TEPEZZA Side Effects and Safety Information

You should be aware of important risk information including warnings and precautions and the most common side effects. Then, hear from an expert about his patients’ experiences with TEPEZZA side effects.

Warnings and precautions

  • Infusion reactions: Infusion reactions can happen during a TEPEZZA treatment or within 24 hours after the treatment is completed. Tell your doctor or nurse right away if you have any of the following symptoms during or after treatment with TEPEZZA:

    • High blood pressure
    • Fast heartbeat
    • Redness of the face/Feeling hot
    • Difficulty breathing
    • Headache
    • Muscle pain

  • Inflammatory bowel disease: If you have inflammatory bowel disease, such as Crohn's disease or ulcerative colitis, TEPEZZA may make your IBD symptoms worse
  • Blood sugar: TEPEZZA may cause an increase in your blood sugar. Before starting treatment with TEPEZZA, tell your doctor if you are currently being treated for diabetes, know your blood sugar is high, or have been diagnosed with diabetes. It is important for you to take your treatments and follow an appropriate diet for glucose control as prescribed by your doctor.

Watch Raymond Douglas, MD, PhD, oculoplastic surgeon and Clinical Study investigator of TEPEZZA, discuss details about side effects

Read transcript

Dr. Raymond Douglas: I'm Dr. Raymond Douglas. I'm a professor of ophthalmology at Cedars-Sinai Medical Center and also in private practice in Beverly Hills. I am an oculoplastic and orbital surgeon. I spend most of my time dealing with and trying to help patients with Thyroid Eye Disease and other orbital problems.

I was also the investigator on phase two and the co-principal investigator on phase three for the clinical trial looking at teprotumumab for Thyroid Eye Disease.

The most common side effects that were observed with TEPEZZA were muscle spasms. There were also other symptoms, including diarrhea, and there was also mild hair loss, and this was all over the body, and wasn't subject to one particular location.

For example, there was some thinning of scalp hair, but many patients also noted that their body hair became thinner during the course of TEPEZZA.

Hearing impairment was also noted with TEPEZZA. This was relatively mild to moderate for the patients who reported it.

One thing to consider in use of TEPEZZA is if you have a history of inflammatory bowel disease. TEPEZZA could make inflammatory bowel disease worse or the symptoms of that disease worse. It would be good to have the disease under control prior to initiation of TEPEZZA, and to certainly review the risk and benefits with your physician.

TEPEZZA can cause an increase in blood sugar, so anyone who has diabetes or may be even pre-diabetic where this is followed with their physician, should consult their physician prior to taking TEPEZZA to know and to follow their blood glucose levels throughout treatment.

Typically, TEPEZZA infusions were very well tolerated in the clinical trial. There were three patients who had infusion reactions. These were relatively mild and well controlled, and there were no anaphylactic reactions that occurred during treatment with TEPEZZA.

INDICATION AND IMPORTANT SAFETY INFORMATION

USE

TEPEZZA is a prescription medicine used to treat Thyroid Eye Disease.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about TEPEZZA?

Infusion reactions can happen during or within 24 hours after your infusion of TEPEZZA. If you have a reaction while receiving TEPEZZA, your doctor or nurse will slow or stop your infusion and treat your reaction. If you have a severe infusion reaction, your doctor may stop your treatment completely.

Tell your doctor or nurse right away if you have any of these symptoms during or after your treatment with TEPEZZA:

  • High blood pressure
  • Fast heartbeat
  • Redness of the face/Feeling hot
  • Difficulty breathing
  • Headache
  • Muscle pain

If you have inflammatory bowel disease (IBD), such as Crohn’s disease or ulcerative colitis, TEPEZZA may make your IBD symptoms worse. Symptoms of worsening IBD may include: an increased number of loose stools with stomach pain or cramps, and blood in your stools. After each TEPEZZA infusion, tell your doctor right away if you have worsening IBD symptoms.

