Sipuleucel-T Suspension for injection

What is this medicine?

SIPULEUCEL-T (SI pu LOO sel - tee) is a vaccine for the treatment of prostate cancer. It is made from cells in your immune system.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• heart disease

• lung or breathing disease, like asthma

• an unusual or allergic reaction to sipuleucel-T, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting. This medicine is made from your own immune cells. Your cells will be collected at a cell collection center approximately 3 days before each infusion of this medicine. Your collected cells are then sent to a special center where they are mixed with a protein to get them ready for your infusion.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment. If you miss an appointment for your infusion of this medicine, your dose will not be able to be used.

What may interact with this medicine?

• medicines that suppress your immune system like some medicines for cancer

• steroid medicines like prednisone or cortisone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Report any side effects that you notice during your treatment right away, such as changes in your breathing, fever, or chills. These may also occur after your infusion.

Tell your doctor or health care professional if you have any other reaction or unusual symptom after getting this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• chest pain or palpitations

• dizziness

• fast,irregular heartbeat

• fever

• nausea, vomiting

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• back pain

• fatigue

• headache

• joint pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is only given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.