Prescription medicine
Elapegademase Brand names: Revcovi
Elapegademase (Revcovi) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the elapegademase FDA label on DailyMed (effective May 31, 2026); every elapegademase label on DailyMed.
Highlights of the record
FDA label of May 31, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageREVCOVI is indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients.
Forms and strengths
- 1.6 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)
- 1 since 2026 0 Class I among all firms' recalls; latest August 19, 2026
- FAERS reports
- 295 through July 30, 2026
What is elapegademase used for?
From the label: indications and usageREVCOVI is indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients. REVCOVI is a recombinant adenosine deaminase indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients.
Source: FDA drug label (Revcovi), Chiesi USA, Inc., effective May 31, 2026 (SPL set 8c073f84-cdd0-40e4-b3a9-172687267f28), via openFDA; the full label on DailyMed
Is there a generic for elapegademase (Revcovi)?
No generic elapegademase is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has elapegademase been recalled?
The FDA's Enforcement Report lists 1 recall naming elapegademase since 2026: 0 Class I (the most serious), 0 Class II, 1 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 19, 2026 | Class III | Chiesi USA, Inc. | Failed Stability Specifications: Out of specification stability result for the protein concentration profile. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for elapegademase?
The FDA Adverse Event Reporting System holds 295 reports that list elapegademase 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 44 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?
- Elapegademase side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other