sipuleucel-T

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Pronunciation: SI pu LOO sel tee

Brand: Provenge

What is the most important information I should know about sipuleucel-T?

Before you are treated with sipuleucel-T, tell your doctor about all of your medical conditions, especially heart disease, asthma, COPD or other breathing problems, or if you have ever had a stroke.

Sipuleucel-T is used in a treatment called autologous (ah-TAL-oh-gus) immunotherapy. Sipuleucel-T is mixed with certain immune cells drawn from your own blood, and this mixture is injected into your body.

Your doctor will determine your schedule for cell collection and sipuleucel-T injection. Follow your doctor's instructions very carefully. The timing of cell collection in relation to sipuleucel-T infusion is extremely important. If you miss an infusion appointment your prepared infusion cannot be used in the future.

Some people receiving a sipuleucel-T injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, tired, or nauseated, or if you have fever, chills, joint pain, severe headache, blurred vision, buzzing in your ears, anxiety, confusion, vomiting, chest pain, fast or uneven heartbeats, wheezing, chest tightness, or trouble breathing. These side effects may occur during the injection or within the first 24 hours after your infusion.

What is sipuleucel-T?

Sipuleucel-T contains a protein that stimulates the body's immune system to help it respond against certain cancer cells.

Sipuleucel-T is used to treat advanced prostate cancer in men.

Sipuleucel-T is mixed with certain immune cells drawn from your own blood, and the mixture is later injected into your body. This type of treatment is called autologous (ah-TAL-oh-gus) immunotherapy.

Sipuleucel-T is usually given after surgery or other medications have been tried without successful treatment.

Sipuleucel-T may also be used for other purposes not listed in this medication guide.

What should I discuss with my health care provider before receiving sipuleucel-T?

Before you are treated with sipuleucel-T, tell your doctor about all of your medical conditions.

If you have any of these conditions, you may need a sipuleucel-T dose adjustment or special tests:

  • heart disease;
  • asthma, chronic obstructive pulmonary disease (COPD), or other breathing problems; or
  • if you have ever had a stroke.

How is sipuleucel-T given?

Approximately 3 days before you receive this medication, your immune cells will be collected with a procedure called leukapheresis (LOO-ka-fe-REE-sis).

During the leukapheresis procedure, your immune cells will be collected through a small tube (catheter) placed into a vein in each of your arms. If the veins in your arms cannot be used, the catheter will be placed into a vein in your neck or upper chest.

The cell-collection catheter is connected to a machine that draws out your blood and separates your immune cells from other parts of the blood.

The cell collection process can take up to 4 hours to complete.

The collected immune cells are then mixed with sipuleucel-T, which contains a special protein that helps activate your body's immune cells. When injected back into your, these activated immune cells may be able to "recognize" and attack certain prostate cancer cells.

Your prepared sipuleucel-T solution will be injected into a vein through an IV. You will receive this injection in a clinic or hospital setting approximately 3 days after your cell collection procedure. Sipuleucel-T must be given slowly, and the IV infusion can take about 60 minutes to complete.

Your doctor will determine your schedule for cell collection and sipuleucel-T injection. Follow your doctor's instructions very carefully. The timing of cell collection in relation to sipuleucel-T infusion is extremely important. If you miss an infusion appointment your prepared infusion cannot be used in the future.

Sipuleucel-T is usually given in 3 doses spaced 2 weeks apart. Follow your doctor's instructions.

You will be given oral medications before your IV infusion to help prevent certain side effects.

What happens if I miss a dose?

Call your doctor for instructions if you miss any appointment in your cell collection or sipuleucel-T infusion schedule.

What happens if I overdose?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving sipuleucel-T?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of sipuleucel-T?

Some people receiving a sipuleucel-T injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, tired, or nauseated, or if you have fever, chills, joint pain, severe headache, blurred vision, buzzing in your ears, anxiety, confusion, vomiting, chest pain, fast or uneven heartbeats, wheezing, chest tightness, or trouble breathing. These side effects may occur during the injection or within the first 24 hours after your infusion.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any other serious side effect, such as:

  • fever;
  • redness, swelling, oozing, or other signs of infection where the IV needle was placed; or
  • signs of infection around the veins your cells were collected from.

Less serious side effects may include:

  • back pain;
  • mild nausea;
  • headache; or
  • mild body aches.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect sipuleucel-T?

Tell your doctor if you use any drugs that weaken your immune system, such as:

  • other cancer medicines;
  • steroids (prednisone and others); or
  • medicines to prevent rejection of a transplanted organ.

This list is not complete and other drugs may interact with sipuleucel-T. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about sipuleucel-T.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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