Approved Use: TEPEZZA is for adults with Thyroid Eye Disease (TED), no matter if they've had TED for months or years.
For US Residents Only
For US Residents Only
Hearing impairment is one of the side effects reported with TEPEZZA, and it's a topic many patients want to understand. Learn how "hearing impairment" was defined in clinical studies and how it can be monitored.
With TEPEZZA, one of the side effects reported in the clinical studies was hearing impairment.
The information below covers what types of changes in hearing to be aware of, how it may be monitored, and what to talk about with your doctor.
The facts about TEPEZZA and Hearing Issues
Please stay tuned for Important Safety Information about TEPEZZA at the end of this video.
If you have Thyroid Eye Disease, or T-E-D, you may be considering TEPEZZA for your treatment.
TEPEZZA is a prescription medicine used to treat Thyroid Eye Disease, No matter if you’ve had T-E-D for months or years.
One possible side effect of TEPEZZA is hearing issues. In this video, you’ll learn about the relationship between thyroid diseases and hearing issues.
And you’ll also hear the facts about what types of hearing issues patients experienced in the clinical studies of TEPEZZA.
For example, TEPEZZA may cause severe hearing problems including hearing loss, which in some cases may be permanent.
First, let’s look at how thyroid conditions, like Graves’ disease, can affect hearing.
Studies have shown that people who have thyroid conditions are at an increased risk for hearing loss, before receiving treatment.
In fact, in one study, about 1 out of 3 patients with thyroid conditions had mild to moderate hearing loss.
This is because thyroid hormones are needed for the development of hearing. So, imbalances in thyroid hormones may play a role in hearing issues.
Now, let’s review how treatment with TEPEZZA could affect hearing.
When considering a connection between hearing issues and TEPEZZA, it’s important to note that patients did not have hearing tests done before they started TEPEZZA in the clinical studies.
Therefore, pre-existing hearing problems were not considered in clinical studies.
That said, some patients taking TEPEZZA did experience hearing issues during the clinical studies.
The FDA approval of TEPEZZA was based on the first two clinical studies.
In those studies, about 1 out of every 10 patients taking TEPEZZA reported some kind of hearing issue.
In the most recent clinical study with patients who had Thyroid Eye Disease for 2 to 10 years, about two in ten patients taking TEPEZZA reported some kind of hearing issue.
When you hear the words “hearing issues,” you may think that this only refers to hearing loss, or deafness. While some hearing loss was one of the side effects experienced with TEPEZZA, “hearing issues” also refers to different types of less severe hearing problems.
The types of hearing issues reported were:
Hypoacusis, which is a general term for hearing loss that can affect one or both ears. With hypoacusis, a person can still hear, but not as well as usual.
Hearing loss or deafness, which means a partial or total inability to hear sounds.
Tinnitus (TIN-uh-tus), which is a ringing or buzzing sound in one or both ears.
Eustachian (you-STAY-kee-uhn) tube dysfunction, which means one of both ears feel like it is plugged with fluid.
And, finally, autophony, which is when it sounds like your own voice is too loud or echoing in your ears.
Across all of the clinical studies, only one person stopped taking TEPEZZA because of hearing problems. This person stopped when they discovered they had hearing problems that were related to an issue they were born with.
Now that you have the facts about how thyroid conditions and treatment with TEPEZZA are related to hearing issues, talk with your doctor about the risks and benefits of TEPEZZA.
TEPEZZA is a prescription medicine used to treat Thyroid Eye Disease (TED), no matter if you’ve had TED for months or years.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about TEPEZZA?
Infusion reactions can happen during or within 24 hours after your infusion of TEPEZZA. If you have a reaction while receiving TEPEZZA, your doctor or nurse will slow or stop your infusion and treat your reaction. If you have a severe infusion reaction, your doctor may stop your treatment completely.
Tell your doctor or nurse right away if you have any of these symptoms during or after your treatment with TEPEZZA:
If you have inflammatory bowel disease (IBD), such as Crohn’s disease or ulcerative colitis, TEPEZZA may make your IBD symptoms worse. Symptoms of worsening IBD may include: an increased number of loose stools with stomach pain or cramps, and blood in your stools. After each TEPEZZA infusion, tell your doctor right away if you have worsening IBD symptoms.
TEPEZZA may cause an increase in your blood sugar. Before starting treatment with TEPEZZA, tell your doctor if you are currently being treated for diabetes, know your blood sugar is high, or have been diagnosed with diabetes. It is important for you to take your treatments and follow an appropriate diet for glucose control as prescribed by your doctor.
TEPEZZA may cause severe hearing problems including hearing loss, which in some cases may be permanent. Tell your doctor if you have any signs or symptoms of hearing problems or changes in hearing.
