Cerezyme® is the commercial brand name of Imiglucerase for Injection, a recombinant human beta-glucocerebrosidase enzyme replacement therapeutic agent developed by Genzyme Ireland Ltd. It hydrolyzes accumulated glucocerebroside deposited in the lysosomes of liver, spleen, bone marrow and other tissues, eliminating abnormal lipid accumulation to reverse multiple organ damages caused by Gaucher disease. This product is only administered via intravenous infusion. It has obtained the imported drug registration approval in China with the registration number SJ20140067.
Main Indications
Long-term enzyme replacement therapy for pediatric patients aged 2 years and older as well as adult patients diagnosed with Type 1 (non-neuronopathic) Gaucher disease or Type 3 (chronic neuronopathic) Gaucher disease, to improve major non-neurological clinical manifestations including anemia, thrombocytopenia, hepatomegaly, splenomegaly and bone lesions caused by Gaucher disease.
Clinical Research
Global multicenter pivotal clinical trials confirmed that imiglucerase can effectively increase hemoglobin and platelet levels, shrink enlarged liver and spleen, and relieve bone damage within 6 months of initiation of enzyme replacement therapy for Gaucher disease patients;
Decades of worldwide real-world long-term observational studies verified persistent stable efficacy in improving hematological indicators, visceral organ lesions and skeletal lesions for both adults and children with Gaucher disease during long-term medication;
Clinical registration trials containing Chinese Gaucher disease patients verified stable therapeutic effect and safety profile consistent with global multi-center research data, providing standardized long-term disease control options for domestic rare disease patients.
Common Side Effects
Serious adverse reactions: Severe anaphylactic shock, high-titer neutralizing antibody production which may weaken therapeutic efficacy;
Common mild adverse reactions: Infusion-related hypersensitivity (urticaria, skin pruritus, rash, chills, fever), fatigue, back pain, dizziness, headache, nausea, vomiting, infusion site local discomfort.
Approval Status in China
Cerezyme® (Imiglucerase for Injection, specification: 400 units per vial, imported registered medicine) was approved for import marketing in China in 2014, being a core first-line enzyme replacement drug for the treatment of Gaucher disease in Chinese rare disease patients.
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