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
Full Answer
How is Provenge different from other cancer treatments?
As a personalized immunotherapy, PROVENGE works differently from other cancer treatments, such as chemotherapy or hormone therapy. PROVENGE is personalized because it’s made from your own immune cells. It empowers your immune system's ability to recognize and remember prostate cancer cells PROVENGE helps certain men with mCRPC live longer.
What happens during a Provenge infusion?
About 3 days before each of your Provenge infusions, you’ll have your immune cells collected at a blood center. This collection procedure is called leukapheresis, and it lasts for about 2 to 4 hours. During leukapheresis, your blood passes through a machine that collects your immune cells and returns the rest of your blood to your body.
What are the phases of Provenge treatment?
There are two phases to treatment with Provenge: 1 Create the vaccine. This involves removing white blood cells from your body. 2 Administer the vaccine. Each procedure will be repeated three times. More ...
What should I tell my doctor before receiving Provenge ®?
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.
How does PROVENGE work on prostate cancer?
Provenge is used to treat late-stage prostate cancer that no longer responds to hormone therapy (metastatic castrate resistant). Provenge uses your own blood. The vaccine stimulates your immune system into recognizing and destroying prostate cancer cells. It's not recommended for everyone with prostate cancer.
What is the success rate of PROVENGE?
Among patients in the lowest baseline prostate-specific antigen (PSA) quartile (≤5.27 ng/mL), nearly half (44.1%) of the men in the registry received no additional cancer treatments for at least 1 year. Of these men, nearly 95% received sipuleucel-T (PROVENGE) as a first-line treatment.
How does the PROVENGE vaccine work?
PROVENGE is manufactured in several steps. First the patient's blood is run through a machine in a process known as leukapheresis. During the process, some of the patient's immune cells are collected. These immune cells are then exposed to a protein intended to stimulate and direct them against prostate cancer.
Is PROVENGE chemotherapy?
Because PROVENGE is not a chemotherapy drug you will not experience the common, sometimes difficult, side effects often seen in chemotherapy. It also is not a hormone therapy.
Does Provenge really work?
Clinical studies have shown Provenge to be effective for treating metastatic, castration-resistant prostate cancer in adult males. In one study, adults with prostate cancer were randomly given either Provenge or a placebo (a treatment with no active drug).
Does Provenge lower PSA?
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 PROVENGE treatment is not to lower PSA level, it is to extend life.
How long do PROVENGE side effects last?
PROVENGE (sipuleucel-T) Side Effects. Most infusion-related side effects lasted 1 or 2 days. Some patients have experienced serious adverse events while taking PROVENGE.
How much does PROVENGE cost?
Each infusion of Provenge will cost $31,000, bringing the full cost of treatment for three infusions to $93,000. As the company put it, the drug will cost about $23,000 per month of life extension, based on the Phase III study that found the drug extended life by 4.1 months.
Who is a candidate for PROVENGE?
POTENTIAL CANDIDATES FOR PROVENGE PROVENGE is indicated for asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). Studies suggest that men who receive PROVENGE when their PSA level is lower live longer.
Does Medicare pay for PROVENGE?
PROVENGE is covered by Medicare and by most private insurance plans. For men receiving PROVENGE, 90% of Medicare fee-for-service members have a supplement and are expected to have minimal or no out-of-pocket costs; 85% of out-of-pocket costs are less than $50.
What kind of vaccine is PROVENGE?
Provenge (sipuleucel-T) is an immunotherapy medication known as a cancer vaccine. Men with certain types of advanced prostate cancer may use Provenge. Provenge is made by using your own cells and can have some serious side effects.
How many treatments are PROVENGE?
Some men have experienced serious adverse events while taking PROVENGE. See Important Safety Information. Treatment is completed in 6 appointments over the course of about a month.
Before Receiving Provenge
Before you are treated with Provenge, tell your doctor about all of your medical conditions.If you have any of these conditions, you may need a Pro...
What Happens If I Miss A Dose?
Call your doctor for instructions if you miss any appointment in your cell collection or Provenge infusion schedule.
What Happens If I Overdose?
Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What Other Drugs Will Affect Provenge?
Tell your doctor if you use any drugs that weaken your immune system, such as: 1. other cancer medicines; 2. steroids (prednisone and others); or 3...
How does Provenge work?
