Provenge

Provenge (sipuleucel-T) is an autologous cellular immunotherapy used to treat metastatic castration-resistant prostate cancer (mCRPC) in certain patients.

As a personalized immunotherapy, Provenge works by stimulating the patient’s own immune system to fight cancer cells, rather than directly attacking cancer cells. The patient's immune cells are collected, activated in a lab to recognize prostate cancer, and then infused back into the body. This process helps the immune system better identify and fight the cancer, with the main benefit being improved overall survival.

Provenge treatment consists of three infusions administered approximately two weeks apart, with the full course completed in about one month. Each Provenge infusion is typically given about three days after the patient’s immune cells are collected.

Provenge is used for:

• Advanced prostate cancer that has spread beyond the prostate, that is
• Resistant to hormone therapy, and
• Patient has few or no symptoms from their cancer.

Provenge step-by-step process:

• Cell collection (leukapheresis) Patient’s immune cells, called antigen-presenting cells (APC) are collected from the blood, which takes 2 to 4 hours
• Cell activation In the laboratory, the antigen-presenting cells are activated by being exposed to a protein found on prostate cancer cells called prostatic acid phosphatase (PAP)
• Reinfusion The activated cells are infused back into the patient, where they stimulate the immune system to recognize and attack prostate cancer cells.

Provenge is made from your own immune cells, your cells will be collected approximately 3 days before each scheduled infusion of Provenge.

Your cells are collected at a cell collection center in a process called “leukapheresis” (pronounced loo-kuh-fuh-REE-sis). Your collected cells are sent to a laboratory where they are mixed with protein prostatic acid phosphatase (PAP) to make them ready for your infusion.

Each Provenge infusion is usually given three days after the patient’s immune cells are collected.

You will get Provenge in 3 intravenous infusions (put into your veins), about 2 weeks apart. Each infusion takes about 60 minutes. Following each infusion, you will be monitored for at least 30 minutes.

Your doctor will give you a schedule for your cell collection and infusion appointments. It is very important that you arrive on time for your appointments. If you miss an appointment and cannot be infused, your PROVENGE dose will not be usable. Your doctor will work with you to schedule a new appointment at the cell collection center. You may also get a new infusion appointment.

Before you are treated with Provenge, tell your doctor about all of your medical conditions, especially heart disease, asthma, COPD or other breathing problems, or if you have ever had a stroke.

Some people receiving this injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, tired, or nauseated, or if you have fever, chills, joint pain, severe headache, blurred vision, buzzing in your ears, anxiety, confusion, vomiting, chest pain, fast or uneven heartbeats, wheezing, chest tightness, or trouble breathing. These side effects may occur during the Provenge injection or within the first 24 hours after your infusion.

Other warnings or precautions

This medicine may cause:

• Thromboembolic events such as deep venous thrombosis and pulmonary embolism
• Vascular disorder, including cerebrovascular disease or cardiovascular disorders
• Risk of transmissible infectious disease to healthcare professionals.

Using either chemotherapy or immunosuppressive agents given together with the leukapheresis procedure or Provenge has not been studied. Evaluate patients carefully to determine whether it is medically appropriate to reduce or discontinue immunosuppressive agents prior to treatment with Provenge

To make sure Provenge is safe for you, tell your doctor if you have ever had:

• heart problems;
• a stroke; or
• breathing problems.

Common Provenge side effects

Common Provenge side effects may include fever, chills, tiredness, back pain; nausea, headache or joint pain.

Serious side effects

Get emergency medical help if you have signs of an allergic reaction to Provenge: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection or within the first 24 hours afterward. Tell your caregiver if you feel tired, dizzy, nauseated, light-headed, feverish, chilled, or have fast heartbeats, trouble breathing, a severe headache, or pounding in your neck or ears.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• racing or irregular heartbeats;
• signs of infection - fever, pain or redness where a needle was placed for blood cell collection or infusion;
• signs of a stroke - sudden numbness or weakness (especially on one side of the body), vision problems, slurred speech;
• signs of a blood clot deep in the body - pain, swelling, warmth, or discoloration in an arm or leg; or
• signs of a blood clot in the lung - chest pain that gets worse with deep breathing, shortness of breath.

Tell your doctor about any side effect that concerns you or does not go away.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Get emergency medical help if you have signs of an allergic reaction to Provenge: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection or within the first 24 hours afterward. Tell your caregiver if you feel tired, dizzy, nauseated, light-headed, feverish, chilled, or have fast heartbeats, trouble breathing, a severe headache, or pounding in your neck or ears.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• racing or irregular heartbeats;
• signs of infection - fever, pain or redness where a needle was placed for blood cell collection or infusion;
• signs of a stroke - sudden numbness or weakness (especially on one side of the body), vision problems, slurred speech;
• signs of a blood clot deep in the body - pain, swelling, warmth, or discoloration in an arm or leg; or
• signs of a blood clot in the lung - chest pain that gets worse with deep breathing, shortness of breath.

Common Provenge side effects may include:

• fever, chills, tiredness;
• back pain;
• nausea;
• headache; or
• joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Provenge Dose for Prostate Cancer: 3 complete doses given at approximately 2-week intervals; infuse the drug intravenously over 60 minutes.Comments:

• Peripheral blood mononuclear cells from patients are obtained via the leukapheresis procedure, which should be performed approximately 3 days prior to each infusion.
• Patients should be pre-medicated orally with acetaminophen and an antihistamine (such as diphenhydramine) approximately 30 minutes prior to administration to minimize potential acute infusion reactions.
• The patient should be observed for acute infusion reactions for at least 30 minutes following each infusion.
• The maximum dosing interval has not been established.
• This drug is intended solely for autologous use.
• This drug is for IV use only; a cell filter should not be used.

Use: Treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.

Call your doctor for instructions if you miss any appointment in your cell collection or Provenge infusion schedule.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Tell your doctor if you use any drugs that weaken your immune system, such as:

• other cancer medicines;
• steroids (prednisone and others); or
• medicines to prevent rejection of a transplanted organ.

This list is not complete. Other drugs may interact with sipuleucel-T, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

The active components of PROVENGE are your own immune cells mixed with the other active component, a protein designed to produce an immune response to prostate cancer. The product is suspended in an infusion solution called Lactated Ringer's Injection, USP, an inactive ingredient.

Dendreon Pharmaceuticals LLCSeal Beach, CA 90740LBS-76022.04