Provenge
Asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC).
3 doses administered IV at approximately 2-week intervals
Each dose is preceded by a leukapheresis procedure approximately 3 days before
Pre-medication: Acetaminophen 650 mg + diphenhydramine 50 mg PO approximately 30 minutes before infusion
Infusion time: Approximately 60 minutes
Do NOT use a cell filter. Do NOT irradiate.
Cell suspension for IV infusion in a patient-specific infusion bag (minimum 50 × 10⁶ autologous CD54+ cells activated with PAP-GM-CSF)
None listed.
- Infusion Reactions: Acute infusion reactions (71%), mostly Grade 1-2 (chills, fever, fatigue). Grade 3 in 3.5%. Pre-medicate.
- Cerebrovascular Events: In 3.5% (vs 2.6% control). Includes hemorrhagic and ischemic stroke.
- Handling Precautions: Product is autologous — verify patient identity. Do not use if bag leaks or clumps cannot be dispersed.
Chills (53%), fatigue (41%), fever (31%), back pain (30%), nausea (22%), joint ache (20%), headache (18%), citrate toxicity (from leukapheresis, 15%), paresthesia (from leukapheresis, 14%), vomiting (13%), anemia (11%), constipation (10%)
Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.
Sipuleucel-T is an autologous cellular immunotherapy. Patient's peripheral blood mononuclear cells (including antigen-presenting cells, APCs) are collected via leukapheresis and cultured ex vivo with a recombinant fusion protein (PA2024) consisting of prostatic acid phosphatase (PAP) linked to granulocyte-macrophage colony-stimulating factor (GM-CSF). During culture, APCs take up and process the PAP-GM-CSF fusion protein, becoming activated. The activated APCs are infused back into the patient, where they present PAP antigen to T cells, stimulating a targeted immune response against PAP-expressing prostate cancer cells.
Not applicable — autologous cell therapy. No traditional PK parameters. Immune response (measured by T-cell proliferation and IFN-γ ELISPOT against PAP) increases with successive doses. Antibody responses to PAP-GM-CSF and PAP detected in majority of treated patients.
Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.
- IMPACT — Sipuleucel-T vs. placebo in metastatic castration-resistant prostate cancer. Phase III, n=512.