Provenge Generic Name & Formulations
Legal Class
Rx
General Description
Sipuleucel-T (autologous CD54+ cells activated with PAP-GM-CSF); minimum 50 million cells/dose; susp for IV infusion.
Pharmacological Class
Autologous cellular immunotherapy.
How Supplied
Patient-specific bag (250mL)—1
Manufacturer
Provenge Indications
Indications
Asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.
Provenge Dosage and Administration
Adult
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.
Children
Not applicable.
Provenge Contraindications
Not Applicable
Provenge Boxed Warnings
Not Applicable
Provenge Warnings/Precautions
Warnings/Precautions
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.
Provenge Pharmacokinetics
See Literature
Provenge Interactions
Interactions
May be antagonized by concomitant chemotherapy or immunosuppressive therapy.
Provenge Adverse Reactions
Adverse Reactions
Infusion reactions (eg, chills, fever, respiratory events, GI upset, hypertension, tachycardia), fatigue, back pain, joint ache, headache.
Provenge Clinical Trials
See Literature
Provenge Note
Notes
If product sterility tests indicate microbial contamination, manufacturer will contact physician (tests are incomplete at time of infusion).
Provenge Patient Counseling
See Literature