Prescription medicine
Alglucosidase alfa Brand names: Lumizyme; first approved as Myozyme
Alglucosidase alfa (Lumizyme) is a prescription medicine with an FDA approval on record since 2006. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the alglucosidase alfa FDA label on DailyMed (effective January 10, 2025, Genzyme Corporation); the BLA 125141 record on Drugs@FDA; every alglucosidase alfa label on DailyMed.
Highlights of the record
FDA label of January 10, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS, IMMUNE-MEDIATED REACTIONS,.
and RISK OF ACUTE CARDIORESPIRATORY FAILURE WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS, IMMUNE-MEDIATED REACTIONS, and RISK OF ACUTE CARDIORESPIRATORY FAILURE See full prescribing information for complete boxed warning. Hypersensitivity Reactions Including Anaphylaxis Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Initiate LUMIZYME 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 LUMIZYME and immediately initiate appropriate medical treatment, including use of epinephrine. ( 5.1 ) Immune-Mediated Reactions Immune-mediated reactions presenting as proteinuria, nephrotic syndrome, and necrotizing skin lesions have occurred in some patients following LUMIZYME treatment. Monitor patients for the development of systemic immune-mediated reactions involving skin and other organs while receiving LUMIZYME. […]
Used for
From the label: indications and usageLUMIZYME ® is a hydrolytic lysosomal glycogen-specific enzyme indicated for patients with Pompe disease (acid α-glucosidase [GAA] deficiency).
Forms and strengths
- 5 mg/ml
Injection (powder) for solution.
On the market
- Earliest approval on file
- April 28, 2006 Myozyme, Genzyme; Drugs@FDA’s file, where older or withdrawn approvals can be missing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)
- 1 since 2015 0 Class I among all firms' recalls; latest December 8, 2015
- FAERS reports
- 2,392 through July 30, 2026
What is alglucosidase alfa used for?
From the label: indications and usageLUMIZYME ® is a hydrolytic lysosomal glycogen-specific enzyme indicated for patients with Pompe disease (acid α-glucosidase [GAA] deficiency). LUMIZYME ® is a hydrolytic lysosomal glycogen-specific enzyme indicated for patients with Pompe disease (GAA deficiency).
FDA pharmacologic class: Hydrolytic Lysosomal Glycogen-specific Enzyme.
Source: FDA drug label (Lumizyme), Genzyme Corporation, effective January 10, 2025 (SPL set d6bfbc45-2d34-439e-8aad-59ee2d53d4df), via openFDA; the full label on DailyMed
Is there a generic for alglucosidase alfa (Lumizyme)?
No generic alglucosidase alfa is approved (Drugs@FDA, October 8, 2026).
- 2006 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has alglucosidase alfa been recalled?
The FDA's Enforcement Report lists 1 recall naming alglucosidase alfa since 2015: 0 Class I (the most serious), 0 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 8, 2015 | Class III | Genzyme Corporation | Labeling: Incorrect or Missing Lot and/or Exp Date |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the alglucosidase alfa label say about other medicines?
The alglucosidase 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 LUMIZYME and immediately initiate appropriate medical treatment, including use of epinephrine. ( 5.1 ) Immune-Mediated Reactions Immune-mediated reactions presenting as proteinuria, nephrotic syndrome, and necrotizing skin lesions have … |
Source: FDA drug label (Lumizyme), Genzyme Corporation, effective January 10, 2025 (SPL set d6bfbc45-2d34-439e-8aad-59ee2d53d4df), via openFDA; the full label on DailyMed
What do FAERS reports show for alglucosidase alfa?
The FDA Adverse Event Reporting System holds 2,392 reports that list alglucosidase alfa among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 116 are coded as a death and 530 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 glycogen-specific enzymes
- the pharmacologic class, with prices and generics
- Alglucosidase alfa side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other