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Prescribing Information

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TEPEZZA Side Effects and Safety

You should be aware of important risk information, including warnings and precautions, as well as the most common side effects.

Warnings and precautions

  • Infusion reactions: Infusion reactions can happen during a TEPEZZA treatment or within 24 hours after the treatment. Tell your doctor or a 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: TEPEZZA may worsen symptoms of inflammatory bowel disease (IBD), even if you don't have a diagnosis of IBD before starting TEPEZZA treatment.
  • 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.
  • Hearing problems: 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.

Watch David Gay, MD, oculoplastic surgeon, TED Specialist, and Layla L, TEPEZZA patient, discuss details about side effects.

Participants were compensated for their time.
  • Read transcript
    Read transcript: Watch David Gay, MD
    LAYLA: During my infusions, I experienced several of the side effects. A little bit of nausea, muscle cramping. It lasted a few days to about a week. I had a little bit of GI issues, mostly fatigue. But then after that week, it got better.

    DR. GAY: Well, I'm glad TEPEZZA worked for you. I'm sorry to hear that you had so many of the side effects, but I'm glad that the benefits outweighed the risks that you undertook. Most of my patients, we talk about the side effects. I bring them in multiple times during their infusions because I want to check in to see what type of side effects they have so I can manage them, take them through them and reassure them.

    DR. GAY: Another side effect can be changes in hearing. For most patients, that's a muffled sound or tinnitus. One thing that I've been doing for my patients, if they have any history of hearing problems, I get a baseline audiology exam and test their hearing prior to starting TEPEZZA.

    INDICATION AND IMPORTANT SAFETY 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.

    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.

Most common side effects of TEPEZZA

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

of patients taking TEPEZZA

of patients taking TEPEZZA

Question to ask your doctor

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

Question to ask your doctor

Are there any liquids I should avoid when feeling nauseous? Are there any drinks like water or other clear liquids that I should drink to help with nausea?
Hair loss 13%

of patients taking TEPEZZA

of patients taking TEPEZZA

Question to ask your doctor

Will the hair loss stop after treatment?
Diarrhea 12%

of patients taking TEPEZZA

of patients taking TEPEZZA

Question to ask your doctor

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

Question to ask your doctor

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

Question to ask your doctor

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

Question to ask your doctor

Watch this video to learn more about hearing problems.

Should I get a hearing test before starting treatment?

Taste changes 8%

of patients taking TEPEZZA

of patients taking TEPEZZA

Question to ask your doctor

If things start to taste differently, what should I do?
Headache 8%

of patients taking TEPEZZA

of patients taking TEPEZZA

Question to ask your doctor

Would an over-the-counter pain medicine help me with headaches?
Dry skin 8%

of patients taking TEPEZZA

of patients taking TEPEZZA

Question to ask your doctor

Would an over-the-counter moisturizing lotion help me with dry skin?
Weight decrease 6%

of patients taking TEPEZZA

of patients taking TEPEZZA

Question to ask your doctor

Should I weigh myself regularly during treatment?
Nail Disorder 5%

of patients taking TEPEZZA

of patients taking TEPEZZA

Question to ask your doctor

Are there vitamins I can take to keep my nails healthy?

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.

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

Dr. Douglas was compensated for his time.
  • Read transcript
    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, and I am an oculoplastic and orbital surgeon. So, 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.

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

    TEPEZZA may cause infusion reactions. Tell your doctor right away if you have high blood pressure, fast heartbeat, redness of the face or feeling hot, difficulty breathing, headache, or muscle pain.

    Please stay tuned for additional Important Safety Information later in this video.

    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. One thing to consider in use of TEPEZZA is inflammatory bowel disease.

    TEPEZZA could make inflammatory bowel disease worse or the symptoms of that disease worse. And it would be good to review the risk and benefits with your physician.

    TEPEZZA can cause an increase in blood sugar, so they should consult their physician prior to taking TEPEZZA to know and to follow their blood glucose levels throughout treatment.

    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

    TEPEZZA may worsen inflammatory bowel disease (IBD), such as Crohn’s disease or ulcerative colitis, even if you don’t have a diagnosis of IBD before starting TEPEZZA treatment. Tell your doctor right away if you have worsening IBD symptoms, which may include diarrhea with stomach pain or cramps, blood in your stools, sudden urgency to have a bowel movement, or feeling like you need to have a bowel movement even when there’s little or no stool to pass.

    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, ear discomfort, 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 see Full Prescribing Information or visit TEPEZZA.com for more information.

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?

Please enter your name & email

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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

TEPEZZA may worsen inflammatory bowel disease (IBD), such as Crohn’s disease or ulcerative colitis, even if you don’t have a diagnosis of IBD before starting TEPEZZA treatment. Tell your doctor right away if you have worsening IBD symptoms, which may include diarrhea with stomach pain or cramps, blood in your stools, sudden urgency to have a bowel movement, or feeling like you need to have a bowel movement even when there’s little or no stool to pass.

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, ear discomfort, 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 see Full Prescribing Information or 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.

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.