Pharmacologic class: Autologous cellular immunotherapy

Therapeutic class: Antineoplastic

Pregnancy risk category None


Not clearly understood. Induces an immune response targeted against prostatic acid phosphatase (PAP), an antigen expressed in most prostate cancers. During ex vivo culture with PAP-GM-CSF (granulocyte macrophage-colony stimulating factor), APCs (tumor suppressor genes) take up and process the recombinant target antigen into small peptides that are then displayed on the APC surface.


Suspension for injection: 50 million autologous CD54+ cells activated with PAP-GM-CSF suspended in 250 ml of lactated Ringer's injection in infusion bag

Indications and dosages

Asymptomatic or minimally symptomatic metastatic castration-resistant (hormone refractory) prostate cancer

Adults: 50 million autologous CD54+ cells activated with PAP-GM-CSF in lactated Ringer's solution by I.V. infusion over approximately 60 minutes; give three complete doses at approximately 2-week intervals




Use cautiously in:

• cardiac or pulmonary conditions

• infusion reactions

• concurrent use of chemotherapy or immunosuppressive therapy.


• Be aware that drug is for autologous use only.

• Don't infuse drug until confirmation of product release has been received from manufacturer.

• Premedicate with acetaminophen and an antihistamine such as diphenhydramine approximately 30 minutes before infusing drug, to prevent infusion reactions.

• Administer by I.V. infusion only. Don't use a cell filter.

• Gently mix and resuspend bag's contents; inspect for clumps and clots. Small clumps of cellular material should disperse with gentle manual mixing. Don't administer if bag leaks during handling or if clumps remain in bag.

Interrupt or slow infusion for acute infusion reactions. If infusion must be interrupted, don't resume infusion if infusion bag is held at room temperature for more than 3 hours.

• Observe patient for at least 30 minutes after each infusion.

• Be aware that if patient is unable to receive scheduled infusion for any reason, patient will need to undergo an additional leukapheresis procedure if course of treatment is to be continued.

• Be aware that drug isn't recommended for patients with visceral disease and less than 6-month life expectancy.

Adverse reactions

CNS: headache, dizziness, fatigue, paresthesia, asthenia, insomnia, tremor, cerebrovascular events

CV: hypertension

GI: nausea, vomiting, diarrhea, constipation, anorexia, oral paresthesia

GU: hematuria, urinary tract infection

Hematologic: anemia

Musculoskeletal: back pain, joint and muscle ache, extremity pain, muscle and bone pain, neck pain, muscle spasms

Respiratory: dyspnea, upper respiratory tract infection, cough

Skin: rash

Other: chills, fever, pain, citrate toxicity, influenza-like illness, peripheral edema, hot flushes, chest pain, sweating, weight loss, risk of transmitting infectious diseases, acute infusion reactions



Patient monitoring

Continue to observe patient for infusion reaction after each infusion.

Monitor patient for cerebrovascu-lar events, including hemorrhagic and ischemic strokes.

Patient teaching

• Inform patient that each infusion is preceded by a leukapheresis procedure approximately 3 days before drug infusion and that it's important to maintain all scheduled appointments and arrive at each appointment on time, because the leukapheresis and infusions must be appropriately spaced and drug expiration time must not be exceeded.

• Explain importance of premedication before starting infusion.

Instruct patient to immediately report signs and symptoms of acute infusion reactions (such as fever, chills, fatigue, breathing problems, dizziness, high blood pressure, nausea, vomiting, headache, or muscle aches).

• Instruct patient to promptly notify prescriber if fever or swelling or redness around catheter site occurs, because these could indicate an infected catheter.

• Instruct patient to tell prescriber about all drugs he's taking, especially immunosuppressants.

• As appropriate, review all other significant and life-threatening adverse reactions mentioned above.

References in periodicals archive ?
Abstract 3066 - A Phase 2 randomized, double-blind study of sipuleucel-T followed by IDO pathway inhibitor, indoximod, or placebo in the treatment of patients with metastatic castration resistant prostate cancer (mCRPC), to be presented on Monday, June 5, 2017, 9:00 a.
Sipuleucel-T (Provenge) is such a vaccine, and it is used to treat metastatic prostate cancer.
A priority at Dendreon is to explore the use of sipuleucel-T in earlier stages of prostate cancer and in combination with other agents that may enhance the immune response and patient outcomes.
15] The phase III IMPACT study, in which 512 patients with mCRPC were randomized (2:1) to receive sipuleucel-T or placebo, has shown a survival advantage in the active treatment group (sipuleucel-T, 25.
A further drug sipuleucel-T has also been shown to extend life in the two-year period.
Key Words: Sipuleucel-T (Provenge[R]), metastatic castrate-resistant prostate cancer (mCRPC), therapeutic vaccine.
The Centers for Medicare and Medicaid Services has determined that the evidence supports the conclusion that the prostate cancer vaccine sipuleucel-T, better known as Provenge, is an effective therapy and should be covered for Medicare beneficiaries.
The immunotherapy sipuleucel-T significantly prolonged survival in a study of 512 men with metastatic castration-resistant prostate cancer, confirming the results of two smaller previous trials of this therapeutic "cancer vaccine," according to a report.
Research presented at the AUA meeting in April indicated that an immunotherapy agent, sipuleucel-T (Provenge), can prolong survival in men with advanced prostate cancer that fails to respond to androgen-deprivation therapy.
In March, an FDA advisory panel gave sipuleucel-T the thumbs-up, but the agency decided to delay approval pending the completion of a large trial in men with prostate cancer.
The approval of sipuleucel-T would open a new front on the war on cancer because although it would be the third cancer vaccine approved, it is the first that is therapeutic.
If approved, sipuleucel-T will be marketed as PROVENGE.