Voraxaze

Product manufactured by Btg International Inc.

Application Nr Approved Date Route Status External Links
BLA125327 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Voraxaze Is Indicated To Reduce Toxic Plasma Methotrexate Concentration (Greater Than 1 Micromole Per Liter) In Adult And Pediatric Patients With Delayed Methotrexate Clearance (Plasma Methotrexate Concentrations Greater Than 2 Standard Deviations Of The Mean Methotrexate Excretion Curve Specific For The Dose Of Methotrexate Administered) Due To Impaired Renal Function. Limitations Of Use: Voraxaze Is Not Recommended For Use In Patients Who Exhibit The Expected Clearance And Expected Plasma Methotrexate Concentration. Reducing Plasma Methotrexate Concentration In These Patients May Result In Subtherapeutic Exposure To Methotrexate [See Clinical Studies ( 14 )] . Voraxaze Is A Carboxypeptidase Indicated To Reduce Toxic Plasma Methotrexate Concentration (Greater Than 1 Micromole Per Liter) In Adult And Pediatric Patients With Delayed Methotrexate Clearance (Plasma Methotrexate Concentrations Greater Than 2 Standard Deviations Of The Mean Methotrexate Excretion Curve Specific For The Dose Of Methotrexate Administered) Due To Impaired Renal Function. ( 1 ) Limitations Of Use: Voraxaze Is Not Recommended For Use In Patients Who Exhibit The Expected Clearance And Expected Plasma Methotrexate Concentration. Reducing Plasma Methotrexate Concentration In These Patients May Result In Subtherapeutic Exposure To Methotrexate. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Glucarpidase

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