Sipuleucel-T injection is used to treat certain types of advanced prostate cancer. Sipuleucel-T injection is in a class of medications 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 (a group of cells, tissues, and organs that protects the body from attack by bacteria, viruses, cancer cells, and other substances that cause disease) 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 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.

Sipuleucel-T injection may cause serious allergic reactions during an infusion and for about 30 minutes afterwards. A doctor or nurse will monitor you during this time to be sure you are not having a serious reaction to the medication. You will be given other medications 30 minutes before your infusion to prevent reactions to sipuleucel-T injection. Tell your doctor or nurse immediately if you experience any of the following symptoms: nausea, vomiting, chills, fever, extreme tiredness, dizziness, difficulty breathing, fast or irregular heartbeat, or chest pain.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

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

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. Be sure to mention any of the following: 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); and tacrolimus (Prograf).
• 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.

Unless your doctor tells you otherwise, continue your normal diet.

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.

Sipuleucel-T injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• chills
• tiredness or weakness
• headache
• back or joint pain
• muscle pain or tightening
• uncontrollable shaking of a part of the body
• sweating

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• redness or swelling near the place on the skin where you received your infusion or where cells were collected
• fever over 100.4°F (38°C)
• slow or difficult speech
• sudden dizziness or faintness
• weakness or numbness of an arm or leg
• difficulty swallowing
• blood in urine

Sipuleucel-T injection may cause other side effects. Call your doctor if you have any unusual problems during your treatment with this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep all appointments with your doctor, the cell collection center, and the laboratory. Your doctor may order certain lab tests to check your body’s response to sipuleucel-T injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Provenge^®