Prescription medicine
Pegunigalsidase alfa Brand names: Elfabrio
Pegunigalsidase alfa (Elfabrio) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the pegunigalsidase alfa FDA label on DailyMed (effective July 8, 2024); every pegunigalsidase alfa label on DailyMed.
Highlights of the record
FDA label of July 8, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS.
Patients treated with ELFABRIO have experienced hypersensitivity reactions, including anaphylaxis. Appropriate medical support measures, including cardiopulmonary resuscitation equipment, should be readily available during ELFABRIO administration. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue ELFABRIO immediately and initiate appropriate medical treatment. In patients with severe hypersensitivity reaction, a desensitization procedure to ELFABRIO may be considered [see Warnings and Precautions ( 5.1 )]. WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS See full prescribing information for complete boxed warning. Appropriate medical support measures, including cardiopulmonary resuscitation equipment, should be readily available. If a severe hypersensitivity reaction occurs, discontinue ELFABRIO immediately and initiate appropriate medical treatment.
Used for
From the label: indications and usageELFABRIO is indicated for the treatment of adults with confirmed Fabry disease.
Forms and strengths
- 5 mg/2.5ml
- 20 mg/10ml
Injection (solution) (concentrate).
On the market
- 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
- 354 through July 30, 2026
What is pegunigalsidase alfa used for?
From the label: indications and usageELFABRIO is indicated for the treatment of adults with confirmed Fabry disease. ELFABRIO is a hydrolytic lysosomal neutral glycosphingolipid-specific enzyme indicated for the treatment of adults with confirmed Fabry disease.
FDA pharmacologic class: Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme.
Source: FDA drug label (ELFABRIO), Chiesi USA, Inc., effective July 8, 2024 (SPL set 6fb674bf-744e-431f-92ef-b2a5a66c8cf3), via openFDA; the full label on DailyMed
Is there a generic for pegunigalsidase alfa (Elfabrio)?
No generic pegunigalsidase alfa is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the pegunigalsidase alfa label say about other medicines?
The pegunigalsidase alfa label names 4 other medicines 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 |
|---|---|---|
| Acetaminophen | warnings and precautions | Up to 40% of patients were pretreated with diphenhydramine, prednisone and/or acetaminophen at least once during the clinical trials. |
| Diphenhydramine | warnings and precautions | Up to 40% of patients were pretreated with diphenhydramine, prednisone and/or acetaminophen at least once during the clinical trials. |
| Epinephrine | warnings and precautions | Patients received treatment that included epinephrine, antihistamines and/or systemic corticosteroids. Prior to ELFABRIO administration, consider pretreating with antihistamines, antipyretics, and/or corticosteroids. |
| Prednisone | warnings and precautions | Up to 40% of patients were pretreated with diphenhydramine, prednisone and/or acetaminophen at least once during the clinical trials. |
Source: FDA drug label (ELFABRIO), Chiesi USA, Inc., effective July 8, 2024 (SPL set 6fb674bf-744e-431f-92ef-b2a5a66c8cf3), via openFDA; the full label on DailyMed
What do FAERS reports show for pegunigalsidase alfa?
The FDA Adverse Event Reporting System holds 354 reports that list pegunigalsidase alfa among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 12 are coded as a death and 65 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other hydrolytic lysosomal neutral glycosphingolipid-specific enzymes
- the pharmacologic class, with prices and generics
- Pegunigalsidase alfa side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other