Sipuleucel-t

What is Sipuleucel-t?

• Sipuleucel-t (Provenge) is an autologous cellular immunotherapy used as a cell-based cancer immunotherapy for prostate cancer (CaP).
• It is an autologous cellular immunotherapy.

What are the uses of this medicine?

• Provenge (Sipuleucel-t) is a prescription medicine that is used to treat certain patients with advanced prostate cancer. Provenge is made from your own immune cells.
• Since Provenge is made from your own immune cells, your cells will be collected approximately 3 days before each scheduled infusion of Provenge.
• You will need to go to a cell collection center for this collection.
• The collection is called “leukapheresis” (pronounced loo-kuh-fuh-REE-sis).
• Your collected cells are sent to a manufacturing center where they are mixed with a protein to make them ready for your infusion.

How does this medicine work?

• Provenge is classified as an autologous cellular immunotherapy.
• While the precise mechanism of action is unknown, Provenge is designed to induce an immune response targeted against PAP, an antigen expressed in most prostate cancers.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No drug interactions have been identified.
• No formal interaction studies have been conducted.

Is this medicine FDA approved?

• Sipuleucel-T was approved by the U.S. Food and Drug Administration (FDA) on April 29, 2010, to treat asymptomatic or minimally symptomatic metastatic HRPC.

How should this medicine be used?

• Premedicate patients with oral acetaminophen and an antihistamine such as diphenhydramine.
• Before infusion, confirm that the patient's identity matches the patient identifiers on the infusion bag.

Recommended dosage:

• Administer 3 doses at approximately 2-week intervals.

Administration:

• Since Provenge is made from your own immune cells, your cells will be collected approximately 3 days before each scheduled infusion of Provenge.
• You will need to go to a cell collection center for this collection.
• The collection is called “leukapheresis” (pronounced loo-kuh-fuh-REE-sis).
• Your collected cells are sent to a manufacturing center where they are mixed with a protein to make them ready for your infusion.

A course of sipuleucel-T treatment consists of three basic steps:

• A patient's own white blood cells, primarily antigen-presenting cells (APCs), also called dendritic cells, are extracted in a leukapheresis procedure.
• The blood product is sent to the factory and incubated with a fusion protein (PA2024) consisting of two parts,
• the antigen prostatic acid phosphatase (PAP), which is present in 95% of prostate cancer cells, and
• an immune signaling factor granulocyte-macrophage colony stimulating factor (GM-CSF) that helps the APCs to mature.
• The activated blood product (APC8015) is returned from the factory to the infusion center and re-infused into the patient to cause an immune response against cancer cells carrying the PAP antigen.

• You will get Provenge in 3 intravenous infusions (put into your veins), about 2 weeks apart.
• Each infusion takes about 60 minutes.
• Following each infusion, you will be monitored for at least 30 minutes.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Suspension for Intravenous Infusion
• 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.

This medicine is available in fallowing brand namesː

• Provenge

What side effects can this medication cause?

The most common side effects of this medicine include:

• chills
• fatigue
• fever
• back pain
• nausea
• joint ache
• headache

Provenge infusion can cause serious reactions include:

• breathing problems, chest pains, racing heart or irregular heartbeats, high or low blood pressure, dizziness, fainting, nausea, or vomiting after getting Provenge. Any of these may be signs of heart or lung problems.
• numbness or weakness on one side of the body, decreased vision in one eye or difficulty speaking. Any of these may be signs of a stroke.
• symptoms of thrombosis which may include: pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain that worsens on deep breathing.
• fever over 100ºF, or redness or pain at the infusion or collection sites. Any of these may be signs of infection.

What special precautions should I follow?

• Acute infusion reactions may occur. If reactions occur, decrease the rate or stop the infusion and administer appropriate medical treatment.
• Syncope and hypotension have also been observed. Closely monitor patients with cardiac or pulmonary conditions.
• Provenge should be used with caution in patients with risk factors for thromboembolic events.
• Provenge is not tested for transmissible infectious diseases and may transmit diseases to health care professionals handling the product. Universal precautions should be followed.
• Concomitant use of chemotherapy and immunosuppressive medications with Provenge has not been studied.

What to do in case of emergency/overdose?

• There are no known instances of overdosage from either a single infusion or a full course of therapy with Provenge.
• Each Provenge infusion comprises the maximum number of cells that can be manufactured from a single leukapheresis procedure. The number of cells in Provenge does not exceed the number of cells collected from the leukapheresis.

Can this medicine be used in pregnancy?

• The safety and effectiveness have not been esatablished in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness have not been esatablished in pediatric patients.

What are the active and inactive ingredients in this medicine?

• The active components of Provenge are your own immune cells mixed with the other active component, a protein designed to produce an immune response to prostate cancer. The product is suspended in an infusion solution called Lactated Ringer's Injection, USP, an inactive ingredient.

Who manufactures and distributes this medicine?

Manufactured by:

• Dendreon Pharmaceuticals LLC Seal Beach, CA

What should I know about storage and disposal of this medication?

• Upon receipt, open the outer cardboard shipping box to verify the product and patient-specific labels located on the top of the insulated container.
• Do not remove the insulated container from the shipping box, or open the lid of the insulated container, until the patient is ready for infusion.

• Dailymed label info on Sipuleucel-t
• FDA Sipuleucel-t

Sipuleucel-t Resources
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