Sipuleucel-T

Sipuleucel-T is a prescription medication used to treat certain types of advanced prostate cancer. Sipuleucel-T injection belongs to a group of drugs called autologous cellular immunotherapy, a type of medication prepared using cells from the patient's own blood. It works by causing the body's immune system to fight the cancer cells.

Sipuleucel-T injection comes as a suspension (liquid) to be injected over about 60 minutes into a vein by a healthcare professional. It is usually given once every 2 weeks for a total of three doses.

Common side effects include chills, fatigue, fever, back pain, nausea, joint ache, and headache.

Sipuleucel-T is a prescription medication used to treat certain types of advanced prostate cancer.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
 

Sipuleucel-T may be found in some form under the following brand names:

• Provenge

Common side effects include the following:

• chills
• fatigue
• fever
• back pain
• nausea
• joint ache
• headache

This is not a complete list of this medication’s side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other medications that affect the immune system such as azathioprine (Imuran)
• cyclosporine (Neoral, Sandimmune)
• medications for cancer
• methotrexate (Rheumatrex)
• oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), prednisolone, and prednisone (Deltasone)
• sirolimus (Rapamune)
• tacrolimus (Prograf)

This is not a complete list of all drug interactions. Ask your doctor or pharmacist for more information.
 

Serious side effects have been reported with sipuleucel-T including the following:

• Sipuleucel-T infusion can cause serious reactions. Tell your doctor right away if you have breathing problems, chest pains, racing heart or irregular heartbeats, dizziness, nausea, or vomiting after getting sipuleucel-T because any of these may be signs of heart or lung problems.
• Tell your doctor right away if you get a fever over 100ºF, or redness or pain at the infusion or collection sites, because any of these may be signs of infection.

Do not take this medication if you are allergic to sipuleucel-T or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of this medication, there are no specific foods that you must exclude from your diet.

Before receiving sipuleucel-T injection,

• tell your doctor and pharmacist if you are allergic to sipuleucel-T injection, any other medications, or any of the ingredients in sipuleucel-T injection. Ask your pharmacist or doctor or check the manufacturer's patient information for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have or have ever had a stroke or heart or lung disease.
• you should know that sipuleucel-T is only for use in men.

Sipuleucel-T injection comes as a suspension (liquid) to be injected over about 60 minutes into a vein by a doctor or nurse in a doctor's office or infusion center. It is usually given once every 2 weeks for a total of three doses.

About 3 days before each dose of sipuleucel-T injection is to be given, a sample of your white blood cells will be taken at a cell collection center using a procedure called leukapheresis (a process that removes white blood cells from the body). This procedure will take about 3 to 4 hours. The sample will be sent to the manufacturer and combined with a protein to prepare a dose of sipuleucel-T injection. Because this medication is made from your own cells, it is to be given only to you.

Talk to your doctor about how to prepare for leukapheresis and what to expect during and after the procedure. Your doctor will tell you what you should eat and drink and what you should avoid before the procedure. You may experience side effects, such as dizziness, fatigue, tingling in the fingers or around the mouth, feeling cold, fainting, and nausea during the procedure. You may feel tired after the procedure, so you may want to plan for someone to drive you home.

Sipuleucel-T injection must be given within 3 days from the time it was prepared. It is important to be on time and not to miss any scheduled appointments for cell collection or to receive each treatment dose.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dosing schedule is 3 doses at approximately 2-week intervals.

Each dose contains a minimum of 50 million autologous (from your own self) CD54+ cells (a cell of the immune system) activated with a protein that will allow your immune system to target and destroy prostate cells.

Since this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.
 

If you miss an appointment to collect your cells, you must call your doctor and the collection center right away. If you miss an appointment to receive sipuleucel-T injection, you must call your doctor right away. You may need to repeat the process to collect your cells if the prepared dose of sipuleucel-T injection will expire before it can be given to you.

Keep all appointments with your doctor, the cell collection center, and the laboratory.