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Precautions and Warnings With Sipuleucel-T

Sipuleucel-T may not be the most appropriate medicine for some people, so make sure your healthcare provider knows if you have heart problems, lung disease, or a history of a stroke. It is also important to tell your healthcare provider about any other medications you are taking. Warnings and precautions with sipuleucel-T also involve potential complications, such as strokes or allergic reactions.

What Should I Tell My Healthcare Provider Before Receiving Sipuleucel-T?

You should talk with your healthcare provider prior to receiving sipuleucel-T (PROVENGE®) 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 Sipuleucel-T Precautions and Warnings

Some warnings and precautions to be aware of prior to receiving this medication include the following:
 
  • In clinical trials, 71.2 percent of people receiving the sipuleucel-T infusion developed reactions, including chills, fever, and fatigue (see Sipuleucel-T 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 sipuleucel-T 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 sipuleucel-T 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 clinical trials for sipuleucel-T. 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 sipuleucel-T 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 sipuleucel-T during pregnancy. However, this medicine is not approved for use in women (see PROVENGE and Pregnancy).
 
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Sipuleucel-T Medication Information

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