Imiglucerase

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Imiglucerase
Clinical data
Trade namesCerezyme
AHFS/Drugs.comMonograph
MedlinePlusa601149
License data
Intravenous infusion
ATC code
Legal status
Legal status
Pharmacokinetic data
Metabolismprobably proteolysis
Elimination half-life3.6–10.4 min
Identifiers
glycosylated)
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Imiglucerase is a medication used in the treatment of Gaucher's disease.[2][3]

It is a

analogue of the human enzyme β-glucocerebrosidase
. Cerezyme is a
intravenously after reconstitution as a treatment for Type 1 and Type 3[4] Gaucher's disease. It is available in formulations containing 200 or 400 units per vial. The specific activity of highly purified human enzyme is 890,000 units/mg,[5] meanwhile the enzyme activity produced by recombinant DNA technology is approximately 40 units/mg.[6] A typical dose is 2.5U/kg every two weeks, up to a maximum of 60 U/kg once every two weeks, and safety has been established from ages 2 and up.[7] It is one of more expensive medications, with an annual cost of $200,000 per person in the United States.[8] Imiglucerase has been granted orphan drug status in the United States, Australia, and Japan.[9]

Cerezyme was one of the drugs manufactured at Genzyme's Allston, Massachusetts plant, for which production was disrupted in 2009 after contamination with Vesivirus 2017.[10]

Side effects

The most common side effect is

angiooedema. Less common side effects include dizziness, headache, nausea, diarrhea, and reactions at the injection site; they are found in less than 1% of patients.[4]

Interactions

No clinical interaction studies have been conducted.[4] Miglustat appears to increase the clearance of imiglucerase by 70%, resulting in decreased enzyme activity.[11]

See also

References

  1. ^ "Cerezyme EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 18 January 2021.
  2. S2CID 72183308
    .
  3. PMID 17079176
    .
  4. ^ a b c Austria-Codex (in German). Vienna: Österreichischer Apothekerverlag. 2018. Cerezyme 400 U-Pulver für ein Konzentrat zur Herstellung einer Infusionslösung.
  5. PMID 29293
    .
  6. ^ "Cerezyme Powder for concentrate for solution for infusion, Annex I: Summary of Product Characteristics" (PDF). Sanofi-Aventis Latvia SIA. Retrieved 26 April 2022 – via Ec.europa.eu.
  7. ^ "Cerezyme (imiglucerase for injection)" (PDF). Genzyme product data sheet. Archived from the original (PDF) on 2003-06-05.
  8. PMID 19828525
    .
  9. ^ "Imiglucerase". Orphanet. Retrieved 26 April 2022.
  10. ^ Ailworth E, Weisman R (June 17, 2009). "Virus shuts Genzyme plant, holds up drugs for 8,000". The Boston Globe.
  11. ^ "Drug interactions between imiglucerase and miglustat". Drugs.com. Retrieved 11 April 2019.
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