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Imiglucerase

Pharmaceutical drug

Pharmaceutical drug

| Drugs.com =

| elimination_half-life = 3.6–10.4 min

Imiglucerase is a medication used in the treatment of Gaucher's disease.

It is a recombinant DNA-produced analogue of the human enzyme β-glucocerebrosidase. Cerezyme is a freeze-dried medicine containing imiglucerase, manufactured by Genzyme Corporation. It is given intravenously after reconstitution as a treatment for Type 1 and Type 3 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, meanwhile the enzyme activity produced by recombinant DNA technology is approximately 40 units/mg. 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. It is one of more expensive medications, with an annual cost of $200,000 per person in the United States. Imiglucerase has been granted orphan drug status in the United States, Australia, and Japan.

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.

Side effects

The most common side effect is hypersensitivity, which occurs in about 3% of patients. It is associated with symptoms such as cough, shortness of breath, rashes, itching, and 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.

Interactions

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

References

References

  1. (17 September 2018). "Cerezyme EPAR".
  2. (August 2008). "Imiglucerase and its use for the treatment of Gaucher's disease". Expert Opinion on Pharmacotherapy.
  3. (February 2007). "The long-term international safety experience of imiglucerase therapy for Gaucher disease". Molecular Genetics and Metabolism.
  4. (2018). "Austria-Codex". Österreichischer Apothekerverlag.
  5. (August 1978). "Gaucher disease: isolation and comparison of normal and mutant glucocerebrosidase from human spleen tissue". Proceedings of the National Academy of Sciences of the United States of America.
  6. "Cerezyme Powder for concentrate for solution for infusion, Annex I: Summary of Product Characteristics". Sanofi-Aventis Latvia SIA.
  7. "Cerezyme (imiglucerase for injection)". Genzyme product data sheet.
  8. (November 2009). "Balancing innovation, access, and profits--market exclusivity for biologics". The New England Journal of Medicine.
  9. "Imiglucerase". Orphanet.
  10. (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.
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