Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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 (119)
- 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.
- ublituximab
ublituximab decreases effects of sipuleucel-T by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressants may decrease therapeutic effect of sipuleucel-T. Consider reducing dose or discontinuing immunosuppressants before initiating sipuleucel-T.
- 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)
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%)
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
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.Pharmacology
Mechanism of Action
Autologous cellular immunotherapy; induces immune response targeted against PAP, an antigen expressed in most prostate cancers
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
Images
Patient Handout
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. It is given as directed by your doctor, usually about every 2 weeks for a total of 3 doses.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 last or get worse, 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 you have any serious side effects, including: 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 receiving sipuleucel-T, tell your doctor or pharmacist if you have any 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, stroke.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication is not usually used by women. It is unlikely to be used during pregnancy or breast-feeding. Consult your doctor if you have any questions about this medication.
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 May 2023. Copyright(c) 2023 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.
Formulary
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.
