Sipuleucel-T (si-pu-LOO-sel - tee)

Treats advanced prostate cancer. This medicine is made from your own immune cells (autologous cellular immunotherapy).

Brand Name(s):

Provenge

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• Your doctor will tell you to have your immune cells collected three days before each scheduled infusion of this medicine. Your collected cells are mixed with a protein to make them ready for your infusion.
• The medicine is usually given as 3 doses, spaced 2 weeks apart. This medicine must be given slowly, so the needle will remain in place for one hour. You may also receive acetaminophen (Tylenol®) and diphenhydramine (Benadryl®) to help prevent possible infusion reactions.

If a dose is missed:

• It is very important that you receive all doses of this medicine. Try to keep all scheduled appointments. If you miss a dose, your medicine 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 appointment for your infusion.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are receiving a treatment or using a medicine that causes a weak immune system. This may include radiation therapy, cancer medicines, or steroid medicines (such as cortisone, dexamethasone, prednisone, Cortef®, or Medrol®).

Warnings While Using This Medicine:

• Make sure your doctor knows if you have heart disease, heart rhythm problems, lung disease or breathing problems, or a history of stroke.
• This medicine may cause fever; chills; dizziness; joint pain; fast heartbeat; nausea and vomiting; shortness of breath; troubled breathing; or unusual tiredness or weakness within a few hours after you receive it. Check with your doctor or nurse right away if you have any of these symptoms.
• Call your doctor right away if you start to have a cough, weight loss, fever, or redness or pain at the infusion or collection sites. These may be signs that you have an infection.
• Check with your doctor right away if you have chest pain or discomfort, dizziness, fainting, pounding or rapid pulse, or fast, slow, or uneven heartbeat. These maybe symptoms of a heart rhythm problem.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, bloody or cloudy urine, or painful urination.
• Chest pain, fast or uneven heartbeat.
• Fever, chills, cough, runny nose, sore throat, and body aches.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed.
• Shortness of breath or troubled breathing.
• Swelling in your hands, ankles, or feet.
• Unusual bleeding or bruising.
• Unusual tiredness or weakness.

If you notice these less serious side effects, talk with your doctor:

• Back, bone, joint, or muscle pain.
• Constipation, diarrhea, nausea, or vomiting.
• Decreased weight.
• Dizziness or headache.
• Loss of appetite.
• Skin rash.
• Trouble sleeping.
• Warmth or redness in your face, neck, arms, or upper chest.

If you notice other side effects that you think are caused by this medicine, tell your doctor

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