Tepezza

Tepezza is the only U.S. Food and Drug Administration-approved medication or drug used to treat thyroid eye disease, or TED. It is also known as Graves’ orbitopathy, Graves’ eye disease or thyroid-associated ophthalmopathy. The FDA approved Tepezza in 2020.

TED is an autoimmune inflammatory disorder of the soft tissues in the eye socket associated with thyroid dysfunction. 

The condition causes antibodies to attack the muscles associated with eye and eyelid movement. This leads to symptoms of pain, inflammation (swelling and redness), bulging eyes, double vision, retraction of the eyelids and, in severe cases, loss of sight.

Tepezza treats the cause of TED, not just the symptoms. The tissue behind the eye has cells with receptors on their surface that act like switches. When a person has TED, the body’s immune system attacks this tissue. The reaction activates molecules, called autoantibodies, to turn on the switches.

This action causes swelling of the muscles, fat and tissue in the eye socket, which are the symptoms of Graves’ eye disease. Tepezza is designed to bind the switch and block it from turning on. Although it does not cure thyroid eye disease, it relieves specific symptoms, including inflammation, bulging eyes and double vision.

A doctor or nurse slowly infuses the drug intravenously in the arm over the course of 90 minutes per Tepezza treatment. The treatments are given every three weeks and include up to eight infusions. In clinical studies, symptoms continued to get better during the entire course of treatments.

Tepezza side effects include hearing loss, hearing changes, muscle spasms and hyperglycemia (high blood sugar). It can also cause infusion-related reactions such as headaches, trouble breathing or feeling hot. The active ingredient in Tepezza, teprotumumab, has been associated with minimal side effects in clinical trials.

The manufacturer indicates other common Tepezza side effects such as muscle cramps or spasms, nausea, hair loss, diarrhea, fatigue, high blood sugar, taste changes, dry skin and menstrual changes. 

The manufacturer has priced Tepezza at $14,900 to $16,301.09 per vial in the United States. Treatment requires up to eight infusions. Total Tepezza cost will depend on your treatment plan.

Coverage for Tepezza varies depending on health insurance plans. Additional support may be available for people with government insurance, including Medicare, Medicare Part D, Medicaid, Medigap, VA, CHAMPUS, Department of Defense, TRICARE or any state patient, foundation or other pharmaceutical program.

People across the nation have filed several lawsuits against Tepezza, claiming the drug caused hearing loss.

Plaintiffs allege the manufacturer failed to warn them or their doctors that the medication could cause hearing loss or tinnitus.

No studies have evaluated the drug interaction potential of Tepezza or its active ingredient, teprotumumab. 

Side effects were similar in men and women and did not change much for patients above and below age 65. The side effects may disappear during treatment as the body adjusts to the medicine. People who experience any infusion reaction symptoms after treatment should consult their doctor.

In July 2023, Horizon added the following warning to the drug’s label:

“Hearing Impairment Including Hearing Loss: Tepezza may cause severe hearing impairment including hearing loss, which in some cases may be permanent. Assess patients’ hearing before, during, and after treatment with Tepezza and consider the benefit-risk of treatment with patients.”