sipuleucel

(redirected from Provenge)

sipuleucel

(si-pu-loo-sel) ,

Provenge

(trade name)

Classification

Therapeutic: antineoplastics
Pharmacologic: autologous cellular immunotherapies

Indications

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

Action

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.

Pharmacokinetics

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

Time/action profile

ROUTEONSETPEAKDURATION
IVunknownunknownunknown

Contraindications/Precautions

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

Respiratory

  • dyspnea

Cardiovascular

  • hypertension
  • peripheral edema

Gastrointestinal

  • constipation
  • diarrhea
  • nausea
  • vomiting

Genitourinary

  • hematuria

Dermatologic

  • flushing
  • rash
  • sweating

Hematologic

  • anemia

Musculoskeletal

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

Neurologic

  • paresthesia
  • tremor

Miscellaneous

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

Interactions

Drug-Drug interaction

Concurrent use of immunosuppressants may alter safety/efficacy.

Route/Dosage

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

Availability

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)

Implementation

  • 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 ?
One group completed PROVENGE two weeks before initiation of androgen deprivation therapy (ADT) and the second received PROVENGE three months after the start of ADT.
Quebec-based Valeant Pharmaceuticals International is looking to buy the global rights to the Provenge prostate cancer vaccine and other assets of American drugmaker Dendreon Corp.
We believe the market potential for PROVENGE is substantial, and the primary issue affecting the dynamics of our launch is the reimbursement knowledge around PROVENGE.
Off-label use of the novel therapeutic prostate cancer vaccine, marketed by Dendreon under the trade name Provenge, would be left to the discretion of local Medicare claims carriers, the agency said.
Seattle WA) reported 2010 revenue of $48 million from its prostate-cancer treatment Provenge and projected sales this year of $350 million to $400 million.
Food and Drug Administration (FDA) to market PROVENGE based on discussions of these data with the FDA.
Two studies examine potential for PROVENGE in combination or sequenced with two approved advanced prostate cancer therapies
April 23, 2014 /PRNewswire/ -- Join Prostate Oncology Specialists for an educational talk about PROVENGE - a treatment to stimulate the immune system for advanced prostate cancer.
Provenge is the first drug designed to train the body's immune system to fight cancer and is the most effective treatment for certain patients with advanced prostate tumors, said Philip Kantoff, a professor of medicine at Harvard Medical School (Boston MA) and the study's lead author.
A final decision on Provenge will not be possible until mid-2009 at the earliest because the controversial prostate cancer vaccine failed to meet the primary end point in an interim look at data in a critical phase III trial.
A group of disappointed patients and disgruntled investors is suing Food and Drug Administration (FDA) officials over the agency's decision to nix a proposed vaccine Provenge [R] for advanced prostate cancer.
Provenge is the company's investigational immunotherapy for the treatment of prostate cancer.