Sipuleucel-T

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.

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

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other medications that affect the immune system such as azathioprine (Imuran)
• cyclosporine (Neoral, Sandimmune)
• medications for cancer
• methotrexate (Rheumatrex)
• oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), prednisolone, and prednisone (Deltasone)
• sirolimus (Rapamune)
• tacrolimus (Prograf)

This is not a complete list of all drug interactions. Ask your doctor or pharmacist for more information.
 

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of this medication, there are no specific foods that you must exclude from your diet.

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.

• It is used to treat prostate cancer.
• It may be given to you for other reasons. Talk with the doctor.

• If you have an allergy to sipuleucel-T or any other part of sipuleucel-T.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.
• Acetaminophen and diphenhydramine may be given before sipuleucel-T to lower fever and chills.
• You will need to have a cell collection called leukopheresis about 3 days before you get this medicine.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

Prostate cancer, metastatic: Treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.

There are no contraindications listed in the manufacturer’s labeling.

Animal reproduction studies have not been conducted. Not indicated for use in women.

Applies to sipuleucel-T: intravenous suspension

Along with its needed effects, sipuleucel-T may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking sipuleucel-T:

• Bladder pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody or cloudy urine
• body aches or pain
• chest pain
• chills
• confusion
• cough
• diarrhea
• difficult, burning, or painful urination
• difficulty with breathing
• difficulty with speaking
• double vision
• ear congestion
• fever
• frequent urge to urinate
• general feeling of discomfort or illness
• headache
• inability to move the arms, legs, or facial muscles
• inability to speak
• joint pain
• loss of appetite
• loss of voice
• lower back or side pain
• muscle aches and pains
• nasal congestion
• nausea
• pale skin
• rapid weight gain
• runny nose
• shivering
• shortness of breath
• slow speech
• sneezing
• sore throat
• sweating
• tightness in the chest
• tingling of the hands or feet
• trouble sleeping
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• vomiting
• wheezing

Some side effects of sipuleucel-T may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Back pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• decreased weight
• dizziness
• feeling of warmth
• lack or loss of strength
• loss of appetite
• muscle ache
• muscle or bone pain
• muscle spasms
• neck pain
• rash
• redness of the face, neck, arms, and occasionally, upper chest
• sleeplessness
• sudden sweating
• unable to sleep
• weight loss

• Shakiness in the legs, arms, hands, or feet
• trembling or shaking of the hands or feet