Does TISAGENLECLEUCEL Cause Off label use? 145 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 145 reports of Off label use have been filed in association with TISAGENLECLEUCEL (KYMRIAH). This represents 3.4% of all adverse event reports for TISAGENLECLEUCEL.
145
Reports of Off label use with TISAGENLECLEUCEL
3.4%
of all TISAGENLECLEUCEL reports
33
Deaths
31
Hospitalizations
How Dangerous Is Off label use From TISAGENLECLEUCEL?
Of the 145 reports, 33 (22.8%) resulted in death, 31 (21.4%) required hospitalization, and 11 (7.6%) were considered life-threatening.
Is Off label use Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for TISAGENLECLEUCEL. However, 145 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 Off label use?
RITUXIMAB (39,751)
INFLIXIMAB (34,801)
DENOSUMAB (34,612)
METHOTREXATE (24,020)
VEDOLIZUMAB (21,017)
ETANERCEPT (20,178)
TOCILIZUMAB (18,256)
PREDNISONE (17,867)
LENALIDOMIDE (17,017)
ADALIMUMAB (16,417)
Which TISAGENLECLEUCEL Alternatives Have Lower Off label use Risk?
TISAGENLECLEUCEL vs TISLELIZUMAB
TISAGENLECLEUCEL vs TISOTUMAB VEDOTIN
TISAGENLECLEUCEL vs TISOTUMAB VEDOTIN-TFTV
TISAGENLECLEUCEL vs TITANIUM DIOXIDE\ZINC
TISAGENLECLEUCEL vs TIVICAY