE is the only FDA-approved prostate cancer treatment option that
uses the body's own immune cells to target and attack prostate cancer. By stimulating the natural
ability of the body’s immune cells to target and attack advanced prostate cancer, PROVENGE may
help patients live longer.
(Must also include Indication and Important Safety Information language found at the end of
this document when mentioning PROVENGE)
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[cont.]
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About Immunotherapy Language:
Immunotherapy is a treatment that is designed to help the immune system (the body’s natural
defense) fight disease. The immune system is made up of immune cells found in the body. These
cells work as the body's natural defense against all types of illness, including prostate cancer.
PROVENGE® (sipuleucel-T) is the only FDA-approved treatment that uses the body's own immune
system to fight prostate cancer.
(Must also include Indication and Important Safety Information language found at the end of
this document when mentioning PROVENGE)
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About Prostate Cancer Language:
Prostate cancer (PCa) is cancer that occurs in a man's prostate - a small walnut-shaped gland that
produces the seminal fluid. The prostate partially surrounds the urethra, which is the part of the
body that carries urine from the bladder out of the body.
Nearly all forms of prostate cancer start in the cells of the prostate gland and are known as
adenocarcinoma or prostate adenocarcinoma. It is commonly thought that prostate cancer begins
with small changes in the size and shape of the prostate gland cells, a change known as prostatic
intraepithelial neoplasia (PIN). About half of all men have PIN by the age of 50.
Prostate cancer is considered advanced if it has spread outside the prostate gland to other parts of
the body. This is also called metastatic prostate cancer.
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Additional Web Site Resources Available:
The following resources are available for you to post on your web site and can be found at
http://www.provengehcp.com/SupportForYourPractice/ProvengeResources/Default.aspx
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PROVENGE MOA Video: a video that shows the PROVENGE mechanism of action
PROVENGE Infuser site logos: logos to include on your web site, emails or other digital
media indicating PROVENGE is available at your practice
___________________________________________________________________________________________
[cont.]
Note: All of the following information must be included when referencing PROVENGE:
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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 made from your own immune cells. Your cells will be collected at a cell collection center
approximately 3 days before each scheduled infusion of PROVENGE. There can be risks associated with the
cell collection process, which you should discuss with your doctor before deciding to begin treatment with
PROVENGE.
PROVENGE can cause serious reactions. In controlled clinical trials for the treatment of prostate cancer,
serious reactions reported in patients in the PROVENGE group included reactions resulting from the
infusion of the drug, which occurred within 1 day of infusion, and strokes. Severe infusion reactions
included chills, fever, fatigue, weakness, breathing problems (shortness of breath, decreased oxygen level,
and wheezing), dizziness, headache, high blood pressure, muscle ache, nausea, and vomiting. Tell your
doctor right away if you have breathing problems, chest pains, racing heart or irregular heartbeats,
dizziness, nausea, or vomiting after getting PROVENGE, because any of these may be signs of heart or lung
problems.
The most common side effects reported with PROVENGE (sipuleucel-T) were chills, fatigue, fever, back
pain, nausea, joint ache, and headache. These are not all the possible side effects of PROVENGE treatment.
For more information on PROVENGE, please see the full Prescribing Information or call
1-800-707-0742.
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