Immune Response

Sustained* immune response and short duration of treatment among patients with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer1

6 month duration

6 months (26 Weeks)

  • *A sustained immune response was seen out to 26 weeks in the pivotal study (the last time point measured). No conclusions could be made regarding the clinical significance of the observed immune responses1
Short duration of treatment
A Sample PROVENGE Schedule

Approximately 1 month

  • PROVENGE is administered in three 1-hour infusions, each preceded by a standard leukapheresis procedure (a standard cell-collection procedure performed at a blood center)
  • The dosing interval ranged from 1 to 15 weeks in controlled clinical trials
  • Apheresis and PROVENGE infusions will be scheduled 2 to 3 days apart and can start on various days of the week
  • Prior to the first leukapheresis procedure, a venous assessment must be done by the prescribing practitioner

REFERENCES:

  1. Provenge [prescribing information]. Seattle, WA: Dendreon Pharmaceuticals; 2014.
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INDICATION

PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.

IMPORTANT SAFETY INFORMATION

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.

Thromboembolic Events: Thromboembolic events, including deep venous thrombosis and pulmonary embolism, can occur following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events. PROVENGE should be used with caution in patients with risk factors for thromboembolic events.

Vascular Disorders: Cerebrovascular events (hemorrhagic/ischemic strokes and transient ischemic attacks) and cardiovascular disorders (myocardial infarctions) have been reported following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events.

Handling Precautions: PROVENGE is not tested for transmissible infectious diseases.

Concomitant Chemotherapy or Immunosuppressive Therapy: Chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied. Concurrent use of immune-suppressive agents may alter the efficacy and/or safety of PROVENGE.

Adverse Reactions: 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.

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