Drug intelligence / Profile preview

fexofenadine + acetaminophen + methylprednisolone

Development stage
Unknown
Lead developer
Amgen
Modality
Small Molecules
Administration
Oral, Intravenous
01

Overview

This premedication regimen is a specific combination of an antihistamine, an antipyretic, and a corticosteroid used as infusion reaction (IR) prophylaxis for patients with uncontrolled gout receiving pegloticase (Krystexxa). Specifically utilized in Amgen's (formerly Horizon Therapeutics) MIRROR clinical trial program, the regimen includes oral fexofenadine, oral acetaminophen, and intravenous methylprednisolone (or hydrocortisone). This prophylaxis is administered to mitigate the risk of hypersensitivity and infusion-related reactions, which are common with pegloticase due to the development of anti-drug antibodies. The use of this regimen, alongside immunomodulatory co-therapy like methotrexate, has been shown to significantly increase the proportion of patients achieving a sustained urate-lowering response by reducing the immunogenicity of pegloticase.

Other names
IR prophylaxisInfusion Reaction ProphylaxisMIRROR premedication regimen
02

Targets

GR (Glucocorticoid receptor)PTGS2 (Prostaglandin-Endoperoxide Synthase 2)HRH1 (Histamine H1 Receptor)

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