Lunsotogene Parvec-Cwha
Lunsotogene parvec-cwha is a gene therapy used to treat severe-to-profound sensorineural hearing loss caused by mutations in the OTOF gene.
🧬 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 →
📖 Lunsotogene Parvec-Cwha: Patient Information Guide
A plain-language walkthrough of Lunsotogene Parvec-Cwha — 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▾
Lunsotogene parvec-cwha (brand name Otarmeni) is a gene therapy approved for a specific genetic cause of profound hearing loss.
- Otarmeni is indicated for the treatment of severe-to-profound and profound sensorineural hearing loss (inner-ear hearing loss with thresholds greater than 90 dB at any frequency) in pediatric and adult patients with molecularly confirmed biallelic variants in the OTOF gene, preserved outer hair cell function, and no prior cochlear implant in the ear being treated.
- This approval is under accelerated approval, meaning it is based on hearing sensitivity improvements at 24 weeks — continued approval depends on results from a confirmatory clinical trial.
- Otarmeni is not recommended when imaging before surgery shows the inner ear cannot be safely reached, including patients with abnormal mastoid pneumatization or significant anatomic variations of the middle or inner ear.
⚙️How it works▾
Otarmeni uses an adeno-associated virus (AAV) — a harmless carrier virus — to deliver a working copy of the OTOF gene directly into the cochlea. The OTOF gene provides the blueprint for a protein called otoferlin, which inner hair cells (the tiny sensory cells inside the cochlea) need in order to release chemical signals to the auditory nerve. In people with OTOF gene variants, otoferlin is absent or does not work properly, so those signals never get sent to the brain. Once Otarmeni delivers the functioning gene, the inner hair cells can make otoferlin again and restore communication with the auditory nerve — as demonstrated in animal studies.
💊How it's taken▾
Otarmeni is given as a single one-time intracochlear infusion (a direct injection into the cochlea) for each treated ear, administered in a surgical suite under general anesthesia. If both ears are being treated, both infusions are done in the same surgical session. Patients receive corticosteroids (anti-inflammatory medicines) starting on the day of the procedure, maintained for two weeks, then tapered over the following two weeks — and antibiotics are given before the surgical incision.
- Otarmeni must be administered within 4 hours of the vial being punctured.
- Certain vaccines, especially those protecting against meningitis, should be completed at least one month before the first corticosteroid dose.
🤒Side effects — in detail▾
The most commonly reported side effects from Otarmeni in clinical trials included:
- Middle ear infection (otitis media)
- Vomiting
- Nausea
- Dizziness
- Procedural pain
- Balance or walking problems (gait disturbance)
- Involuntary eye movements (nystagmus)
Less common but important reactions included temporary balance disorder, abnormal otoacoustic emissions (a test of outer hair cell function), and wound dehiscence (the surgical wound reopening). Contact your doctor right away if you develop signs of infection, sudden facial weakness, severe vertigo, or any symptom that concerns you.
⚠️Warnings & precautions▾
- Procedure-related risks: Because Otarmeni is delivered through inner ear surgery, there is a risk of vertigo, tinnitus, cerebrospinal fluid leak, facial nerve weakness on the treated side, taste changes, meningitis, wound infection, mastoiditis, numbness near the ear, fluid or blood at the surgical site, and labyrinthitis (inner ear inflammation). Your team will monitor you after the procedure.
- Meningitis risk: Inner ear surgery carries a known risk of meningitis. Vaccination against meningitis-causing organisms is required before surgery.
- Inflammation: Corticosteroids are given around the time of the procedure to reduce the risk of inflammatory and immune reactions to the gene therapy vector.
- Imaging requirement: Preoperative imaging must confirm that the inner ear can be safely accessed before proceeding with treatment.
🔀What it interacts with▾
The FDA label for Otarmeni does not identify specific drug-drug interactions. However, there are important medication considerations related to the procedure:
- Corticosteroids are required around the time of treatment to prevent inflammatory reactions — your care team will manage this regimen.
- Antibiotics are required before the surgical incision to reduce infection risk.
- Vaccines must be given at least one month before the first corticosteroid dose and at least one month after the last dose, to ensure they are effective.
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▾
- Genetic testing required: A confirmed lab result showing changes in both copies of the OTOF gene is required before treatment.
- Pregnancy: A negative pregnancy test is required before receiving Otarmeni; there are no human safety data in pregnancy.
- Breastfeeding: It is unknown whether Otarmeni passes into breast milk; discuss the risks and benefits with your doctor.
