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1. Voraxaze
1. 9074-87-7
2. Q5572303
| Molecular Weight | 261.5 g/mol |
|---|---|
| Molecular Formula | Zn4+8 |
| Hydrogen Bond Donor Count | 0 |
| Hydrogen Bond Acceptor Count | 0 |
| Rotatable Bond Count | 0 |
| Exact Mass | 261.70916 g/mol |
| Monoisotopic Mass | 255.71657 g/mol |
| Topological Polar Surface Area | 0 Ų |
| Heavy Atom Count | 4 |
| Formal Charge | 8 |
| Complexity | 0 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 4 |
Used in patients on methotrexate treatment who have kidney dysfunction, and are experiencing an abnormally high plasma concentration of methotrexate (> 1 micromole per liter).
FDA Label
Treatment of methotrexate toxicity
Voraxaze is indicated to reduce toxic plasma methotrexate concentration in adults and children (aged 28 days and older) with delayed methotrexate elimination or at risk of methotrexate toxicity.
Glucarpidase acts as an antidote to toxic methotrexate levels by elminating methotrexate by a non-kidney route.
V03AF09
V - Various
V03 - All other therapeutic products
V03A - All other therapeutic products
V03AF - Detoxifying agents for antineoplastic treatment
V03AF09 - Glucarpidase
Absorption
In healthy patients not taking methotrexate, the average maximum concentration for glucarpidase was 3.3 g/mL.
Route of Elimination
Route of elmination was not determined.
Volume of Distribution
Glucarpidase is likely limited to the plasma volume since its volume of distribution is 3.6 L.
Clearance
In healthy patients not taking methotrexate, glucarpidase has a clearance of 7.5 mL/min.
Metabolism was not determined.
In healthy patients not taking methotrexate, glucarpidase has an elimination half-life of 5.6 hours. In patients with severe renal impairment (creatinine clearance <30 mL/min), glucarpidase has an longer elimination half-life at 8.2 hours.
Glucarpidase inactivates methotrexate, and other antifolates, by hydrolyzing glutamate on the carboxyl terminal of these compounds. For methotrexate specifically, it is hydrolyzed to the inactive metabolites glutamate and 4-deoxy-4-amino-N10-methylpteroic acid (DAMPA).
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A Glucarpidase manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glucarpidase, including repackagers and relabelers. The FDA regulates Glucarpidase manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glucarpidase API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Glucarpidase supplier is an individual or a company that provides Glucarpidase active pharmaceutical ingredient (API) or Glucarpidase finished formulations upon request. The Glucarpidase suppliers may include Glucarpidase API manufacturers, exporters, distributors and traders.
click here to find a list of Glucarpidase suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Glucarpidase CEP of the European Pharmacopoeia monograph is often referred to as a Glucarpidase Certificate of Suitability (COS). The purpose of a Glucarpidase CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Glucarpidase EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Glucarpidase to their clients by showing that a Glucarpidase CEP has been issued for it. The manufacturer submits a Glucarpidase CEP (COS) as part of the market authorization procedure, and it takes on the role of a Glucarpidase CEP holder for the record. Additionally, the data presented in the Glucarpidase CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Glucarpidase DMF.
A Glucarpidase CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Glucarpidase CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Glucarpidase suppliers with CEP (COS) on PharmaCompass.
Glucarpidase Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Glucarpidase GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Glucarpidase GMP manufacturer or Glucarpidase GMP API supplier for your needs.
A Glucarpidase CoA (Certificate of Analysis) is a formal document that attests to Glucarpidase's compliance with Glucarpidase specifications and serves as a tool for batch-level quality control.
Glucarpidase CoA mostly includes findings from lab analyses of a specific batch. For each Glucarpidase CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Glucarpidase may be tested according to a variety of international standards, such as European Pharmacopoeia (Glucarpidase EP), Glucarpidase JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Glucarpidase USP).
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