"The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for"...
Provenge Side Effects Center
Medical Editor: Melissa Conrad Stöppler, MD
Provenge (sipuleucel-T) suspension for intravenous infusion is a preparation made from the patient's own immune cells that is used for the treatment of prostate cancer. The most common side effects with Provenge are chills, fatigue, fever, back pain, nausea, joint ache, and headache. No studies of drug interactions have been performed with Provenge. Patients should inform their doctors of heart problems, lung problems, and history of stroke.
Provenge is given in three intravenous infusions (into the veins), about two weeks apart. Each infusion takes about 60 minutes. Following each infusion, patients will be monitored for at least 30 minutes.
Since Provenge is made from patients' own immune cells, cells will be collected approximately three days before each scheduled infusion of Provenge. Patients will need to go to a cell collection center for this collection. The collection is called "leukapheresis" (pronounced loo-kuh-fuh-REE-sis). Collected cells are sent to a special manufacturing center where they are mixed with a protein to make them ready for infusion.
Our Provenge Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Provenge in Detail - Patient Information: Side Effects
Some people receiving a sipuleucel-T injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, tired, or nauseated, or if you have fever, chills, joint pain, severe headache, blurred vision, buzzing in your ears, anxiety, confusion, vomiting, chest pain, fast or uneven heartbeats, wheezing, chest tightness, or trouble breathing. These side effects may occur during the injection or within the first 24 hours after your infusion.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any other serious side effect, such as:
- redness, swelling, oozing, or other signs of infection where the IV needle was placed; or
- signs of infection around the veins your cells were collected from.
Less serious side effects may include:
- back pain;
- mild nausea;
- headache; or
- mild body aches.
Read the entire detailed patient monograph for Provenge (Sipuleucel-T Suspension for Intravenous Infusion)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Provenge Overview - Patient Information: Side Effects
Symptoms of an infusion reaction that may occur during sipuleucel-T treatment include chills, tiredness, fever, nausea, vomiting, shortness of breath, fast/irregular heartbeat, and joint pain. Tell your health care professional right away if you have any of these symptoms during or after receiving your treatment. Your doctor will have you monitored closely and may slow the infusion or temporarily stop your treatment if a severe reaction occurs.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: weakness on one side of the body, confusion, slurred speech.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Provenge (Sipuleucel-T Suspension for Intravenous Infusion)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Provenge FDA Prescribing Information: Side Effects
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety evaluation of PROVENGE is based on 601 prostate cancer patients in the PROVENGE group who underwent at least 1 leukapheresis procedure in four randomized, controlled clinical trials. The control was non-activated autologous peripheral blood mononuclear cells.
Almost all (98.3%) patients in the PROVENGE group and 96.0% in the control group reported an adverse event. The most common adverse events, reported in patients in the PROVENGE group at a rate ≥ 15%, were chills, fatigue, fever, back pain, nausea, joint ache, and headache. In 67.4% of patients in the PROVENGE group, these adverse events were mild or moderate in severity. Severe (Grade 3) and life-threatening (Grade 4) adverse events were reported in 23.6% and 4.0% of patients in the PROVENGE group compared with 25.1% and 3.3% of patients in the control group. Fatal (Grade 5) adverse events were reported in 3.3% of patients in the PROVENGE group compared with 3.6% of patients in the control group. The most common ( ≥ 2%) Grade 3-5 adverse events reported in the PROVENGE group were back pain and chills.
Serious adverse events were reported in 24.0% of patients in the PROVENGE group and 25.1% of patients in the control group. Serious adverse events in the PROVENGE group included acute infusion reactions [see WARNINGS AND PRECAUTIONS], cerebrovascular events, and single case reports of eosinophilia, rhabdomyolysis, myasthenia gravis, myositis, and tumor flare.
PROVENGE was discontinued in 1.5% of patients in Study 1 due to adverse events. Some patients who required central venous catheters for treatment with PROVENGE developed infections, including sepsis. A small number of these patients discontinued treatment as a result. Monitoring for infectious sequelae in patients with central venous catheters is recommended.
Each dose of PROVENGE requires a standard leukapheresis procedure approximately 3 days prior to the infusion. Adverse events that were reported ≤ 1 day following a leukapheresis procedure in ≥ 5% of patients in controlled clinical trials included citrate toxicity (14.2%), oral paresthesia (12.6%), paresthesia (11.4%), and fatigue (8.3%).
Table 1 provides the frequency and severity of adverse events reported in ≥ 5% of patients in the PROVENGE group of randomized, controlled trials of men with prostate cancer. The population included 485 patients with metastatic castrate resistant prostate cancer and 116 patients with non-metastatic androgen dependent prostate cancer who were scheduled to receive 3 infusions of PROVENGE at approximately 2-week intervals. The population was age 40 to 91 years (median 70 years), and 90.6% of patients were Caucasian.
