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Treatment Name: Sipuleucel-t (Provenge®)

Sipuleucel-t (Provenge®) is a Treatment Regimen for Prostate Cancer

How does Sipuleucel-t work?
The exact way Sipuleucel-t works is unknown. However, Sipuleucel-t is thought to assist in treating prostate cancer by helping your immune system recognize the prostate cancer cells. A patient’s cells are collected by a process called leukapheresis, and then activated in a laboratory. Once the cells are activated, they are delivered to an outpatient infusion center and given to the patient by I.V. infusion.

Goals of therapy:
Sipuleucel-t is given I.V. to activate the immune system to help fight prostate cancer. Sipuleucel-t has been shown to improve survival time, but is not commonly given with the goal of curing prostate cancer.

Schedule

  • A minimum of 50 million activated cells are infused every two weeks for three doses. Sipuleucel-t is usually infused over one hour in an outpatient infusion center, allowing the person to go home afterwards

Estimated total infusion time for this treatment:

  • Up to 2 total hours when including pre-medications
  • Infusion times are based on clinical studies, but may vary depending on doctor preference or patient tolerability. Pre-medications and intravenous (I.V.) fluids, such has hydration, may add more time

Side Effects

In clinical studies, the most commonly reported side effects with Sipuleucel-T are shown here:

Side effect videos Side Effect Videos
Fatigue Fatigue PainPainNausea and VomitingNausea and VomitingAnemiaAnemiaDiarrheaDiarrheaConstipationConstipation

Monitoring

How often monitoring needed?
Labs (blood tests) may be checked before each treatment. Labs often include: Complete Blood Count (CBC), and Comprehensive Metabolic Panel (CMP), plus any others your doctor may order.

How often is imaging needed?
Imaging may be checked before treatment and as determined by your physician.

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue chemotherapy as planned, or delay or switch therapy.

ChemoExperts Tips

  • The delivery of Sipuleucel-t is typically by airplane to most U.S. cities the morning of infusion, then by a delivery truck to the infusion center. This may add wait time for the patient to get started. The manufacturer (laboratory) will send a FAX to the pharmacy the morning of delivery confirming shipment of the medication. Delays can occur due to airline traffic and street traffic depending on where the infusion center is located in relation to the airport
  • This product is not tested for transmissible infectious diseases.  All persons handling the bag and its contents should use universal precautions
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for myeloma. Ask your doctor if any studies are currently enrolling in your area or go to clinicaltrials.gov and search “prostate cancer” to find other centers offering study medications

Patient Assistance & Co-payment Coverage

Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Sipuleucel-t (Provenge®), we have provided links that may help.

Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Sipuleucel-t (Provenge®). Depending upon your income, they may be able to help cover the cost of:

  • Sipuleucel-t

For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.

  • If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.

Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Sipuleucel-t (Provenge®) and are the best source to help you understand drug cost.

  • Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.

Emotional Wellness

What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.

Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.

Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.

Learn more about pursuing emotional wellness while receiving treatment with Sipuleucel-t (Provenge®)

Individual Drug Label Information

Sipuleucel-t (Provenge®)

  • Sipuleucel-t is an intravenous infusion
  • Is slightly pink to yellow/orange in color
  • Contents of the infusion bag should be manually mixed gently. Small clumps in the infusion bag should disperse after mixing
  • The medication should be used within 3 hours after removing it from the insulated container
  • Patient should be observed for at least 30 minutes after each infusion for any reactions 
General Sipuleucel-t (Provenge) Side Effects

Reactions during infusion
  • chills
  • fatigue
  • back pain
  • fever
  • nausea
  • joint pain
  • vomiting
  • headache
  • dizziness
  • shortness of breath
  • low or high blood pressure
  • high heart rate
  • muscle aches
Blood clotting events
  • DVT (deep vein thrombosis), and PE (pulmonary embolism), and heart attacks (M.I.’s) can occur but are rare
Bleeding disorders
  • strokes from bleeding in the brain have occurred in a small number of patients
Click on the Sipuleucel-t (Provenge) package insert below for reported side effects and possible drug interactions

Side Effect Videos
DiarrheaDiarrheaFatigue Fatigue ConstipationConstipationPainPainAnemiaAnemia

See DailyMed package insert.

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References

Kantoff PW, Higano CS, Shore ND, et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010;363:411-422.

Created: December 16, 2015 Updated: January 18, 2016

What is Prostate Cancer?

A disease of the cells found in the prostate gland in men.  Prostate cancer is a common condition caused by abnormal growth and rate changes in the prostate gland cells that form tumors.  The stage of prostate cancer can vary at diagnosis and throughout treatment.  The staging includes both the TNM + Grade, which is based on exam of tissue removed by surgery, and clinical staging: Stage I, IIa, IIb, III, IV.  The effectiveness of the treatment may depend upon the stage at diagnosis.

NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

What is leukapheresis?

A procedure done in a laboratory or infusion center where a person's blood is drawn out through an I.V. and the white blood cells are separated and collected by a machine, then the rest of the blood is infused back into the patient's body.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium