Tepezza (teprotumumab)
An approved treatment for Thyroid Eye Disease.
The same compound appears under different names depending on the context. Here is how to identify Teprotumumab wherever you encounter it, plus the key facts at a glance.
- Generic name
- Teprotumumab
- Brand name
- Tepezza
- Development codes
- RV 001, HZN-001
- Drug class
- IGF-1R inhibitor monoclonal antibody
- Manufacturer
- Amgen
- How it's taken
- Given as an intravenous infusion over 60 to 90 minutes.
The first FDA-approved medication for thyroid eye disease. Tepezza is an infusion given 8 times over about 5 months that reduces eye bulging, and it was the first treatment shown to reverse proptosis rather than only manage inflammation.
Where Teprotumumab fits
The first FDA-approved drug for thyroid eye disease; a second IGF-1R antibody, Lumvoa (veligrotug), was approved in June 2026. Steroids reduce inflammation but do not reverse eye bulging, and orbital decompression surgery does but is invasive. Teprotumumab occupies the space between them, and the 2023 label expansion moved it from a treatment only for active disease to one available across the full course of the condition.
How Teprotumumab works
In thyroid eye disease, autoantibodies overstimulate cells in the tissue behind the eye. Those cells carry a receptor called IGF-1R, and when it is switched on they multiply and produce substances that draw in water, so the muscle and fat in the eye socket swell. Because the socket is a closed bony space, that swelling has only one direction to go, which pushes the eyeball forward and produces the bulging, pressure and double vision that define the disease. Teprotumumab binds IGF-1R and blocks its activation, interrupting the signal before the expansion happens. That mechanism is why it can reduce proptosis rather than only calm inflammation, which is what steroids do. The label notes the mechanism in thyroid eye disease has not been fully characterized.
Mechanism: Monoclonal antibody that binds the insulin-like growth factor-1 receptor (IGF-1R) and blocks its activation, interrupting the signaling that drives tissue expansion behind the eye
Side effects and safety
- Hearing impairment including hearing loss. may be severe and in some cases permanent; hearing is assessed before, during and after treatment
- Infusion reactions. in about 4% of patients, during an infusion or within 90 minutes after; the infusion is slowed or stopped and treated
- Inflammatory bowel disease. can flare, including in people with no history of it; treatment stops if a flare is suspected
- High blood sugar. glucose checked before each infusion and kept controlled throughout, particularly with diabetes or prediabetes
- Hearing assessment before, during and after the 8-infusion course
- Blood glucose before each infusion
- Bowel symptoms after each infusion
- Contraception before, during and for at least 6 months after the last dose
Hearing problems are the risk that most deserves a conversation before the first infusion. The label warns that Tepezza may cause severe hearing impairment including hearing loss, which in some cases is permanent, and tells prescribers to assess hearing before, during and after treatment. Report any change in hearing, ringing, or a plugged sensation immediately rather than waiting for the next appointment. The most common reactions in trials were muscle spasms (25% versus 7% on placebo), nausea (17% versus 9%), hair loss (13% versus 8%), diarrhea (12% versus 8%), fatigue (12% versus 7%) and high blood sugar (10%). Blood sugar deserves particular attention if you have diabetes or prediabetes, since the label asks prescribers to check glucose before each infusion and keep it controlled throughout. Infusion reactions occurred in roughly 4% of patients and can appear during an infusion or within 90 minutes after. The label also warns that inflammatory bowel disease can flare, including in people with no history of it, and that treatment should stop if a flare is suspected. There is no boxed warning.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Teprotumumab
Given as an intravenous infusion over 60 to 90 minutes. The first dose is 10 mg/kg, followed by 20 mg/kg every 3 weeks for 7 more infusions, so a full course is 8 infusions across roughly 21 weeks. It is supplied as a 500 mg single-dose vial of powder that a pharmacist reconstitutes and dilutes in saline before use. Unlike drugs taken indefinitely, this is a defined course with an end date rather than an ongoing prescription.
Availability and cost
Only available as the brand-name product.
A monoclonal antibody dosed by body weight across 8 infusions, each requiring pharmacy preparation and infusion-center time. Because the course is finite rather than lifelong, the cost lands as a large one-time total rather than an indefinite monthly expense, which changes how insurers evaluate it and makes prior authorization the main obstacle.
Help paying for Tepezza
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Amgen Commercial Co-Pay Program: eligible commercially insured patients may pay as little as $0 per dose of TEPEZZA.
For: private insurance · source - Infusion cost help
Same program may cover infusion costs, as little as $0. Massachusetts and Rhode Island residents cannot get infusion (administration) help.
For: private insurance · source - Insurance and case manager help
A Patient Access Liaison checks benefits, explains prior authorization steps, estimates costs, and helps schedule infusions and find infusion centers.
For: private insurance, Medicare, Medicaid, no insurance · source
Good to know: Copay program excludes Medicare, Part D, Medicaid, Medigap, VA, CHAMPUS, DoD, TRICARE and state or foundation programs. For government-insured or uninsured patients, the official page lists only independent foundations. 1-833-483-7399 is the TEPEZZA Nurse Advocate line for TED questions, not the support program.
- From a charity · The Assistance FundThyroid Eye Disease (TED) fundOpen
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
The foundation says: “OPEN — Accepting New Patients. TAF is currently accepting new patient enrollments for this program.”
Access and eligibility
The label covers adults with thyroid eye disease regardless of how active the disease is or how long it has been present, so a person with chronic disease of several years is no longer excluded as they were under the original 2020 label. Hearing should be assessed before starting, and the label asks prescribers to weigh benefit against risk with each patient. Blood glucose should be controlled before and during treatment, particularly for anyone with diabetes or prediabetes. It is not recommended in pregnancy, since the mechanism can cause fetal harm, and effective contraception is advised before starting, during treatment, and for at least 6 months after the last dose.
Source: Tepezza.com (Amgen)
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Clinical trial results
Approval rested on 2 randomized, double-masked, placebo-controlled trials in 171 patients, Study 1 (NCT01868997) and Study 2 (NCT03298867), with 84 patients on teprotumumab and 87 on placebo. Participants had a median age of 52, 73% were women, 73% had double vision at baseline and 27% were smokers. The main measure was the proportion of patients whose proptosis improved by at least 2 mm at week 24 without the other eye worsening. In Study 1 that was reached by 71% on teprotumumab versus 20% on placebo, and in Study 2 by 83% versus 10%. Average proptosis reduction was 2.5 mm in Study 1 and 2.8 mm in Study 2, against 0.2 mm and 0.5 mm on placebo. Improvement appeared as early as 6 weeks and continued through week 24. For scale, surgical decompression achieves a comparable range of reduction, which is why a drug producing it was treated as a turning point.
Development history
Teprotumumab was first developed as a cancer drug and shelved when it did not perform, then revived for thyroid eye disease on the reasoning that IGF-1R sits at the center of the tissue expansion behind the eye. The FDA approved it on January 21, 2020 as the first medication ever approved for thyroid eye disease, a condition previously managed with steroids to control inflammation, radiation, or surgery to decompress the eye socket. The original label limited use to active disease. In April 2023 the FDA expanded it to cover thyroid eye disease regardless of activity or duration, which brought in patients with long-standing chronic disease who had been told nothing further could be done. Horizon Therapeutics, which acquired the program from River Vision Development in 2017 and carried it through approval, was itself acquired by Amgen in a deal completed in October 2023.
Explore Thyroid Eye Disease trials
Other Thyroid Eye Disease treatments
Thyroid eye disease was managed for decades without a drug aimed at the disease itself. Corticosteroids suppress the inflammation and can relieve pain and swelling, but they do not move the eye back, and the benefit fades when they stop. Orbital radiotherapy and surgical decompression address the mechanical problem directly and remain the answer for sight-threatening disease, though surgery is usually reserved until the disease has stabilized.
Teprotumumab changed that by targeting IGF-1R signaling, the step that drives the tissue expansion. In June 2026 the FDA approved a second IGF-1R antibody, Lumvoa (veligrotug), given as 5 infusions over 12 weeks. Other IGF-1R drugs are in clinical development, including subcutaneous versions that would replace the infusion schedule.
The practical question for most patients is no longer whether a drug exists but whether their insurer will approve a finite course of it, and whether their hearing and blood sugar can be monitored properly while they take it.
Common questions about Teprotumumab
▸What is Teprotumumab (Tepezza)?
The first FDA-approved medication for thyroid eye disease. Tepezza is an infusion given 8 times over about 5 months that reduces eye bulging, and it was the first treatment shown to reverse proptosis rather than only manage inflammation.
▸How does Teprotumumab work?
In thyroid eye disease, autoantibodies overstimulate cells in the tissue behind the eye. Those cells carry a receptor called IGF-1R, and when it is switched on they multiply and produce substances that draw in water, so the muscle and fat in the eye socket swell. Because the socket is a closed bony space, that swelling has only one direction to go, which pushes the eyeball forward and produces the bulging, pressure and double vision that define the disease. Teprotumumab binds IGF-1R and blocks its activation, interrupting the signal before the expansion happens. That mechanism is why it can reduce proptosis rather than only calm inflammation, which is what steroids do. The label notes the mechanism in thyroid eye disease has not been fully characterized.
▸What are the side effects of Teprotumumab?