TEPEZZA may cause an increase in your blood sugar. Before starting treatment with TEPEZZA, tell your doctor if you are currently being treated for diabetes, know your blood sugar is high, or have been diagnosed with diabetes. It is important for you to take your treatments and follow an appropriate diet for glucose control as prescribed by your doctor.

Before receiving TEPEZZA, tell your doctor if you:

  • Have inflammatory bowel disease (Crohn’s disease or ulcerative colitis).
  • Are currently being treated for diabetes, have been diagnosed with diabetes, or know your blood sugar is high.
  • Are pregnant or plan to become pregnant. TEPEZZA may harm your unborn baby. Tell your doctor if you become pregnant or suspect you are pregnant during treatment with TEPEZZA.
    • Women who are able to become pregnant should use an effective form of birth control (contraception) prior to starting treatment, during treatment and for at least 6 months after the final dose of TEPEZZA.
  • Are breastfeeding or plan to breastfeed. It is not known if TEPEZZA passes into your breast milk. Talk to your doctor about the best ways to feed your baby during treatment with TEPEZZA.
  • Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, dietary and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

What are the possible side effects of TEPEZZA?

The most common side effects of TEPEZZA include muscle cramps or spasms, nausea, hair loss, diarrhea, feeling tired, high blood sugar, hearing problems, taste changes, headache, dry skin, weight loss, nail problems, and changes in menstruation.

This is not a complete list of all possible side effects. Tell your doctor or treatment team about any side effect you may have.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch, or call 1-800-FDA-1088.

Please visit TEPEZZA.com for more information.

Most common side effects of TEPEZZA

Side effects % of patients who experienced the side effects in clinical studies What people in the clinical studies experienced Questions to ask
your doctors
Muscle spasmsMuscle 25%

of patients taking TEPEZZA

of patients taking TEPEZZA

 Patients who had muscle spasms were usually able to manage them. In clinical studies, no patients stopped taking TEPEZZA because of muscle spasms. Will things such as an ice pack, hot compress, or Epsom salt baths help me with muscle spasms?
Nausea 17%

of patients taking TEPEZZA

of patients taking TEPEZZA

 Some patients experienced nausea or felt queasy during the first 2 infusions. No one dropped out of the studies due to nausea. Are there any liquids I should avoid when feeling nauseous? Are there any that I should drink to help with nausea, like water or other clear liquids?
Hair loss 13%

of patients taking TEPEZZA

of patients taking TEPEZZA

 Some people had hair loss during treatment. All cases of hair loss were mild, with the exception of 1 person who had a moderate case. Will the hair loss stop after treatment?
Diarrhea 12%

Of patients taking TEPEZZA

of patients taking TEPEZZA

 Almost all cases of diarrhea were mild. Only 1 person had a severe case of diarrhea. That person had a history of ulcerative colitis, which is an inflammatory bowel disease (IBD) that affects the colon. Would fluids like coffee or alcohol make diarrhea worse? If so, would clear liquids like water or broth be better to drink?
Feeling tired 12%

of patients taking TEPEZZA

of patients taking TEPEZZA

 Some people felt overly tired and lacking in energy. Most people who reported tiredness had mild cases, while 2 people described their tiredness as moderate. Would it help to get a good night’s sleep before each infusion, and schedule time afterwards to relax?
High blood sugar 10%

of patients taking TEPEZZA

of patients taking TEPEZZA

In some people without diabetes, blood sugar levels became higher than normal. But these levels were managed by their doctors.

In some people who had diabetes, higher blood sugar levels were noticed and treated with changes to their diabetes medicine.

Please see page 14 of this brochure for more information about tracking your blood sugar levels.

Be sure to talk with your doctor about having your blood sugar tested and tracked during treatment.

