Revakinagene Taroretcel-Lwey
Revakinagene taroretcel-lwey is a cell-based gene therapy used to treat idiopathic macular telangiectasia type 2 (MacTel), a rare eye disease that damages the retina.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Revakinagene Taroretcel-Lwey: Patient Information Guide
A plain-language walkthrough of Revakinagene Taroretcel-Lwey — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Revakinagene taroretcel-lwey is a cell-based gene therapy currently supported for one approved use:
- Encelto (intravitreal implant) is indicated for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel) — a rare, progressive disease affecting the macula (the central part of the retina responsible for sharp, detailed vision).
⚙️How it works▾
Encelto contains living donor retinal pigment epithelial cells that have been engineered to continuously produce a protein called recombinant human ciliary neurotrophic factor (rhCNTF). These cells are sealed inside a tiny capsule that is implanted in the eye, where they release rhCNTF directly into the vitreous (the gel inside the eye) over time. The rhCNTF is thought to activate supportive retinal cells called Müller glia, triggering a cascade of signals that may help protect photoreceptors — the light-sensing cells that MacTel can destroy. The exact mechanism is not fully understood, and rhCNTF does not appear to enter the bloodstream in meaningful amounts.
💊How it's taken▾
Encelto is not taken by mouth or self-administered. It is a single surgical procedure in which one implant is placed inside the affected eye by a qualified ophthalmologist in a sterile operating room setting.
- One implant is used per affected eye.
- After surgery, antibiotic eye drops are used four times a day for 7 days.
- A steroid eye drop taper (prednisolone acetate 1% or equivalent) is used starting the day after surgery and continued for 28 days, gradually decreasing in frequency.
- Follow your surgeon's exact post-operative instructions — do not adjust the drop schedule without guidance.
🤒Side effects — in detail▾
The most commonly reported side effects with Encelto include:
- Conjunctival hemorrhage (bleeding on the surface of the eye)
- Delayed dark adaptation (slower adjustment from bright to dim light)
- Foreign body sensation in the eye
- Eye pain
- Suture-related complications (irritation, erosion, or granuloma from stitches)
- Miosis (pupil becoming smaller)
- Conjunctival hyperemia (redness of the eye)
- Vitreous hemorrhage (bleeding inside the eye) and vitreous floaters
- Blurred vision, dry eye, eye irritation, and eye discharge
- Cataract progression or new cataract formation
- Headache
Serious adverse reactions occurred in about 5% of patients and included significant suture complications and implant extrusion. Severe vision loss (loss of 3 or more lines on a vision chart) occurred in a small number of patients. Contact your ophthalmologist immediately if you experience sudden vision changes, severe eye pain, or signs of infection.
⚠️Warnings & precautions▾
- Severe vision loss has occurred after Encelto implantation — patients should be monitored and report any changes in vision promptly.
- Infectious endophthalmitis (serious infection inside the eye) is a risk; signs include worsening eye pain, vision loss, and eye redness. The implant may need to be removed.
- Retinal tears and detachment can occur — watch for sudden flashing lights, new floaters, or loss of side or central vision, and seek urgent care.
- Vitreous hemorrhage (bleeding inside the eye) has occurred, especially in patients on blood thinners. Blood-thinning medications should be paused before surgery. A late-onset bleed (more than a year post-surgery) may signal implant extrusion.
- Implant extrusion (the implant shifting out of position) has occurred — patients should be evaluated at 6 months and yearly after that to confirm correct placement.
- Cataract formation has been reported, including several types of lens clouding.
- Delayed dark adaptation — difficulty adjusting vision in dim lighting — was persistent throughout the study period. Avoid driving at night or in low-light conditions if this affects you.
- Suture-related complications such as conjunctival erosion, granuloma, or wound opening occurred in 15% of patients receiving Encelto.
🔀What it interacts with▾
There is one key interaction category identified for Encelto:
- Antithrombotic medications — including oral anticoagulants (blood thinners like warfarin), aspirin, and NSAIDs (such as ibuprofen or naproxen) — increase the risk of vitreous hemorrhage (bleeding inside the eye) during the implantation surgery. Your doctor will likely instruct you to temporarily stop these medications before the procedure.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Active or suspected eye or periocular (around-the-eye) infection: Encelto is contraindicated — do not proceed until infection is resolved.
