sipuleucel-T (Rx)

Brand and Other Names:Provenge
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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

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

and sipuleucel-T

No Results

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (1)

              • belatacept

                belatacept and sipuleucel-T both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Concomitant use of sipuleucel-T and immunosuppressives should be avoided.

              Monitor Closely (118)

              • abatacept

                abatacept decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • adalimumab

                adalimumab decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • alefacept

                alefacept decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • alemtuzumab

                alemtuzumab decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • anakinra

                anakinra decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • antithymocyte globulin equine

                antithymocyte globulin equine decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • antithymocyte globulin rabbit

                antithymocyte globulin rabbit decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • arsenic trioxide

                arsenic trioxide decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • auranofin

                auranofin decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • azacitidine

                azacitidine decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • azathioprine

                azathioprine decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • basiliximab

                basiliximab decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • beclomethasone, inhaled

                beclomethasone, inhaled decreases effects of sipuleucel-T by unspecified interaction mechanism. Use Caution/Monitor. Drugs that suppress the immune system may inhibit clinical activity of sipuleucel-T.

              • belatacept

                belatacept decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • belimumab

                belimumab decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • bendamustine

                bendamustine decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • betamethasone

                betamethasone decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • budesonide

                budesonide decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • busulfan

                busulfan decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • C1 inhibitor human

                C1 inhibitor human decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • cabazitaxel

                cabazitaxel decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • canakinumab

                canakinumab decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • capecitabine

                capecitabine decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • carboplatin

                carboplatin decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • carmustine

                carmustine decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • certolizumab pegol

                certolizumab pegol decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • chlorambucil

                chlorambucil decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • chloroquine

                chloroquine decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • cisplatin

                cisplatin decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • cladribine

                cladribine decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • cortisone

                cortisone decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • cyclophosphamide

                cyclophosphamide decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • cyclosporine

                cyclosporine decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • cytarabine

                cytarabine decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • dacarbazine

                dacarbazine decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • dactinomycin

                dactinomycin decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • daunorubicin

                daunorubicin decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • decitabine

                decitabine decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • dexamethasone

                dexamethasone decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • docetaxel

                docetaxel decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • doxorubicin

                doxorubicin decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • doxorubicin liposomal

                doxorubicin liposomal decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • epirubicin

                epirubicin decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • eribulin

                eribulin decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • etanercept

                etanercept decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • etoposide

                etoposide decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • everolimus

                everolimus decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • fingolimod

                fingolimod decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • floxuridine

                floxuridine decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • fludarabine

                fludarabine decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • fludrocortisone

                fludrocortisone decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • fluorouracil

                fluorouracil decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • gemcitabine

                gemcitabine decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • glatiramer

                glatiramer decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • gold sodium thiomalate

                gold sodium thiomalate decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • golimumab

                golimumab decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • hydrocortisone

                hydrocortisone decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • hydroxychloroquine sulfate

                hydroxychloroquine sulfate decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • hydroxyurea

                hydroxyurea decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

                hydroxyurea decreases effects of sipuleucel-T by Other (see comment). Use Caution/Monitor. Comment: Avoid combination. Immunosuppressants may decrease clinical efficacy of sipuleucel-T.

              • ibritumomab tiuxetan

                ibritumomab tiuxetan decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • idarubicin

                idarubicin decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • ifosfamide

                ifosfamide decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

                ifosfamide, sipuleucel-T. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • imatinib

                imatinib decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • infliximab

                infliximab decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • irinotecan

                irinotecan decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • irinotecan liposomal

                irinotecan liposomal decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • ixabepilone

                ixabepilone decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • leflunomide

                leflunomide decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • lenalidomide

                lenalidomide decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • lomustine

                lomustine decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

                lomustine and sipuleucel-T both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects.

              • mechlorethamine

                mechlorethamine, sipuleucel-T. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • melphalan

                melphalan decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

                melphalan decreases effects of sipuleucel-T by immunosuppressive effects; risk of infection. Use Caution/Monitor. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects.

              • mercaptopurine

                mercaptopurine decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • methotrexate

                methotrexate decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • methylprednisolone

                methylprednisolone decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • mitomycin

                mitomycin decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • mitotane

                mitotane decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • mitoxantrone

                mitoxantrone decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • muromonab CD3

                muromonab CD3 decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • mycophenolate

                mycophenolate decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • natalizumab

                natalizumab decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • nelarabine

                nelarabine decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • ofatumumab

                ofatumumab decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • oxaliplatin

                oxaliplatin and sipuleucel-T both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Consider avoiding such combinations when clinically appropriate. If such a combination is used, monitor the patient closely for clinical response.

