pharmacopeia
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Mechanism of action

Sourced from openFDA

PROVENGE is classified as an autologous cellular immunotherapy. While the precise mechanism of action is unknown, PROVENGE is designed to induce an immune response targeted against PAP, an antigen expressed in most prostate cancers.

Indications

Sourced from openFDA
  • PROVENGE ® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer. PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.ICD-10: C61

Contraindications

Sourced from openFDA
  • None. None.contraindicated

Dosage & administration

Sourced from openFDA

For autologous use only. For intravenous use only. For autologous use only. For intravenous use only. Administer 3 doses at approximately 2-week intervals. ( 2.1 ) Premedicate patients with oral acetaminophen and an antihistamine such as diphenhydramine. ( 2.2 ) Before infusion, confirm that the patient's identity matches the patient identifiers on the infusion bag. ( 2.2 ) Infuse PROVENGE intravenously over a period of approximately 60 minutes. Do Not Use a Cell Filter. ( 2.2 ) Interrupt or slow infusion for acute infusion reactions, depending on the severity of the reaction. ( 2.2 ) 2.1 Dose Each dose of PROVENGE contains a minimum of 50 million autologous CD54 + cells activated with PAP-GM-CSF [ see Description ( 11 ) ]. The recommended course of therapy for PROVENGE is 3 complete doses, given at approximately 2-week intervals. In controlled clinical trials, the median dosing interval between infusions was 2 weeks (range 1 to 15 weeks); the maximum dosing interval has not been established. If, for any reason, the patient is unable to receive a scheduled infusion of PROVENGE, the patient will need to undergo an additional leukapheresis procedure prior to continuing a course of treatment. Advise patients of this possibility prior to initiating treatment. 2.2 Administration Do not use PROVENGE until confirmation of product release is received from Dendreon. Dendreon will send the Final Product Disposition Notification form containing the patient identifiers, expiration date and time, and the disposition status (approved for infusion or rejected), to the infusion site.

Warnings & precautions

Sourced from openFDA

Acute infusion reactions may occur. If reactions occur, decrease the rate or stop the infusion and administer appropriate medical treatment. ( 5.1 ) Syncope and hypotension have also been observed. Closely monitor patients with cardiac or pulmonary conditions. ( 5.1 ) PROVENGE should be used with caution in patients with risk factors for thromboembolic events. ( 5.2 ) PROVENGE is not tested for transmissible infectious diseases and may transmit diseases to health care professionals handling the product. Universal precautions should be followed. ( 5.4 ) Concomitant use of chemotherapy and immunosuppressive medications with PROVENGE has not been studied. ( 5.5 ) 5.1 Acute Infusion Reactions Acute infusion reactions (reported within 1 day of infusion) may occur and include nausea, vomiting, fatigue, fever, rigor or chills, respiratory events (dyspnea, hypoxia, and bronchospasm), syncope, hypotension, hypertension, and tachycardia. Acute infusion reactions (reported within 1 day of infusion) may occur and include nausea, vomiting, fatigue, fever, rigor or chills, respiratory events (dyspnea, hypoxia, and bronchospasm), syncope, hypotension, hypertension, and tachycardia. In controlled clinical trials, 71.2% of patients in the PROVENGE group developed an acute infusion reaction. The most common events (≥ 20%) were chills, fever, and fatigue. In 95.1% of patients reporting acute infusion reactions, the reactions were mild or moderate. Fevers and chills generally resolved within 2 days (71.9% and 89%, respectively).

Adverse reactions

Sourced from openFDA

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. The most common adverse reactions (incidence ≥ 15%) are chills, fatigue, fever, back pain, nausea, joint ache, and headache. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Dendreon Pharmaceuticals LLC at 1-877-336-3736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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.

Use in specific populations

Sourced from openFDA

8.5 Geriatric In controlled clinical trials, 72.9% of patients (438 of 601) in the PROVENGE group were ≥ 65 years of age. There were no apparent differences in the safety of PROVENGE between patients ≥ 65 years of age and younger patients. In a survival analysis of the controlled clinical trials of PROVENGE in metastatic castrate-resistant prostate cancer, 78.3% of randomized patients (382 of 488) were ≥ 65 years of age. The median survival of patients in the PROVENGE group ≥ 65 years of age was 23.4 months (95% confidence interval 22.0, 27.1), compared with 17.3 months in the control group (95% confidence interval: 13.5, 21.5). 8.6 Race In controlled clinical trials, 90.6% of patients were Caucasian, 5.8% were African American, and 3.7% were “Other”. Due to the low numbers of non-Caucasian patients in the trials, no conclusions can be made regarding the safety or efficacy of PROVENGE by race.

Overdosage

Sourced from openFDA

Each PROVENGE infusion comprises the maximum number of cells that can be manufactured from a single leukapheresis procedure. The number of cells in PROVENGE does not exceed the number of cells collected from the leukapheresis. There are no known instances of overdosage from either a single infusion or a full course of therapy with PROVENGE.

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
5,578 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Chills5289.5%
  2. 2Infusion Related Reaction4538.1%
  3. 3Fatigue3596.4%
  4. 4Pyrexia2955.3%
  5. 5Malaise2835.1%
  6. 6Nausea2674.8%
  7. 7Asthenia2544.6%
  8. 8Disease Progression2494.5%
  9. 9Vomiting2013.6%
  10. 10Culture Positive1923.4%
  11. 11Back Pain1893.4%
  12. 12Dizziness1873.4%
  13. 13Ill-defined Disorder1853.3%
  14. 14Fall1763.2%
  15. 15Urinary Tract Infection1592.9%

Clinical trials

View JSON

The 10 most recently updated of 46 ClinicalTrials.gov registrations naming Sipuleucel-t as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Sipuleucel-t work?
PROVENGE is classified as an autologous cellular immunotherapy. While the precise mechanism of action is unknown, PROVENGE is designed to induce an immune response targeted against PAP, an antigen expressed in most prostate cancers.
What is Sipuleucel-t used for?
According to FDA labeling, Sipuleucel-t carries indications including: PROVENGE ® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer. PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Sipuleucel-t?
Sipuleucel-t is classified as Other immunostimulants, Autologous Cellular Immunotherapy, Cell-mediated Immunity, Increased Immunologic Activity.
What are the brand names for Sipuleucel-t?
Sipuleucel-t is marketed under brand names including Provenge.
What are the contraindications for Sipuleucel-t?
Sipuleucel-t labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.
Note. Data for sipuleucel-t is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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