Sipuleucel-T, Infusion

________________________________________________________________________

KEY POINTS

• This medicine is given by infusion to treat prostate cancer.
• You may get infections more easily when you are taking this medicine.
• This medicine may cause a serious reaction within 1 day of the infusion. This medicine may also cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: antineoplastic (anticancer)

Generic and brand names: sipuleucel-T, infusion; Provenge

What is this medicine used for?

This medicine is given by infusion to treat advanced prostate cancer. This medicine is made from your own immune cells.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine, to dimethyl sulfoxide (DMSO), or to cows or beef
• A stroke or transient ischemic attack (TIA)
• A weakened immune system from cancer treatment, diseases such as HIV/AIDS, or from taking steroid medicines or medicines to prevent organ transplant rejection
• Heart or lung problems

Females of childbearing age: This medicine is not indicated for use in women.

How do I use it?

Immune cells are collected from your blood about 3 days before each treatment. This medicine is given by IV infusion (slow drip through a needle into a large vein) by your healthcare provider. You will usually have 3 treatments, with 2 weeks between each treatment.

You may be given medicine to prevent infusion reactions before you receive this medicine. You will be monitored closely while receiving this medicine and after receiving this medicine.

What if I miss a dose?

Do not miss an appointment for a treatment. The cells will expire if you miss a treatment and must be thrown out. If you miss an appointment for a treatment, contact your healthcare provider to reschedule your appointment.

What should I watch out for?

This medicine may cause a serious reaction within 1 day of the infusion. Tell your healthcare provider right away or get emergency medical care if you have symptoms such as:

• Fever and chills
• Severe headache or muscle pain
• Nausea or vomiting
• Chest pain
• Fast or irregular heartbeat
• Shortness of breath

Contact your healthcare provider if you have a fever, cough, sore throat, or if you have redness or pain around the infusion site or cell collection site. These may be signs of an infection. While receiving this medicine, do not have any vaccines unless you get your healthcare provider's approval first. Talk with your healthcare provider about this.

This medicine may make you dizzy. Do not drive or operate machinery until you know how this medicine will affect you.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are receiving this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Fast or irregular heartbeat; chest pain; severe joint or muscle pain; trouble breathing; fever and chills; swelling, numbness, or tingling in your hands or feet; unusual tiredness or weakness; severe dizziness; changes in urination; severe nausea or vomiting; redness, pain, or swelling around the infusion or collection site.

Other: Mild tiredness, weakness, or dizziness; joint pain; back pain; mild headache; constipation; diarrhea; nausea; trouble sleeping; loss of appetite; flushing; heavy sweating.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Cancer medicines such as cisplatin, doxorubicin (Doxil), hydroxyurea (Droxia, Hydrea), vinblastine, and vincristine (Marqibo)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Immunosuppressants such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), mycophenolate (CellCept, Myfortic), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Medicines to treat psoriasis, rheumatoid arthritis, and other immune disorders such as adalimumab (Humira), anakinra (Kineret), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), leflunomide (Arava), tocilizumab (Actemra), tofacitinib (Xeljanz), and ustekinumab (Stelara)
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Multiple sclerosis medicines such as fingolimod (Gilenya), glatiramer (Copaxone), natalizumab (Tysabri), and teriflunomide (Aubagio)
• Radiation therapy
• Vaccines

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.