Pronunciation:

si-pu-LOO-sel - tee

Brand Names:

• Provenge

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

Immunological Agent

Uses of This Medicine:

Sipuleucel-T is used to treat certain types of advanced prostate cancer. This medicine is made from your own immune cells (autologous cellular immunotherapy).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

No information is available on the relationship of age to the effects of sipuleucel-T in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sipuleucel-T in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart disease or
• Heart rhythm problems (e.g., arrhythmia) or
• Lung disease or breathing problems or
• Stroke, history of—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

Your doctor will tell you to have your immune cells collected three days before each scheduled infusion of this medicine at a cell collection center. This collection process is called leukapheresis. Your collected blood cells are mixed with a protein to make them ready for your infusion.

The medicine is usually given as 3 doses, spaced 2 weeks apart. This medicine must be given slowly, so the needle will remain in place for one hour. You may also receive acetaminophen (e.g., Tylenol®) and diphenhydramine (e.g., Benadryl®) to help prevent possible infusion reactions.

It is very important that you receive all doses of this medicine. Try to keep all scheduled appointments. If you miss a dose, your medicine will not be usable. Your doctor will work with you to schedule a new appointment at the cell collection center. You may also get a new appointment for your infusion.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. Your doctor will do blood tests to make sure that sipuleucel-T is working properly and to check for unwanted effects.

This medicine may cause fever; chills; dizziness; fast heartbeat; joint pain; nausea and vomiting; shortness of breath; troubled breathing; or unusual tiredness or weakness within a few hours after you receive it. Check with your doctor or nurse right away if you have any of these symptoms.

Call your doctor right away if you start to have a cough, weight loss, fever, or redness or pain at the infusion or collection sites. These may be signs that you have an infection.

Check with your doctor right away if you have chest pain or discomfort, dizziness, fainting, pounding or rapid pulse, or fast, slow, or uneven heartbeat. These maybe symptoms of a heart rhythm problem.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine 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:

More common

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 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:

More common

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

Less common

Shakiness in the legs, arms, hands, or feet

trembling or shaking of the hands or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.