Molecule
Imiglucerase is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for the treatment of non-central nervous system (CNS) manifestations of Type 1 or Type 3 Gaucher disease in adults and pediatric patients. MedsAcross supplies Imiglucerase for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
CEREZYME is indicated for the treatment of non-central nervous system (CNS) manifestations of Type 1 or Type 3 Gaucher disease in adults and pediatric patients. CEREZYME is a hydrolytic lysosomal glucocerebrosidase-specific enzyme indicated for the treatment of non-central nervous system (CNS) manifestations of Type 1 or Type 3 Gaucher disease in adults and pediatric patients.
Source: US FDA prescribing information
Gaucher disease is characterized by a deficiency of β-glucocerebrosidase activity, which results in accumulation of glucocerebroside in various tissues including liver, spleen, and bone marrow. The mannose sugars on imiglucerase mediate binding to and internalization by cells including macrophages. CEREZYME catalyzes the hydrolysis of glucocerebroside to glucose and ceramide.
Source: US FDA prescribing information
Administer CEREZYME under the supervision of a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis. The recommended dosage is 2.5 units/kg three times a week to 60 units/kg once every two weeks administered intravenously. Titrate the dosage based on disease severity and therapeutic goals for the patient. See the full prescribing information for dosage modifications due to hypersensitivity reactions and/or IARs. See the full prescribing information for preparation and administration instructions.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Boxed 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. Infusion-Associated Reactions (IARs): If a severe IAR occurs, discontinue CEREZYME immediately and initiate appropriate medical treatment. Hypersensitivity Reactions Including Anaphylaxis Life-threatening hypersensitivity reactions, including anaphylaxis, have been reported in patients treated with enzyme replacement therapies, including CEREZYME. In addition, other hypersensitivity reactions have included pruritus, flushing, urticaria, angioedema, chest discomfort, dyspnea, cough, cyanosis, tachycardia, and hypotension.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions Including Anaphylaxis Infusion-Associated Reactions Adverse reactions reported in adults and pediatric patients include back pain, chills, dizziness, fatigue, headache, hypersensitivity reactions, nausea, pyrexia, and vomiting.
Source: US FDA prescribing information
Store refrigerated at 2°C to 8°C (36°F to 46°F). For storage of reconstituted and diluted solution.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Imiglucerase, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Cerezyme 40 units/mL powder for injectionIntravenous Cold chain | Genzyme | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Imiglucerase in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 1 presentations of Imiglucerase and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Imiglucerase, including Cerezyme.
Yes. The US FDA first approved Imiglucerase on 23 May 1994, according to Drugs@FDA.
Yes. Imiglucerase has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Imiglucerase must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Imiglucerase is classified under ATC code A16AB02 (Imiglucerase).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.