Gaucher Registry | Cerezyme® (imiglucerase)

The ICGG Gaucher Registry (sponsored by Sanofi) is the world’s largest cooperative observational study on Gaucher disease

The ICGG established the Gaucher registry in 1991 as a longitudinal database tracking outcomes of routine clinical practice

All patients with a confirmed diagnosis of Gaucher disease are eligible for inclusion
By enrolling patients in the Gaucher Registry, participating physicians will receive patient-specific reports to monitor disease status

Data from the ICGG Gaucher Registry provide insight into Gaucher disease. Publications based on these data have helped increase understanding of Gaucher disease, its natural history, diagnosis, treatment, and management as well as bone disease, pediatric presentation, and genotypes. The ICGG Gaucher Registry maintains its integrity by a commitment to patient privacy and confidentiality, as well as a commitment to the quality of data.

Reporting. Collaborating. Advancing. Help to improve the quality of care for patients with Gaucher disease. Visit the ICGG Gaucher Registry to learn more.

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Indication

Indication and Usage:

Cerezyme^® (imiglucerase) for injection is indicated for treatment of adults and pediatric patients 2 years of age and older with Type 1 Gaucher disease that results in one or more of the following conditions:

anemia
thrombocytopenia
bone disease
hepatomegaly or splenomegaly

Important Safety Information

WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS

Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy.

Initiate CEREZYME in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue CEREZYME and immediately initiate appropriate medical treatment, including use of epinephrine. Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis, and to seek immediate medical care should symptoms occur.

Warnings and Precautions:

Hypersensitivity Reactions Including Anaphylaxis: See Boxed WARNING.
Patients with antibody to imiglucerase have a higher risk of hypersensitivity reactions. Consider periodic monitoring during the first year of treatment for lgG antibody formation.

Consider risks and benefits of readministering Cerezyme to individual patients following a severe reaction. Consider reducing the rate of infusion, pretreat with antihistamines and/or corticosteroids, and monitor patients for new signs and symptoms of a severe hypersensitivity reaction.

Infusion-Associated Reactions:
Infusion associated reactions (IARs) have been observed in patients treated with Cerezyme. If an IAR occurs, decreasing the infusion rate, temporarily stopping the infusion and/or administering antihistamines and/or antipyretics may ameliorate the symptoms. Closely monitor patients who have experienced IARs when re-administering Cerezyme.

Adverse Reactions:
Adverse reactions reported in adults include back pain, chills, dizziness, fatigue, headache, hypersensitivity reactions, nausea, pyrexia, and vomiting.

Adverse reactions reported in pediatric patients 2 years of age and older are similar to adults.

Please see full Prescribing Information, including Boxed WARNING.

The International Collaborative Gaucher Group (ICGG) Gaucher Registry

The ICGG Gaucher Registry (sponsored by Sanofi) is the world’s largest cooperative observational study on Gaucher disease

The ICGG established the Gaucher registry in 1991 as a longitudinal database tracking outcomes of routine clinical practice

Gain a deeper understanding of Gaucher disease

Looking for more treatment information?

Indication

Indication and Usage:

Important Safety Information

Warnings and Precautions:

Indication

Important Safety Information