Tepezza is a brand-name prescription medication. It’s FDA-approved to treat thyroid eye disease (TED) in adults.

TED is an autoimmune condition, which means it’s caused by your immune system attacking your healthy tissues by mistake.

TED typically develops in people with hyperthyroidism (an overactive thyroid gland) that’s caused by Graves’ disease. TED is also sometimes called Graves’ eye disease, Graves’ ophthalmopathy, and Graves’ orbitopathy. Symptoms of TED can include eye irritation, double vision, proptosis (bulging of your eyes), and blindness.

For more details about TED and how Tepezza treats it, see the “Tepezza for thyroid eye disease” section below.

Drug details

Tepezza contains the active drug teprotumumab. It belongs to a class of drugs called insulin-like growth factor-1 receptor inhibitors. (Drug classes describe medications grouped together by similar effects or uses.)

Tepezza is a biologic drug that’s a monoclonal antibody. Biologics are drugs made by using living cells. And monoclonal antibodies are drugs that act like proteins made by your immune system.

Tepezza comes as powder inside vials. Each vial contains 500 milligrams of the active drug. It’s mixed with a liquid solution and given by healthcare providers as an intravenous (IV) infusion. (With an IV infusion, the drug is given into your vein over a period of time.)

FDA approval

In January 2020, the Food and Drug Administration (FDA) approved Tepezza for the use described above. It’s the first and only prescription drug approved for this use by the FDA.

Approved with orphan status

Tepezza was approved with “orphan status” by the FDA.

Orphan status is awarded to drugs made for rare conditions that don’t have effective treatment options. The FDA reviews the safety and efficacy information for these drugs with priority. If the drugs are approved with orphan status, they can become available on the market faster than usual.

Manufacturers must request orphan status from the FDA for their specific medication. But even after initial approval on orphan drugs, studies are still done on the drugs to prove their safety and efficacy.

Effectiveness

For information about the effectiveness of Tepezza, see the “Tepezza for thyroid eye disease” section below.

Tepezza contains the active drug teprotumumab-trbw. The reason “-trbw” appears at the end of the drug’s name is to show that the drug is distinct from similar medications that may be created in the future. In this article, we’ll refer to Tepezza’s active drug as simply “teprotumumab.”

Tepezza is only available as a brand-name, biologic medication. Biologic drugs, which are made by using living cells, don’t have generic forms. Instead, they may sometimes have approved biosimilar forms. However, Tepezza doesn’t have an approved biosimilar.

Biosimilars are drugs that are similar to brand-name biologics (their parent drug). Unlike generics, which are made for drugs made from chemicals, biosimilars aren’t exact copies of their parent drug. Because biologics are made using living organisms, it’s not possible to copy them exactly. (The process of making biologics results in small differences in the drug.)

However, approved biosimilars are considered to be just as safe and effective as their parent biologic. And they typically cost less than their parent drug.

As with all medications, the cost of Tepezza can vary. To find current prices for Tepezza in your area, check out WellRx.com.

The cost you find on WellRx.com is what you may pay without insurance. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

It’s important to note that you’ll get Tepezza at a healthcare facility or through a specialty pharmacy. (These pharmacies are authorized to dispense specialty medications, which may be expensive or require help from healthcare providers to be used safely and effectively.)

Before approving coverage for Tepezza, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Tepezza, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Tepezza, or if you need help understanding your insurance coverage, help is available.

Horizon Therapeutics, the manufacturer of Tepezza, offers a program called Horizon Patient Services. Through this program you may be able to find ways to lower the cost of Tepezza treatment. You also have access to patient access managers who can help assist you in understanding how much Tepezza will cost.

For more information and to find out if you’re eligible for support, call 833-469-8331 or visit the drug’s website.

If you don’t have insurance, you can ask your doctor or pharmacist about online pharmacy options.

Generic or biosimilar version

Tepezza is only available as a brand-name, biologic medication.

Biologic drugs don’t have generic forms. Instead, they may sometimes have approved biosimilar forms. However, Tepezza doesn’t have an approved biosimilar.

Biosimilars are drugs that are similar to brand-name biologics (their parent drug). Unlike generics, which are made for drugs made from chemicals, biosimilars aren’t exact copies of their parent drug. Because biologics are made using living organisms, it’s not possible to copy them exactly. (The process of making biologics results in small differences in the drug.)

However, approved biosimilars are considered to be just as safe and effective as their parent biologic. And they typically cost less than their parent drug.

Tepezza can cause mild or serious side effects. The following lists contain some of the key side effects that may occur during treatment with Tepezza. These lists do not include all possible side effects.

