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Provenge

Last reviewed on RxList: 6/14/2019
Provenge Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 6/14/2019

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. Common side effects of Provenge include chills, fatigue, fever, back pain, nausea, joint ache, body aches, and headache.

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. Provenge may interact with other cancer medicines, steroids, or medicines to prevent rejection of a transplanted organ. Tell your doctor all medications and supplements you use. Provenge is not recommended for use by women, so it is unlikely to be used during pregnancy or breastfeeding.

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.

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Provenge Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection or within the first 24 hours afterward. Tell your caregiver if you feel tired, dizzy, nauseated, light-headed, feverish, chilled, or have fast heartbeats, trouble breathing, a severe headache, or pounding in your neck or ears.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • racing or irregular heartbeats;
  • signs of infection--fever, pain or redness where a needle was placed for blood cell collection or infusion;
  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), vision problems, slurred speech;
  • signs of a blood clot deep in the body--pain, swelling, warmth, or discoloration in an arm or leg; or
  • signs of a blood clot in the lung--chest pain that gets worse with deep breathing, shortness of breath.

Common side effects may include:

  • fever, chills, tiredness;
  • back pain;
  • nausea;
  • headache; or
  • joint pain.

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.

Read the entire detailed patient monograph for Provenge (Sipuleucel-T Suspension for Intravenous Infusion)

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Provenge Professional Information

SIDE EFFECTS

The most common adverse reactions reported in clinical trials (≥ 15% of patients receiving PROVENGE) were chills, fatigue, fever, back pain, nausea, joint ache, and headache.

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 group (n = 303) received non-activated autologous peripheral blood mononuclear cells. Patients received 3 infusions of PROVENGE or control every other week over a period of 4 weeks.

Almost all (98.3%) patients in the PROVENGE group and 96% in the control group reported an adverse event. 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% 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% 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 [ see WARNINGS AND PRECAUTIONS], 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 nonmetastatic 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 PROVENGE

  PROVENGE
(N= 601)
Control*
(N = 303)
All Grades
n (%)
Grade 3-5
n (%)
All Grades
n (%)
Grade 3-5
n (%)
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 group received non-activated autologous peripheral blood mononuclear cells.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of PROVENGE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Nervous system disorders: syncope, transient ischemic attack, strokes [see WARNINGS AND PRECAUTIONS]
  • Vascular disorders: hypotension [see WARNINGS AND PRECAUTIONS]
  • Cardiovascular disorders: myocardial infarction [see WARNINGS AND PRECAUTIONS]
  • Thromboembolic disorders: deep venous thrombosis and pulmonary embolism [see WARNINGS AND PRECAUTIONS]

Read the entire FDA prescribing information for Provenge (Sipuleucel-T Suspension for Intravenous Infusion)

Related Resources for Provenge

Read the Provenge User Reviews »

© Provenge Patient Information is supplied by Cerner Multum, Inc. and Provenge Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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