Does TISAGENLECLEUCEL Cause Sepsis? 105 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 105 reports of Sepsis have been filed in association with TISAGENLECLEUCEL (KYMRIAH). This represents 2.5% of all adverse event reports for TISAGENLECLEUCEL.
105
Reports of Sepsis with TISAGENLECLEUCEL
2.5%
of all TISAGENLECLEUCEL reports
66
Deaths
54
Hospitalizations
How Dangerous Is Sepsis From TISAGENLECLEUCEL?
Of the 105 reports, 66 (62.9%) resulted in death, 54 (51.4%) required hospitalization, and 19 (18.1%) were considered life-threatening.
Is Sepsis Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for TISAGENLECLEUCEL. However, 105 reports have been filed with the FAERS database.
What Other Side Effects Does TISAGENLECLEUCEL Cause?
Cytokine release syndrome (1,660)
Pyrexia (1,030)
Malignant neoplasm progression (582)
Hypotension (425)
Immune effector cell-associated neurotoxicity syndrome (416)
Neurotoxicity (411)
Platelet count decreased (397)
White blood cell count decreased (392)
Hypogammaglobulinaemia (374)
Lymphocyte count decreased (365)
What Other Drugs Cause Sepsis?
RITUXIMAB (4,043)
CYCLOPHOSPHAMIDE (4,041)
METHOTREXATE (3,933)
ADALIMUMAB (3,169)
DEXAMETHASONE (3,150)
LENALIDOMIDE (2,956)
VINCRISTINE (2,791)
DOXORUBICIN (2,740)
PREDNISONE (2,634)
PREDNISOLONE (2,281)
Which TISAGENLECLEUCEL Alternatives Have Lower Sepsis Risk?
TISAGENLECLEUCEL vs TISLELIZUMAB
TISAGENLECLEUCEL vs TISOTUMAB VEDOTIN
TISAGENLECLEUCEL vs TISOTUMAB VEDOTIN-TFTV
TISAGENLECLEUCEL vs TITANIUM DIOXIDE\ZINC
TISAGENLECLEUCEL vs TIVICAY