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sipuleucel-T (Rx)Brand and Other Names:Provenge

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

intravenous injection

  • Minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF and suspended in 250 mL lactated Ringer solution
  • Potency determined by measuring increased expression of CD54 molecules (ICAM-1) on surface of APCs
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Prostate Cancer

Autologous cellular immunotherapy indicated for asymptomatic or minimally symptomatic prostate cancer with metastases that is resistant to standard hormone treatment

Administer 3 doses (>50 million autologous CD54+ activated cells/dose) IV at approximately 2-week intervals (median dosing interval, 2 week; range, 1-15 week)

Infuse IV over 60 min

Other Information

For autologous use only

Do not initiate IV infusion of expired product

Do not use cell filter during IV infusion

Premedicate with acetaminophen (650 mg) PO and an antihistamine (eg, diphenhydramine-50 mg) 30 min prior to infusion to minimize risk of infusion reaction

Before IV infusion, confirm patient’s identity matches patient identifiers on infusion bag

Not indicated for pediatric use

Prostate Cancer

Autologous cellular immunotherapy indicated for asymptomatic or minimally symptomatic prostate cancer with metastases that is resistant to standard hormone treatment

Administer 3 doses (>50 million autologous CD54+ activated cells/dose) IV at approximately 2-week intervals (median dosing interval, 2 week; range, 1-15 week)

Infuse IV over 60 min

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Interactions

Interaction Checker

sipuleucel-T and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            Sort by :  
             activity indicator 
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            Adverse Effects

            >10%

            Chills (53.1%)

            Fatigue (41.1%)

            Fever (31.3%)

            Back pain (29.6%)

            Nausea (21.5%)

            Joint ache (19.6%)

            Headache (18.1%)

            Citrate toxicity (14.8%)

            Paresthesia (14.1%)

            Vomiting (13.3%)

            Anemia (12.5%)

            Constipation (12.3%)

            Pain (12.3%)

            Paresthesia oral (12.3%)

            Pain in extremity (12.1%)

            Dizziness (11.8%)

            Muscle ache (11.8%)

            1-10%

            Asthenia (10.8%)

            Diarrhea (10%)

            Influenza-like illness (9.7%)

            Musculoskeletal pain (9%)

            Dyspnea (8.7%)

            Peripheral edema (8.3%)

            Hot flush (8.2%)

            Hematuria (7.7%)

            Muscle spasms (7.7%)

            Hypertension (7.5%)

            Anorexia (6.5%)

            Bone pain (6.3%)

            Upper respiratory tract infection (6.3%)

            Insomnia (6.2%)

            Musculoskeletal chest pain (6%)

            Cough (5.8%)

            Neck pain (5.7%)

            Weight loss (5.7%)

            Urinary tract infection (5.5%)

            Rash (5%)

            Sweating (5%)

            Tremor (5%)

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            Warnings

            Contraindications

            None known

            Cautions

            Intended solely for autologous use

            Acute infusion reactions have been observed (decrease infusion rate or stop infusion if severe, and administer supportive therapy)

            Monitor patient for 30 min following infusion

            Closely monitor if cardiac or pulmonary conditions coexist

            Since preparation is autologous in nature, it is not routinely tested for transmissible infectious diseases and may transmit diseases to healthcare professionals handling the product (follow universal precautions)

            Use with concomitant chemotherapy and immunosuppressive medications has not been studied

            Because of the autologous nature of product preparation, adhering to the personalized leukapheresis and infusion schedules is important

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            Pregnancy & Lactation

            Pregnancy Category: N/A

            Lactation: N/A

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Autologous cellular immunotherapy; induces immune response targeted against PAP, an antigen expressed in most prostate cancers

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            Administration

            IV Administration

            Do not initiate IV infusion of expired product

            Do not use cell filter during IV infusion

            Premedicate with acetaminophen PO and an antihistamine (eg, diphenhydramine) to minimize risk of infusion reaction

            Before IV infusion, confirm patient’s identity matches patient identifiers on infusion bag

            Infuse IV over 60 min

            Handling

            Since preparation is autologous in nature, it is not routinely tested for transmissible infectious diseases and may transmit diseases to healthcare professionals handling the product (follow universal precautions

            Storage

            Provenge infusion bag must remain within insulated polyurethane container that it was shipped in until the time of administration; do not remove the insulated container from the outer cardboard shipping box

            Other Information

            Shipped directly to the infusing provider

            Arrives in cardboard shipping box with special insulated polyurethane container inside with gel packs designed to maintain the appropriate transportation and storage temperature until infusion

            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 insulated container from the shipping box, or open lid of the insulated container, until the patient is ready for infusion

            Do not infuse until confirmation of product release has been received from manufacturer (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

            Infusion must begin prior to the expiration date and time indicated on the Cell Product Disposition Form and Product Label; do not initiate infusion if expired

            Once infusion bag is removed from the insulated container, it should remain at room temperature for no more than 3 hr; do not returned product to the shipping container

            Once the patient is prepared for infusion and the Cell Product Disposition Form has been received, remove infusion bag from insulated container and inspect for signs of leakage; bag contents will be slightly cloudy, with a cream-to-pink color

            Gently mix and resuspend 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 bag leaks or if clumps remain in the bag

            Prior to PROVENGE infusion, match the patient’s identity with the patient identifiers on the Cell Product Disposition Form and the PROVENGE infusion bag

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            Images

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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