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Prescribing Information (PDF)

Cerezyme Profile

Since its approval, Cerezyme® (imiglucerase for injection) and enzyme replacement therapy have become the standard of care for Type 1 Gaucher disease.[1]

Over 3,500 patients have been treated with Cerezyme, and in some, there have been as many as 10 years of follow-up.[2]

Cerezyme has been shown to arrest, decrease, or normalize many of the major signs and symptoms of Type 1 Gaucher disease.[3]

Indications and usage

Cerezyme® (imiglucerase for injection) is indicated for long-term enzyme replacement therapy for adult and pediatric patients with a confirmed diagnosis of Type 1 Gaucher disease that results in one or more of the following conditions:[4]

Anemia
Thrombocytopenia
Bone disease
Hepatomegaly or splenomegaly

Please see the full prescribing information (PDF) for Cerezyme and the important safety information below.

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.




References

1. Grabowski GA. Lysosomal storage diseases. In: Braunwald E, Fauci AS, eds. Harrison’s Principles of Internal Medicine. 15th ed. New York, NY: McGraw-Hill; 2001:2276-2281.

2. The Gaucher Registry. Data on file.

3. Weinreb NJ, Charrow J, Andersson HC, et al. Effectiveness of enzyme replacement therapy in 1028 patients with type 1 Gaucher disease after 2 to 5 years of treatment: a report from the Gaucher registry. Am J Med. 2002;113:112-119.

4. Prescribing Information for Cerezyme® (imiglucerase for injection).


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