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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 Therapeutics Goals Laminated Card (PDF).

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Important Safety Information

Approximately 15% of patients have developed immune responses (antibodies). These patients have a higher risk of an allergic reaction (hypersensitivity). Use Cerezyme® (imiglucerase for injection) carefully if you have had an allergic reaction to the product in the past. Symptoms suggestive of allergic reaction happened in 6.6% of patients, and include anaphylactoid reaction (a serious allergic reaction), itching, flushing, hives, an accumulation of fluid under the skin, chest discomfort, shortness of breath, coughing, cyanosis (a bluish discoloration of the skin due to diminished oxygen), and low blood pressure. Side effects related to Cerezyme 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 side effects include nausea, vomiting, abdominal pain, diarrhea, rash, fatigue, headache, fever, dizziness, chills, backache, and rapid heart rate. Because Cerezyme therapy is administered by intravenous infusion, reactions at the site of injection may occur: discomfort, itching, burning, swelling or uninfected abscess. Cerezyme is available by prescription only. For more information, consult your physician. 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

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