For more information about the possible side effects of Tepezza, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Tepezza, you can do so through MedWatch.

Mild side effects

Mild side effects* of Tepezza can include:

  • nausea
  • hair loss
  • fatigue (lack of energy) or weakness
  • changes in taste
  • headache
  • dry skin
  • muscle spasms
  • hearing problems, such as hearing loss‡
  • diarrhea

Most of these side effects may go away during or after treatment with Tepezza. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* To learn more about mild side effects of Tepezza, talk with your doctor or pharmacist or view Tepezza’s prescribing information.
† For more information about this side effect, see “Side effect details” below.
‡ In clinical studies of Tepezza, hearing side effects resolved in most people or they occurred in people who’d had hearing problems in the past.

Serious side effects

Serious side effects from Tepezza can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects* can include:

* For more information about these side effects, see “Side effect details” below.

Side effect details

Here’s some detail on certain side effects this drug may cause.

Infusion reactions

During Tepezza treatment, you may have reactions related to getting intravenous (IV) infusions of the drug. (With an IV infusion, the drug is given into your vein over a period of time.)

Infusion reactions aren’t common with Tepezza. However, they’re possible.

Infusion reactions that may occur with Tepezza can result in:

A healthcare provider will give Tepezza infusions to you in a hospital or infusion center. Each infusion will be given over a period of 60 to 90 minutes. You’ll be monitored during this time for infusion reaction.

It’s possible to have symptoms of infusion reaction at any time during a Tepezza infusion. Or, these reactions may start within 1.5 hours after your infusion.

Management of infusion reactions

Tell your healthcare provider if you have any new or unusual symptoms during or after Tepezza infusions.

If you’re having a mild to moderate infusion reaction, your healthcare provider will manage your symptoms with a corticosteroid or antihistamine medication. And they may slow down your Tepezza infusion or pause it to help manage your symptoms.

To prevent reactions to future infusions, your healthcare provider may:

  • give you certain medications before starting your Tepezza infusions
  • infuse Tepezza at a slower rate than usual

However, if you have a serious infusion reaction with Tepezza, your doctor may stop your treatment with the drug.

High blood sugar levels

Tepezza may increase your blood sugar levels or cause hyperglycemia. With hyperglycemia, your blood sugar levels are too high.

Increased blood sugar levels are a common side effect of Tepezza. However, your risk may be higher if you have diabetes or prediabetes before starting Tepezza.

You may not notice any symptoms of hyperglycemia. So, during Tepezza treatment, your doctor will order tests to check your blood sugar levels. Your doctor will check your levels even if you don’t have diabetes or prediabetes before starting the drug.

However, if you have certain symptoms during Tepezza treatment, tell your doctor. Symptoms that could indicate hyperglycemia include:

  • feeling overly thirsty
  • fatigue (lack of energy)
  • blurry vision
  • urinating more than usual
  • fruity breath

If you have diabetes, your doctor will make sure your blood sugar levels are managed before having you start Tepezza. And during treatment, they may adjust your diabetes treatment plan to help manage the levels.

If you don’t have diabetes, but your blood sugar levels are high with Tepezza, your doctor may suggest ways to manage the levels. This could include suggesting certain diet changes or pairing diet changes with medication.

Muscle spasms

During Tepezza treatment, you may have muscle spasms. In fact, during clinical studies, this was the most common side effect of the drug.

A muscle spasm is a cramp or twitch that happens suddenly in one or more of your muscles. Muscle spasms may be painful or cause other bothersome symptoms, such as weakness.

If you have mild muscle spasms that bother you, talk with your doctor. They may prescribe a muscle relaxant to help reduce the spasms. Or, your doctor may suggest nondrug treatments, such as massage.

If you have moderate to severe muscle spasms, see your doctor right away.

Also, tell your doctor if you have muscle spasms along with diarrhea. Diarrhea is a common side effect of Tepezza that may cause dehydration (low fluid level in your body). And dehydration is a common cause of muscle spasms.

Allergic reaction

As with most drugs, some people can have an allergic reaction from Tepezza treatment.

Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth, swelling, or redness or discoloration in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have an allergic reaction to Tepezza, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Tepezza is approved to treat thyroid eye disease (TED) in adults. For more information about this condition, see the “Tepezza for thyroid eye disease” section below.

It’s not clearly understood how Tepezza works. However, Tepezza is an insulin-like growth factor-1 receptor (IGF-1R) inhibitor. This means it prevents IGF-1R from being activated.

