Otarmeni (lunsotogene parvec-cwha)

It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*None.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

The most common adverse reactions (incidence >=5%) include otitis media, vomiting, nausea, dizziness, procedural pain, gait disturbance, and nystagmus.

There are no severe adverse reactions for this drug.

More Frequent

• Acute bacterial otitis media
• Dizziness
• Nausea
• Surgical wound dehiscence
• Vomiting

Less Frequent

• Ataxia
• Gait abnormality
• Nystagmus

No enhanced messaging available.

The safety and effectiveness of lunsotogene parvec-cwha have been established in pediatric patients with OTOF gene associated profound sensorineural hearing loss. The use of lunsotogene parvec-cwha was supported by evidence from one clinical study that treated 24 pediatric patients 10 months to 16 years of age.

There are no data from the use of lunsotogene parvec-cwha in pregnant women. Animal reproductive and developmental toxicity studies have not been conducted with lunsotogene parvec-cwha.

In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

There are no data on the presence of lunsotogene parvec-cwha in human milk, the effects on the breastfed infant, or the effects on milk production.

Lunsotogene parvec-cwha has not been studied in patients 65 years of age and older.