Sipuleucel-T

Indications

Sipuleucel-T is used for: Prostate Cancer, Autologous cellular immunotherapy indicated for asymptomatic or minimally symptomatic prostate cancer with metastases that is resistant to standard hormone treatment

Adult Dose

Prostate Cancer Autologous cellular immunotherapy indicated for asymptomatic or minimally symptomatic prostate cancer with metastases that is resistant to standard hormone treatment Administer 3 doses (>50 million autologous CD54+ activated cells/dose) IV at approximately 2-week intervals (median dosing interval, 2 week; range, 1-15 week) Infuse IV over 60 min

Child Dose

Renal Dose

Administration

IV Administration Do not initiate IV infusion of expired product Do not use cell filter during IV infusion Premedicate with acetaminophen PO and an antihistamine (eg, diphenhydramine) to minimize risk of infusion reaction Before IV infusion, confirm patient’s identity matches patient identifiers on infusion bag Infuse IV over 60 min

Contra Indications

Precautions

Intended solely for autologous use Acute infusion reactions have been observed (decrease infusion rate or stop infusion if severe, and administer supportive therapy) Monitor patient for 30 min following infusion Closely monitor if cardiac or pulmonary conditions coexist Since preparation is autologous in nature, it is not routinely tested for transmissible infectious diseases and may transmit diseases to healthcare professionals handling the product (follow universal precautions) Use with concomitant chemotherapy and immunosuppressive medications has not been studied Because of the autologous nature of product preparation, adhering to the personalized leukapheresis and infusion schedules is important

Pregnancy-Lactation

Pregnancy Category: N/A Lactation: N/A

Interactions

Adverse Effects

Side effects of Sipuleucel-T : >10% Chills (53.1%) Fatigue (41.1%) Fever (31.3%) Back pain (29.6%) Nausea (21.5%) Joint ache (19.6%) Headache (18.1%) Citrate toxicity (14.8%) Paresthesia (14.1%) Vomiting (13.3%) Anemia (12.5%) Constipation (12.3%) Pain (12.3%) Paresthesia oral (12.3%) Pain in extremity (12.1%) Dizziness (11.8%) Muscle ache (11.8%) 1-10% Asthenia (10.8%) Diarrhea (10%) Influenza-like illness (9.7%) Musculoskeletal pain (9%) Dyspnea (8.7%) Peripheral edema (8.3%) Hot flush (8.2%) Hematuria (7.7%) Muscle spasms (7.7%) Hypertension (7.5%) Anorexia (6.5%) Bone pain (6.3%) Upper respiratory tract infection (6.3%) Insomnia (6.2%) Musculoskeletal chest pain (6%) Cough (5.8%) Neck pain (5.7%) Weight loss (5.7%) Urinary tract infection (5.5%) Rash (5%) Sweating (5%) Tremor (5%)

Mechanism of Action

Autologous cellular immunotherapy; induces immune response targeted against PAP, an antigen expressed in most prostate cancers