With TED, your immune system attacks cells in the back of your eyes by mistake. And this attack activates IGF-1R.

IGF-1R is thought to play a key part in the inflammation involved in TED. IGF-1R may also be involved with signals that tell your body to make tissue, such as muscle or fat, behind your eye.

Tepezza binds to IGF-1R and keeps it from being activated by your immune system. This may prevent inflammation and the creation of tissue, both of which cause symptoms of TED.

Tepezza may help treat TED in other ways, too.

How long does it take to work?

How long Tepezza takes to improve your TED may depend on certain factors, including the severity your condition.

In two clinical studies, after 24 weeks of Tepezza treatment, some people had reduced symptoms of TED. Their improvements included:

In these studies, some people had an improvement in certain symptoms after just 6 weeks. However, for the drug to work as it’s meant to, you should receive one dose every 3 weeks for a total of eight doses. So, this means your Tepezza treatment will last about 5 months.

If you have questions, talk with your doctor about when you can expect results from Tepezza treatment.

The Tepezza dosage your doctor prescribes will depend on several factors. These include:

  • your body weight
  • whether it’s your first dose of the drug

The following information describes dosages that are commonly used or recommended. However, be sure to follow the Tepezza treatment plan your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Tepezza comes as powder inside single-dose vials. Each vial contains 500 milligrams (mg) of the active drug, teprotumumab.

Your healthcare provider will use the powder in the vial to make a solution. Then, they’ll give the Tepezza solution to you as an intravenous (IV) infusion. (With an IV infusion, the drug is given into your vein over a period of time.)

Tepezza infusions typically last 60 to 90 minutes.

Dosage for thyroid eye disease

Typically, for thyroid eye disease, you’ll receive a Tepezza infusion once every 3 weeks. And you’ll be given a total of eight infusions.

Your Tepezza dosage will be based on:

  • your body weight in kilograms (one kilogram [kg] equals 2.2 pounds), and
  • which of the eight infusions you’re receiving

The table below lists the usual dosages for Tepezza infusions. But always follow the treatment plan prescribed by your doctor.

Infusion number:Dose given:
110 mg/kg
2 to 820 mg/kg

What if I miss an infusion?

For Tepezza to work as it’s meant to, you’ll need to receive all eight infusions as prescribed by your doctor.

If you’re unable to keep an appointment for an infusion, call your healthcare provider right away to reschedule.

Will I need to use this drug long term?

Tepezza isn’t meant to be used as a long-term treatment. For Tepezza to be effective for thyroid eye disease, you should receive one infusion every 3 weeks, for a total of eight infusions. So, you’ll likely complete your Tepezza treatment in about 5 months.

If your condition doesn’t improve after completing Tepezza treatment, your doctor can recommend a new treatment plan.

The Food and Drug Administration (FDA) approves prescription drugs such as Tepezza to treat certain conditions. Tepezza may also be used off-label for other conditions. Off-label drug use means using a drug for a purpose other than what it’s been approved for by the FDA.

Tepezza is FDA-approved to treat thyroid eye disease (TED) in adults.

About thyroid eye disease

TED is an autoimmune condition, which means it’s caused by your immune system attacking your healthy tissues by mistake.

This condition typically develops in people with hyperthyroidism (an overactive thyroid gland) that’s caused by Graves’ disease. TED is also known as Graves’ eye disease, Graves’ ophthalmopathy, and Graves’ orbitopathy.

Graves’ disease is also an autoimmune condition. It causes your immune system to attack your thyroid gland by mistake. It also causes your immune system to attack cells behind your eyes. Over time, this attack causes swelling, damage, a buildup of tissue, and symptoms of TED.

Eye symptoms occur often with Graves’ disease. And they usually occur shortly after Graves’ disease is diagnosed. But eye problems can happen at any time, including after Graves’ disease has been treated.

Symptoms related to your eyes can get worse over time, too. And things like smoking or being exposed to secondhand smoke can also make your condition worse.

Common symptoms of TED can include:

  • eye pain or irritation, including a gritty feeling in your eyes
  • eye redness or inflammation (swelling) of the whites of your eyes
  • swollen eyelids
  • sensitivity to light
  • proptosis (bulging of your eyes)
  • double vision
  • reduced eye movement

Rarely, in serious cases, TED can cause pressure on your optic nerve. And this can lead to vision loss or blindness.

Treatment of thyroid eye disease

Treatment goals for TED are to manage symptoms of the condition and prevent eye damage. TED treatment is usually more effective when it’s started early in the disease process.

