Sipuleucel-T
Sipuleucel-T (PROVENGE) is an autologous cellular immunotherapy used to treat certain types of prostate cancer. It is designed to stimulate the patient's own immune system to recognize and attack cancer cells expressing prostatic acid phosphatase (PAP), an antigen commonly found on prostate cancer cells.
An individualized immunotherapy that harnesses the patient's immune cells to target prostate cancer.
Key facts at a glance
- ATC
- L03AX17
- RxNorm
- 997261
- Generic
- Sipuleucel-T
- Class
- atc-l03
- Brands
- Provenge
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- injection
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
7 groupspregnancy
generalavoid if possible
avoid use during pregnancy unless potential benefits justify potential risks to fetus; drug not intended for use in women
regular fetal monitoring if used
Use with caution and monitor for adverse effects.
lactation
generalnot recommended
avoid breastfeeding during treatment and for some time after last dose; drug not intended for use in women
no specific monitoring available
pediatric_age
children adolescentsnot applicable
not indicated for use in pediatric populations; contraindicated in patients under 18 years of age
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
elderly 65 and olderno adjustment required
no dosage adjustment needed; monitor for immune-related adverse reactions
routine monitoring for adverse reactions
renal_impairment
mild to moderateno specific adjustment
use with caution; no formal dose adjustment studies conducted
monitor renal function
Use with caution and monitor for adverse effects.
hepatic_impairment
mild to moderateno specific adjustment
use with caution; no formal dose adjustment studies conducted; drug works via autologous immune activation
monitor liver function tests
Use with caution and monitor for adverse effects.
other
immunocompromiseduse with caution
use with caution in immunocompromised patients; may have diminished response to therapy
monitor immune response and for infections
Use with caution and monitor for adverse effects.
Statistics and clinical data
Drug class
Classification as cellular immunotherapy for prostate cancer
FDA approval year
FDA approval information for Sipuleucel-T
Indication
Therapeutic indication for Sipuleucel-T
Mechanism of action
Pharmacological mechanism description
Asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). It is typically used when the cancer has spread beyond the prostate and is no longer responding to hormone therapy.
Sipuleucel-T is manufactured individually for each patient. White blood cells are collected from the patient and exposed to a recombinant protein (PAP linked to GM-CSF) that activates antigen-presenting cells. These activated cells are then infused back into the patient to stimulate an immune response against PAP-expressing prostate cancer cells.
Each treatment requires leukapheresis and subsequent infusion, typically given in three cycles about two weeks apart. Common side effects may include infusion-related reactions, chills, fatigue, fever, and joint ache. As an individualized therapy, it cannot be stored or used for other patients.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy