Sipuleucel-T Injection
Sipuleucel-T is a personalized immune therapy used intravenously to treat asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Sipuleucel-T Injection: Patient Information Guide
A plain-language walkthrough of Sipuleucel-T Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Sipuleucel-T is an ingredient-level immunotherapy. Here is the full set of supported uses based on the available product evidence:
- Provenge (intravenous): Treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer — prostate cancer that has spread and no longer responds to standard hormone therapy, but is not yet causing significant symptoms
⚙️How it works▾
Provenge works by harnessing your own immune system. Before each dose, a sample of your white blood cells — specifically antigen-presenting cells (APCs), which act like messengers to the immune system — is collected through a procedure called leukapheresis. In the lab, those cells are exposed to a fusion protein called PAP-GM-CSF. PAP (prostatic acid phosphatase) is a protein found on most prostate cancer cells. The lab exposure activates the APCs, teaching them to display fragments of PAP on their surface. When infused back into your body, these trained cells may help stimulate T cells and antibody responses targeting PAP-expressing cancer cells. The precise mechanism linking this immune activation to clinical benefit is not fully understood.
💊How it's taken▾
Provenge is given as an intravenous infusion — into a vein — over about 60 minutes per session. The full treatment course is 3 infusions, each about 2 weeks apart. Each dose is custom-made: roughly 3 days before every infusion, you undergo a leukapheresis procedure to collect your white blood cells. If you miss a scheduled infusion for any reason, you will need another leukapheresis before continuing.
- Take acetaminophen and an antihistamine (like diphenhydramine) by mouth about 30 minutes before each infusion
- Staff will observe you for at least 30 minutes after each infusion
- Follow your care team's instructions exactly — do not adjust the schedule on your own
🤒Side effects — in detail▾
The most common side effects reported in clinical trials (in 15% or more of patients) include:
- Chills — the most frequently reported reaction, occurring in over half of patients
- Fatigue
- Fever
- Back pain
- Nausea
- Joint ache
- Headache
- Vomiting
- Dizziness
- Muscle ache
Most infusion reactions are mild or moderate and resolve within a day or two. However, seek immediate medical attention if you experience severe breathing difficulty, fainting, chest pain, signs of stroke, or any sign of serious infection — especially if you have a central venous catheter.
⚠️Warnings & precautions▾
- Infusion reactions: More than 70% of patients experience some reaction — chills, fever, fatigue, nausea — within a day of infusion. Severe reactions occurred in about 3.5% of patients. Patients with heart or lung conditions need extra monitoring.
- Blood clots: Deep vein thrombosis (leg clots) and pulmonary embolism (lung clots) have occurred following infusion. Use with caution if you have risk factors for clotting.
- Stroke and cardiovascular events: Cerebrovascular events (including strokes and mini-strokes) and heart attacks have been observed in patients after infusion. Most patients had other pre-existing risk factors.
- Chemotherapy or immune-suppressing drugs: Using these at the same time as Provenge has not been studied and may affect how well Provenge works or how safe it is.
- Infection risk: Provenge is not screened for all transmissible diseases. If you have a central venous catheter, watch for signs of infection.
🔀What it interacts with▾
The FDA label for Provenge does not identify specific drug interactions, but there is one important caution to be aware of:
- Chemotherapy and immunosuppressive drugs (e.g., systemic corticosteroids): Using these at the same time as Provenge — or during the leukapheresis procedure — has not been studied. Because Provenge works by stimulating the immune system, drugs that suppress the immune system could potentially reduce its effectiveness or change its safety profile. Talk to your doctor before starting, stopping, or changing any other medications.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Heart or lung conditions: You will need closer monitoring during and after each infusion due to risk of cardiovascular reactions.
- History of blood clots: Tell your doctor if you have had deep vein thrombosis, pulmonary embolism, or other clotting problems — Provenge should be used with caution.
- Immunosuppressive or chemotherapy drugs: Tell your doctor about all medications you take — concurrent use with Provenge has not been studied.
- Central venous catheter: If you need a catheter for treatment, be alert for signs of infection including sepsis.
- Older adults: About 73% of patients in clinical trials were 65 or older — no differences in safety were identified compared to younger patients, so age alone is not a reason to avoid treatment.
- Provenge has no listed contraindications — there are no groups who absolutely must not receive it based on the current label.
🚑If you take too much▾
Each Provenge infusion contains the maximum number of cells that can be manufactured from a single leukapheresis session — so the dose cannot exceed what your own body provided. There are no known cases of overdose from a single infusion or a full course of Provenge therapy.
📡Pharmacodynamics — effects in the body▾
Provenge is designed to activate the immune system against PAP (prostatic acid phosphatase), a protein expressed on most prostate cancer cells. In clinical studies, patients who received Provenge developed measurable antibody responses (IgM and IgG) against the PAP-GM-CSF fusion protein and PAP antigen, as well as T cell responses, which persisted through follow-up. However, the clinical significance of these immune responses — that is, exactly how they connect to patient outcomes — has not been established.
📦How to store it▾
temperature of PROVENGE until infusion.
📄 Written from Sipuleucel-T Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Sipuleucel-T Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Provenge, and how is it different from regular cancer drugs? ▾
What should I expect during and after each infusion? ▾
How many treatments will I need, and how does the scheduling work? ▾
Are there any serious side effects I should watch out for after I leave the clinic? ▾
Can I keep taking my other medications while I'm on Provenge? ▾
I'm in my 70s — is Provenge safe for older patients? ▾
When was Sipuleucel-T Injection first available? ▾
💬 Answers drafted from Sipuleucel-T Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Sipuleucel-T Injection comes
Sipuleucel-T Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Provenge is used intravenously to treat asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer
- Provenge is infused intravenously over approximately 60 minutes; do not use a cell filter during infusion
- Provenge is given as 3 complete doses at approximately 2-week intervals
- Before each Provenge infusion, take acetaminophen and an antihistamine (such as diphenhydramine) by mouth about 30 minutes beforehand to reduce infusion reaction risk
- Confirm your identity matches the patient identifiers on the Provenge infusion bag before infusion begins
📊 Sipuleucel-T Injection across the U.S. market
How Sipuleucel-T Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
🔍 Compare Sipuleucel-T Injection products
A representative set of FDA-listed product records for Sipuleucel-T Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 50000000 1 | Intravenous | Dendreon Pharmaceuticals LLC | BLA | View NDC → |
| 50000000 1-Jan | Intravenous | Dendreon Pharmaceuticals LLC | BLA | View NDC → |
| SIPULEUCEL-T 50000000 1 | Intravenous | Dendreon Pharmaceuticals LLC | BLA | View NDC → |
Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Sipuleucel-T Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Sipuleucel-T Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Sipuleucel-T Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Sipuleucel-T Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 997261 1 dose form · 1 strength
-
Dose form (SCDF) Injection RxCUI 1726181In current FDA listingsClinical drug / strength (SCD) 250 ML sipuleucel-T 200000 CELLS/MLRxCUI 997264
Look up RxCUI 997261 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Sipuleucel-T Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Sipuleucel-T Injection belongs to the Autologous Cellular Immunotherapy class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Dendreon Pharmaceuticals LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.