Table 1: Incidence of Adverse Events Occurring in ≥ 5%
of Patients Randomized to PROVENCE
|All Grades n (%)||PROVENCE
(N = 601)
(N = 303)
|Any Adverse Event||591 (98.3)||186 (30.9)||291 (96.0)||97 (32.0)|
|Chills||319 (53.1)||13 (2.2)||33 (10.9)||0 (0.0)|
|Fatigue||247 (41.1)||6(1.0)||105 (34.7)||4(1.3)|
|Fever||188 (31.3)||6(1.0)||29 (9.6)||3 (1.0)|
|Back pain||178 (29.6)||18(3.0)||87 (28.7)||9 (3.0)|
|Nausea||129 (21.5)||3 (0.5)||45 (14.9)||0 (0.0)|
|Joint ache||118 (19.6)||11(1.8)||62 (20.5)||5(1.7)|
|Headache||109 (18.1)||4(0.7)||20 (6.6)||0 (0.0)|
|Citrate toxicity||89 (14.8)||0 (0.0)||43 (14.2)||0 (0.0)|
|Paresthesia||85 (14.1)||1 (0.2)||43 (14.2)||0 (0.0)|
|Vomiting||80 (13.3)||2 (0.3)||23 (7.6)||0 (0.0)|
|Anemia||75 (12.5)||11(1.8)||34(11.2)||7 (2.3)|
|Constipation||74 (12.3)||1 (0.2)||40 (13.2)||3 (1.0)|
|Pain||74 (12.3)||7(1.2)||20 (6.6)||3 (1.0)|
|Paresthesia oral||74 (12.3)||0 (0.0)||43 (14.2)||0 (0.0)|
|Pain in extremity||73 (12.1)||5 (0.8)||40 (13.2)||1 (0.3)|
|Dizziness||71 (11.8)||2 (0.3)||34(11.2)||0 (0.0)|
|Muscle ache||71 (11.8)||3 (0.5)||17 (5.6)||0 (0.0)|
|Asthenia||65 (10.8)||6(1.0)||20 (6.6)||2 (0.7)|
|Diarrhea||60 (10.0)||1 (0.2)||34(11.2)||3 (1.0)|
|Influenza-like illness||58 (9.7)||0 (0.0)||11(3.6)||0 (0.0)|
|Musculoskeletal pain||54 (9.0)||3 (0.5)||31 (10.2)||3 (1.0)|
|Dyspnea||52 (8.7)||11(1.8)||14 (4.6)||3(1.0)|
|Edema peripheral||50 (8.3)||1 (0.2)||31 (10.2)||1 (0.3)|
|Hot flush||49 (8.2)||2 (0.3)||29 (9.6)||1 (0.3)|
|Hematuria||46 (7.7)||6(1.0)||18(5.9)||3 (1.0)|
|Muscle spasms||46 (7.7)||2 (0.3)||17 (5.6)||0 (0.0)|
|Hypertension||45 (7.5)||3 (0.5)||14 (4.6)||0 (0.0)|
|Anorexia||39 (6.5)||1 (0.2)||33 (10.9)||3 (1.0)|
|Bone pain||38 (6.3)||4 (0.7)||22 (7.3)||3 (1.0)|
|Upper respiratory tract infection||38 (6.3)||0 (0.0)||18 (5.9)||0 (0.0)|
|Insomnia||37 (6.2)||0 (0.0)||22 (7.3)||1 (0.3)|
|Musculoskeletal chest pain||36 (6.0)||2 (0.3)||23 (7.6)||2 (0.7)|
|Cough||35 (5.8)||0 (0.0)||17 (5.6)||0 (0.0)|
|Neck pain||34 (5.7)||3 (0.5)||14 (4.6)||2 (0.7)|
|Weight decreased||34 (5.7)||2 (0.3)||24 (7.9)||1 (0.3)|
|Urinary tract infection||33 (5.5)||1 (0.2)||18 (5.9)||2 (0.7)|
|Rash||31 (5.2)||0 (0.0)||10 (3.3)||0 (0.0)|
|Sweating||30 (5.0)||1 (0.2)||3 (1.0)||0 (0.0)|
|Tremor||30 (5.0)||0 (0.0)||9 (3.0)||0 (0.0)|
|* Control was non-activated autologous peripheral blood mononuclear cells.|
In controlled clinical trials, cerebrovascular events, including hemorrhagic and ischemic strokes, were observed in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in the control group.
Read the entire FDA prescribing information for Provenge (Sipuleucel-T Suspension for Intravenous Infusion)
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