Care During Chemotherapy and Beyond
Generic Name: Sipuleucel-T
Sipuleucel-T is the generic name for the trade name drug Provenge®. In some cases,
health care professionals may use the trade name Provenge® when referring to the
generic drug name Sipuleucel-T.
Provenge is an autologous cellular immunotherapy. This means that it is a drug
made by a person's own blood cells and is meant to be used only for the person
whose blood cells were used to create it. Provenge works by stimulating
the man's own immune system to fight his prostate cancer. (For more detail,
see "How Provenge Works", below)
What Provenge Is Used For:
Provenge is indicated for the treatment of metastatic prostate cancer in men whose
disease had progressed following hormonal treatment who have either no or very minimal
symptoms related to the prostate cancer.
How Provenge Is Given:
Provenge is given in 3 doses with 1-2 weeks in between each dose. Each individual
dose is comprised of > 50 million activated cells.
Each patient has these cells taken from him during a process called leukapheresis.
The cells are then sent to a processing plant to be treated with the vaccine.
The treated cells are then sent back to the physician’s office to be re-infused
(an IV is placed and the cells administered, like a blood transfusion) to the donating
Prior to each Provenge infusion pre-medications are given to decrease the chance
of having a reaction to the infusion. Each infusion takes about 60 minutes
and you will be monitored for about 30 minutes afterwards. This process is
repeated 3 times over about a 1 month time frame (once every 1-2 weeks). Your
doctor and the drug manufacturer will determine your exact leukapheresis and infusion
Important things to remember about the side effects of Provenge:
Most people will not experience all of the Provenge side effects listed.
Provenge side effects are often predictable in terms of their onset, duration, and
Provenge side effects will improve or completely resolve after therapy is complete.
Provenge side effects may be quite manageable. There are many options to minimize
or prevent the side effects of Provenge.
The following side effects are common (occurring in greater than 30%) for
patients taking Provenge:
- Infusion Reaction - usually occurs at the time of infusion or within 1 day of infusion.
It is a group of symptoms including, but were not limited to, fever, chills, shortness
of breath, bronchospasm, nausea, vomiting, fatigue, hypertension, and an increased
heart rate. In clinical trials, these symptoms were serious in about 3.5% of patients
- Loss of
- Back pain
These are less common (occurring in 10-29%) side effects for patients receiving
- Citrate Toxicity: Citrate is the substance used in blood products to prevent
clotting of the infusing blood, this is broken down by the liver. Giving
blood products quickly may cause your calcium and magnesium levels to decrease
because the citrate binds calcium and magnesium. This can cause the blood's ability
to clot to be impaired. Infusing blood products slowly allows citrate to be
metabolized, and decreases this risk.
- Anemia(low red
blood cell counts)
- Myalgia (muscle
- Flu-like Syndrome:
Usually occurs within the 2 days following the Provenge infusion.
Not all side effects are listed above. Side effects that are very rare -- occurring
in less than about 10 percent of patients -- are not listed here. But you should
always inform your health care provider if you experience any unusual symptoms.
When to contact your doctor or health care provider:
Contact your health care provider immediately, day or night, if you should
experience any of the following symptoms:
- Fever of 100.4° F (38° C) or higher
- Breathing problems
- Severe headache
- Signs of a cerebrovascular event (stroke) such as one-sided weakness, confusion,
slurred speech, and/or facial droop.
The following symptoms require medical attention, but are not necessarily an emergency.
Contact your health care provider within 24 hours of noticing any of the
- Nausea (interferes with ability to eat and unrelieved with prescribed medication)
- Severe chills
- Unusually high blood pressure
- Vomiting (more than 4-5 episodes in 24 hours)
- Significant muscle aches
- Any symptoms of irregular heartbeat (such as chest pain, shortness of breath, palpitations)
Always inform your health care provider if you experience any unusual symptoms.
- Before starting Provenge, make sure you tell your doctor about any other
medications you are taking (including prescription, over-the-counter, vitamins,
herbal remedies, etc.).
- Provenge is designed to stimulate the immune system. Use of immunosuppressive
agents, such as steroids like prednisone / hydrocortisone / dexamethasone with Provenge,
may alter the effectiveness and/or safety of sipuleucel-T. Therefore, if you
are on an immunosuppressive medication, you should be carefully evaluated to determine
whether it is medically appropriate to reduce or discontinue those agents prior
to treatment with Provenge. Make sure to tell your doctor if you are taking
any kind of immunosuppressive agent.
- Because of the risk of acute infusion reactions, patients with cardiac and/or pulmonary
conditions should be closely monitored while getting treatment with Provenge.
- Provenge is intended solely for autologous use (meaning using the patient’s own
blood cells for making the drug for treatment).