              • paclitaxel

                paclitaxel decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • paclitaxel protein bound

                paclitaxel protein bound decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • pazopanib

                pazopanib decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • pemetrexed

                pemetrexed decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • pentostatin

                pentostatin decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • pralatrexate

                pralatrexate decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • prednisolone

                prednisolone decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • prednisone

                prednisone decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • procarbazine

                procarbazine decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

                procarbazine decreases effects of sipuleucel-T by unknown mechanism. Use Caution/Monitor. Consider avoiding such combinations when clinically appropriate. If such a combination is used, monitor the patient closely for clinical response.

              • rilonacept

                rilonacept decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • rituximab

                rituximab decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • rituximab-hyaluronidase

                rituximab-hyaluronidase decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • siponimod

                siponimod decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • sirolimus

                sirolimus decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • sorafenib

                sorafenib decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • streptozocin

                streptozocin decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • sunitinib

                sunitinib decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • tacrolimus

                tacrolimus decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • temozolomide

                temozolomide decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • temsirolimus

                temsirolimus decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • teniposide

                teniposide decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • thalidomide

                thalidomide decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • thioguanine

                thioguanine decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • thiotepa

                thiotepa decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • tocilizumab

                tocilizumab decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • topotecan

                topotecan decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • trastuzumab deruxtecan

                trastuzumab deruxtecan decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • triamcinolone acetonide injectable suspension

                triamcinolone acetonide injectable suspension decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • ustekinumab

                ustekinumab decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • valrubicin

                valrubicin decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • vinblastine

                vinblastine decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • vincristine

                vincristine decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • vincristine liposomal

                vincristine liposomal decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • vinorelbine

                vinorelbine decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              Minor (0)

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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

                No images available for this drug.
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                Patient Handout

                Patient Education
                sipuleucel-T in lactated ringers intravenous

                SIPULEUCEL-T - INJECTION

                (SI-pu-LOO-sel-tee)

                COMMON BRAND NAME(S): Provenge

                USES: This medication is used to treat advanced prostate cancer. Sipuleucel-T is a type of vaccine created from your own immune system cells that works by causing your immune system to attack prostate cancer cells. This requires that you have a procedure to remove some of your white blood cells, which are used to prepare sipuleucel-T. Talk to your doctor about the risks and benefits of this treatment.

                HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using sipuleucel-T and each time you get a refill. If you have any questions, ask your doctor or pharmacist.This medication is created specifically for you from your own blood and should not be given to another patient. Three days before your dose you will have a procedure in which your own white blood cells are removed and then used to create sipuleucel-T.Sipuleucel-T is given as a slow infusion into a vein by a health care professional, roughly every 2 weeks for a total of 3 doses, as directed by your doctor.Your doctor may prescribe premedications (such as acetaminophen, antihistamines) to lessen infusion reactions (see also Side Effects section). These medications are usually given 30 minutes before your dose of sipuleucel-T.To get the most benefit from this medication, do not miss any doses. To help you remember, mark the days on the calendar when you need to receive the medication.

                SIDE EFFECTS: Headache, sweating, muscle aches, or back pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Symptoms of an infusion reaction that may occur during sipuleucel-T treatment include chills, tiredness, fever, nausea, vomiting, shortness of breath, fast/irregular heartbeat, and joint pain. Tell your health care professional right away if you have any of these symptoms during or after receiving your treatment. Your doctor will have you monitored closely and may slow the infusion or temporarily stop your treatment if a severe reaction occurs.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if any of these unlikely but serious side effects occur: weakness on one side of the body, confusion, trouble speaking.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                PRECAUTIONS: Before using sipuleucel-T, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems, lung problems, history of stroke.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Sipuleucel-T is not recommended for use by women.

                DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

                OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

                NOTES: Do not share this medication with others.It is very important to be on time to each of your appointments. This product has a short expiration period and must be used before it expires, or additional procedures will be needed to collect your white blood cells to prepare more sipuleucel-T.

                MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

                STORAGE: Store in the refrigerator. Do not freeze. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

                Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

                IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                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.
                • Manage and view all your plans together – even plans in different states.
                • 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.
                Additional Offers
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.