Sipuleucel-T (Intravenous)

Sipuleucel-T is also known under US brand name, Provenge. It is a drug that is used in the treatment of particular strands of advanced prostate cancer.


Sipuleucel-T is a medication that is used to treat certain strands of advanced prostate cancer. Sipuleucel-T is a type of vaccine that is created from your own immune system cells. It works by causing your immune system to attack the cancer cells in the prostate. Your own white blood cells are used to prepare sipuleucel-T, so a procedure to remove them is required. This medication is only available via prescription from your doctor and is available in the dosage form: suspension for injection.

Conditions Treated

  • Metastatic prostate carcinoma

Type of Medicine

  • Suspension for injection

Side Effects

Along with its intended effects, the use of Sipuleucel-T can produce some unwanted side effects which could be severe. Side effects are listed below in terms of urgency.

You should inform your doctor or a healthcare professional immediately if you experience any of the side effects listed below whilst taking sipuleucel-T:

  • Bladder pain
  • Cloudy or bloody urine
  • Swelling or bloating of the arms, face, feet, hands or lower legs
  • Chills
  • Body pains or aches
  • Chest pain
  • Burning, or painful urination
  • Confusion
  • Diarrhea
  • Cough
  • Difficulty with speaking
  • Ear congestion
  • Double vision
  • Difficulty with breathing
  • Frequent urge to urinate
  • Fever
  • General feeling of illness or discomfort
  • Inability to move the legs, arms or facial muscles
  • Headache
  • Inability to speak
  • Loss of appetite
  • Joint pain
  • Loss of voice
  • Muscle pains and aches
  • Lower side or back pain
  • Nasal congestion
  • Pale skin
  • Nausea
  • Rapid weight gain
  • Shivering
  • Runny nose
  • Slow speech
  • Shortness of breath
  • Sore throat
  • Sneezing
  • Sweating
  • Tingling in the feet or hands
  • Tightness in the chest
  • Trouble sleeping
  • Unusual weakness or tiredness
  • Troubled breathing with exertion
  • Unusual bruising or bleeding
  • Unusual weight loss or gain
  • Wheezing
  • Vomiting

If you experience any of the following side effects listed below, they usually do not require urgent medical attention. However, if you find they are bothering your day-to-day life, then contact a health care professional or your doctor for advice on ways to prevent or reduce the effects. If you have any queries or questions then contact a healthcare professional or ask your local pharmacist for advice.

More common:

  • Back pain
  • Decreased weight
  • Crawling, burning, itching, numbness, "pins and needles", prickling or tingling feelings
  • Dizziness
  • Loss or lack of strength
  • Feeling of warmth
  • Muscle ache
  • Loss of appetite
  • Muscle spasms
  • Bone or muscle pain
  • Rash on body
  • Neck pain
  • Redness of the neck, face, arms, and occasionally, upper chest
  • Sudden sweating
  • Sleeplessness
  • Unexplained weight loss
  • Unable to sleep

Less common:

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

Remember that you can report all side effects to the FDA on 1-800-FDA-1088.


The specific dose of Sipuleucel-T that you will receive will depend on a number of factors. These include your age, weight and height, your previous medical history, the severity of your condition and your reaction to the first dosage you are given. The following dosage guidelines are typical of usual treatment.

  • The typical dose for adults with prostate cancer is three complete doses given at around two-week intervals. The drug is infused intravenously over a period of sixty minutes.
  • Approximately three days prior to each infusion, peripheral blood mononuclear cells must be obtained from patients. This process is known as leukapheresis. The collected blood cells are then mixed with a protein to ensure they are ready for infusion.
  • Approximately thirty minutes proper to administration, patients should be orally given medication with an antihistamine and acetaminophen. This is to lessen the risk of acute infusion reactions.
  • At least thirty minutes following each infusion, patients should be observed for acute infusion reactions.
  • Sipuleucel-T is solely intended for autologous use.
  • Sipuleucel-T is only for IV use; a cell filter should not be used.
  • If acute infusion reactions occur, two precautions should be taken.
  • Slow or interrupt the infusion depending on the severity of the reaction, and administer appropriate medical treatment as needed.
  • You should not resume an interrupted infusion if the infusion bag will be at room temperature for more than three hours.


Interactions can happen between drugs which cause unwanted side effects, some of which could be fatal. Below are the most common interactions. You should inform your doctor or health care professional with a list of all the current and past medications you have taken. This is including herbal remedies and vitamins. You should also inform them of any past and current illnesses you suffer from and any family medical history. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

There are over 190 known drugs that have a moderate reaction with sipuleucel-T. Some of these are listed below.

You should inform your doctor if you are taking any of the following medications:

