Gaucher Registry
The Gaucher Registry is the world’s largest cooperative observational study on Gaucher disease. The International Collaborative Gaucher Group (ICGG) established the registry in 1991 as a longitudinal database tracking outcomes of routine clinical practice. As of 2010, over 5,600 patients have enrolled in the registry.
All patients with a confirmed diagnosis of Gaucher disease are eligible for inclusion. By enrolling patients in the registry, participating physicians will receive patient-specific reports to monitor disease status and access to information on current treatment guidelines and practice patterns.
The Gaucher Registry maintains its integrity by a commitment to patient privacy and confidentiality in compliance with HIPAA (Health Insurance Portability and Accountability Act), as well as a commitment to the quality of the data. To ensure the most comprehensive data, the Gaucher Registry is open to all patients with Gaucher disease, regardless of treatment modality.
Genzyme is committed to helping meet the needs of people who are living with Gaucher disease. As part of this commitment, we provide links to other organizations that provide information and support to the Gaucher community, such as the ICGG.
To learn more about how to enroll your patients, visit the Gaucher Registry.
Indication & Usage
Cerezyme® (imiglucerase for injection) is indicated for long-term enzyme replacement therapy for pediatric and adult patients with a confirmed diagnosis of Type 1 Gaucher disease that results in one or more of the following conditions:
- anemia
- thrombocytopenia
- bone disease
- hepatomegaly or splenomegaly
Important Safety Information
Approximately 15% of patients have developed IgG antibodies, and these patients have a higher risk of hypersensitivity reaction. Therefore periodic monitoring is suggested; caution should be exercised in patients with antibodies or prior symptoms of hypersensitivity. Symptoms suggestive of hypersensitivity occurred in 6.6% of patients, and include anaphylactoid reaction, pruritus, flushing, urticaria, angioedema, chest discomfort, dyspnea, coughing, cyanosis and hypotension.
Reactions 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 adverse events include nausea, abdominal pain, vomiting, 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 at the site of injection.
To report suspected adverse reactions, contact Genzyme at 800-745-4447, option 2 or FDA at 800-FDA-1088 or http://www.fda.gov/Safety/MedWatch
Please see Full Prescribing Information (PDF).