FULL PRESCRIBING INFORMATION

PROVENGE: IMMUNOTHERAPY IN A MONTH1

Treatment process can be completed in 6 appointments throughout the course of about a month.

PROVENGE immunotherapy process

PROVENGE treatment process overview

PROVENGE immunotherapy process overview
1.

A venous assessment is ordered by the prescribing practitioner.

2.

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

3.

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.

4.

The first PROVENGE infusion is given approximately 3 days later.

Steps 2 to 4 are repeated 2 more times.

Day 1
Cell Collection
Step 1. Cell collection
In the days leading up to his cell-collection appointment, your patient should
Stay hydrated by drinking more water than usual
Eat calcium-rich foods, such as dairy products and leafy greens, or take supplements
On the day of his appointment your patient should
Avoid caffeinated beverages.
Eat a hearty meal within 4 hours of his appointment
Wear loose-fitting clothes, with sleeves that can be raised above the elbow
Bring a current photo ID
Consider arranging transportation to and from the procedure
Day 3 or 4
Infusion
Step 2. PROVENGE infusion
The infusion of PROVENGE will take place at your office or at a PROVENGE Treatment Center. Infusion takes about 1 hour, followed by 30 minutes of postinfusion monitoring.
Your patient should:
Wear loose-fitting clothes, with sleeves that can be raised above the elbow
Bring a current photo ID
Step 3: Treatment follow-up
After 3 cycles, the patient’s treatment with PROVENGE is complete
Your patient will receive a Patient Care Kit to help him feel as comfortable as possible throughout his treatment with PROVENGE.

PATIENT EDUCATION

Several resources can introduce your patients to PROVENGE and help them understand the important role that personalized immunotherapy with PROVENGE can play in their treatment journey.

DOWNLOAD THE PROVENGE TREATMENT GUIDE:

IN ENGLISH >>
IN SPANISH >>

DOWNLOAD THE PATIENT BROCHURE:

IN ENGLISH >>
IN SPANISH >>

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)?

What are the American Urological Association (AUA) recommendations for PROVENGE?

What are the Society for Immunotherapy of Cancer (SITC) recommendations for PROVENGE?

When was PROVENGE approved by the FDA?

Who manufactures PROVENGE?

What is immunotherapy?

Where can I find full Prescribing Information for PROVENGE?

Where can I find an overview of PROVENGE for physicians?

Where can I find an overview of PROVENGE for patients?

What is the efficacy benefit of PROVENGE?

What is the safety profile of PROVENGE?

What is leukapheresis?

REIMBURSEMENT SUPPORT SERVICES FAQ

What is the reimbursement coverage for PROVENGE?

Is there support for patients receiving PROVENGE?

Rapid benefits verification

How do I become a PROVENGE Treatment Center?

Treatment information FAQ

Which patients may be appropriate for PROVENGE?

How does PROVENGE affect prostate-specific antigen (PSA) level?

How long is the PROVENGE treatment process?

INDICATION

PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.

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.

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.

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.

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 has not been studied. Concurrent use of immune-suppressive agents may alter the efficacy and/or safety of PROVENGE.

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.

Click here for full Prescribing Information.