
PROVENGE: IMMUNOTHERAPY IN A MONTH1
Treatment process can be completed in 6 appointments throughout the course of about a month.

PROVENGE treatment process overview

A venous assessment is ordered by the prescribing practitioner.

The first cell collection is taken prior to the first dose of PROVENGE.

Autologous cells are cultured with PAP-GM-CSF at a Dendreon facility to produce each dose of PROVENGE.
PAP=prostatic acid phosphatase.
GM-CSF=granulocyte-macrophage colony-stimulating factor.

The first PROVENGE infusion is given approximately 3 days later.
Steps 2 to 4 are repeated 2 more times.

Cell Collection


Infusion





FOR PROVENGE TREATMENT-PROCESS SUPPORT,
VISIT Dendreon On Call >>
PATIENT EDUCATION


The video below was created to help patients prepare for leukapheresis

FINANCIAL RESOURCES AND
REIMBURSEMENT ASSISTANCE
Dendreon On Call offers comprehensive support for you and your
PROVENGE patients






Dendreon On Call provides comprehensive support to your practice and your patients
Dedicated case managers provide enrollment support, benefit verification, and streamlined initiation of therapy and more

ANSWERS TO FREQUENTLY ASKED PROVENGE QUESTIONS (FAQ)
What is PROVENGE?
What are the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommendations for sipuleucel-T (PROVENGE)?
Sipuleucel-T (PROVENGE) is a prominent category 1 recommendation1,a
NCCN Guidelines® recommend considering sipuleucel-T (PROVENGE) as a first-line, preferred treatment option with a prominent category 1 designation in asymptomatic and minimally symptomatic mCRPC patients.
Sipuleucel-T (PROVENGE) is also a category 2A recommendation1,b
NCCN Guidelines also recommend considering sipuleucel-T (PROVENGE®) as a preferred second-line treatment option after abiraterone or enzalutamide. Treatment with sipuleucel-T (PROVENGE) does not preclude the use of subsequent therapies.1,2
bBased upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
References:
What are the American Urological Association (AUA) recommendations for PROVENGE?
In mCRPC patients who are asymptomatic or minimally symptomatic, clinicians may offer sipuleucel-T. In sequencing agents, clinicians should consider prior treatment and consider recommending therapy with an alternative mechanism of action (Evidence Level: Grade B).
Reference: Cookson MS, Roth BJ, Dahm P, et al. Castration-resistant prostate cancer: AUA guideline.
What are the Society for Immunotherapy of Cancer (SITC) recommendations for PROVENGE?
The current evidence-based recommendation for the use of sipuleucel-T (PROVENGE) in the management of mCRPC in asymptomatic or minimally symptomatic patients is supported by Level A evidence from randomized trials and meta-analyses. Sipuleucel-T (PROVENGE) may achieve greater benefit among mCPRC patients treated earlier in the course of the disease.
Reference: McNeel DG, Bander NH, Beer TM, et al. The Society for Immunotherapy of Cancer consensus statement on
immunotherapy for the treatment of prostate carcinoma.
When was PROVENGE approved by the FDA?
The US Food & Drug Administration approved PROVENGE on April 29, 2010.
Who manufactures PROVENGE?
PROVENGE is manufactured by Dendreon Pharmaceuticals, LLC, headquartered in Seal Beach, California. Dendreon is a commercial-stage biopharmaceutical company and pioneer in the development of treatments that harness the power of the immune system to extend life. Dendreon’s flagship product, PROVENGE® (sipuleucel-T), was the first FDA-approved immunotherapy to be made from a patient’s own immune cells. Nearly 40,000 men with advanced prostate cancer have been prescribed PROVENGE in the United States since 2010. For more information, please visit www.dendreon.com.
LEARN MORE ABOUT DENDREON >>What is immunotherapy?
Immunotherapy is a treatment that empowers the immune system to identify and fight foreign substances such as cancer and other diseases. PROVENGE is a personalized immunotherapy for men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). PROVENGE is made by culturing a patient’s own immune cells with a recombinant protein that is prostate specific. When infused into the patient, PROVENGE activates resting T cells to target and attack prostate cancer.
Reference: PROVENGE [prescribing information]. Seal Beach, CA: Dendreon Pharmaceuticals LLC; 2017.
LEARN MORE ABOUT PROVENGE AS IMMUNOTHERAPY >>Where can I find full Prescribing Information for PROVENGE?
Where can I find an overview of PROVENGE for physicians?
On this website, you can find information about PROVENGE survival data, mechanism of action, and safety profile.
Where can I find an overview of PROVENGE for patients?
A PROVENGE treatment brochure and video were created for men who are considering treatment with PROVENGE. Your patients may find it helpful to review the brochure with you or a member of your staff. You may also direct your patients to the PROVENGE website for patients.
DOWNLOAD THE PROVENGE TREATMENT GUIDE : IN ENGLISH >> IN SPANISH >>
Watch the PROVENGE Patient-Consult Video >>What is the efficacy benefit of PROVENGE?
PROVENGE may help extend life for certain men with mCRPC. Men who receive PROVENGE when their prostate-specific antigen (PSA) level is lower may live longer.

aMedian overall survival in all quartiles of the PROCEED Registry (PSA <5.27 ng/mL, 47.7 months; PSA ≥5.27-≤15.08 ng/mL, 33.2 months; PSA >15.08-≤46 ng/mL, 27.2 months; PSA >46 ng/mL, 18.4 months). Individual results may vary.
bPROCEED was a registry without a control group; all patients received PROVENGE. Patients may have received subsequent anti-cancer interventions per the local investigator’s standard of care.

