Questions about TED or TEPEZZA® (teprotumumab-trbw)? Join us for
a
live, online event with a TED Eye Specialist and TEPEZZA Patient!
Questions about TED or TEPEZZA?
Call a Nurse Advocate at: 1-833-483-7399
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.
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:
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:
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.
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.
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 (TED), no matter if you've had TED for months of 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:
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:
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.
| 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 spasms
|
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:
|
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? |
Weight decrease
|
6%
of patients taking TEPEZZA of patients taking TEPEZZA |
Some people taking TEPEZZA lost weight during treatment. | Should I weigh myself regularly during treatment? |
Nail Disorder
|
5%
of patients taking TEPEZZA of patients taking TEPEZZA |
Some people saw changes to their nails, including changes in the nail color and broken nails. These changes were not painful. | 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.
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:
Use this Treatment Progress Tracker to note any changes to how your eyes look and feel in between infusion appointments.
P-TEP-US-01353 10/23
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.
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.
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.
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 02/25
