Provenge - Sipuleucel-T injection

What is this medication?

SIPULEUCEL-T (SI pu LOO sel - tee) is a vaccine for the treatment of prostate cancer. It is made from cells in your immune system.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Provenge

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

  • heart disease
  • lung or breathing disease, like asthma
  • an unusual or allergic reaction to sipuleucel-T, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medication?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting. This medicine is made from your own immune cells. Your cells will be collected at a cell collection center approximately 3 days before each infusion of this medicine. Your collected cells are then sent to a special center where they are mixed with a protein to get them ready for your infusion.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment. If you miss an appointment for your infusion of this medicine, your dose will not be able to be used.

What may interact with this medication?

  • medicines that suppress your immune system like some medicines for cancer
  • steroid medicines like prednisone or cortisone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Report any side effects that you notice during your treatment right away, such as changes in your breathing, fever, or chills. These may also occur after your infusion.

Tell your doctor or health care professional if you have any other reaction or unusual symptom after getting this medicine.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • breathing problems
  • chest pain or palpitations
  • dizziness
  • fast,irregular heartbeat
  • fever
  • nausea, vomiting

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • back pain
  • fatigue
  • headache
  • joint pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This drug is only given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

© 2024 Elsevier/Gold Standard (2017-01-19 00:00:00)


Additional Information From Chemocare.com About Provenge

Self-Care Tips:

  • Each infusion of Provenge is preceded by a leukapheresis procedure 3 days before the vaccine infusion.  It is critical that you follow the given appointment schedule and arrive at each appointment on time, as there are expiration times for each vaccine product made, which cannot be adjusted, changed, or exceeded.  If you are unable to receive the prepared Provenge infusion, you will need to undergo the entire leukapheresis procedure again. 
  • Follow the preparation instructions for the leukapheresis procedures.  (See leukapheresis section below).
  • Prior to your first leukapheresis procedure, you will be assessed to determine if you have adequate ‘venous access’ (meaning will your veins support intravenous catheters) to support both the leukapheresis procedure and the Provenge infusions. If there is concern that the veins in your arms will not support the leukapheresis procedure and the Provenge infusions, you may need a central venous catheter placed. If a central line is necessary, you will be instructed how to care for the line, will have arrangements made to have it flushed regularly to keep it from developing a clot that would close it off, and will also be instructed on the signs to look for indicating that it may have become infected. 
  • Get plenty of rest.
  • Maintain good nutrition.
  • It is important to report signs and symptoms of acute infusion reactions such as fever, chills, fatigue, breathing problems, dizziness, high blood pressure, nausea, vomiting, headache, or muscle aches.

If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.


When to contact your doctor or health care provider:

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

  • Fever of 100.4° F (38° C) or higher
  • Breathing problems
  • Severe headache
  • Signs of a cerebrovascular event (stroke) such as one-sided weakness, confusion, slurred speech, and/or facial droop.

The following symptoms require medical attention, but are not necessarily an emergency. Contact your health care provider within 24 hours of noticing any of the following:

  • Nausea (interferes with ability to eat and unrelieved with prescribed medication)
  • Severe chills
  • Dizziness
  • Unusually high blood pressure
  • Vomiting (more than 4-5 episodes in 24 hours)
  • Significant muscle aches
  • Any symptoms of irregular heartbeat (such as chest pain, shortness of breath, palpitations)

Always inform your health care provider if you experience any unusual symptoms.


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