Care During Chemotherapy and Beyond
(si pu LOO sel tee)
Trade Name: Provenge®
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.
Sipuleucel-T 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. Sipuleucel-T works
by stimulating the man's own immune system to fight his prostate cancer (for
more detail, see "How Sipuleucel-T Works", below)
What Sipuleucel-T Is Used For:
Sipuleucel-T 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 Sipuleucel-T Is Given:
Sipuleucel-T 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 man.
Prior to each sipuleucel-t 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 sipuleucel-T:
Most people will not experience all of the sipuleucel-t side effects listed.
Sipuleucel-T side effects are often predictable in terms of their onset, duration,
Sipuleucel-T side effects will improve or completely resolve after therapy is complete.
Sipuleucel-T side effects may be quite manageable. There are many options to minimize
or prevent the side effects of sipuleucel-t.
The following side effects are common (occurring in greater than 30%) for
patients taking sipuleucel-T:
- 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 sipuleucel-T 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 sipuleucel-T, make sure you tell your doctor about any other
medications you are taking (including prescription, over-the-counter, vitamins,
herbal remedies, etc.).
- Sipuleucel-T is designed to stimulate the immune system. Use of immunosuppressive
agents, such as steroids like prednisone / hydrocortisone / dexamethasone with sipuleucel-T,
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 sipuleucel-T. 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 sipuleucel-T.
- Sipuleucel-T 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 sipuleucel-T; 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 sipuleucel-T. Barrier methods of contraception, such as condoms, are
- Each infusion of sipuleucel-T 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 cannot be adjusted, changed, or exceeded. If
you are unable to receive the prepared sipuleucel-T 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 intravenous catheters)
to support both the leukapheresis procedure and the sipuleucel-T infusions. If there
is concern that the veins in your arms will not support the leukapheresis procedure
and the sipuleucel-T 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 sipuleucel-T,
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 sipuleucel-t, 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 sipuleucel-t.
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 sipuleucel-t.
• Sipuleucel-t is then shipped to the physician’s office/infusion center for infusion
into the patient, 3 days later.
How Sipuleucel-T 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 immunization of the patient (with a vaccine, such as sipuleucel-t),
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
Sipuleucel-t 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 sipuleucel-t 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 advice.
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