Dosing and uses of Provenge (sipuleucel-T)
Adult dosage forms and 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
Pediatric dosage forms and strengths
Not indicated for pediatric use
Geriatric dosage forms and strengths
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
Provenge (sipuleucel-T) adverse (side) 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 and 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 of Provenge (sipuleucel-T)
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
