Description
Lunsotogene parvec-cwha injection is used to treat a type of hearing loss called sensorineural hearing loss caused by changes in the OTOF gene (otoferlin), preserved outer hair cell function, and no prior cochlear implant in the same ear.
This medicine is to be given only by or under the direct supervision of a doctor with specialized training in intracochlear surgery.
This product is available in the following dosage forms:
- Suspension
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of lunsotogene parvec-cwha injection in children. Safety and efficacy have been established.
Geriatric
Appropriate studies on the relationship of age to the effects of lunsotogene parvec-cwha injection have not been performed in the geriatric population.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Proper Use
A doctor or other trained health professional will give this medicine in a hospital. It is given through a small tube that is placed in the inner ear.
This medicine is a virus vector-based gene treatment. The virus may spread to other people through body waste (eg, urine, saliva, stool) contact. Follow these instructions for 2 weeks after you receive treatment:
- Wash your hands with soap and water after direct contact with patient's body waste.
- Place patient's body waste in a sealable bag and throw them into the trash.
Your doctor will give you other medicines (eg, antibiotics, steroid medicine) to help prevent unwanted effects.
All age-appropriate vaccines should be given prior to starting this treatment, at least 1 month before the first dose or at least 1 month after the last dose. Ask your doctor if you have any questions about this.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests are needed to check for unwanted effects.
If you can get pregnant, you must have a negative pregnancy test before receiving this medicine.
This medicine may cause procedure-related risks. Check with your doctor right away if you have confusion, continuing ringing or buzzing or other unexplained noise in the ears, drowsiness, hearing loss, nausea, numbness in the ear, red, tender, or oozing skin at the incision, severe headache, or stiff neck or back.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
- Dizziness
- earache
- nausea
- pain, redness, or swelling in the ear
- problems with walking
- uncontrolled eye movements
- vomiting
Incidence not known
- Confusion
- continuing ringing or buzzing or other unexplained noise in the ears
- drowsiness
- numbness in the ear
- severe headache
- stiff neck or back
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-80011889
