Prescription medicine
Vestronidase alfa Brand names: Mepsevii
Vestronidase alfa (Mepsevii) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the vestronidase alfa FDA label on DailyMed (effective November 18, 2025); every vestronidase alfa label on DailyMed.
Highlights of the record
FDA label of November 18, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
ANAPHYLAXIS Anaphylaxis has occurred with MEPSEVII administration, as early as the first dose [see Warnings and Precautions ( 5.1 )], therefore appropriate medical support should be readily available when MEPSEVII is administered. Closely observe patients during and for 60 minutes after MEPSEVII infusion [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.1 )]. Immediately discontinue the MEPSEVII infusion if the patient experiences anaphylaxis [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.1 )]. WARNING: ANAPHYLAXIS See full prescribing information for complete boxed warning. Anaphylaxis has occurred with MEPSEVII administration, as early as the first dose ( 5.1 ), therefore appropriate medical support should be readily available when MEPSEVII is administered. Closely observe patients during and for 60 minutes after MEPSEVII infusion ( 2.2 , 5.1 ). Immediately discontinue the MEPSEVII infusion if the patient experiences anaphylaxis ( 2.2 , 5.1 ).
Used for
From the label: indications and usageMEPSEVII is indicated in pediatric and adult patients for the treatment of Mucopolysaccharidosis VII (MPS VII, Sly syndrome).
Forms and strengths
- 2 mg/ml
Injection.
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
- 63 through July 30, 2026
What is vestronidase alfa used for?
From the label: indications and usageMEPSEVII is indicated in pediatric and adult patients for the treatment of Mucopolysaccharidosis VII (MPS VII, Sly syndrome). Limitations of Use The effect of MEPSEVII on the central nervous system manifestations of MPS VII has not been determined. MEPSEVII is a recombinant human lysosomal beta glucuronidase indicated in pediatric and adult patients for the treatment of Mucopolysaccharidosis VII (MPS VII, Sly syndrome). Limitations of Use The effect of MEPSEVII on the central nervous system manifestations of MPS VII has not been determined.
FDA pharmacologic class: Lysosomal beta Glucuronidase.
Source: FDA drug label (MEPSEVII), Ultragenyx Pharmaceutical Inc., effective November 18, 2025 (SPL set 925d4e21-fd98-474d-a34d-a0b3558ed750), via openFDA; the full label on DailyMed
Is there a generic for vestronidase alfa (Mepsevii)?
No generic vestronidase 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 do FAERS reports show for vestronidase alfa?
The FDA Adverse Event Reporting System holds 63 reports that list vestronidase alfa among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6 are coded as a death and 22 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?
- Vestronidase alfa side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other