OTARMENI 30000000000000 {GC}/mL
lunsotogene parvec · INJECTION, SOLUTION · Regeneron Pharmaceuticals, Inc.
OTARMENI is a injection, solution containing lunsotogene parvec at 30000000000000 {GC}/mL, taken intracochlear. Manufactured by Regeneron Pharmaceuticals, Inc..
Key Facts
- Brand Name
- OTARMENI
- Generic Name
- lunsotogene parvec
- NDC Code (Product)
61755-062- Manufacturer
- Regeneron Pharmaceuticals, Inc.
- Strength
- 30000000000000 {GC}/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRACOCHLEAR
- Marketing Status
- Application #
- BLA125874
- Marketing Start
- 04/23/2026
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE OTARMENI is indicated for the treatment of pediatric and adult patients with severe-to-profound and profound sensorineural hearing loss (any frequency >90 dB HL) associated with molecularly confirmed biallelic variants in the OTOF gene, preserved outer hair cell function, and no prior cochlear implant in the same ear. This indication is approved under accelerated approval based on the improvement of hearing sensitivity assessed by average pure tone audiometry (PTA) at Week 24 [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory clinical trial. Limitations of Use OTARMENI is not recommended in patients in whom preoperative imaging demonstrates that access to the inner ear is not feasible including those with abnormal mastoid pneumatization or clinically significant anatomic variations of the middle ear and inner ear. OTARMENI is an adeno-associated virus vector-based gene therapy indicated for the treatment of pediatric and adult patients with severe-to-profound and profound sensorineural hearing loss (any frequency >90 dB HL) associated with molecular…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For intracochlear infusion only. Recommended dose of OTARMENI for each ear is 7.2 × 10 12 vector genomes (vg) in a total volume of 0.24 mL, administered by a single-dose intracochlear infusion. ( 2.2 ) 2.1 Critical Dosing and Administration Information Confirm patient has biallelic, likely pathogenic or pathogenic OTOF variants. OTARMENI should be administered by a surgeon experienced in intracochlear surgery and trained in the administration procedure. Administer bilateral OTARMENI, if applicable, in a single surgical session. For prophylaxis against inflammatory and immunological responses, administer systemic oral corticosteroids equivalent in strength to prednisone at 1 mg/kg/day the day of the OTARMENI infusion, maintain the same dose for two weeks, and taper over the following two weeks. The total corticosteroid dose should not exceed 60 mg/day. For prophylaxis against post-operative infection, administer antibiotics before incision. Administer age-appropriate vaccination prior to treatment with OTARMENI. Administer vaccines at least 1 month before the first corticosteroid dose and at least 1 month after the last dose. Vaccinate patients against mi…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions (incidence ≥5%) include otitis media, vomiting, nausea, dizziness, procedural pain, gait disturbance, and nystagmus. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Regeneron at 1-866-500-GENE or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described in this section reflect exposure to OTARMENI in one study (Study DB-OTO-001) which treated 24 patients with OTOF gene associated profound sensorineural hearing loss. A total of 10 patients received unilateral dosing, and a total of 14 patients received bilateral dosing of OTARMENI at a nominal dose of 7.2 × 10 12 vg per ear. The median duration of follow-up was 45 weeks (range 9 to 115 weeks) [see Clinical Studies (14) ] . Table 1 lists the most common adverse reactions that occurred in ≥ 5% patients in Study DB-OTO-001. Table 1: Adverse Reactions Occurring in ≥5% of …
Frequently Asked Questions
What is OTARMENI used for?
OTARMENI contains lunsotogene parvec. It is a injection, solution taken intracochlear. Consult your doctor for specific uses.
Is OTARMENI a controlled substance?
OTARMENI is not classified as a controlled substance by the DEA.
What is the generic name for OTARMENI?
The generic name for OTARMENI is lunsotogene parvec. There are no other listed brand versions of lunsotogene parvec.
What is the NDC code for OTARMENI 30000000000000 {GC}/mL?
The NDC (National Drug Code) for OTARMENI 30000000000000 {GC}/mL is 61755-062, listed by Regeneron Pharmaceuticals, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)