Prescription medicine
Revakinagene taroretcel-lwey Brand names: Encelto
Revakinagene taroretcel-lwey (Encelto) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the revakinagene taroretcel-lwey FDA label on DailyMed (effective August 26, 2026); every revakinagene taroretcel-lwey label on DailyMed.
Highlights of the record
FDA label of August 26, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageENCELTO is indicated for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel).
Forms and strengths
Implant.
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
- 6 through July 30, 2026
What is revakinagene taroretcel-lwey used for?
From the label: indications and usageENCELTO is indicated for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel). ENCELTO is an allogeneic encapsulated cell-based gene therapy indicated for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel).
Source: FDA drug label (ENCELTO), Neurotech Pharmaceuticals, Inc., effective August 26, 2026 (SPL set 1ae9482a-b478-4e21-9166-b5fd52d3ef9c), via openFDA; the full label on DailyMed
What does the patient leaflet for revakinagene taroretcel-lwey say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid after placement of ENCELTO?Immediately post-operative: Avoid heavy lifting (over 20 pounds) for one week. Keep water out of the eye (e.g., close your eye while showering) for one week. Protect your eyes by wearing glasses or protective eyewear during the day and using an eye shield at night for one week. Do not drive or use machinery until the eye shield has been removed and your ophthalmologist informs you that your vision has recovered to an acceptable level. Post operative care: Use a topical antibiotic solution at a frequency of 1 drop four times a day for 7 days. Use a steroid drop taper of prednisolone acetate 1% (or equivalent) starting the day after surgery with the following taper: 1 drop four times a day for the first 7 days; 1 drop three times a day for the next 7 days; 1 drop two times a day for the next 7 days; 1 drop once a day for the last 7 days. […]
Source: FDA drug label (ENCELTO), Neurotech Pharmaceuticals, Inc., effective August 26, 2026 (SPL set 1ae9482a-b478-4e21-9166-b5fd52d3ef9c), via openFDA; the full label on DailyMed
Is there a generic for revakinagene taroretcel-lwey (Encelto)?
No generic revakinagene taroretcel-lwey 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 revakinagene taroretcel-lwey label say about other medicines?
The revakinagene taroretcel-lwey 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 |
|---|---|---|
| Aspirin | warnings and precautions | Patients receiving antithrombotic medication (e.g., oral anticoagulants, aspirin, nonsteroidal anti-inflammatory drugs) may be at increased risk of vitreous hemorrhage. |
Source: FDA drug label (ENCELTO), Neurotech Pharmaceuticals, Inc., effective August 26, 2026 (SPL set 1ae9482a-b478-4e21-9166-b5fd52d3ef9c), via openFDA; the full label on DailyMed
What do FAERS reports show for revakinagene taroretcel-lwey?
The FDA Adverse Event Reporting System holds 6 reports that list revakinagene taroretcel-lwey among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 1 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?
- Revakinagene taroretcel-lwey side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other