If your condition is mild, your doctor may suggest nondrug treatments to manage your symptoms. These treatments can include:

  • wearing sunglasses or special eyeglasses
  • using over-the-counter lubricant eye drops
  • applying cool compresses on your eyes
  • sleeping with your head elevated

If you have moderate to severe TED symptoms, your doctor may suggest an immunosuppressant or corticosteroid drug. (Immunosuppressants decrease the activity of your immune system.) These drugs can help to reduce inflammation in your eyes. Or, your doctor may recommend certain surgeries to improve your vision or appearance. Your doctor may also suggest Tepezza to treat TED.

Effectiveness for thyroid eye disease

In two clinical studies, Tepezza was effective in treating TED that was recently diagnosed. This study included people who were diagnosed with TED within 9 months of noticing symptoms. (This is typically when TED symptoms are changing or getting worse.)

For details on Tepezza’s effectiveness for this condition, visit the drug’s website. Or, for more clinically described study details, read Tepezza’s prescribing information.

Currently, there aren’t any specific guidelines in the United States for treating TED. If you have questions about whether Tepezza is effective for your condition, talk with your doctor.

Tepezza and children

It’s unknown if Tepezza is safe and effective for use in children with TED. So, Tepezza isn’t approved for use in children.

Tepezza doesn’t interact with alcohol.

However, in general, consuming too much alcohol isn’t healthy for you. Also, alcohol may worsen certain common side effects of Tepezza, such as nausea, diarrhea, and headache.

In addition, alcohol may affect your blood sugar levels. Tepezza can also increase your blood sugar levels, especially if you have diabetes or prediabetes.

If you drink alcohol, ask your doctor whether it’s safe to drink alcohol with your condition and Tepezza treatment.

Many drugs can interact with other medications. Different interactions can cause different effects. For instance, some interactions can affect how well a drug works. Other interactions can increase side effects or make them more severe.

However, Tepezza doesn’t have any known drug interactions. It also doesn’t interact with any herbs, supplements, or foods.

Studies of drug interactions haven’t been done for Tepezza. Most drugs are metabolized (broken down) in your liver. But your liver doesn’t break down monoclonal antibody drugs, such as Tepezza. Instead, your body breaks them down in other ways.

Because Tepezza isn’t metabolized in your liver with other drugs, it generally doesn’t interact with other drugs. But to be safe, talk with your doctor or pharmacist about taking other medications with Tepezza.

Tepezza and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Tepezza. However, you should still check with your doctor or pharmacist before using any of these products during Tepezza treatment.

Tepezza and foods

There aren’t any foods that have been specifically reported to interact with Tepezza. If you have any questions about eating certain foods with Tepezza, talk with your doctor.

Below, we briefly describe how Tepezza comes and how it’s administered. But follow Tepezza treatment according to your doctor’s or healthcare provider’s instructions.

To learn more about starting Tepezza treatment, visit the drug’s website.

About Tepezza infusions

Tepezza comes as a powder that your healthcare provider will mix with liquid to make a solution. Then, your healthcare provider will give the solution to you as an intravenous (IV) infusion. (With an IV infusion, the drug is given into your vein over a period of time.)

Typically, you’ll receive Tepezza infusions in a hospital or infusion center. The infusions last about 60 to 90 minutes.

Your healthcare provider will monitor you during your infusion and for a short time afterward. This allows them to check and see if you’re having any side effects from the infusion.

When it’s given

Typically, you’ll receive a Tepezza infusion once every 3 weeks. And you’ll receive a total of eight infusions.

For Tepezza to work as it’s meant to, you need to receive all eight infusions as prescribed by your doctor. If you’re unable to keep an infusion appointment, call your doctor’s office right away to reschedule.

Tepezza treatment with food

You can receive Tepezza infusions on a full or empty stomach. Eating food doesn’t affect how your body responds to Tepezza.

However, Tepezza may increase your blood sugar levels. If you have this side effect of the drug, your doctor may recommend certain diet changes to help manage your blood sugar levels. Talk with your doctor if you have questions about this. And for more information, see the “Tepezza side effects” section above.

You should not receive Tepezza during pregnancy. Doing so may cause harm to a developing fetus.

Tepezza hasn’t been studied in pregnant people. But the drug did cause harm when it was studied in pregnant animals. Animal studies don’t always predict a drug’s effects in people. But to be safe, it’s recommended that you don’t receive Tepezza during pregnancy.

Before starting Tepezza, talk with your doctor if you’re pregnant or planning to become pregnant. To help make sure you’re not pregnant, your doctor may order a pregnancy test for you before you start treatment.