Similar to a vaccine, PROVENGE works to boost your immune system’s ability to target and attack prostate cancer cells immediately, with effects that last over time. SHOW ME PROVENGE RESULTS >>.
Why is provenance different from other cancer treatments?
PROVENGE is personalized because it’s made from your own immune cells. It empowers your immune system's ability to recognize and remember prostate cancer cells.
What is provenge prostate?
Prostate cancer occurs in the prostate gland (part of the male reproductive system.) Provenge works by helping your immune system work better against cancer cells. (Your immune system helps protect your body from abnormal cells such as germs and cancer cells.)
What is provenge on call?
Dendreon Pharmaceuticals LLC, the manufacturer of Provenge, offers a program called Dendreon ON Call. This program offers ways to help lower the cost of Provenge treatment. For more information and to find out if you’re eligible for support, call 877-336-3736 or visit the program website.
How long does provenge last?
It’s given as an intravenous (IV) infusion, which is an injection into your vein over a period of time. Provenge infusions typically last for about 1 hour.
How long before Provenge infusion?
About 30 minutes before starting your Provenge infusion, your doctor will likely give you two other medications. This is to help prevent infusion reactions, which are side effects that may occur during or shortly after you receive a drug by intravenous (IV) infusion. (With IV infusions, the drug is slowly injected into a vein over a certain period of time.)
What to take before Provenge?
The medications you’re most likely to receive before your Provenge infusion are acetaminophen (Tylenol) and an antihistamine, usually diphenhydramine ( Benadryl ). As well as giving you these medications, your doctor will monitor you for side effects during and after your Provenge infusion.
How long does it take for Provenge to go away?
numbness or tingling in your arms, legs, hands, or feet. Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist. * This is a partial list of mild side effects from Provenge.
Can provenge be used off label?
Provenge may also be used off-label for other conditions. Off-label drug use means using a drug for a purpose other than what it’s been approved for by the FDA. Provenge is approved for use in adult males with metastatic, castration-resistant * prostate cancer.
What is provenge infusion?
Each Provenge infusion comprises the maximum number of cells that can be manufactured from a single leukapheresis procedure. The number of cells in Provenge does not exceed the number of cells collected from the leukapheresis. There are no known instances of overdosage from either a single infusion or a full course of therapy with Provenge.
What is provenge immunotherapy?
Provenge (sipuleucel-T) is an autologous cellular immunotherapy available as a suspension for intravenous infusion. Provenge consists of autologous peripheral blood mononuclear cells, including antigen presenting cells (APCs), that have been activated during a defined culture period with a recombinant human protein, PAP-GM-CSF, consisting of prostatic acid phosphatase (PAP), an antigen expressed in prostate cancer tissue, linked to granulocyte-macrophage colony-stimulating factor (GM-CSF), an immune cell activator. Each dose of Provenge contains a minimum of 50 million autologous CD54 + cells activated with PAP-GM-CSF, suspended in 250 mL of Lactated Ringer's Injection, USP.
How long should you wait to observe a patient after an infusion?
Do not use a cell filter. Observe the patient for acute infusion reactions for at least 30 minutes following each infusion. If acute infusion reactions occur, such as chills, fatigue, fever, nausea, and joint ache, interrupt or slow the infusion and administer appropriate medical treatment as needed.
Can provenge be used for thromboembolic events?
Most patients had multiple risk factors for these events. Provenge should be used with caution in patients with risk factors for thromboembolic events. Thromboembolic events, including deep venous thrombosis and pulmonary embolism, can occur following infusion of Provenge.
Is provenge a transmissible disease?
Provenge is not tested for transmissible infectious diseases. Therefore, patient leukapheresis material and Provenge may carry the risk of transmitting infectious diseases to health care professionals handling the product. Accordingly, health care professionals should employ universal precautions when handling leukapheresis material or Provenge.
What is provenge used for?
You may think of vaccines as preventive, but this is a therapeutic vaccine. Provenge is used to treat late-stage prostate cancer that no longer responds to hormone therapy (metastatic castrate resistant). Provenge uses your own blood.
How effective is Provenge for prostate cancer?
How effective is it for the treatment of prostate cancer? Provenge was approved for treatment of metastatic hormone-resistant prostate cancer in 2010. It’s intended for men who are having no symptoms or minimal symptoms. The vaccine encourages your immune system to seek out and attack prostate cancer cells.
