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PROVENGE Experience

PROVENGE Experience

Treatment plan Mon through Fri

PROVENGE: Immunotherapy treatment can be completed in about a month.

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

PROVENGE treatment overview

venous assessment being ordered

1. A venous assessment is ordered by the prescribing practitioner.

cell collection

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

cells are cultured

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.

PROVENGE infusion being given

4. The first PROVENGE infusion is given approximately 3 days later.

Steps 2 to 4 are repeated 2 more times.

PROVENGE process

Step 1:

Cell Collection

In the days leading up to his cell-collection appointment, your patient should:

  • Get the venous assessment before the first cell collection appointment
  • 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

Your patient will receive a Patient Care Kit to help him feel as comfortable as possible throughout his treatment with PROVENGE.

cell collection icon

Step 2:

PROVENGE Infusion

The infusion of PROVENGE will take place at your healthcare provider’s office or infusion 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
PROVENGE infusion icon

Step 3:

Treatment Follow-Up

After 3 cycles of leukapharesis and infusion, the patient’s treatment with PROVENGE will be complete.

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Answers to frequently asked PROVENGE questions

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.

Full Prescribing Information.

To report an adverse event, please email our Pharmacovigilance department at drugsafety@dendreon.com, or fax adverse event details to 833-464-0123. Please provide details pertaining to the adverse event and provide contact information so that our Pharmacovigilance team may contact you with any questions.
To report a product complaint, email our Quality department at CQAcomplaints@dendreon.com. Please provide details pertaining to the quality issue and provide contact information so that our Quality team may contact you with any questions.
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