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Provenge

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Provenge

Provenge

INDICATIONS

PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

DOSAGE AND ADMINISTRATION

For Autologous Use Only.

For Intravenous Use Only. Do Not Use a Cell Filter.

Do Not Initiate Infusion of Expired Product.

Dose and Schedule

Each dose of PROVENGE contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF [see DESCRIPTION].

The recommended course of therapy for PROVENGE is 3 complete doses, given at approximately 2-week intervals. In controlled clinical trials, the median dosing interval between infusions was 2 weeks (range 1 to 15 weeks); the maximum dosing interval has not been established.

If, for any reason, the patient is unable to receive a scheduled infusion of PROVENGE, the patient will need to undergo an additional leukapheresis procedure if the course of treatment is to be continued. Patients should be advised of this possibility prior to initiating treatment.

Premedication

To minimize potential acute infusion reactions such as chills and/or fever, it is recommended that patients be premedicated orally with acetaminophen and an antihistamine such as diphenhydramine approximately 30 minutes prior to administration of PROVENGE [see WARNINGS AND PRECAUTIONS].

Handling Precautions for Control of Infectious Disease

PROVENGE is not routinely tested for transmissible infectious diseases. Therefore, patient leukapheresis material and PROVENGE may carry the risk of transmitting infectious diseases to health care professionals handling the product. Employ universal precautions in handling leukapheresis material or PROVENGE. [See Storage and Handling]

Storage

The PROVENGE infusion bag must remain within the insulated polyurethane container until the time of administration. Do not remove the insulated polyurethane container from the outer cardboard shipping box. [See Storage and Handling]

Confirm Product Release Before Infusion

Do not infuse PROVENGE until confirmation of product release has been received from Dendreon. Dendreon will send a Cell Product Disposition Form containing the patient identifiers, expiration date and time, and the disposition status (approved for infusion or rejected), to the infusion site. [See Storage and Handling]

Preparation for Infusion

See Storage and Handling for full handling instructions.

Confirm Patient Identity

PROVENGE is intended solely for autologous use. Confirm the proper product has been received according to the label on the outside of the insulated polyurethane container. Prior to PROVENGE infusion, match the patient's identity with the patient identifiers on the Cell Product Disposition Form and the PROVENGE infusion bag.

Inspect the Infusion Bag

Remove the infusion bag from the insulated polyurethane container and inspect the bag for signs of leakage. Do not administer if the bag leaks.

Contents of the bag will be slightly cloudy, with a cream-to-pink color. Gently mix and re-suspend the contents of the bag, inspecting for clumps and clots. Small clumps of cellular material should disperse with gentle manual mixing. Do not administer if the bag leaks during handling or if clumps remain in the bag.

Administration

Infusion must begin prior to the expiration date and time indicated on the Cell Product Disposition Form and Product Label. Do not initiate infusion of expired PROVENGE.

Administer PROVENGE via intravenous infusion over a period of approximately 60 minutes. Do not use a cell filter. PROVENGE is supplied in a sealed, patient-specific infusion bag; the entire volume of the bag should be infused.

Observe the patient for at least 30 minutes following each infusion.

Administration Modification for Infusion Reactions

Acute infusion reactions such as chills, fatigue, fever, nausea, and joint ache were frequently observed in studies of PROVENGE. To mitigate such reactions, premedication, consisting of acetaminophen and an antihistamine such as diphenhydramine, was administered in clinical studies prior to infusion.

In the event of an acute infusion reaction, the infusion may be interrupted or slowed, depending on the severity of the reaction. Appropriate medical therapy should be administered as needed. In controlled clinical trials, symptoms of acute infusion reactions were treated with acetaminophen, intravenous HI and/or H2 blockers, and low dose intravenous meperidine.

If the infusion of PROVENGE must be interrupted, the infusion should not be resumed if the PROVENGE infusion bag will be held at room temperature for more than 3 hours. [See Storage and Handling]

HOW SUPPLIED

Dosage Forms and Strengths

Each dose of PROVENGE contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF, suspended in 250 mL of Lactated Ringer's Injection, USP in a sealed, patient-specific infusion bag.

PROVENGE IS INTENDED SOLELY FOR AUTOLOGOUS USE. PROVENGE is a 250 mL suspension containing a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF in Lactated Ringer's Injection, USP, and supplied in an infusion bag labeled for the specific recipient. The identity of the patient must be matched with the patient identifiers on the infusion bag and the Cell Product Disposition Form prior to infusion. PROVENGE is not routinely tested for transmissible infectious diseases. Therefore, patient leukapheresis material and PROVENGE may carry the risk of transmitting infectious diseases to health care professionals handling the product. Accordingly, health care professionals should employ universal precautions when handling leukapheresis material or PROVENGE.

Handling Instructions

  1. PROVENGE is shipped directly to the infusing provider.
  2. PROVENGE will arrive in a cardboard shipping box with a special insulated polyurethane container inside. The insulated container and gel packs within the container are designed to maintain the appropriate transportation and storage temperature of PROVENGE until infusion.
  3. Upon receipt, the outer cardboard shipping box should be opened to verify the product and patient-specific labels located on the top of the insulated container. Do not remove this insulated container from the shipping box, or open the lid of the insulated container, until the patient is ready for infusion.
  4. Do not infuse PROVENGE until confirmation of product release has been received from Dendreon. Dendreon will send a Cell Product Disposition Form containing the patient identifiers, expiration date and time, and the disposition status (approved for infusion or rejected), to the infusion site.
  5. Infusion must begin prior to the expiration date and time indicated on the Cell Product Disposition Form and Product Label. Do not initiate infusion of expired PROVENGE. Once the PROVENGE infusion bag is removed from the insulated container, it should remain at room temperature for no more than 3 hours. PROVENGE should not be returned to the shipping container.
  6. Once the patient is prepared for infusion and the Cell Product Disposition Form has been received, remove the PROVENGE infusion bag from the insulated container and inspect the bag for signs of leakage. Contents of the bag will be slightly cloudy, with a cream-to-pink color. Gently mix and re-suspend the contents of the bag, inspecting for clumps and clots. Small clumps of cellular material should disperse with gentle manual mixing. Do not administer if the bag leaks or if clumps remain in the bag.
  7. Prior to PROVENGE infusion, match the patient's identity with the patient identifiers on the Cell Product Disposition Form and the PROVENGE infusion bag.

Dendreon Corporation 3005 First Avenue Seattle, Washington 98121

Last reviewed on RxList: 7/18/2011
This monograph has been modified to include the generic and brand name in many instances.

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