  • Abacavir / zidovudine / lamivudine
  • Abemaciclib
  • Abatacept
  • Adalimumab
  • Aldesleukin
  • Alemtuzumab
  • Alefacept
  • Altretamine
  • Anti-thymocyte globulin (rabbit)
  • Anakinra
  • Asparaginase erwinia chrysanthemi
  • Atezolizumab
  • Asparaginase escherichia coli
  • Azacitidine
  • Basiliximab
  • Azathioprine
  • Belatacept
  • Belinostat
  • Belimumab
  • Bendamustine
  • Bexarotene
  • Betamethasone
  • Bleomycin
  • Bortezomib
  • Blinatumomab
  • Bosutinib
  • Brigatinib
  • Brentuximab
  • Brodalumab
  • Busulfan
  • Bupivacaine / triamcinolone / lidocaine
  • Canakinumab
  • Cabazitaxel
  • Carboplatin
  • Capecitabine
  • Carfilzomib
  • Certolizumab
  • Carmustine
  • Cisplatin
  • Clofarabine
  • Cladribine
  • Cobimetinib
  • Chlorambucil
  • Corticorelin
  • Copanlisib
  • Cortisone
  • Corticotropin
  • Cosyntropin
  • Cyclosporine
  • Cyclophosphamide
  • Cytarabine liposomal / daunorubicin liposomal
  • Cytarabine
  • Daclizumab
  • Dacarbazine
  • Dactinomycin
  • Dasatinib
  • Daratumumab
  • Daunorubicin liposomal
  • Daunorubicin
  • Deflazacort
  • Decitabine
  • Denileukin diftitox
  • Lidocaine/ dexamethasone
  • Dexamethasone
  • Dimethyl fumarate
  • Durvalumab
  • Doxorubicin
  • Docetaxel
  • Doxorubicin liposomal
  • Efalizumab
  • Dupilumab
  • Epirubicin
  • Elotuzumab
  • Eribulin
  • Etoposide
  • Etanercept
  • Floxuridine
  • Everolimus
  • Fludarabine
  • Fluorouracil
  • Gemcitabine
  • Fludrocortisone
  • Gemtuzumab
  • Guselkumab
  • Golimumab
  • Rituximab/ hyaluronidase
  • Hydrocortisone
  • Ibritumomab
  • Hydroxyurea
  • Ibrutinib
  • Idelalisib
  • Idarubicin
  • Ifosfamide
  • Imatinib
  • Inotuzumab ozogamicin
  • Infliximab
  • Interferon alfa-2a/2b
  • Lamivudine / zidovudine
  • Leflunomide
  • Lenalidomide
  • Mechlorethamine
  • Letrozole / ribociclib
  • Methotrexate
  • Mercaptopurine
  • Methylprednisolone
  • Midostaurin
  • Melphalan
  • Mitoxantrone
  • Mitomycin
  • Mycophenolate mofetil
  • Muromonab-cd3
  • Natalizumab
  • Mycophenolic acid
  • Nilotinib
  • Nelarabine
  • Ocrelizumab
  • Niraparib
  • Obinutuzumab
  • Ofatumumab
  • Olaratumab
  • Olaparib
  • Omacetaxine
  • Oxaliplatinribociclib
  • Osimertinib
  • Rilonacept
  • Romidepsin
  • Rituximab
  • Sarilumab
  • Ruxolitinib
  • Siltuximab
  • Secukinumab
  • Streptozocin
  • Sirolimus

Disease interactions

There are two known disease interactions. You should inform your doctor if you suffer or have suffered from any of the following diseases below.

Thrombotic/Thromboembolic Disorder

Sipuleucel-T can cause thromboembolism, including pulmonary embolism and deep venous thrombosis. It's recommended that caution is exercised when using this agent in those with risk factors of thromboembolic events. Patients should be closely monitored.

Myocardial Infarction/ Cerebral Vascular Disorder

Vascular disorders that include, cardiovascular and cerebrovascular events have occurred when using sipuleucel-T. It's therefore recommended that caution is exercised when this agent is used in those with risk factors for vascular disorders such as ischemic and hemorrhagic strokes, and myocardial infarctions. Patients should be closely monitored.


  • Before using sipuleucel-T, you should inform your doctor or healthcare professional if you are allergic to it, or if you have suffered allergic reactions to any other drugs, foods, preservatives, dyes, animals etc. Sipuleucel-T may contain inactive ingredients, which could cause an allergic reaction. Speak with your pharmacist for further details.
  • Before using sipuleucel-T, you should inform your pharmacist or doctor of your past medical history, especially if you've had any problems related to lung problems, heart problems, or a history of stroke. This also includes close family history.
  • Before you have surgery, you should inform your doctor about all the various drugs and medication you use, including vitamins, prescription/nonprescription drugs, and herbal remedies.
  • Sipuleucel-T is not recommended for women.
  • You should visit your doctor regularly as they will do regular blood tests to ensure the medication is working as it should. They will also test for unwanted side effects.
  • Sipuleucel-T may cause chills, fever, dizziness, increased heartbeat, nausea, joint pain and vomiting, weakness, shortness of breath, within a few hours after you receive it. Check with a healthcare professional or your doctor immediately if you experience any of the above symptoms.


The infusion bag should be mixed gently and re-suspended manually to disperse any small clumps of cellular material that exist. It should also remain in the insulated polyurethane container and the lid of the insulated container shouldn't be opened until it is time to administer the medication. Once the infusion bag is removed from its insulated container, it needs to remain in room temperate for no longer than three hours. It cannot be administered if it has gone beyond this time threshold.


If used correctly sipuleucel-T is successful in the treatment of various types of prostate cancer. The effective use of the medication in those under the age of 18 has not been established. A trained health professional will administer this medicine in a hospital and it is given through a needle placed in one of your veins. The medication is given slowly, so the needle will remain in place for one hour. To avoid any interactions and unwanted side effects, inform your doctor of all the medications you are currently taking and if you suffer from any current illnesses. It's important that you don't miss any doses of this drug as it will reduce its effectiveness. Speak with your doctor for instructions if you miss an appointment in your sipuleucel-T infusion schedule.

Last Reviewed:
January 30, 2018
Last Updated:
January 27, 2018
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