Generic Name and Formulations:
Sipuleucel-T (autologous CD54+ cells activated with PAP-GM-CSF); minimum 50 million cells/dose; suspension for IV infusion.
Indications for PROVENGE:
Asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.
Autologous use only. Obtain product release from manufacturer, match patient identity on product and Cell Product Disposition form, check expiration date and time on product before infusing. Premedicate 30 minutes before infusion with acetaminophen and antihistamine. Give three doses at 2-week intervals. For each dose: give entire contents of bag by IV infusion over 60 minutes; do not use filter; do not use if clumps do not disperse with gentle mixing. Observe patient for at least 30 minutes after infusion. May interrupt or slow infusion if acute transfusion reaction occurs; do not restart if product at room temp for >3 hours.
Cardiac or pulmonary conditions. Each dose requires a standard leukapheresis procedure about 3 days before infusion. If scheduled infusion is missed, do an additional leukapheresis procedure if treatment course is to be continued. Risk of disease transmission. Pregnancy, lactation: not applicable.
Autologous cellular immunotherapy.
May be antagonized by concomitant chemotherapy or immunosuppressive therapy.
Infusion reactions (eg, chills, fever, respiratory events, GI upset, hypertension, tachycardia), fatigue, back pain, joint ache, headache.
If product sterility tests indicate microbial contamination, manufacturer will contact physician (tests are incomplete at time of infusion).
Patient-specific bag (250mL)—1