Hearing problems are the risk that most deserves a conversation before the first infusion. The label warns that Tepezza may cause severe hearing impairment including hearing loss, which in some cases is permanent, and tells prescribers to assess hearing before, during and after treatment. Report any change in hearing, ringing, or a plugged sensation immediately rather than waiting for the next appointment. The most common reactions in trials were muscle spasms (25% versus 7% on placebo), nausea (17% versus 9%), hair loss (13% versus 8%), diarrhea (12% versus 8%), fatigue (12% versus 7%) and high blood sugar (10%). Blood sugar deserves particular attention if you have diabetes or prediabetes, since the label asks prescribers to check glucose before each infusion and keep it controlled throughout. Infusion reactions occurred in roughly 4% of patients and can appear during an infusion or within 90 minutes after. The label also warns that inflammatory bowel disease can flare, including in people with no history of it, and that treatment should stop if a flare is suspected. There is no boxed warning.
▸How is Teprotumumab taken?
Given as an intravenous infusion over 60 to 90 minutes. The first dose is 10 mg/kg, followed by 20 mg/kg every 3 weeks for 7 more infusions, so a full course is 8 infusions across roughly 21 weeks. It is supplied as a 500 mg single-dose vial of powder that a pharmacist reconstitutes and dilutes in saline before use. Unlike drugs taken indefinitely, this is a defined course with an end date rather than an ongoing prescription.
▸Is Teprotumumab FDA approved?
Yes, Teprotumumab (Tepezza) is FDA approved (2020) for the treatment of Thyroid Eye Disease.
▸What is Tepezza approved to treat?
Tepezza (teprotumumab) is approved for thyroid eye disease in adults, regardless of how active the disease is or how long it has been present. It was approved in January 2020 as the first medication ever for the condition, and the label was expanded in April 2023 to remove the original restriction to active disease. In June 2026 the FDA approved a second drug for thyroid eye disease, Lumvoa (veligrotug), which targets the same receptor.
▸How much does Tepezza reduce eye bulging?
In the 2 trials behind approval, average proptosis fell by 2.5 mm and 2.8 mm after 24 weeks, compared with 0.2 mm and 0.5 mm on placebo. A reduction of at least 2 mm was reached by 71% and 83% of treated patients versus 20% and 10% on placebo. Improvement began as early as 6 weeks. That range is comparable to what orbital decompression surgery achieves, which is why an infused drug producing it was significant.
▸Can Tepezza cause hearing loss?
Yes, and this is the most important risk to understand before starting. The label warns that Tepezza may cause severe hearing impairment including hearing loss that is sometimes permanent, and instructs prescribers to assess hearing before, during and after treatment. Any new ringing, muffling, plugged sensation or difficulty hearing should be reported immediately rather than at the next scheduled visit, since continuing treatment through a developing problem is what risks making it permanent.
▸How is Tepezza given and for how long?
It is an intravenous infusion given over 60 to 90 minutes. The first dose is 10 mg/kg and the following 7 are 20 mg/kg, spaced 3 weeks apart, so the complete course is 8 infusions over roughly 21 weeks. It is a finite course with a defined end rather than an ongoing medication.
▸Does Tepezza work for chronic or long-standing thyroid eye disease?
The label now covers thyroid eye disease regardless of duration, following the April 2023 expansion. Before that change the approval applied only to active disease, and people whose disease had burned out years earlier were formally outside it. Response in long-standing disease is generally more modest than in active disease, so it is worth asking your ophthalmologist what they expect in your specific situation.
▸What should I monitor while taking Tepezza?
Hearing, blood sugar and bowel symptoms. The label asks for hearing assessment before, during and after the course, for blood glucose to be checked and controlled throughout (particularly with diabetes or prediabetes), and for watchfulness for inflammatory bowel disease flares even in people with no history of IBD. Infusion reactions occurred in about 4% of patients and can happen during or within 90 minutes after an infusion.
▸Is Tepezza a cure for thyroid eye disease?
No. It reduces proptosis, double vision and other signs, but it does not treat the underlying thyroid autoimmunity that drives the disease, and some patients see proptosis return after the course ends. Thyroid function still needs separate management, and stopping smoking remains one of the most effective things a patient can do for the eye disease itself.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- Horizon Therapeutics / Amgen · 2026. TEPEZZA (teprotumumab-trbw) for injection, for intravenous use: US Prescribing Information. https://www.hzndocs.com/TEPEZZA-Prescribing-Information.pdf
- U.S. Food and Drug Administration · 2020-01-21. TEPEZZA approval history and label supplements (BLA 761143). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761143
- ClinicalTrials.gov. Teprotumumab (RV 001) Treatment in Patients With Active Thyroid Eye Disease (Phase 2, Study 1). https://clinicaltrials.gov/study/NCT01868997
- ClinicalTrials.gov. Treatment of Graves' Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis With Teprotumumab Infusions (OPTIC, Phase 3, Study 2). https://clinicaltrials.gov/study/NCT03298867