Source: FDA, National Drug Code (US) Revision Year: 2019
Glucarpidase is a carboxypeptidase produced by recombinant DNA technology in genetically modified Escherichia coli. Glucarpidase is a 390-amino acid homodimer protein with a molecular weight of 83 kDa. Each potency Unit corresponds to the enzymatic cleavage of 1 µmol/L of methotrexate per minute at 37°C.
VORAXAZE (glucarpidase) for injection, for intravenous use is supplied as a sterile, preservative-free, white lyophilized powder in single-dose vials. Each vial contains 1,000 Units of glucarpidase, lactose monohydrate (10 mg), Tris-HCl (0.6 mg) and zinc acetate dihydrate (0.002 mg).
| Dosage Forms and Strengths |
|---|
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For injection: 1,000 Units as a white lyophilized powder in a single-dose vial for reconstitution. |
| How Supplied |
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VORAXAZE (glucarpidase) for injection is supplied as a sterile, preservative-free white lyophilized powder in an individually packaged glass single-dose vial closed with a bromo butyl elastomeric stopper and blue flip-off seal. 1,000 Units of glucarpidase per vial (1 vial per carton) - NDC 50633-210-11 |
| Drug | Countries | |
|---|---|---|
| VORAXAZE | Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United States |
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