Label: PROVENGE- sipuleucel-t injection

  • NDC Code(s): 30237-8900-5, 30237-8900-6
  • Packager: Dendreon Pharmaceuticals LLC
  • Category: CELLULAR THERAPY
  • DEA Schedule: None
  • Marketing Status: Biologic Licensing Application

Drug Label Information

Updated October 10, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use PROVENGE - ® (sipuleucel-T) safely and effectively. See full prescribing information for PROVENGE. PROVENGE - ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    PROVENGE - ® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant ...
  • 2 DOSAGE AND ADMINISTRATION
    For autologous use only. For intravenous use only. 2.1 Dose - Each dose of PROVENGE contains a minimum of 50 million autologous CD54 - + cells activated with ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Each dose of PROVENGE contains a minimum of 50 million autologous CD54 - + cells activated with PAP-GM-CSF, suspended in 250 mL of Lactated Ringer's Injection, USP ...
  • 4 CONTRAINDICATIONS
    None.
  • 5 WARNINGS AND PRECAUTIONS
    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 ...
  • 6 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. 6.1 Clinical ...
  • 7 DRUG INTERACTIONS
  • 8 USE IN SPECIFIC POPULATIONS
    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 ...
  • 10 OVERDOSAGE
    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 ...
  • 11 DESCRIPTION
    PROVENGE (sipuleucel-T) is an autologous cellular immunotherapy available as a suspension for intravenous infusion. PROVENGE consists of autologous peripheral blood mononuclear cells, including ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - PROVENGE is classified as an autologous cellular immunotherapy. While the precise mechanism of action is unknown, PROVENGE is designed to induce an immune response ...
  • 13 NONCLINICAL TOXICOLOGY
  • 14 CLINICAL STUDIES
    The effect of PROVENGE on patients with metastatic castrate-resistant (hormone-refractory) prostate cancer was studied in three similar randomized, double-blind, placebo-controlled, multicenter ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    PROVENGE is a 250 mL suspension containing a minimum of 50 million autologous CD54 - + cells activated with PAP-GM-CSF in Lactated Ringer's Injection, USP. It is supplied in ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling ( Patient Information). Inform the patient or caregiver about the ...
  • PATIENT PACKAGE INSERT
    PATIENT INFORMATION - PROVENGE® (sipuleucel-T) This leaflet is designed to help you understand treatment with PROVENGE (pronounced PROH-venj). The more you understand your treatment, the better ...
  • PRINCIPAL DISPLAY PANEL
    Principal Display Panel – Carton Label - NDC 30237-8900-6 - sipuleucel-T - PROVENGE - ® RX ONLY FOR AUTOLOGOUS USE ONLY - No U.S. standard of potency - CONTENTS: A minimum of 50 million ...
  • PRINCIPAL DISPLAY PANEL
    Principal Display Panel – Bag Label - NDC 30237-8900-5 - sipuleucel-T - PROVENGE - ® RX ONLY FOR AUTOLOGOUS USE ONLY - No U.S. standard of potency - CONTENTS: A minimum of 50 million ...
  • PRINCIPAL DISPLAY PANEL
    Package Label 2 - sipuleucel-T 250 mL Lot XXXXXX-X - Store Refrigerated 2-8°C DO NOT FREEZE - Expiration Date: DD-MMM-YYYY - Expiration Time: XX:XX Time Zone: First Name MI: Last Name: Date of ...
  • INGREDIENTS AND APPEARANCE
    Product Information