Provenge (sipuleucel-t) is a brand-name drug that’s prescribed for prostate cancer in certain situations. As with other drugs, Provenge can cause side effects, such as infusion reactions.

Provenge can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are just a few of the more common side effects reported by people who took Provenge in clinical trials:

* For more information about this side effect, see “Side effect specifics.”

Mild side effects can occur with Provenge use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Provenge’s prescribing information.

Mild side effects that have been reported with Provenge include:

  • anemia
  • mild infusion reactions*, including chills, fever, or fatigue
  • constipation
  • dizziness
  • headache
  • nausea
  • pain, including back or joint pain
  • paresthesia (numbness, burning, or tingling in your extremities)
  • vomiting

These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews the side effects of the medication. If you develop a side effect while taking Provenge and want to tell the FDA about it, visit MedWatch.

* For more information about this side effect, see “Side effect specifics.”

Provenge may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Provenge’s prescribing information.

If you develop serious side effects while taking Provenge, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects that have been reported and their symptoms include:

  • stroke, including transient ischemic attack or ministroke, which may include symptoms such as:
    • numbness or weakness, especially on one side of your body
    • vision problems in one or both eyes
    • difficulty speaking, walking, or understanding speech
  • heart attack, which may include symptoms such as:
    • a sensation of crushing, pressure, tightness, or squeezing in your chest
    • pain in your chest, which may spread to your arms, jaw, neck, or back
    • a sweaty and clammy feeling
  • blood clots*
  • severe infusion reactions*

* For more information about this side effect, see “Side effect specifics.”

ALLERGIC REACTION

For some people, Provenge can cause an allergic reaction. But this side effect wasn’t reported in the drug’s studies.

In general, symptoms of allergic reaction can be mild or serious.

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Provenge, your doctor may recommend taking a different medication instead.

Learn more about some of the side effects that Provenge may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Provenge.

Infusion reactions

Infusion reactions were the most common side effect reported in studies of Provenge. Infusion reactions caused by Provenge may be mild or serious.

Infusion reactions are symptoms that happen after receiving your Provenge infusion. (Provenge is given by intravenous (IV) infusion by a healthcare professional.) These reactions may occur during your infusion or shortly after your infusion.

Infusion reactions reported with Provenge include:

In studies, severe reactions were most likely to occur after the second Provenge infusion. (Treatment with Provenge typically consists of three separate infusions.)

Certain factors can increase your risk of this side effect with Provenge, including having a heart condition such as high blood pressure or a breathing or lung condition such as asthma.

What you can do

Provenge is given as an IV infusion by a healthcare professional. Before the infusion, they’ll likely give you medications to lower the risk of infusion reactions. Usually, these medications include acetaminophen (Tylenol) and an antihistamine such as diphenhydramine (Benadryl).

Your healthcare team will monitor you closely during and immediately after your infusion. If you develop symptoms of an infusion reaction, they’ll slow or stop your Provenge infusion. They’ll also monitor you for at least 30 minutes after your infusion ends. Depending on your symptoms, they may also prescribe a treatment for your reactions.

Blood clots

Blood clots can happen after receiving a Provenge infusion. It’s not clear how often this side effect happened in studies of Provenge.

Blood clots reported with Provenge include deep vein thrombosis and pulmonary embolism. Symptoms of a blood clot can include:

  • pain, swelling, and warmth on your affected limb
  • red or discolored skin on your affected limb
  • difficulty breathing
  • chest pain that worsens when coughing or taking a deep breath
  • rapid breathing
  • increased heart rate

Certain factors can increase your risk of this side effect with Provenge, including having a heart problem, such as heart disease, or smoking tobacco.

What you can do

If you think you’re having symptoms of a blood clot after receiving Provenge, get immediate medical attention. Call 911 or go to the closest emergency room.

Before taking Provenge, discuss your health history with your doctor. Provenge may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

  • lung or breathing condition, such as asthma
  • heart problem, such as heart disease
  • stroke in the past
  • tobacco use
  • previous allergic reaction to this or a similar drug
  • pregnancy
  • breastfeeding
  • alcohol consumption

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.