Prescription medicine
Elosulfase alfa Brand names: Vimizim
Elosulfase alfa (Vimizim) is a prescription medicine with an FDA approval on record since 2014. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the elosulfase alfa FDA label on DailyMed (effective October 30, 2025, BioMarin Pharmaceutical Inc.); the BLA 125460 record on Drugs@FDA; every elosulfase alfa label on DailyMed.
Highlights of the record
FDA label of October 30, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
HYPERSENSITIVITY REACTIONS INCLUDING.
ANAPHYLAXIS and RISK OF ACUTE RESPIRATORY COMPLICATIONS 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 VIMIZIM 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 VIMIZIM 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) ]. Patients with acute respiratory illness may be at risk of serious acute exacerbation of their respiratory compromise due to hypersensitivity reactions and require additional monitoring [see Warnings and Precautions (5.2) ]. WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS and RISK OF ACUTE RESPIRATORY COMPLICATIONS 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. […]
Used for
From the label: indications and usageVIMIZIM (elosulfase alfa) is indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA;
Forms and strengths
- 5 mg/5ml
Injection (solution) (concentrate).
On the market
- Earliest approval on file
- February 14, 2014 Vimizim, Biomarin Pharm; Drugs@FDA’s file, where older or withdrawn approvals can be missing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)
- No recall recorded
- FAERS reports
- 5,380 through July 30, 2026
What is elosulfase alfa used for?
From the label: indications and usageVIMIZIM (elosulfase alfa) is indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome). VIMIZIM is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome).
FDA pharmacologic class: Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme.
Source: FDA drug label (VIMIZIM), BioMarin Pharmaceutical Inc., effective October 30, 2025 (SPL set 0caa2565-12b2-0ad0-1f9a-273e81c3d4cc), via openFDA; the full label on DailyMed
Is there a generic for elosulfase alfa (Vimizim)?
No generic elosulfase alfa is approved (Drugs@FDA, October 8, 2026).
- 2014 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the elosulfase alfa label say about other medicines?
The elosulfase 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 | … (anaphylaxis) occurs, discontinue VIMIZIM and immediately initiate appropriate medical treatment, including use of epinephrine. ( 5.1 ) Patients with acute respiratory illness may be at risk of serious acute exacerbation of their respiratory compromise due to hypersensitivity reactions, and require additional … |
Source: FDA drug label (VIMIZIM), BioMarin Pharmaceutical Inc., effective October 30, 2025 (SPL set 0caa2565-12b2-0ad0-1f9a-273e81c3d4cc), via openFDA; the full label on DailyMed
What do FAERS reports show for elosulfase alfa?
The FDA Adverse Event Reporting System holds 5,380 reports that list elosulfase alfa among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 131 are coded as a death and 1,135 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 glycosaminoglycan-specific enzymes
- the pharmacologic class, with prices and generics
- Elosulfase alfa side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other