Does TISAGENLECLEUCEL Cause Leukoencephalopathy? 15 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 15 reports of Leukoencephalopathy have been filed in association with TISAGENLECLEUCEL (KYMRIAH). This represents 0.4% of all adverse event reports for TISAGENLECLEUCEL.
15
Reports of Leukoencephalopathy with TISAGENLECLEUCEL
0.4%
of all TISAGENLECLEUCEL reports
7
Deaths
6
Hospitalizations
How Dangerous Is Leukoencephalopathy From TISAGENLECLEUCEL?
Of the 15 reports, 7 (46.7%) resulted in death, 6 (40.0%) required hospitalization, and 6 (40.0%) were considered life-threatening.
Is Leukoencephalopathy Listed in the Official Label?
Yes, Leukoencephalopathy is listed as a known adverse reaction in the official FDA drug label for TISAGENLECLEUCEL.
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 Leukoencephalopathy?
METHOTREXATE (717)
CYTARABINE (208)
VINCRISTINE (138)
CYCLOPHOSPHAMIDE (137)
RITUXIMAB (118)
DEXAMETHASONE (107)
FLUOROURACIL (103)
FLUDARABINE (89)
TACROLIMUS (79)
CAPECITABINE (77)
Which TISAGENLECLEUCEL Alternatives Have Lower Leukoencephalopathy Risk?
TISAGENLECLEUCEL vs TISLELIZUMAB
TISAGENLECLEUCEL vs TISOTUMAB VEDOTIN
TISAGENLECLEUCEL vs TISOTUMAB VEDOTIN-TFTV
TISAGENLECLEUCEL vs TITANIUM DIOXIDE\ZINC
TISAGENLECLEUCEL vs TIVICAY