Tepezza Infusion: Treatment for Thyroid Eye Disease

Tepezza (teprotumumab-trbw) is a prescription medicine used to treat thyroid eye disease (TED). It’s supplied as a powder that’s reconstituted with sterile water to form a liquid for administration. The medication is delivered by intravenous (IV) infusion.

Tepezza is prescribed for adults with TED. In TED, the immune system attacks the muscles and fatty tissue behind the eyes, which can result in protruding eyes, eye discomfort and redness, and double vision. TED is also referred to as Graves’ eye disease, Graves’ ophthalmopathy, or Graves’ orbitopathy.

Tepezza basics

Tepezza is given as an IV infusion — an injection into a vein (typically in the arm) over a set period. Infusions are scheduled every three weeks, and a full course of therapy generally spans about five months. Treatments may be administered in a hospital, an infusion center, a physician’s office, and in some situations, at home.

Tepezza contains the biologic drug teprotumumab-trbw. Biologics are products derived from living organisms. Tepezza currently has no biosimilar alternative. (Biosimilars are analogous to generics but for biologic therapies; they are not identical copies the way generics are for conventional drugs.) Teprotumumab is therefore available only as the brand-name product Tepezza.

Biosimilars use the same core active ingredient name as the reference biologic but receive unique suffixes. That is why the active ingredient name ends with “-trbw” — to distinguish it from any future biosimilar products.

What are Tepezza’s side effects?

As with most medications, Tepezza can cause both mild and serious side effects. The lists below include some of the more commonly reported effects but don’t exhaust every possible reaction.

Side effects can vary depending on factors such as:

• your age
• other medical conditions you have
• other drugs you’re taking

Your physician or pharmacist can give you more information about potential side effects and offer strategies to help manage them.

Mild side effects

Some of the milder side effects seen with Tepezza include the items below. For a more complete list, consult your doctor, pharmacist, or Tepezza’s prescribing information.

Reported mild side effects include:

• muscle spasms*
• nausea
• diarrhea
• fatigue (low energy)
• hair thinning or hair loss
• altered taste
• headache
• dry skin

Mild adverse effects often resolve within days to a couple of weeks. If they become troublesome, speak with your healthcare provider.

* See the “Side effect focus” section below for more on this effect.

Serious side effects

Although uncommon, Tepezza can cause serious adverse effects. If you experience a serious reaction, contact your doctor promptly. In a medical emergency, call 911 or your local emergency number.

Serious side effects reported with Tepezza include:

• elevated blood sugar
• hearing loss*
• infusion-related reactions such as rapid heart rate and high blood pressure*
• allergic reaction*

* See the “Side effect focus” section below for additional details.

Side effect focus

More information about a few notable side effects linked to Tepezza is provided below. For further details, consult your healthcare provider.

Hearing loss

Some individuals receiving Tepezza have experienced hearing issues, including reduced hearing or deafness. Other auditory changes, such as heightened sensitivity to sound (for example, your own voice or breathing seeming louder), have also been reported.

In clinical studies, hearing-related problems were commonly observed with Tepezza. Most cases of hearing loss were mild to moderate and improved after stopping treatment, though there are case reports of more severe or persistent hearing impairment.

What might help

If you notice any changes in your hearing during treatment, inform your doctor promptly. They can determine whether it’s safe to continue therapy.

Your doctor may perform hearing evaluations before, during, and after your course of Tepezza.

Discuss your individual risk for hearing loss with your physician.

Infusion-related side effects

Tepezza is administered by IV infusion, which can occasionally trigger infusion-related reactions that occur during or soon after the infusion.

Symptoms of infusion-related reactions may include:

• feeling hot
• rapid heart rate
• high blood pressure
• shortness of breath
• headache
• muscle pain

In trials, infusion reactions were uncommon and typically mild or moderate when they occurred.

What might help

You will be observed for adverse effects during the infusion and for 90 minutes after it ends. Report any symptoms to your care team.

If an infusion reaction occurs, the infusion may be slowed or stopped until symptoms improve. Your doctor may treat the reaction with medications such as corticosteroids or antihistamines. For subsequent infusions, your provider may give premedications and/or administer the infusion more slowly to prevent another reaction.

Muscle spasms

Muscle spasms — sudden twitches or cramps in one or more muscles — have been reported with Tepezza and can cause discomfort or weakness.

In studies, muscle spasms were the most frequently reported side effect.

What might help

Mild cramps may ease with stretching or massage of the affected muscle. For bothersome or severe cramps, talk with your doctor; they may recommend treatments such as muscle relaxants.

