FULL PRESCRIBING INFORMATION

What is the immune system?

The immune system is made of a variety of cells working together as the body’s defense against foreign invaders, such as infection or cancer cells. One of the natural abilities of the immune system is to detect abnormal cells, including cancer cells, and destroy or prevent them from spreading. In some cases, cancer may overwhelm or hide from the immune system and spread to other parts of the body.

What is immunotherapy?

Immunotherapy is a type of cancer treatment that helps your immune system fight cancer. There are several different types of immunotherapy (for example, cellular therapies, CAR T therapies, and checkpoint inhibitors). Although they work differently from one another, they are all designed to stimulate an immune response.

Why PROVENGE immunotherapy?

PROVENGE immunotherapy for advanced prostate cancer
PROVENGE is a personalized immunotherapy that activates your body’s immune system to fight advanced prostate cancer. Studies have shown that certain men who receive PROVENGE live longer.

PROVENGE is recommended by nationally recognized
medical organizations.

How does PROVENGE work?

PROVENGE has been proven to extend life for certain men with mCRPC.
Men who receive PROVENGE when their PSA level is lower may live longer.
how does PROVENGE work

What to expect with PROVENGE

PROVENGE has been proven to help certain men live longer. Perhaps PROVENGE can help you.
The PROCEED Registry is the most recent study of PROVENGE
PROCEED was an observational study, in a medical practice setting, that evaluated the safety and survival of nearly 2,000 men who received PROVENGE. The patients were followed between 2011 and 2017.
These men may have received other therapies, in addition to PROVENGE, as prescribed by their doctor.
Men who started PROVENGE when their PSA level was lowera had a median overall survival of nearly 4 years (47.7 months).
The most common side effects reported during this registry were consistent with previous studies: generally mild to moderate and well tolerated. Please see Important Safety Information for additional details.
In a post hoc analysis, men who
started PROVENGE with a lower
PSA level lived longera
44% of men in this registry did not receive any additional cancer treatments for at least 1 year. Nearly 95% of these men were treated with PROVENGE as a first-line treatment option.
A powerful advantage in African American men

was found in a statistical analysis of the subset of PSA-matched African American and Caucasian men treated with PROVENGE in the PROCEED Registry.

In men with baseline PSA >29.48 ng/mL who received PROVENGE, African American men lived 5.1 months longer than Caucasian men.

bThe PROCEED registry evaluated side effects and, secondarily, survival following treatment with PROVENGE® (sipuleucel-T) in a medical practice setting where all patients received PROVENGE and there was no untreated group. Patients may have received other cancer treatments as prescribed by their physician. Scientists used the survival data to identify groups of patients who may live longer after treatment with PROVENGE. Exploratory analyses like these are limited in their ability to reliably predict treatment effects and individual results may vary.

Exploratory Analysis of IMPACT

IMPACT was a randomized, placebo-controlled trial that studied men diagnosed with mCRPC. This study included 512 men, comparing men who received PROVENGE with men who did not receive PROVENGE.

In all 4 groups of the exploratory analysis, men in the group that received PROVENGE saw improved median overall survival.
In IMPACT, PROVENGE extended life for certain men with mCRPC. Further analysis suggests that men with a lower PSA level who receive PROVENGE may live longer.
In a retrospective analysis of the IMPACT trial, PROVENGE extended life for men with a lower PSA levelc at the start of treatment with PROVENGE.
cPSA less than or equal to 22.1 ng/mL.
In all 4 groups of the exploratory analysis, men who received PROVENGE saw improved median overall survival when compared to men who did not receive PROVENGE (control).

PROVENGE and PSA level

PROVENGE works differently from other cancer treatments, such as chemotherapy or hormone therapy.
Unlike these treatments, PROVENGE may not lower your PSA level.
The goal of treatment with PROVENGE is not to lower PSA level, it is to extend life.

When is the right time for PROVENGE?

The American Urological Association (AUA), the National Comprehensive Cancer Network® (NCCN),a and the Society for Immunotherapy of Cancer (SITC) recommend considering sipuleucel-T (PROVENGE) as a treatment option for certain men with mCRPC.
PROVENGE may be considered before or after receiving other treatments for advanced prostate cancer.
aReferenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.2.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed May 21, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

Common side effects

The most common side effects of PROVENGE are generally mild to moderate and are well tolerated.
Most infusion-related side effects are resolved within 1 or 2 days.
There are potential risks associated with PROVENGE:
In controlled clinical trials, 71.2% of men treated with PROVENGE developed an acute infusion reaction
The most common adverse events ≥20% were chills, fever, and fatigue. In 95.1% of men reporting acute infusion reactions, the reactions were mild or moderate. Fevers and chills generally resolved within 2 days (71.9% and 89%, respectively)
1.5% of men discontinued their treatment with PROVENGE due to adverse events
The most common side effects of treatment with PROVENGE include:
Chills Fatigue Fever Back pain Nausea Joint ache Headache
PROVENGE infusion can cause serious reactions. Tell your doctor right away if:
You have breathing problems, chest pains, racing heart or irregular heartbeats, high or low blood pressure, dizziness, fainting, nausea, or vomiting after receiving PROVENGE. Any of these may be signs of heart or lung problems
You develop numbness or weakness on one side of the body, decreased vision in one eye, or difficulty speaking. Any of these may be signs of a stroke
You 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, unexplained shortness of breath, chest pain that worsens on deep breathing
You get a fever over 100°F, or redness or pain at the infusion or collection sites. Any of these may be signs of infection
These are not all the possible side effects of treatment with PROVENGE. For more information, talk with your doctor. Please see Important Safety Information.
INDICATION

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.

IMPORTANT SAFETY INFORMATION

Before receiving PROVENGE®, tell your doctor about any medical conditions, including heart or lung problems, or if you have had a stroke.