Otarmeni (lunsotogene parvec) is a one-time treatment for certain children and adults with severe hearing loss. It’s a gene therapy delivered in the inner ear that can help your body make a protein that helps with hearing.
Like most medicines, Otarmeni may cause side effects. Some risks are linked to the surgery required to deliver the treatment into the inner ear, rather than the medicine itself.
Keep reading to learn about possible Otarmeni side effects, interactions, and important safety considerations.
This article does not include all possible side effects or precautions. Talk to your health care provider about any concerns or bothersome symptoms, even if they are not listed.
Common Otarmeni Side Effects
In a clinical trial of 12 children who were treated with Otarmeni, the most common side effects were:
- Middle ear infection
- Nausea and vomiting
- Dizziness
- Procedure-related pain
- Trouble with walking or balance problems
- Rapid involuntary eye movements
These side effects are usually temporary and improve on their own, but some may require medical treatment or closer monitoring. Contact your health care provider if you have symptoms that feel severe or last a long time.
Serious Side Effects of Otarmeni
Otarmeni is given as a one-time infusion into the inner ear. Because this requires inner ear surgery, there are procedure-related risks you should know about.
Potentially serious side effects or procedure-related problems may include:
- Vertigo
- Ringing in the ears (tinnitus)
- Leakage of fluid around the brain or spine
- Facial weakness or numbness
- Changes in taste
- Wound infection
- Infection of the membranes that cover the brain and spinal cord (meningitis)
- Mastoiditis, which is a serious infection of the bone behind the ear
- Inflammation of part of your inner ear (labyrinthitis)
- Buildup of blood or fluid around the surgical site
Contact your health care provider right away if you or your child develops severe dizziness, fever, worsening pain, drainage from the ear, facial weakness, or severe headache. In some cases, serious side effects may require urgent medical care. Your provider can examine your symptoms and explain what steps to take next.
Tips for Managing Otarmeni Side Effects
Some side effects can be managed with supportive care and close follow-up with your health care team. The sections below take a closer look at four possible Otarmeni side effects.
1. Ear infection
Infection of the middle ear (otitis media) is a common side effect of Otarmeni. It affected 9 out of 12 children in Otarmeni’s clinical trial.
Possible symptoms of a middle ear infection include:
- Ear pain or pressure
- Fever
- Drainage from the ear
- Hearing loss
- Trouble sleeping
- Increased fussiness, irritability, or ear pulling in young children
To lower the risk of an ear infection or catch it early, be sure to follow all aftercare instructions carefully and attend all follow-up visits. All household members should make handwashing a habit to help prevent infections.
If you have symptoms of an ear infection, tell your health care provider right away. They may prescribe antibiotics. They may also recommend an over-the-counter (OTC) pain reliever, such as acetaminophen or ibuprofen.
2. Nausea or vomiting
Nausea and vomiting can happen after surgery or anesthesia. About a third of clinical trial participants had nausea and/or vomiting after receiving Otarmeni.
These symptoms usually go away as the anesthesia medicines wear off. To help reduce nausea:
- Follow your health care provider’s instructions for before and after the procedure, including when you can safely eat or drink.
- Start with bland foods such as toast, rice, applesauce, or crackers.
- Sip clear fluids throughout the day, or an oral rehydration solution like Pedialyte.
- Rest with your head slightly elevated.
Contact your health care provider if vomiting is severe, does not improve, or causes signs of dehydration. They may recommend anti-nausea medicine or suggest going to the emergency room for IV fluids.
3. Dizziness and balance problems
Dizziness and balance-related symptoms were among the more common side effects seen after Otarmeni treatment. Some people may feel unsteady while walking or experience spinning sensations shortly after surgery.
Tips that may help during recovery include:
- Move slowly when standing up or walking.
- Avoid sudden head movements. You may also want to avoid bending over for the first few days.
- Use handrails or ask for support if balance feels off, especially while walking or climbing stairs.
- Rest up when symptoms feel worse.
- Stay hydrated.
Tell your health care provider if dizziness or balance worsens, lasts a long time, or causes falls.
4. Pain
Some discomfort or pain around the ear and surgical area is common after Otarmeni treatment.
In addition to following your surgeon’s aftercare instructions, these tips may help:
- Take any pain medicines exactly as directed.
- Prioritize rest during the first several days after surgery.
- Avoid activities that could affect the treated ear(s) or get water in them, such as swimming.
- Use a cold compress if recommended by your care team.
Pain that suddenly worsens or comes with fever, swelling, or drainage should be examined by a health care provider right away.
What to Know About Otarmeni Interactions
Otarmeni is a one-time gene therapy given by a specially trained surgeon during an inner ear procedure. The treatment is performed in a hospital or clinic under anesthesia, and some people may receive treatment in both ears during the same surgery.
Several medicines may be used during and around the time of the procedure, including corticosteroids, antibiotics, anesthesia medicines, and medicines to help prevent nausea or discomfort after surgery. To avoid unsafe interactions, it’s important to tell your health care provider and pharmacist about all prescription and OTC medicines, vitamins, and supplements you use.
Some medicines or supplements may need to be stopped or adjusted before surgery because they could increase certain risks or interact with anesthesia or other medicines used during treatment. Your care team will also review vaccination timing before treatment because corticosteroids used with Otarmeni can affect how the immune system responds to vaccines.
Recommendations typically include:
- Giving any needed vaccines at least one month before the first corticosteroid dose
- Waiting at least one month after the last corticosteroid dose before receiving additional vaccines
To help reduce the risk of complications and interactions, carefully follow all instructions from your health care team and keep all follow-up appointments after the procedure.
Reducing Your Risk of Otarmeni Side Effects
Because Otarmeni is given during inner ear surgery and requires close monitoring and follow-up, make sure to follow your care team’s instructions before and after treatment.
You can help lower the risk of side effects and complications if you:
- Attend all scheduled appointments and hearing tests after the procedure.
- Follow your surgeon’s aftercare instructions carefully.
- Ask your health care provider or pharmacist before you start any new medicines, vitamins, or supplements.
- Keep track of new or changing symptoms and report them to your health care provider.
- Contact your health care provider if side effects do not improve or begin to interfere with daily activities.
Your health care provider can answer questions and help you understand what to expect before, during, and after treatment with Otarmeni.