Thyroid eye disease happens when your immune system is not working right and attacks and damages the muscles and other tissues around your eyes. It happens most often in people with a thyroid problem called Graves’ disease but can also happen in people with other types of thyroid problems. Until 2020, the only medicines available for thyroid eye disease were ones that treated its symptoms (like steroids such as methylprednisolone for eye inflammation or artificial tears for eye dryness). In 2020, Tepezza (teprotumumab-trbw) was approved by the FDA to treat thyroid eye disease.
How Is Tepezza Given?
Doses of Tepezza are given by an intravenous infusion through a blood vessel in your arm. This infusion is usually given at a hospital, health care provider’s office, or infusion center. Sometimes you can get the infusion from a health care professional in your own home. Talk to your health care provider to see if this is an option for you.
Your dose of Tepezza is based on how much you weigh at the time of each visit. Tepezza is usually given as an infusion once every three weeks for a total of eight infusions. The first two infusions of Tepezza will last for 90 minutes each. After that, your infusions may be shortened to about 60 minutes each but may be longer if you experience side effects from the infusion.
How Was Tepezza Studied for Thyroid Eye Disease?
Tepezza was studied in two trials that included about 200 people with thyroid eye disease. People included in the study had bulging eyes (exophthalmos) and most (73%) also had double vision (diplopia). They were given either Tepezza or a placebo (containing no medicine), infused into their veins, once every three weeks for a total of eight infusions. The dose of Tepezza given was based on how much they weighed at the time of infusion.
The average age of people in the trials was about 52, most were female (73%), and about a quarter of people in the studies were smokers. About 85% were White, about 10% were Black or African-American, 4% were Asian, and 1% were identified as having a race of “other.” The main goal of both studies was to see if there was an improvement in eye bulging in people who were given Tepezza for six months compared to people who were given placebo.
What Benefits Were Seen?
After six months of treatment, the studies reported the following key results:
Eye bulging
- In Study 1, eye bulging improved in more people who were given Tepezza (70%) than were given a placebo (20%).
- In Study 2, 83% of people who were given Tepezza had improvements in eye bulging compared to 10% of people who were given a placebo.
Double vision
- Of people who had double vision at the start of the study, more people who were given Tepezza had improvements in double vision (53%) compared to people who were given placebo (25%).
Your results may differ from what was seen in clinical studies.
How Long Does It Take for Tepezza to Work?
In studies of people with thyroid eye disease, some people treated with Tepezza started to notice improvements in redness, swelling, and bulging of the eye(s) after two doses, or approximately six weeks. For some people, it took longer to notice improvements after starting Tepezza. However, people who had improvement in their thyroid eye disease while taking Tepezza continued to get better while they received more infusions. It is important that you continue treatment with Tepezza to see the full effects of the medicine. Talk with your health care provider about the right dosing for you.
How Can I Prevent and Manage Side Effects?
The most common side effects seen in people with thyroid eye disease treated with Tepezza are:
- Muscle spasm
- Nausea
- Hair loss
- Diarrhea
- Tiredness
- High blood sugar
- Hearing problems
- Dry skin
- Change in how things taste
- Headache
- Weight loss
- Nail problems
To limit headaches, be sure you are getting enough sleep, staying hydrated, exercising, and not skipping meals. Hot or cold compresses, meditation, resting in a cool, dark room, and massage may also help. You can also take over-the-counter pain medicines such as acetaminophen or ibuprofen to help. Call your health care provider if your headaches are not getting better or are becoming worse.
If you experience diarrhea, make sure to drink plenty of fluids to stay hydrated. If you experience nausea, try taking Tepezza with food or a light snack. Eating smaller, more frequent meals may also help. Getting plenty of rest and drinking enough water can help with headaches.
If you are having problems with hearing, tell your health care provider right away. Your health care provider will help you decide if you should stop taking Tepezza.
These are not all the possible side effects of Tepezza. Contact your health care provider for medical advice about side effects if you are having symptoms that bother you. You can also report side effects to the FDA at 800-FDA-1088 (800-332-1088).
What Happens If My Symptoms Come Back After Treatment?
Some people may have their thyroid eye disease symptoms come back after finishing a full course of Tepezza. If your symptoms come back after you finish a course of Tepezza, you may be able to use a second course of the medicine. In a small study that looked at what happened to people after they were treated with a full course of Tepezza, about a quarter of the people had their thyroid eye disease symptoms come back and needed a second course of Tepezza. In the study, people who needed a second course of Tepezza were older in age (on average, about 60 years old) compared to those who did not (on average, about 53 years old). If your thyroid eye disease symptoms come back after a full course of Tepezza, talk to your health care provider to see if a second course of Tepezza is an option for you.
Is There Any Cost Assistance Available?
There is a copay assistance program available from the drugmaker that may allow you to pay as little as $0 a month for both Tepezza and the IV infusion process. Whether you are eligible depends on your insurance coverage. You can find out more at www.tepezza.com/cost-and-support or by calling 833-483-7399.