Also, you should use effective birth control before, during, and after Tepezza treatment. For more information, see the “Tepezza and birth control” section below.

If you become pregnant during Tepezza treatment, tell your doctor right away.

Tepezza treatment is not safe during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs with Tepezza treatment.

For more information about taking Tepezza during pregnancy, see the “Tepezza and pregnancy” section above.

For females using Tepezza

If you’re a female* who can become pregnant, you should use birth control prior to starting Tepezza. You should continue to use birth control during treatment, and for at least 6 months after your last dose of the drug.

For males using Tepezza

It’s not known if Tepezza affects reproductive health or offspring in males.* If you’re a male taking this drug, talk with your doctor about whether you’ll need to use birth control while you’re taking Tepezza.

* In this article, use of the terms “male” and “female” refer to a person’s sex assigned at birth.

It’s not known if it’s safe to breastfeed during Tepezza treatment. So, you should not breastfeed while receiving this drug.

Talk with your doctor about healthy ways to feed your child during Tepezza treatment.

Here are answers to some frequently asked questions about Tepezza.

Does Tepezza cure thyroid eye disease?

No, Tepezza doesn’t cure thyroid eye disease (TED). However, treatment with Tepezza may help relieve certain symptoms of this condition.

In two 24-week clinical studies, Tepezza reduced TED symptoms, such as bulging of the eyes and double vision.

It’s not fully clear how long these effects last after stopping Tepezza treatment. Some people who used Tepezza kept their improvement in certain TED symptoms for 1 year after stopping the studies.

Talk with your doctor to find out what you can expect with Tepezza treatment.

Can older people use Tepezza?

Yes, Tepezza can be used to treat thyroid eye disease (TED) in older people.

The safety and effectiveness of Tepezza was looked at in two clinical studies that included people ages 65 years and older. No differences in safety or efficacy were seen between people 65 years and older and people who were younger.

Can I take Tepezza if I have diabetes or use insulin for diabetes?

Yes, you can likely take Tepezza if you have diabetes or you use insulin to treat high blood sugar levels.

However, Tepezza treatment may increase your blood sugar levels or cause hyperglycemia. (With hyperglycemia, your blood sugar levels are too high.)

These are common side effects of Tepezza. And your risk may be higher if you have diabetes or prediabetes before starting this drug.

If you have diabetes, your doctor will make sure your blood sugar levels are managed before having you start Tepezza. During treatment, they may adjust your diabetes treatment plan, if needed, for your blood sugar levels.

During Tepezza treatment, check your blood glucose levels and watch for symptoms of hyperglycemia. These can include:

  • blurry vision
  • increased urination or thirst
  • fruity breath

You should watch for these signs even if you don’t have diabetes or prediabetes before starting Tepezza.

If you have high blood sugar levels and you’re unsure how to manage them, talk with your doctor.

Before starting Tepezza, talk with your doctor about your health history. Tepezza may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Diabetes or prediabetes. Treatment with Tepezza may increase your blood sugar levels or cause hyperglycemia. (With hyperglycemia, your blood glucose levels are too high.) This risk may be higher if you already have diabetes or prediabetes. Before starting Tepezza, tell your doctor if you have diabetes or prediabetes. They will make sure your blood sugar levels are managed before having you start this treatment. They may also adjust your diabetes treatment plan to help manage your blood sugar levels while you’re receiving Tepezza.
  • Inflammatory bowel disease (IBD). If you have an IBD, such as Crohn’s disease, Tepezza treatment may cause an IBD flare-up. With a flare-up, your IBD is active and causing symptoms. Before starting Tepezza, tell your doctor if you have IBD. Tell them about your IBD even if it’s in remission. (During periods of remission, your IBD isn’t causing symptoms.) During Tepezza treatment, tell your doctor about any IBD symptoms, including bloody stools, diarrhea, belly pain, rectal cramping, urgent stools, or incontinence. If you have an IBD flare-up with Tepezza, your doctor may stop Tepezza treatment.
  • Allergic reaction. If you’ve had an allergic reaction to Tepezza or any of its ingredients, you shouldn’t take Tepezza. Ask your doctor what other medications are better options for you.
  • Pregnancy. Tepezza treatment is not safe during pregnancy. For more information, see the “Tepezza and pregnancy” section above.
  • Breastfeeding. Tepezza treatment is not safe while breastfeeding. For more information, see the “Tepezza and breastfeeding” section above.

Note: For more information about the potential negative effects of Tepezza, see the “Tepezza side effects” section above.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.