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Sipuleucel T

Side Effects

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.

Precautions

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.

Proper Use

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.

Before Using

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.

Pediatric

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.

Geriatric

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

Breastfeeding

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.

Drug Interactions

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.

Description

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.