Allergic reaction Some individuals may develop an allergic reaction to Tepezza. While allergic reactions were not observed in trials, they remain possible. Symptoms of a mild allergic response can include:

• skin rash
• itching
• flushing (temporary warmth, redness, or deepening of skin color)

A more serious allergic reaction is rare but can occur. Signs include swelling under the skin (often in the eyelids, lips, hands, or feet) and swelling of the tongue, mouth, or throat that can cause breathing difficulty. Contact your doctor right away if you suspect an allergic reaction to Tepezza. In a medical emergency, call 911 or your local emergency number.

Tepezza cost

Cost can be an important consideration whether or not you have insurance. Your out-of-pocket expense for Tepezza depends on factors such as your treatment plan and the pharmacy or infusion provider you use.

If you’re unsure about how to cover the cost, talk with your physician or pharmacist. The manufacturer offers a support program called Amgen By Your Side that may help with access and affordability.

For tips on saving on prescriptions, see related articles. For more cost-specific information about Tepezza, review additional resources.

What is Tepezza used for?

Tepezza is approved for a single indication: treatment of thyroid eye disease (TED) in adults.

TED is an autoimmune disorder in which the immune system mistakenly attacks healthy tissues. In TED, the immune system targets the muscles and fat behind the eyes, causing inflammation and swelling that can push the eyes forward. This may lead to eye irritation, pain, and double vision; in rare cases, swelling may compress the optic nerve and threaten vision.

TED most often occurs in people with Graves’ disease, an autoimmune condition that affects the thyroid and causes hyperthyroidism. When Graves’ disease involves the tissue behind the eyes, it manifests as TED. However, TED can also arise in people without Graves’ disease. Note that Tepezza is not approved to treat Graves’ disease itself.

Symptoms of TED may include:

• protruding eyes
• eye pain, including pain behind the eye or with eye movement
• redness and swelling of the eyes and eyelids
• double vision

Tepezza can help reduce these TED symptoms.

Frequently asked questions about Tepezza

Answers to some common questions about Tepezza are provided below.

Can I view before-and-after photos of people treated with Tepezza?

Yes. The manufacturer’s website features images of people with TED who have been treated with Tepezza.

Keep in mind that individual results vary. Talk with your doctor to set expectations for your own treatment.

How does Tepezza work?

Tepezza treats TED, which results from the immune system attacking the muscles and fat behind the eyes.

The exact mechanism by which Tepezza helps TED isn’t fully understood. The drug binds to specific proteins on cell surfaces and blocks activation of those proteins by the immune system, helping protect the tissues behind the eyes from immune-mediated damage.

Is it safe to use eye drops while on Tepezza?

Generally, using eye drops during Tepezza treatment is safe. Your doctor may recommend certain eye drops to manage symptoms while you wait for Tepezza to take effect.

For dry, itchy, gritty, or irritated eyes, lubricant drops may be suggested. Steroid eye drops can be prescribed to reduce ocular inflammation.

Eye drops aren’t known to interact with Tepezza, but discuss all medications, including topical eye treatments, with your doctor to confirm they’re safe to use with Tepezza.

What is Tepezza’s dosage?

Your doctor will determine the appropriate Tepezza dose for you. The following describes commonly used dosing, but your regimen will be individualized.

Form

Tepezza is supplied as powder in single-dose vials. The powder is mixed into a liquid solution by your healthcare provider and administered intravenously over a set time.

Recommended dosage

For TED, Tepezza infusions are typically given every three weeks for a total of eight infusions over about five months.

The recommended initial infusion dose is 10 mg per kilogram (mg/kg) of body weight. The subsequent seven infusions are each 20 mg/kg.

For example, a person weighing 60 kg (approximately 132 pounds) would receive about 600 mg for the first infusion and 1,200 mg for each of the next seven infusions.

For more details about dosing, consult additional resources or your provider.

Questions about Tepezza dosing

• What if I miss a dose of Tepezza? It’s important to keep scheduled infusions. If you miss an appointment, contact your doctor’s office as soon as possible to reschedule.
• Will I need long-term Tepezza treatment? No. The course is limited to eight infusions over about five months.
• How long before Tepezza works? Some people notice improvement within about six weeks, but response times vary. Speak with your doctor about what to expect.

How is Tepezza administered?

Your healthcare team will explain the administration schedule, dose, and frequency of Tepezza infusions.

Receiving Tepezza

Tepezza is given by IV infusion, usually in a hospital or infusion center. Treatments are spaced every three weeks for a total of eight doses.

The first two infusions generally last about 90 minutes. You’ll be observed during the infusion and for 90 minutes afterward. Notify your care team about any symptoms.

If you tolerate the first two infusions without issues, subsequent infusions are typically given over about 60 minutes.

If you experience reactions during the initial infusions, later doses may continue to be administered over about 90 minutes, and the infusion may be slowed or paused until symptoms subside.