- Reproductive, fertility, and mutagenicity (genetic mutations) studies were not done
on Provenge; so it is unknown if it is safe to father a child while getting this
treatment. Therefore, it is recommended that men, whose partners are able
to bear children, use contraception and do not conceive a child (get pregnant) while
taking Provenge. Barrier methods of contraception, such as condoms, are recommended.
- Each infusion of Provenge is preceded by a leukapheresis procedure 3 days before
the vaccine infusion. It is critical that you follow the given appointment
schedule and arrive at each appointment on time, as there are expiration times for
each vaccine product made, which can not be adjusted, changed, or exceeded. If
you are unable to receive the prepared Provenge infusion, you will need to undergo
the entire leukapheresis procedure again.
- Follow the preparation instructions for the leukapheresis procedures. (See
leukapheresis section below).
- Prior to your first leukapheresis procedure, you will be assessed to determine if
you have adequate ‘venous access’ (meaning will your veins support intervenous catheters)
to support both the leukapheresis procedure and the Provenge infusions. If there
is concern that the veins in your arms will not support the leukapheresis procedure
and the Provenge infusions, you may need a central venous catheter placed. If a
central line is necessary, you will be instructed how to care for the line, will
have arrangements made to have it flushed regularly to keep it from developing a
clot that would close it off, and will also be instructed on the signs to look for
indicating that it may have become infected.
- Get plenty of rest.
- Maintain good nutrition.
- It is important to report signs and symptoms of acute infusion reactions such as
fever, chills, fatigue, breathing problems, dizziness, high blood pressure, nausea,
vomiting, headache, or muscle aches.
If you experience symptoms or side effects, be sure to discuss them with your health
care team. They can prescribe medications and/or offer other suggestions that are
effective in managing such problems.
Monitoring and Testing:
You will be checked regularly by your doctor while you are taking Provenge, to monitor
side effects. Periodic blood work will be obtained to monitor your complete blood
count (CBC) to make sure it is safe for you to undergo the leukapheresis procedure.
Your doctor may also order blood work to monitor the function of other organs
(such as your kidneys and liver).
In order to make Provenge, which is tailor made for each patient, a particular type
of white blood cell needs to be taken from the patient and sent to the vaccine manufacturing
plant. The process of taking these white blood cells from a person is called
leukapheresis [loo-KA-fer-ee-ses]. Leukapheresis involves having
an intravenous catheter (IV) placed in each arm (unless you have an appropriately
sized central line catheter). Blood is taken out of one of the IVs, filtered
through a machine that pulls out the necessary white blood cells, and the rest of
the blood is then given back to you through the second IV. This process takes
about 3-4 hours and is done 3 days prior to the infusion of Provenge.
When preparing to go for your leukapheresis procedure, it is important to remember
the following helpful tips:
• Stay well hydrated in the few days before each procedure
• On the day of leukapheresis, avoid caffeinated beverages
• On the day of leukapheresis, eat a calcium-rich breakfast
• Wear loose-fitting clothing, especially clothing with sleeves that can be raised
above the elbow (if you don’t have a central venous catheter).
• You will not be able to get up and move around during the procedure. So,
for example, if you need to void, it will be in a portable urinal, so wear pants
that are easy to maneuver.
• The immune cells collected during the leukapheresis procedure are sent to a manufacturing
facility to be manufactured into Provenge.
• Provenge is then shipped to the physician’s office/infusion center for infusion
into the patient, 3 days later.
How Provenge Works:
Immunotherapy is the use of the immune system to reject and/or fight cancer.
The immune system can be stimulated to attack the cancer cells. This can be
either through immuniztion of the patient (with a vaccine, such as Provenge), during
which a patient's own immune system is trained to recognize tumor cells as targets
to be destroyed, or through the administration of therapeutic antibodies (in drug
form), which directly destroy cancer cells.
The immune system acts through a number of different ways. Most of these ways
identify the abnormal cells by their "antigen" which is a specific marker or code, present
on the surface of these cells. Autologous cellular immunotherapy involves
taking a patient's own blood cells, pulling out specific immune cells, and 'loading'
those cells with a vaccine. These 'loaded' cells are re-infused into the patient.
The loaded cells then activate certain types of immune cells, causing those cells
to multiply, recognize and target abnormal cancer cells by identifying their unique
Provenge is an autologous immunotherapy that activates a man's immune cells to multiply
and attack prostate cancer cells by way of activating certain immune cells with
a vaccine that triggers immune cells to identify prostate cancer cells by an antigen
that is highly specific to prostate cancer. By targeting this antigen, these
loaded cells are primed to identify and attack prostate cancer cells.
The specific mechanism by which Provenge works remains unknown. What is known
is that the vaccine appears to improve the survival in some men who receive it,
however, it does not result in a decrease in PSA and does not replace the need for
other treatment for your prostate cancer.
Note: We strongly encourage you to talk with your health care professional about
your specific medical condition and treatments. The information contained in this
website is meant to be helpful and educational, but is not a substitute for medical
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