How long does provenge last?
But Provenge has been shown to lengthen life in people with late-stage prostate cancer by an average of four months, with minimal side effects.
What does it mean when your PSA is going down?
Talking to your doctor. Your doctor will monitor the prostate-specific antigen (PSA) levels in your blood. If your PSA level is going down, it usually means treatment is working . A rise in PSA levels may mean treatment isn’t effective.
Is Provenge safe for men?
Provenge is generally considered safe for men with advanced prostate cancer. The product label doesn’t list any known interactions with foods or other medications. You should still review all your over-the-counter and prescription medications with your doctor before starting treatment.
What is the purpose of the Provenge?
PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). It is the first FDA-approved immunotherapy for prostate cancer. PROVENGE is made by culturing a patient's own immune cells with a recombinant antigen a ...
What are the risks of using Provenge?
PROVENGE should be used with caution in patients with risk factors for thromboembolic events. 1. Vascular Disorders: Cerebrovascular events (hemorrhagic/ischemic strokes and transient ischemic attacks) and cardiovascular disorders (myocardial infarctions) have been reported following infusion of PROVENGE.
How is Provenge made?
PROVENGE is made by culturing a patient's own immune cells with a recombinant antigen a that is prostate specific. When infused into the patient, PROVENGE activates T cells to target and attack prostate cancer cells. a The recombinant antigen used to make PROVENGE is called PAP-GM-CSF.
What is provenance treatment?
Immunotherapy is a treatment that empowers the immune system to identify and fight foreign substances such as cancer and other diseases. PROVENGE is a personalized immunotherapy for men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). PROVENGE is made by culturing a patient’s own immune cells ...
What is the recombinant antigen used to make prove?
a The recombinant antigen used to make PROVENGE is called PAP-GM-CSF. It consists of prostatic acid phosphatase (PAP), an antigen expressed in more than 95% of prostate cancers, and granulocyte-macrophage colony-stimulating factor (GM-CSF), an immune cell activator. Reference: PROVENGE [prescribing information].
Who makes Provenge?
PROVENGE is manufactured by Dendreon Pharmaceuticals, LLC, headquartered in Seal Beach, California. Dendreon is a commercial-stage biopharmaceutical company and pioneer in the development of treatments that harness the power of the immune system to extend life.
Is sipuleucel T a 2A?
Sipuleucel-T (PROVENGE) is also a category 2A recommendation 1,b. NCCN Guidelines also recommend considering sipuleucel-T (PROVENGE ®) as a preferred second-line treatment option after abiraterone or enzalutamide. Treatment with sipuleucel-T (PROVENGE) does not preclude the use of subsequent therapies. 1,2.
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.
Side Effects
Most people will not experience all of the Provenge side effects listed.
Precautions
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.).
Self-Care Tips
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 cannot be adjusted, changed, or exceeded.
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.
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.
What are the side effects of Provenge?
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.
How long does it take to get the Provenge treatment?
The PROVENGE treatment can be completed in about a month. The PROVENGE treatment process includes 3 personalized cycles using your own immune cells, activating them to empower your immune system. This process can be completed in 6 appointments, outlined on the previous page, throughout the course of about a month.
How long does it take for leukapheresis to work?
Treatment begins at your local blood center with leukapheresis, a 2-4 hour cell collection process where your blood is passed through a machine that extracts a small amount of your immune cells, along with some platelets and red blood cells. The remainder of the blood is returned back to your body.
Is Provenge a mild or moderate infusion?
The Most Common Side Effects of PROVENGE are Generally Mild to Moderate and Well Tolerated. Serious adverse events have occurred in some men who received PROVENGE. Tell your doctor right away if you experience any side-effects. 95% of infusion-related side effects were mild to moderate.
Indications and Usage For Provenge
Dosage Forms and Strengths
Warnings and Precautions
Adverse Reactions
Use in Specific Populations
Overdosage
Provenge Description
Provenge - Clinical Pharmacology
- Mechanism of Action
Provenge is classified as an autologous cellular immunotherapy. While the precise mechanism of action is unknown, Provenge is designed to induce an immune response targeted against PAP, an antigen expressed in most prostate cancers. During ex vivo culture with PAP-GM-CSF, APCs tak…
Clinical Studies
How Supplied/Storage and Handling