Before receiving TEPEZZA, tell your doctor if you:
What are the possible side effects of TEPEZZA?
The most common side effects of TEPEZZA include muscle cramps or spasms, nausea, hair loss, diarrhea, feeling tired, high blood sugar, hearing problems, taste changes, headache, dry skin, weight loss, nail problems, and changes in menstruation.
This is not a complete list of all possible side effects. Tell your doctor or treatment team about any side effect you may have.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch, or call 1-800-FDA-1088.
Please visit TEPEZZA.com for more information.
You can watch more about side effects of TEPEZZA at TEPEZZAse.com or hear from a T-E-D Specialist during a live online event—register at EyesOnT-E-D.com.
In initial clinical studies,* about
patients recently diagnosed with TED who took TEPEZZA experienced hearing impairment.
In another clinical study,† about
patients who had TED for 2 to 10 years and took TEPEZZA experienced hearing impairment.
*In the initial clinical studies, 171 patients who had been diagnosed with TED within 9 months of beginning the study were evaluated. These patients had eye bulging, high inflammation, and other symptoms of TED. Of these 171 patients, 84 received TEPEZZA. Hearing impairment events were reported in 8 of the 84 patients who received TEPEZZA.
†In the most recent clinical study, 62 patients who had been diagnosed with TED between 2 and 10 years prior received study treatment. These patients had eye bulging, 1 or 2 other symptoms, and “stable disease,” meaning they had not had symptom changes for at least 1 year before the start of the study. Of these, 41 patients received TEPEZZA. Hearing impairment events were reported in 9 of the 41 patients who received TEPEZZA.
When you hear the words "hearing impairment," you may think that this only refers to hearing loss or deafness. While hearing loss was a side effect experienced with TEPEZZA, "hearing impairment" covered a range of changes in hearing, many of which were less severe. The types of hearing impairment events reported in the TEPEZZA clinical studies were:
Across all of the clinical studies, only one person stopped taking TEPEZZA because of hearing impairment. This person stopped when they discovered they had hearing problems that were related to an issue they were born with.
The doctor who treats your TED may also send you to a hearing specialist—like an ear, nose, and throat doctor or an audiologist—to check your hearing.
Studies have suggested that people with thyroid conditions are, in general, at an increased risk for hearing loss. In one study, about 1 out of 3 people with thyroid conditions had mild-to-moderate hearing loss.
It is believed that thyroid hormones can influence the inner ear or hearing pathways, which could play a role in hearing difficulties.
Infusion reactions can happen during or within 24 hours after your infusion of TEPEZZA. If you have a reaction while receiving TEPEZZA, your doctor or nurse will slow or stop your infusion and treat your reaction. If you have a severe infusion reaction, your doctor may stop your treatment completely.
TEPEZZA may worsen inflammatory bowel disease (IBD), such as Crohn’s disease or ulcerative colitis, even if you don’t have a diagnosis of IBD before starting TEPEZZA treatment. Tell your doctor right away if you have worsening IBD symptoms, which may include diarrhea with stomach pain or cramps, blood in your stools, sudden urgency to have a bowel movement, or feeling like you need to have a bowel movement even when there’s little or no stool to pass.
TEPEZZA may cause an increase in your blood sugar. Before starting treatment with TEPEZZA, tell your doctor if you are currently being treated for diabetes, know your blood sugar is high, or have been diagnosed with diabetes. It is important for you to take your treatments and follow an appropriate diet for glucose control as prescribed by your doctor.
TEPEZZA may cause severe hearing problems including hearing loss, which in some cases may be permanent. Tell your doctor if you have any signs or symptoms of hearing problems or changes in hearing.
Cases of encephalopathy, a condition that affects how the brain works, have been reported in people treated with TEPEZZA. Tell your healthcare provider right away if you, your family member, or caregiver notice any change in your mental status (e.g., confusion, changes in thinking or behavior, memory problems, excessive sleepiness, difficulty speaking, seizures or decreased responsiveness). Your healthcare provider may stop or delay TEPEZZA while they evaluate and treat you as required.
The most common side effects of TEPEZZA include muscle cramps or spasms, nausea, hair loss, diarrhea, feeling tired, high blood sugar, hearing problems, taste changes, headache, dry skin, ear discomfort, weight loss, nail problems, and changes in menstruation.
This is not a complete list of all possible side effects. Tell your doctor or treatment team about any side effect you may have.
TEPEZZA is a prescription medicine used to treat Thyroid Eye Disease (TED), no matter if you’ve had TED for months or years.
Infusion reactions can happen during or within 24 hours after your infusion of TEPEZZA. If you have a reaction while receiving TEPEZZA, your doctor or nurse will slow or stop your infusion and treat your reaction. If you have a severe infusion reaction, your doctor may stop your treatment completely.