- Known allergy to Endothelial Serum Free Media (Endo-SFM): Encelto is contraindicated in these patients.
- Pregnancy: No human safety data exists. Animal studies at high doses showed reduced implantations and live fetuses in rabbits and reduced corpora lutea in rats. Discuss the risks carefully with your doctor.
- Breastfeeding: It is unknown whether Encelto components appear in breast milk or affect a nursing infant. Discuss with your doctor before proceeding.
- Children and adolescents: Safety and effectiveness have not been established in pediatric patients.
- Older adults (65+): Were included in studies but in limited numbers — it is not yet clear if they respond differently than younger patients.
- Blood-thinning medications: Tell your surgeon about all anticoagulants, aspirin, or anti-inflammatory drugs you take, as these need to be managed around the time of surgery.
🔬Pharmacokinetics — how your body processes it▾
After Encelto is implanted inside the eye, the rhCNTF it releases remains concentrated locally in the vitreous and aqueous humor (the fluids inside the eye). Studies in animals showed no detectable rhCNTF in the bloodstream after implantation for up to 9 months. In human patients, rhCNTF levels in the blood were also below the limit of detection, confirming that systemic (whole-body) exposure is negligible. This local delivery profile means the protein works where it is needed — in the eye — without circulating through the rest of the body.
📦How to store it▾
stored within the acceptable range, a “✓” will be shown at the top of the screen. Store ENCELTO in the corepack at 16º to 37ºC (61º to 99ºF) until ready for use. Do not freeze or refrigerate.
📄 Written from Revakinagene Taroretcel-Lwey’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Revakinagene Taroretcel-Lwey — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Encelto, and how is it different from regular eye drops or injections? ▾
What happens after the surgery — do I need to do anything at home? ▾
What side effects should I expect, and which ones mean I need to call my doctor right away? ▾
I take aspirin every day for my heart. Do I need to stop it before the surgery? ▾
Once the implant is in, is it there forever? Can it be removed? ▾
Is Encelto safe to use if I'm pregnant or trying to get pregnant? ▾
Is Revakinagene Taroretcel-Lwey available over the counter? ▾
When was Revakinagene Taroretcel-Lwey first available? ▾
💬 Answers drafted from Revakinagene Taroretcel-Lwey’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Revakinagene Taroretcel-Lwey comes
Revakinagene Taroretcel-Lwey is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Eye drops
How this form is used
- Encelto is used to treat adults with idiopathic macular telangiectasia type 2 (MacTel), a rare retinal disease
- Encelto is surgically implanted into the vitreous cavity of the affected eye by a qualified ophthalmologist in an operating room — it is not self-administered
- Encelto is a single implant per affected eye; the procedure is performed once under sterile surgical conditions
- After Encelto implantation, use a topical antibiotic eye drop four times daily for 7 days and a prednisolone acetate 1% steroid drop taper for 28 days as directed by your surgeon
- Encelto must be removed by a surgeon if certain complications occur, such as serious eye infection or if a vitrectomy with full gas or silicone oil fill is needed
📊 Revakinagene Taroretcel-Lwey across the U.S. market
How Revakinagene Taroretcel-Lwey appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
🔍 Compare Revakinagene Taroretcel-Lwey products
A representative set of FDA-listed product records for Revakinagene Taroretcel-Lwey — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Eye drops | ||||
| 440000 [arb'U] | Intravitreal | Neurotech Pharmaceuticals, Inc. × 3 listings | BLA | View NDC → |
Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Revakinagene Taroretcel-Lwey NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Revakinagene Taroretcel-Lwey — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Revakinagene Taroretcel-Lwey in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Revakinagene Taroretcel-Lwey went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2708830 1 dose form · 1 strength
-
Dose form (SCDF) Drug Implant RxCUI 2708834No current FDA listingClinical drug / strength (SCD) lwey 440000 CELLSRxCUI 2708837
Look up RxCUI 2708830 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Revakinagene Taroretcel-Lwey is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Neurotech Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.