Prescription medicine
Taliglucerase alfa Brand names: Elelyso
Taliglucerase alfa (Elelyso) is a prescription medicine with an FDA approval on record since 2012. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the taliglucerase alfa FDA label on DailyMed (effective December 29, 2025, Pfizer Laboratories Div Pfizer Inc); the BLA 22458 record on Drugs@FDA; every taliglucerase alfa label on DailyMed.
Highlights of the record
FDA label of December 29, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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 ELELYSO 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 ELELYSO 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 [see Warnings and Precautions (5.1) ]. WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS See full prescribing information for complete boxed warning.
Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. ( 5.1 )
Initiate ELELYSO in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. […]
Used for
From the label: indications and usageELELYSO is indicated for the treatment of patients 4 years of age and older with a confirmed diagnosis of Type 1 Gaucher disease.
Forms and strengths
- 5ml
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- May 1, 2012 Elelyso, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2018 0 Class I among all firms' recalls; latest February 27, 2020
- FAERS reports
- 566 through July 30, 2026
What is taliglucerase alfa used for?
From the label: indications and usageELELYSO 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 ( 1 ).
FDA pharmacologic class: Hydrolytic Lysosomal Glucocerebroside-specific Enzyme.
Source: FDA drug label (ELELYSO), Pfizer Laboratories Div Pfizer Inc, effective December 29, 2025 (SPL set fa3cbd5d-677c-4b19-9032-d9182cb69a83), via openFDA; the full label on DailyMed
Is there a generic for taliglucerase alfa (Elelyso)?
No generic taliglucerase alfa is approved (Drugs@FDA, October 8, 2026).
- 2012 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has taliglucerase alfa been recalled?
The FDA's Enforcement Report lists 2 recalls naming taliglucerase alfa since 2018: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 27, 2020 | Class II | Pfizer Inc. | Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to … |
| September 19, 2018 | Class II | Pfizer Inc. | Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the taliglucerase alfa label say about other medicines?
The taliglucerase alfa label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Epinephrine | boxed warning | If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue ELELYSO and immediately initiate appropriate medical treatment, including use of epinephrine. |
Source: FDA drug label (ELELYSO), Pfizer Laboratories Div Pfizer Inc, effective December 29, 2025 (SPL set fa3cbd5d-677c-4b19-9032-d9182cb69a83), via openFDA; the full label on DailyMed
What do FAERS reports show for taliglucerase alfa?
The FDA Adverse Event Reporting System holds 566 reports that list taliglucerase alfa among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 49 are coded as a death and 114 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other hydrolytic lysosomal glucocerebroside-specific enzymes
- the pharmacologic class, with prices and generics
- Taliglucerase alfa side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other