Here are some questions you may want to ask:

  • Who is going to perform the testing?
  • Who is going to review the results?
  • How often should levels be reviewed?
Hearing problems 10%

of patients taking TEPEZZA

of patients taking TEPEZZA

 Some people had issues with their hearing, including: deafness, having one or both ears plugged with fluid, a disorder in loudness perception, and an impaired ability to hear certain sounds. If I’m having issues with hearing, would you recommend seeing an ear, nose, and throat (ENT) doctor?
Taste changes 8%

of patients taking TEPEZZA

of patients taking TEPEZZA

 Some people described changes to their taste. However, all cases of taste change were mild. If things start to taste differently, what should I do?
Headache 8%

of patients taking TEPEZZA

of patients taking TEPEZZA

 All cases of headache were mild. Would an over-the-counter pain medicine help me with headaches?
Dry skin 8%

of patients taking TEPEZZA

of patients taking TEPEZZA

 All cases of dry skin were mild. Would an over-the-counter moisturizing lotion help me with dry skin?

Contraindications: TEPEZZA has no known interactions with other medications

Changes in menstruation: In clinical studies, about 23% (5 out of 22) of menstruating women saw changes in menstruation. These changes included missing period(s), spotting, and painful menstruation or cramps.

Graphic of statistic that 9 out of 10 people treated with TEPEZZA completed all 8 infusions in clinical studies Graphic of statistic that 9 out of 10 people treated with TEPEZZA completed all 8 infusions in clinical studies Graphic of statistic that 9 out of 10 people treated with TEPEZZA completed all 8 infusions in clinical studies

In clinical studies, most side effects were mild or moderate and could be managed by the doctors. Most side effects went away during or after treatment.

If you think you’re having a side effect, talk to your doctor or nurse right away. They will probably want to know a few things about what you’re going through. Write down your answers to these questions so you can refer to them later:

  • What side effect or issue are you experiencing?
  • What date did you first notice it?
  • Do you still have the side effect, or did it go away? When?
Tracking Progess Tracking Progess

Tracking your progress

Use this Treatment Progress Tracker to note any changes to how your eyes look and feel in between infusion appointments.

Open Email a copy

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USE and IMPORTANT SAFETY INFORMATION

What is the most important information I should know about TEPEZZA?

Infusion reactions can happen during or within 24 hours after your infusion of TEPEZZA. If you have a reaction while receiving TEPEZZA, your doctor or nurse will slow or stop your infusion and treat your reaction. If you have a severe infusion reaction, your doctor may stop your treatment completely.

Tell your doctor or nurse right away if you have any of these symptoms during or after your treatment with TEPEZZA:
  • High blood pressure
  • Fast heartbeat
  • Redness of the face/Feeling hot
  • Difficulty breathing
  • Headache
  • Muscle pain

If you have inflammatory bowel disease (IBD), such as Crohn's disease or ulcerative colitis, TEPEZZA may make your IBD symptoms worse. Symptoms of worsening IBD may include: an increased number of loose stools with stomach pain or cramps, and blood in your stools. After each TEPEZZA infusion, tell your doctor right away if you have worsening IBD symptoms.

TEPEZZA may cause an increase in your blood sugar. Before starting treatment with TEPEZZA, tell your doctor if you are currently being treated for diabetes, know your blood sugar is high, or have been diagnosed with diabetes. It is important for you to take your treatments and follow an appropriate diet for glucose control as prescribed by your doctor.

TEPEZZA may cause severe hearing problems including hearing loss, which in some cases may be permanent. Tell your doctor if you have any signs or symptoms of hearing problems or changes in hearing.

Before receiving TEPEZZA, tell your doctor if you:
  • Have inflammatory bowel disease (Crohn's disease or ulcerative colitis).
  • Are currently being treated for diabetes, have been diagnosed with diabetes, or know your blood sugar is high.
  • Are pregnant or plan to become pregnant. TEPEZZA may harm your unborn baby. Tell your doctor if you become pregnant or suspect you are pregnant during treatment with TEPEZZA.
    • Women who are able to become pregnant should use an effective form of birth control (contraception) prior to starting treatment, during treatment and for at least 6 months after the final dose of TEPEZZA.
  • Are breastfeeding or plan to breastfeed. It is not known if TEPEZZA passes into your breast milk. Talk to your doctor about the best ways to feed your baby during treatment with TEPEZZA.
  • Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, dietary and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
What are the possible side effects of TEPEZZA?

