• Prostate and other male cancers

Provenge Generic Name & Formulations

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


Provenge Indications


Asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.

Provenge Dosage and Administration


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.


Not applicable.

Provenge Contraindications

Not Applicable

Provenge Boxed Warnings

Not Applicable

Provenge 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


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


If product sterility tests indicate microbial contamination, manufacturer will contact physician (tests are incomplete at time of infusion).

Provenge Patient Counseling

See Literature