cThis post hoc analysis was not powered for statistical significance, and the population within the subgroups was not randomized. Therefore, the findings are limited by their exploratory nature.
dMedian overall survival improvement was found in all quartiles of the post hoc analysis (PSA ≤22.1 ng/mL, 13.0 months; PSA >22.1-50.1 ng/mL: 7.1 months, PSA >50.1-134.1 ng/mL, 5.4 months; PSA >134.1 ng/mL: 2.8 months). Individual results may vary.
What is the safety profile of PROVENGE?
The most common side effects of PROVENGE are generally mild to moderate and well tolerated. In IMPACT, the pivotal clinical trial, 1.5% of patients discontinued treatment with PROVENGE due to adverse events.1
IMPORTANT SAFETY INFORMATION
Acute Infusion Reactions: Acute infusion reactions (reported within 1 day of infusion) may occur and include nausea, vomiting, fatigue, fever, rigor or chills, respiratory events (dyspnea, hypoxia, and bronchospasm), syncope, hypotension, hypertension, and tachycardia.1
Thromboembolic Events: Thromboembolic events, including deep venous thrombosis and pulmonary embolism, can occur following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events. PROVENGE should be used with caution in patients with risk factors for thromboembolic events.1
Vascular Disorders: Cerebrovascular events (hemorrhagic/ischemic strokes and transient ischemic attacks) and cardiovascular disorders (myocardial infarctions) have been reported following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events.1
Handling Precautions: PROVENGE is not tested for transmissible infectious diseases.
Concomitant Chemotherapy or Immunosuppressive Therapy: Chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE have not been studied. Concurrent use of immune-suppressive agents may alter the efficacy and/or safety of PROVENGE.1
Adverse Reactions: The most common adverse reactions reported in clinical trials (≥15% of patients receiving PROVENGE) were chills, fatigue, fever, back pain, nausea, joint ache, and headache.1
Adverse events experienced by patients receiving PROVENGE can generally be managed in the outpatient setting. PROVENGE does not require dosage adjustments, monitoring of liver/kidney functions, or concomitant steroids.

Reference: PROVENGE [prescribing information]. Seal Beach, CA: Dendreon Pharmaceuticals LLC; 2017.
LEARN MORE ABOUT THE SAFETY PROFILE OF PROVENGE >>What is leukapheresis?
Leukapheresis is a cell-collection procedure performed at a local blood center. During a leukapheresis procedure, blood is drawn from a patient and is passed through a machine that removes a small portion of immune cells, along with some platelets and red blood cells. The machine returns the rest of the blood to the patient.
Prior to the first leukapheresis procedure, a venous assessment must be conducted by the prescribing practitioner to determine whether the patient’s veins can accommodate the procedure. If they cannot, placement of a central venous catheter (CVC) may be necessary. In IMPACT, the pivotal clinical trial for PROVENGE, 23% of patients received CVCs. 1
Following leukapheresis, the immune cells will be sent to a Dendreon manufacturing facility to be made into a dose of PROVENGE for the patient. Once the personal dose of PROVENGE is completed, it is tranported to the patient's local infusion center and infused back into the patient.
The autologous treatment cycle occurs 2 additional times over the course of about a month.
Reference:
1. Data on file. Dendreon, LLC.

REIMBURSEMENT SUPPORT SERVICES FAQ
What is the reimbursement coverage for PROVENGE?
Automatic crossover with supplement.
These plans generally adhere to the Medicare-allowable (fee schedule) listed at CMS.gov
In addition, Dendreon provides support services to help facilitate treatment with PROVENGE. These services focus on patient assistance, supporting the reimbursement process, and product support.
Dendreon On Call (DOC) is a resource for healthcare professionals seeking to use PROVENGE for their patients. DOC reimbursement coordinators and Dendreon Corporate Account Managers provide support with the reimbursement process, and local Regional Market Access Managers are available.
Learn more about PROVENGE reimbursement resources here, or call Dendreon On Call at 877-366-3736.
Is there support for patients receiving PROVENGE?
Dendreon is committed to helping every patient who is eligible for treatment with PROVENGE.
Contact Dendreon On Call to learn more about:
Valuable patient assistance programs

Support for patients
covered by Medicare

Co-pay assistance
Eligibility for PROvideTM commercial co-pay assistance is determined by Dendreon. Check with individual foundations for eligibility criteria

Support for uninsured or rendered uninsured patientsc
Eligibility criteria are determined by Dendreon

Support for patients covered by Medicare

Co-pay assistance
Eligibility for PROvideTM commercial co-pay assistance is determined by Dendreon. Check with individual foundations for eligibility criteria

Support for uninsured or rendered uninsured patientsc
Eligibility criteria are determined by Dendreon
Rapid benefits verification
Once you initiate enrollment, Dendreon On Call will complete benefits verification and patient assistance eligibility checks within 48 hours.a
How do I become a PROVENGE Treatment Center?
Help your patients in their fight against advanced prostate cancer by becoming a PROVENGE Treatment Center and personally administering their PROVENGE treatment.
Visit Dendreon On Call online or call 877-336-3736 to learn more.

Treatment information FAQ
Which patients may be appropriate for PROVENGE?
PROVENGE is indicated for certain men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC).1
Consider PROVENGE if your patient1:
- 1. Has progressed despite treatment with hormone therapy
- 2. Has testosterone levels <50 ng/dL1
- 3. Has confirmed metastatic disease
- 4. Does not take narcotics for cancer-related pain
Treatment with sipuleucel-T (PROVENGE) does not preclude the use of subsequent therapies.2