Does GIVOSIRAN Cause Off label use? 18 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 18 reports of Off label use have been filed in association with GIVOSIRAN (GIVLAARI). This represents 1.5% of all adverse event reports for GIVOSIRAN.
18
Reports of Off label use with GIVOSIRAN
1.5%
of all GIVOSIRAN reports
0
Deaths
7
Hospitalizations
How Dangerous Is Off label use From GIVOSIRAN?
Of the 18 reports, 7 (38.9%) required hospitalization.
Is Off label use Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for GIVOSIRAN. However, 18 reports have been filed with the FAERS database.
What Other Side Effects Does GIVOSIRAN Cause?
Porphyria acute (381)
Hospitalisation (141)
Nausea (91)
Product dose omission issue (85)
Fatigue (84)
Therapy interrupted (83)
Pain (74)
Intentional dose omission (63)
Abdominal pain (62)
Vomiting (58)
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 GIVOSIRAN Alternatives Have Lower Off label use Risk?
GIVOSIRAN vs GLASDEGIB
GIVOSIRAN vs GLATIRAMER
GIVOSIRAN vs GLECAPREVIR\PIBRENTASVIR
GIVOSIRAN vs GLEEVEC
GIVOSIRAN vs GLICLAZIDE