Molecule
Taliglucerase alfa is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for the treatment of patients 4 years of age and older with a confirmed diagnosis of Type 1 Gaucher disease. MedsAcross supplies Taliglucerase alfa 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.
ELELYSO is indicated for the treatment of patients 4 years of age and older with a confirmed diagnosis of Type 1 Gaucher disease. ELELYSO is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for the treatment of patients 4 years and older with a confirmed diagnosis of Type 1 Gaucher disease.
Source: US FDA prescribing information
Gaucher disease is an autosomal recessive disorder caused by mutations in the human glucocerebrosidase gene, which results in a reduced activity of the lysosomal enzyme glucocerebrosidase. Glucocerebrosidase catalyzes the conversion of the sphingolipid glucocerebroside into glucose and ceramide. The enzymatic deficiency results in accumulation of substrate glucocerebroside primarily in the lysosomal compartment of macrophages, giving rise to foam cells or "Gaucher cells," which accumulate in the liver, spleen and bone marrow. ELELYSO, an enzyme replacement therapy, is a recombinant analog of human lysosomal glucocerebrosidase that catalyzes the hydrolysis of glucocerebroside to glucose and ceramide, reducing the amount of accumulated glucocerebroside.
Source: US FDA prescribing information
Recommendations Prior to ELELYSO Treatment: • Administration of ELELYSO should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis. Recommended Dosage in Patients 4 Years and Older: • Treatment-naïve: 60 units/kg administered every other week as a 60- to 120-minute intravenous infusion. • Patients switching from imiglucerase: Initiate ELELYSO intravenous treatment (60- to 120-minute infusion) with the same units/kg imiglucerase dosage and subsequently administer ELELYSO every other week. Dosage adjustments can be based on achievement and maintenance of each patient’s therapeutic goals. Preparation and Administration: • Reconstitute, dilute and administer under the supervision of a healthcare professional. • See Full Prescribing Information for complete 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. See boxed warning Hypersensitivity Reactions Including Anaphylaxis Life‑threatening h ypersensitivity reactions, including anaphylaxis, have occurred in patients treated with enzyme replacement therapies, including ELELYSO.
Source: US FDA prescribing information
The most common adverse reactions are: • Treatment-Naïve Adults (≥5%): headache, arthralgia, fatigue, nausea, dizziness, abdominal pain, pruritus, flushing, vomiting, urticaria. • Patients who Switched from Imiglucerase, after 9 Months on Treatment (≥10%): arthralgia, headache, pain in extremity.
Source: US FDA prescribing information
Refrigerate ELELYSO at 2 °C to 8 °C (36 °F to 46 °F) in the original carton to protect from light. Do not freeze.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Taliglucerase alfa, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Elelyso 200 units/5 mL powder for injectionIntravenous Cold chain | Pfizer Laboratories | 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.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 1 May 2012 | Drugs@FDA |
| EU (EMA) | Refused | EMA medicines data |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 1 presentations of Taliglucerase alfa and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Taliglucerase alfa, including Elelyso.
Yes. The US FDA first approved Taliglucerase alfa on 1 May 2012, according to Drugs@FDA.
At least one listed presentation of Taliglucerase alfa must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Taliglucerase alfa is classified under ATC code A16AB11 (Taliglucerase alfa).
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