The most common side effects of TEPEZZA include muscle cramps or spasms, nausea, hair loss, diarrhea, feeling tired, high blood sugar, hearing problems, taste changes, headache, dry skin, weight loss, nail problems, and changes in menstruation.

This is not a complete list of all possible side effects. Tell your doctor or treatment team about any side effect you may have.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch, or call 1-800-FDA-1088.
Please visit TEPEZZA.com for more information.

USE

TEPEZZA is a prescription medicine used to treat Thyroid Eye Disease (TED), no matter if you’ve had TED for months or years.

P-TEP-US-00841-3 07/23

USE and IMPORTANT SAFETY INFORMATION

What is the most important information I should know about TEPEZZA?

Infusion reactions can happen during or within 24 hours after your infusion of TEPEZZA. If you have a reaction while receiving TEPEZZA, your doctor or nurse will slow or stop your infusion and treat your reaction. If you have a severe infusion reaction, your doctor may stop your treatment completely.

Tell your doctor or nurse right away if you have any of these symptoms during or after your treatment with TEPEZZA:
  • High blood pressure
  • Fast heartbeat
  • Redness of the face/Feeling hot
  • Difficulty breathing
  • Headache
  • Muscle pain

If you have inflammatory bowel disease (IBD), such as Crohn's disease or ulcerative colitis, TEPEZZA may make your IBD symptoms worse. Symptoms of worsening IBD may include: an increased number of loose stools with stomach pain or cramps, and blood in your stools. After each TEPEZZA infusion, tell your doctor right away if you have worsening IBD symptoms.

TEPEZZA may cause an increase in your blood sugar. Before starting treatment with TEPEZZA, tell your doctor if you are currently being treated for diabetes, know your blood sugar is high, or have been diagnosed with diabetes. It is important for you to take your treatments and follow an appropriate diet for glucose control as prescribed by your doctor.

TEPEZZA may cause severe hearing problems including hearing loss, which in some cases may be permanent. Tell your doctor if you have any signs or symptoms of hearing problems or changes in hearing.

Before receiving TEPEZZA, tell your doctor if you:
  • Have inflammatory bowel disease (Crohn's disease or ulcerative colitis).
  • Are currently being treated for diabetes, have been diagnosed with diabetes, or know your blood sugar is high.
  • Are pregnant or plan to become pregnant. TEPEZZA may harm your unborn baby. Tell your doctor if you become pregnant or suspect you are pregnant during treatment with TEPEZZA.
    • Women who are able to become pregnant should use an effective form of birth control (contraception) prior to starting treatment, during treatment and for at least 6 months after the final dose of TEPEZZA.
  • Are breastfeeding or plan to breastfeed. It is not known if TEPEZZA passes into your breast milk. Talk to your doctor about the best ways to feed your baby during treatment with TEPEZZA.
  • Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, dietary and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
What are the possible side effects of TEPEZZA?

The most common side effects of TEPEZZA include muscle cramps or spasms, nausea, hair loss, diarrhea, feeling tired, high blood sugar, hearing problems, taste changes, headache, dry skin, weight loss, nail problems, and changes in menstruation.

This is not a complete list of all possible side effects. Tell your doctor or treatment team about any side effect you may have.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch, or call 1-800-FDA-1088.
Please visit TEPEZZA.com for more information.

USE

TEPEZZA is a prescription medicine used to treat Thyroid Eye Disease (TED), no matter if you’ve had TED for months or years.

P-TEP-US-00841-3 07/23