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(si-pu-loo-sel) ,


(trade name)


Therapeutic: antineoplastics
Pharmacologic: autologous cellular immunotherapies


Asymptomatic/minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.


Autologous immunotherapy produced by collecting peripheral mononuclear cells during leukapheresis. Cells include antigen presenting cells (APCs), which are activated during a culture period with prostatic acid phosphatase (PAP, an antigen found in prostatic cancer tissue) linked to granulocyte-macrophage colony-stimulating factor (GM-CSF, which activates immune cells). Induces an immune response against prostatic acid phosphatase.

Therapeutic effects

↓ spread of prostate cancer.


Absorption: IV administration results in complete bioavailability.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: Unknown.

Time/action profile



Contraindicated in: None noted.
Use Cautiously in: Intended for autologous use only.

Adverse Reactions/Side Effects

Central nervous system

  • fatigue (most frequent)
  • headache (most frequent)
  • dizziness
  • insomnia


  • dyspnea


  • hypertension
  • peripheral edema


  • constipation
  • diarrhea
  • nausea
  • vomiting


  • hematuria


  • flushing
  • rash
  • sweating


  • anemia


  • back pain (most frequent)
  • joint pain (most frequent)
  • extremity pain
  • muscle spasms
  • musculoskeletal pain


  • paresthesia
  • tremor


  • chills (most frequent)
  • fever (most frequent)
  • acute infusion reactions
  • citrate toxicity


Drug-Drug interaction

Concurrent use of immunosuppressants may alter safety/efficacy.


Intravenous (Adults) One dose every 2 wk for a total of 3 doses.


Suspension for IV infusion: minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF suspended in 250 mL lactated ringer's injection

Nursing implications

Nursing assessment

  • Monitor for signs of acute infusion reaction (fever, chills, dyspnea, hypoxia, bronchospasm, dizziness, nausea, vomiting, fatigue, headache, muscle aches, hypertension, tachycardia), especially patients with cardiac or pulmonary conditions. If signs occur, infusion may be slowed or interrupted, depending on severity of reaction. If infusion must be interrupted, do not resume if infusion bag will be at room temperature for >3 hr. Monitor patient for at least 30 min following each infusion.

Potential Nursing Diagnoses

Deficient knowledge, related to medication regimen (Patient/Family Teaching)


  • Intravenous Administration
  • pH: No Data.
  • Each infusion must be preceded by a leukaphresis procedure approximately 3 days prior. If patient is unable to receive an infusion, patient will need to undergo an additional leukaphresis procedure.
  • Medication is not routinely tested for transmissible infectious diseases. Employ universal precautions in handling leukapheresis material or sipuleucel.
  • Premedicate patient with acetaminophen and an antihistamine (diphenhydramine) 30 min prior to administration to minimize acute infusion reactions.
  • Upon receipt of sipuleucel from manufacturer, open outer cardboard shipping box to verify product and patient-specific labels. Do not remove insulated container from shipping box or open lid of insulated container until patient is ready for infusion. Do not infuse until confirmation of product release has been received from manufacturer.
  • Infusion must begin prior to expiration date and time. Do not infuse expired sipuleucel. Once infusion bag is removed from insulated container, infuse within 3 hr; do not return to shipping container.
  • Intermittent Infusion: Once patient is prepared for infusion and Cell Product Disposition Form has been received, remove infusion bag from insulated container, and inspect bag for leakage. Contents will be slightly cloudy, with cream-to-pink color. Gently mix and re-suspend contents of bag, inspecting for clumps and clots. Small clumps should disperse with gentle manual mixing; do not administer if bag leaks or if clumps remain.
  • Sipuleucel is solely for autologous use. Match patient's identity with the patient identifiers on the Cell Product Disposition Form and infusion bag.
  • Rate: Infuse the entire volume of the bag over 60 min. Do not use a cell filter.

Patient/Family Teaching

  • Explain the purpose of sipuleucel and the importance of maintaining all scheduled appointments, adhering to preparation instructions for leukaphresis procedure to patient.
  • Inform patient that a central venous catheter may be required if adequate peripheral venous access is not available.
  • Advise patient to notify health care professional if fever over 100°F, swelling or redness around catheter site, pain at infusion or collection sites, symptoms of cardiac arrhythmia (chest pains, racing heart, irregular heartbeats), signs of acute infusion reaction, or persistent side effects occur.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products, especially immunosuppressive agents, being taken and consult health care professional before taking any new medications.

Evaluation/Desired Outcomes

  • ↓ in the spread of prostate cancer.
Mentioned in ?
References in periodicals archive ?
Provenge, made by Dendreon of Seattle, does not prevent or cure prostate cancer, which killed 27 000 men in the USA last year and more than 10 000 in the UK in 2008.
Dreicer says, "but hopefully now that we've achieved some level of success with Provenge, others will follow."
One that came to light in May 2007 is a new immunotherapeutic drug, Provenge, which, in spite of apparent clinical benefit, was not approved because of its failure to meet pre-specified endpoints at conventional measures of statistical significance.
But in May, the FDA declined to approve Provenge and asked for more clinical data.
But the treatment, called Provenge, is unlikely to make an early appearance in the UK.
Provenge is the first in a new classification of vaccines known as autologous cellular immunotherapy.
Provenge, based on a treatment called immunotherapy, stimulates the patient's immune system to fight the disease.
Another program, DC-NILV, is designed to stimulate dendritic cells against cancer which is similar in concept to what Seattle-based Dendreon does with its marketed product, sipuleucel-T (Provenge).
These findings suggest that men with mCRPC and visceral spread of their disease can activate their immune cells to produce PROVENGE.
According to Paz, the complex poetic and cultural protocols for the expression of love, dedication, and even desire, trace a trajectory--philosophical, religious, poetic--from Platonism into Arabic Sufi mysticism into the Troubadour poetry of Provenge, and then into Renaissance and Spanish Golden Age literature and culture (Electra Arenal and Amanda Powell also consider the influence of Troubadour poetic conventions that likely conditioned the overt eroticism in Sor Juana poems to the vicereine).
"Nonetheless, February was a busy month for biotech-a flurry of mergers, including Johnson & Johnson's $2.4 billion bid for Scios, were announced; products such as Dendreon's Provenge prostate cancer drug advanced through clinical trials; and the FDA gave its blessing to several new drugs and indications, including Xoma's Raptiva for psoriasis and Biovail's Cardizem for hypertension."
Provenge could turn out to be an additional option for treatment besides chemotherapy, not a replacement for chemotherapy, Dr.