Provenge

What is PROVENGE?

(PROVENGE) This medication is used to treat advanced prostate cancer. Sipuleucel-T is a type of vaccine created from your own immune system cells that works by causing your immune system to attack prostate cancer cells. This requires that you have a procedure to remove some of your white blood cells, which are used to prepare sipuleucel-T. Talk to your doctor about the risks and benefits of this treatment.

How should I use PROVENGE?

Read the Patient Information Leaflet if available from your pharmacist before you start using sipuleucel-T and each time you get a refill. If you have any questions, ask your doctor or pharmacist. This medication is created specifically for you from your own blood and should not be given to another patient. Three days before your dose you will have a procedure in which your own white blood cells are removed and then used to create sipuleucel-T. Sipuleucel-T is given as a slow infusion into a vein by a health care professional. It is given as directed by your doctor, usually about every 2 weeks for a total of 3 doses. Infusion reactions may happen during or after the infusion of this drug. Your doctor may prescribe other medications (such as acetaminophen, antihistamines) to help prevent these side effects. Tell your doctor right away if you have any symptoms of infusion reaction such as chills, tiredness, fever, nausea, vomiting, shortness of breath, fast/irregular heartbeat, or joint pain. Your doctor may give you other medications to help with these side effects or may slow down or stop your treatment for some time. To get the most benefit from this medication, do not miss any doses. To help you remember, mark the days on the calendar when you need to receive the medication.

What should I tell my health care provider before I take PROVENGE?

Before receiving sipuleucel-T, tell your doctor or pharmacist if you have any allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems, lung problems, stroke. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This medication is not usually used by women. It is unlikely to be used during pregnancy or breastfeeding. Consult your doctor if you have any questions about this medication.

What may interact with PROVENGE?

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

What if I miss a dose of PROVENGE?

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

What side effects may I notice from receiving PROVENGE?

See also How to Use section. Headache, sweating, muscle aches, or back pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: weakness on one side of the body, confusion, trouble speaking. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Where should I keep PROVENGE?

Store in the refrigerator. Do not freeze. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.