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Prescribing Information (PDF)

Cerezyme Profile

Cerezyme® (imiglucerase for injection) is the only therapy for the treatment of type 1 Gaucher with over 16 years of use in patients, including children.[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. [1]

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:[3]

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

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.




References

1. 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.

2. The Gaucher Registry. Data on file.

3. 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