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Overview: Otarmeni is used to treat a specific type of severe hearing loss. It is given as a one-time treatment by a health care provider, who delivers it directly into the inner ear during a surgical procedure. The treatment works by helping the ear make a protein needed to send sound signals to the brain. Common side effects include dizziness, nausea, ear infection, pain, and problems with balance or movement. Because it is given during surgery, there are also some procedure-related risks, but your health care provider will monitor you closely before, during, and after treatment.

Uses

What is Otarmeni used for?

Otarmeni is commonly used for people who have a specific genetic form of severe hearing loss.

What to Know About Otarmeni for Hearing Loss

Otarmeni may also be used for other conditions as determined by your health care provider.

How does Otarmeni work (mechanism of action)?

Otarmeni is a type of gene therapy. It is designed to treat hearing loss caused by changes in the OTOF gene. This gene normally helps make a protein called otoferlin, which is important for sending sound signals from the inner ear to the brain.

Otarmeni uses a special tool, called a vector, to deliver the medicine. It works by providing a healthy copy of the missing or nonworking gene directly into the hearing cells of the inner ear. This helps those cells produce otoferlin, which may improve communication between the ear and the brain.

How is Otarmeni supplied (dosage forms)?

Otarmeni is given as a one-time treatment by a health care provider directly into the inner ear (intracochlear infusion).

How should I store Otarmeni?

Otarmeni is given by a health care provider in a hospital or clinic. You will not store it at home.

Side Effects

What are the most common side effects of Otarmeni?

The most common side effects of Otarmeni are listed below. Tell your health care provider if you have any of these side effects that bother you.

There may be other side effects of Otarmeni that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Otarmeni?

While less common, the most serious side effects of Otarmeni are described below, along with what to do if they happen.

Procedure-Related Problems. Because Otarmeni is given during ear surgery, there are some risks related to the procedure itself. Some side effects can include dizziness, ringing in the ears (tinnitus), changes in taste, or temporary weakness on one side of the face. There may also be numbness around the ear or a buildup of fluid or blood at the surgical site. Less commonly, more serious problems can occur, such as a leak of fluid around the brain and spinal cord, inflammation in part of your ear, or infection (including meningitis). Your health care provider will monitor you during and after the procedure and manage any issues if they arise.

Severe Allergic Reactions. Otarmeni may cause allergic reactions, which can be serious. Get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Warnings & Precautions

Who should not use Otarmeni?

Allergies to Ingredients. People who are allergic to any of the following should not take Otarmeni.

  • Lunsotogene Parvec
  • Otarmeni
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Otarmeni.

What should I know about Otarmeni before using it?

Otarmeni is given by a health care provider in a hospital or clinic. It is given as a one-time infusion into the inner ear. You will be given medicines to make you sleep through the procedure. 

Treatment with Otarmeni involves careful planning before, during, and after the procedure to help keep you as safe as possible. It is very important to keep all appointments with your health care team.

Before receiving Otarmeni, your health care provider will confirm that it is the right treatment for you based on your genetic test results. The treatment must be given by a surgeon who is specially trained in inner ear procedures, and if both ears are treated, this is usually done during the same surgery.

To help reduce the risk of side effects, you may need to take certain medicines, such as steroids and antibiotics, around the time of the procedure. Your health care provider will also make sure you are up to date on recommended vaccines before receiving Otarmeni.

After receiving Otarmeni, small amounts of the vector (an inactive virus used to carry the gene therapy) can be found in bodily fluids and poop for a short time. This is normal and does not mean you have or are spreading an infection. As a precaution, practice good hand hygiene and place any soiled materials in a sealed bag before throwing them away. You can throw the sealed bag in the regular trash. These precautions are usually needed for about 2 weeks after treatment.

What should I tell my health care provider before using Otarmeni?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Otarmeni is right for you.

In particular, make sure that you discuss any of the following.

Vaccines. Before receiving Otarmeni, it is important to be up to date on recommended vaccines for your age. Your health care provider can help you plan the timing around certain medicines that you will need to take to prepare for Otarmeni treatment.

Pregnancy. It is not known if or how Otarmeni could affect pregnancy or harm a fetus. If you can get pregnant, you should have a test to make sure you are not pregnant before you receive Otarmeni. Tell your health care provider if you are pregnant or plan to become pregnant.

Breastfeeding. It is not known if Otarmeni passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Otarmeni?

For more information about Otarmeni, you can visit the drugmaker’s website at www.regeneron.com.

Interactions

Does Otarmeni interact with foods or drinks?

There are no known interactions between Otarmeni and foods or drinks.

It is unknown if drinking alcohol will affect Otarmeni.

Does Otarmeni interact with other medicines (drug interactions)?

Otarmeni may interact with certain medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Otarmeni?

If you or someone else has used too much Otarmeni, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Otarmeni?

Otarmeni is given by a health care provider in a hospital or clinic. Your health care provider will make sure you are receiving Otarmeni as scheduled.