Lunsotogene parvec-cwha Intracochlear

Lunsotogene is used to treat certain types of inherited hearing loss. Lunsotogene is in a class of medications called gene therapy. It works by helping to produce a protein to restore function of a nerve that is necessary for hearing.

Lunsotogene comes as a solution to be infused into a part of your inner ear by a surgeon as a procedure under general anesthesia.

You will be given medication before and after your procedure to prevent adverse reactions to lunsotogene and the procedure from occurring.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving lunsotogene,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have or have ever had any other medical conditions.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You will need to have a pregnancy test before receiving lunsotogene. If you become pregnant after receiving lunsotogene, call your doctor.
• if you or your child will be treated with lunsotogene, you or your child should be vaccinated against meningitis before receiving treatment. Also talk to you or your child's doctor about receiving age-appropriate vaccinations before treatment.

Unless your doctor tells you otherwise, continue your normal diet.

Lunsotogene may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• numbness around ear
• dizziness, changes in walking ability
• uncontrollable eye movements
• ringing in the ear
• changes in taste
• nausea, vomiting

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately or get emergency medical treatment:

• pain, drainage of blood or fluid in ear, fever, or other signs of infection
• uable to move muscles of face

Lunsotogene may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep all appointments with your doctor.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

• Otarmeni^®