PROVENGE Warnings and Precautions

People who have heart disease or a history of a stroke may not be able to safely receive PROVENGE. Other important safety precautions to be aware of include warnings of potential drug interactions and an increased risk for having a stroke. Make sure to contact your healthcare provider if you develop confusion, numbness or weakness, or a sudden, severe headache.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to receiving PROVENGE® (sipuleucel-T) if you have:
Also, let your healthcare provider know if you are:
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Precautions and Warnings With PROVENGE

Some warnings and precautions to be aware of prior to receiving PROVENGE include the following:
  • In clinical trials, 71.2 percent of people receiving the PROVENGE infusion developed reactions, including chills, fever, and fatigue (see PROVENGE Side Effects for a more complete list). The reactions generally occurred within one day of receiving the infusion. Most problems were mild to moderate in severity; however, some required hospitalization. Fever and chills usually went away within two days.
  • Your PROVENGE dose is created specifically for you, from your white blood cells. It cannot be used for anyone else.
  • It is important to keep all of your appointments during treatment, and to arrive at each appointment on time. This medication is only usable for a short period of time after it is made from your white blood cells. If you miss a dose, you will need another leukapheresis procedure (the procedure that separates the white blood cells from your blood).
  • You should know that your prostate-specific antigen (PSA) levels might not change during treatment. This does not mean the medication is not working.
  • Make sure you know how to prepare for your leukapheresis procedure. Ask your healthcare provider if you are unsure. This procedure is an important part of PROVENGE treatment.
  • If your healthcare provider cannot adequately access a vein (blood vessel) near the surface of your skin (usually on your arm), you may need a central venous catheter (CVC). A CVC is a long, thin, hollow tube that is placed into a large vein, usually in the upper chest or arm. The CVC stays in place for your entire treatment period, and will require special care by you to help prevent it from becoming infected.
  • There were reports of strokes occurring in some men during the PROVENGE clinical trials. Contact your healthcare provider immediately if you experience signs of a stroke (see Stroke Symptoms), such as:
    • A sudden, severe headache
    • One-sided face, arm, or leg numbness or weakness
    • Confusion.
  • It is unknown if PROVENGE passes through breast milk. However, this medicine should not be used in breastfeeding women, as it is only approved for use in men (see PROVENGE and Breastfeeding).
  • There is no information on the use of PROVENGE during pregnancy. However, PROVENGE is not approved for use in women (see PROVENGE and Pregnancy).
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