See the “What are Tepezza’s side effects?” section above for more on infusion-related reactions.

Receiving Tepezza with other drugs

If you develop an infusion reaction, your care team may give treatments such as corticosteroids or antihistamines to manage symptoms. Before future infusions, premedications like acetaminophen, corticosteroids, or antihistamines may be given to help prevent recurrent reactions.

Questions about receiving Tepezza

• Can Tepezza be taken orally? No. Tepezza is only administered by IV infusion.
• Should I take Tepezza with food? It’s not necessary; infusions can be done on a full or empty stomach.

Questions for your doctor You may have concerns about Tepezza and your treatment plan. Discuss them openly with your physician. Tips to prepare:

• Before your visit, jot down questions like: How might Tepezza affect my body, mood, or daily life?
• Bring someone with you if that helps you feel more comfortable.
• If something is unclear, ask your doctor to explain it in plain language.

Remember that your healthcare team is there to support you and wants you to receive the best possible care.

What should be considered before taking Tepezza?

Before starting Tepezza, consider your overall health, existing medical conditions, and current medications. Talk with your doctor about how Tepezza may affect you.

Interactions

Drug, food, or supplement interactions can alter how a medication works. There are no known interactions between Tepezza and other drugs or supplements. Nevertheless, tell your doctor about all prescription and over-the-counter medications, vitamins, herbs, and supplements you take so they can evaluate potential interactions.

Warnings

Tepezza may not be appropriate for everyone. Discuss your medical history with your doctor. Consider the following:

• Allergic reaction: If you’ve had an allergic response to Tepezza or any component of the product, your doctor will likely avoid prescribing it and can suggest alternatives.
• Diabetes or prediabetes: Tepezza can raise blood glucose levels. If you have diabetes or prediabetes, your risk is higher. Your doctor will ensure your blood sugar is controlled before starting Tepezza and will monitor glucose closely during treatment, adjusting diabetes therapies if needed.
• Inflammatory bowel disease: Conditions like ulcerative colitis or Crohn’s disease may worsen with Tepezza. Report new or worsening diarrhea, rectal bleeding, abdominal pain, or other symptoms. Your doctor may stop treatment if gastrointestinal symptoms worsen.

Tepezza and alcohol

There’s no known direct interaction between Tepezza and alcohol. However, alcohol can exacerbate some side effects like nausea, headache, or diarrhea. If you drink alcohol, ask your doctor whether it’s advisable while undergoing Tepezza therapy.

Pregnancy and breastfeeding

Tepezza is unsafe during pregnancy and may harm a fetus. If you are pregnant or planning pregnancy, discuss other treatment options with your doctor.

If you can become pregnant, you should use reliable birth control before starting treatment, during therapy, and for at least six months after your final dose. Discuss contraception options with your provider before beginning Tepezza.

It’s unknown whether Tepezza is safe during breastfeeding. If you are breastfeeding or plan to breastfeed, speak with your doctor before starting treatment.

What to ask your doctor

If you’re considering Tepezza for TED, discuss it with your doctor. They can review alternatives and help determine whether Tepezza is suitable for you.

You may find the following resource useful:

• Your FAQs answered: How is thyroid eye disease treated?

Examples of questions to ask your provider:

• Can Tepezza cure my TED?
• Am I eligible to receive Tepezza infusions at home?
• What other treatment options exist for TED?
• If my Graves’ disease is treated, will my TED improve?
• Could Tepezza affect irritable bowel syndrome (IBS)?

For further reading on Tepezza, consider these articles:

• Dosage Details for Tepezza
• Tepezza and Cost: What You Need to Know
• Tepezza Side Effects: What You Need to Know

Ask a pharmacist

Q:

Should I change my diet while receiving Tepezza?

A:

Some people may need dietary adjustments during Tepezza treatment, particularly those with diabetes or prediabetes, since Tepezza can increase blood sugar.

Your doctor may modify your diabetes care plan while you’re on Tepezza, which could include dietary changes.

The American Diabetes Association recommends the Diabetes Plate Method to help manage blood sugar, emphasizing a balance of carbohydrates, proteins, and vegetables. Your doctor can discuss specifics and tailor recommendations.

If you have questions about diet while receiving Tepezza, consult your physician.

Disclaimer: Every effort has been made to ensure the information here is accurate, complete, and up to date. This article is not a substitute for professional medical advice. Always consult a licensed healthcare professional before starting any medication. Drug information is subject to change and may not cover every possible indication, instruction, precaution, warning, interaction, allergic reaction, or adverse effect. The absence of specific warnings does not guarantee a drug regimen is safe, effective, or appropriate for all patients or circumstances.