SIPULEUCEL-T

(SI pu LOO sel tee) Brand: Provenge

What is the most significant information I must know about sipuleucel-T?

• Till you are treated with sipuleucel-T, speak your doctor about all of your medical conditions, especially heart malady, asthma, COPD or another 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 determined 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 significant. If you miss an infusion appointment your prepared infusion can't be used in the future.

• Some people receiving a sipuleucel-T injection have had a reaction to the infusion (when the medication is injected into the vein). Speak your caregiver right away if you feel dizzy, weary, or nauseated, or if you have fever, chills, joint pain, severe headache, blurred vision, buzzing in your ears, anxiety, confusion, vomiting, chest pain, quick 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 determined cancer cells.

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

Sipuleucel-T is mixed with determined 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 generally given after surgery or another medications have been tried without successful treatment.

Sipuleucel-T may also be used for another purposes not listed in this medicine guide.

What must I discuss with my health care provider till receiving sipuleucel-T?

• Till you are treated with sipuleucel-T, speak your doctor about all of your medical conditions.

• If you have any of these conditions, you may need a sipuleucel-T doze adjustment or particular tests:

· heart disease;

· asthma, chronic obstructive pulmonary malady (COPD), or another breathing problems; or

· if you have ever had a stroke.

How is sipuleucel-T given?

• Approximately 3 days till you receive this medicine, 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 little pipe (catheter) placed into a vein in every of your arms. If the veins in your arms can't be used, the catheter will be placed into a vein in your neck or upper chest.

• The cell-collection catheter is connected to a car that draws out your blood and separates your immune cells from another 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 particular protein that helps activate your body's immune cells. When injected back into your, these activated immune cells may be able to "recognize" and onslaught determined 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 should 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 significant. If you miss an infusion appointment your prepared infusion can't be used in the future.

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

• You will be given oral medications till your IV infusion to help prevent determined 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 medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What must 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 medication is injected into the vein). Speak your caregiver right away if you feel dizzy, weary, or nauseated, or if you have fever, chills, joint pain, severe headache, blurred vision, buzzing in your ears, anxiety, confusion, vomiting, chest pain, quick 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 abnormal medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your person, lips, tongue, or throat.

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

· fever;

· redness, swelling, oozing, or another signs of infection where the IV needle was placed; or

· signs of infection near the veins your cells were collected from.

• Smaller 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 message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect sipuleucel-T?

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

· another cancer medicines;

· steroids (prednisone and others); or

· medicines to prevent rejection of a transplanted organ.

• This list is not complete and another drugs may interact with sipuleucel-T. Speak your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal commodity. Do not start a new medicine without telling your doctor.

Where can I get more information?

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

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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