sipuleucel-T

sipuleucel-T

Provenge

Pharmacologic class: Autologous cellular immunotherapy

Therapeutic class: Antineoplastic

Pregnancy risk category None

Action

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.

Availability

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

Contraindications

None

Precautions

Use cautiously in:

• cardiac or pulmonary conditions

• infusion reactions

• concurrent use of chemotherapy or immunosuppressive therapy.

Administration

• 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

Interactions

None

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 ?
Patients who were randomized to placebo had the option of receiving immunotherapy in which they received a version of sipuleucel-T prepared from their own cryopreserved cells, which had been harvested at the time of placebo generation.
This immunotherapy manufacturing facility, which is located in Morris Plains, New Jersey, is a 173,100 square foot state-of-the-art IMF, featuring revolutionary capabilities to manufacture PROVENGE (sipuleucel-T), the first autologous cellular immunotherapy to receive US Food and Drug Administration approval for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer.
11 November 2010 - US biotechnology company Dendreon Corporation (NASDAQ: DNDN) said yesterday it has completed the submission of the post-approval supplement to the PROVENGE (sipuleucel-T) Biologics License Application (BLA) for the Morris Plains, New Jersey manufacturing facility.
The struggle to gain FDA approval for sipuleucel-T, to be marketed as Provenge by Dendreon Corp., has been marked by a raucous FDA meeting, picketing in Washington, congressional lobbying, a federal lawsuit, conspiracy theories, conflict of interest allegations, death threats against scientists, investor fury, scientists' indignation, and the use of bodyguards at a major cancer meeting.
This Atlanta cancer immunotherapy manufacturing facility is the company's the third location, where it will manufacture PROVENGE (sipuleucel-T), to help meet the needs of patients across the US with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
As a member of the Dendreon executive management team, Bishop will be responsible for preparing for and leading the commercial launch of PROVENGE (sipuleucel-T), including sales and marketing, as well as manufacturing, supply chain, quality and facilities engineering.
Biotechnology company Dendreon Corp (Nasdaq:DNDN) presented safety data from the integrated analysis of randomised PROVENGE (sipuleucel-T) clinical trials this Monday at the 105th Annual Scientific Meeting of the American Urological Association (AUA) in San Francisco.
Currently, the only vaccine to treat cancer approved in the United States is Sipuleucel-T, which can be used to treat advanced prostate cancer.
M2 PHARMA-February 20, 2019-Dendreon Offers New Clinical Data Analysis On Survival Benefit Three Years after Treatment with Sipuleucel-T
The collaboration is aimed at implementing genomic tumour profiling using the Decipher assay and GRID software to identify prostate cancer patients on active surveillance who are likely to benefit most from treatment with sipuleucel-T.
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.m.
Sipuleucel-T (Provenge) is such a vaccine, and it is used to treat metastatic prostate cancer.