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SIPULEUCEL-T
DIR Classification
Classification:Less-DIR concern
Severity Score:1
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- ADVERSE REACTIONS
- Clinical Trials Experience
- Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
- The safety evaluation of PROVENGE is based on 601 prostate cancer patients in the PROVENGE group who underwent at least 1 leukapheresis procedure in four randomized, controlled clinical trials. The control group (n = 303) received non-activated autologous peripheral blood mononuclear cells. Patients received 3 infusions of PROVENGE or control every other week over a period of 4 weeks.
- Almost all (98.3%) patients in the PROVENGE group and 96% in the control group reported an adverse event. In 67.4% of patients in the PROVENGE group, these adverse events were mild or moderate in severity. Severe (Grade 3) and life-threatening (Grade 4) adverse events were reported in 23.6% and 4% of patients in the PROVENGE group compared with 25.1% and 3.3% of patients in the control group. Fatal (Grade 5) adverse events were reported in 3.3% of patients in the PROVENGE group compared with 3.6% of patients in the control group. The most common (≥ 2%) Grade 3-5 adverse events reported in the PROVENGE group were back pain and chills.
- Serious adverse events were reported in 24% of patients in the PROVENGE group and 25.1% of patients in the control group. Serious adverse events in the PROVENGE group included acute infusion reactions [see Warnings and Precautions (5.1)], cerebrovascular events [see Warnings and Precautions (5.3)], and single case reports of eosinophilia, rhabdomyolysis, myasthenia gravis, myositis, and tumor flare.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
Rhabdomyolysis
1
42911
Other ADRs
2931
14114348
Odds Ratio = 0.113
Drug Property Information
ATC Code(s):
- L03AX17 - sipuleucel-t
- L03AX - Other immunostimulants
- L03A - IMMUNOSTIMULANTS
- L03 - IMMUNOSTIMULANTS
- L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:sipuleucel-t
Active Ingredient UNII:8Q622VDR18
Drugbank ID:DB06688
PubChem Compound:N/A
CAS Number:917381-47-6
Dosage Form(s):injection
Route(s) Of Administrator:intravenous
Daily Dose:
Chemical Structure: 
SMILE Code:
-
-
Reference
COHORT STUDY:
N/AOTHER REFERENCE(S):
N/ADisclaimer:
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