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Monitoring Guidelines

A multisystemic disease may require multiple modes of evaluation. In Type 1 Gaucher disease, the range of possible symptoms and potential for severe disease progression may require the clinician to evaluate and monitor a number of areas.

The monitoring guidelines document below outlines the assessments and testing frequency recommended at diagnosis and for follow-up.[1] These assessments may be used both to monitor the outcome of enzyme replacement therapy (ERT) and to gauge disease progression in those not receiving ERT.

These recommendations were devised by the International Collaborative Gaucher Group (ICGG), which oversees the Gaucher Registry, the largest database of patients with Gaucher disease. Monitoring results may be used to evaluate various parameters indicating disease progression or therapeutic progress.

Download the ICGG Monitoring Guidelines (PDF).

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Important Safety Information

Adverse reactions related to Cerezyme® (imiglucerase for injection) administration have been reported in less than 15% of patients. Each of the following events occurred in less than 2% of the total patient population. Reported adverse events include nausea, vomiting, abdominal pain, diarrhea, rash, fatigue, headache, fever, dizziness, chills, backache, and tachycardia. Adverse events associated with the route of administration include discomfort, pruritus, burning, swelling or sterile abscess at the site of venipuncture. Symptoms suggestive of hypersensitivity include anaphylactoid reaction, pruritus, flushing, urticaria, angioedema, chest discomfort, dyspnea, coughing, cyanosis and hypotension. Approximately 15% of patients have developed IgG antibodies; periodic monitoring is suggested. Side effects should be reported promptly to Genzyme Medical Information at 800-745-4447, option 2. To learn more, please see full product information (PDF), or contact Genzyme at 1-800-745-4447.




Reference

1. The Gaucher Registry. Data on File.


Highlights
Did You Know...
Gaucher disease is an autosomal recessive disorder defined by the presence of two mutant alleles for the glucocerebrosidase gene.

Resources
The Gaucher Registry is the world's largest cooperative observational study on Gaucher disease.
Learn more about participating in the registry
.

Contact Information
Genzyme Therapeutics
500 Kendall Street
Cambridge, MA 02142

800-745-4447
617-768-9000

Contact Genzyme