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
Side 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%)
Mode of Action
Autologous cellular immunotherapy; induces immune response targeted against PAP, an antigen expressed in most prostate cancers