How TEPEZZA is Given

Karen: I was very scared at the beginning. I was very intimidated by needles but I knew that this was the course of action that I had to take to help me get better.

To avoid everything else that was on the road for me, such as the steroids and the surgery, the infusion didn't sound so bad and I'll be honest with you, my first encounter with the infusion center, I was very nervous when I initially got there. For me, it wasn't such a bad experience and three weeks later, I went back for the second and it was the same thing.

And at that point in time, you're there for a couple of hours so you're starting to talk to the people there. They become your family there. They would make me very comfortable. I didn't even think of it as, "Oh my gosh, I'm sitting here getting an infusion. This is terrible." I thought, "Hey, this isn't bad." They started testing my eyes and they were showing improvement.

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, and dry skin.

This is not a complete list of all possible side effects. Tell your doctor or treatment team if you have any side effect that bothers you or that does not go away.

Please visit TEPEZZA.com for more information.

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

Jeanne: So I went to my doctor and he told me about TEPEZZA. He told me that it was an infusion, that it was going to be eight infusions over 24 weeks, so once every three weeks. He explained that it's about a two-hour infusion the first time, and the next, subsequent infusions would be about an hour.

I'm a nurse, I do infusions all the time. So I didn't really think it was a big deal, but it was a little scary that I was going put something new into my body. And I was hopeful that it was going to work. So I was elated, I was elated when I got the call that I was going to be able to get TEPEZZA.

The surprise was actually how easy it was to get infused. I think that some people may have an issue, but the nurse started up the infusion and I didn't feel a thing. It was very comfortable, I was sitting in an infusion chair, very private, very comfortable. It was start an IV, get the infusion going, and you're out of the office. It was fabulous. I didn't schedule myself for work that night, and I didn't schedule myself for work the night after because I was thinking, "Okay, I don't know how this is going to go. I don't know if I'm going to have any side effects. Let's see how this works."

And every infusion I had, there was a little improvement with each subsequent infusion. I just found that my eyes were regressing: They weren't as proptotic as they were when I first started. My eyelids became kind of a normal-looking eyelid. I could feel the mobility of my eyes in the eye socket. I could feel less pressure from behind my eyes. They felt lighter. They felt free. And it just felt better and better with each subsequent infusion. It was the best feeling.

It's a hard diagnosis to have, it's hard to live with and to not have the heaviness behind your eyes, to not have the pain behind your eyes, to not have the itchiness, the bulgy red eyes. If I could sum up the entire infusion process in one word or phrase, I think I would say, "Illuminating, it was very illuminating."

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, and dry skin.

This is not a complete list of all possible side effects. Tell your doctor or treatment team if you have any side effect that bothers you or that does not go away.

Please visit TEPEZZA.com for more information.

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