- Reproductive potential: There are not enough data to recommend how long to use contraception after treatment; discuss with your doctor.
- Children: Otarmeni has been studied in pediatric patients as young as 10 months, and its use in this age group is supported by clinical evidence.
- Older adults (65+): Otarmeni has not been studied in patients 65 years and older.
- Prior cochlear implant: Patients who already have a cochlear implant in the ear to be treated are not eligible for Otarmeni in that ear.
- Ear anatomy: Patients with certain inner or middle ear anatomical variations may not be suitable candidates based on imaging results.
🔬Pharmacokinetics — how your body processes it▾
After a single intracochlear infusion of Otarmeni, the gene therapy vector DNA reaches its highest concentration in the cochlea, where it stays active over time — gene expression in the cochlea was sustained for up to 27 weeks in monkeys and 60–90 days in mice. Some vector DNA spreads into the bloodstream and body fluids shortly after the procedure, but it clears quickly: it was detectable in blood, urine, and saliva only on Day 1 and was gone by Week 2. In stool, it was detectable through Week 6 and undetectable by Week 12. Distribution to tissues outside the ear was limited — at least 10 times lower than cochlear levels in monkeys — with minimal detection in reproductive tissues.
📦How to store it▾
Store and transport OTARMENI (package 1) frozen at -80°C (-112°F). stored in the refrigerator (2°C to 8°C ) for up to 24 hours or at room temperature (up to 25°C ) for up to 8 hours . Store at room temperature in original carton separately from OTARMENI until time of use.
📄 Written from Lunsotogene Parvec-Cwha’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 Lunsotogene Parvec-Cwha — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly does this treatment do — is it a cure? ▾
Is this a surgery? What will the procedure be like? ▾
What side effects should I watch out for after the procedure? ▾
Do I need to take other medicines along with this treatment? ▾
Can children receive this treatment? ▾
What if I'm pregnant or thinking about getting pregnant? ▾
Is Lunsotogene Parvec-Cwha available over the counter? ▾
When was Lunsotogene Parvec-Cwha first available? ▾
Who makes Lunsotogene Parvec-Cwha? ▾
💬 Answers drafted from Lunsotogene Parvec-Cwha’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 Lunsotogene Parvec-Cwha comes
Lunsotogene Parvec-Cwha 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.
Injection
How this form is used
- Otarmeni is used to treat severe-to-profound and profound sensorineural hearing loss in children and adults with confirmed biallelic OTOF gene variants, preserved outer hair cell function, and no prior cochlear implant in the treated ear
- Otarmeni is not recommended when preoperative imaging shows the inner ear cannot be safely accessed
- Otarmeni is given as a single intracochlear infusion into each treated ear, administered in a surgical suite under general anesthesia by a trained surgeon
- Otarmeni must be administered within 4 hours of puncturing the vial; the thawed vial should be gently inverted 5 times — do not shake
- If both ears are being treated, Otarmeni should be given to both ears in the same surgical session
- Otarmeni is given alongside a corticosteroid course starting on the day of infusion and continuing for approximately four weeks, plus antibiotics before the surgical incision
📊 Lunsotogene Parvec-Cwha across the U.S. market
How Lunsotogene Parvec-Cwha 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.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
🔍 Compare Lunsotogene Parvec-Cwha products
A representative set of FDA-listed product records for Lunsotogene Parvec-Cwha — 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 |
|---|---|---|---|---|
| 💊Injection | ||||
| LUNSOTOGENE PARVEC 30000000000000 {GC}/mL | — | Catalent Pharma Solutions, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| LUNSOTOGENE PARVEC 3' VECTOR 30000000000000 {GC}/mL | Intracochlear | Regeneron Pharmaceuticals, Inc. | BLA | View NDC → |
| LUNSOTOGENE PARVEC 30000000000000 {GC}/mL | Intracochlear | Regeneron Pharmaceuticals, Inc. | BLA | View NDC → |
Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Lunsotogene Parvec-Cwha 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 Lunsotogene Parvec-Cwha — 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 Lunsotogene Parvec-Cwha 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 Lunsotogene Parvec-Cwha 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 2741616 1 dose form · 1 strength
-
Dose form (SCDF) Injection RxCUI 2741619In current FDA listingsClinical drug / strength (SCD) 0.63 ML lunsotogene parvec-cwha 30000000000000 VECTOR-GENOMES/MLRxCUI 2741622
Look up RxCUI 2741616 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 Lunsotogene Parvec-Cwha 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. Regeneron 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.