TEPEZZA® (teprotumumab-trbw) FAQ

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TEPEZZA® (teprotumumab-trbw) Has Resumed Production
Frequently Asked Questions

Horizon Therapeutics, the developer of TEPEZZA, prepared this document to address questions from the Thyroid Eye Disease (TED) community about the resumed production of TEPEZZA, a medicine for TED. Patients can now schedule their infusions. Read on for information about how to schedule infusions, insurance considerations and answers to other frequently asked questions.

Note: If you choose to share or post these FAQs, please share the full document and not select pieces of it, in order to comply with regulatory guidelines.

Questions about TEPEZZA? Talk to Horizon Patient Services.
Call 1-833-583-7399, Mon-Fri, 8 a.m.-8 p.m. EST.
Horizon Patient Services does not provide individual patient care or medical advice.

1. What is the current status of TEPEZZA availability?

On March 30, 2021, Horizon announced that the U.S. Food and Drug Administration (FDA) has approved the increased scale production of TEPEZZA drug product, which will allow Horizon to produce enough medicine to end the supply disruption that was announced in December 2020.

2. Can I schedule my TEPEZZA infusions now?

If you have approval from your doctor and insurance company, and have identified an infusion center, then we suggest you begin to take steps to schedule your TEPEZZA infusions.

3. How do I schedule my TEPEZZA infusions?

If you have been affected by the TEPEZZA supply disruption, you should talk with your doctor about your plan for starting or resuming treatment and share the plan with your infusion center. You can contact your infusion center directly to schedule your infusions or call your Horizon Patient Access Liaison (PAL) if you have questions about the process of starting or resuming treatment. To enroll in Horizon Patient Services, please call 1‐833‐583‐7399 Monday to Friday, 8 a.m. through 8 p.m. ET.

4. Is there enough TEPEZZA for everyone who wants it to get it right away?

While we can’t plan for all scenarios, and ultimately do not control how the infusion centers schedule their patients, we plan to begin to distribute TEPEZZA in a way that accommodates patients as quickly as possible.

Many patients have been affected by this disruption and we are doing all that we can to make this process as seamless as possible; however, there may be delays depending on your individual circumstances. We are committed to partnering with you throughout this process.

5. Does my doctor need to provide approval before I can schedule my infusions?

Some infusion centers may require approval from your doctor to start or resume treatment. It is always a good idea to consult a doctor to discuss medical care. When you are ready to schedule your infusions, you can contact your infusion center directly or call your Horizon Patient Access Liaison if you have questions about the process of starting or resuming treatment.

6. What should I do if my insurance authorization for TEPEZZA has expired or is about to expire?

There may be steps you can take to request a reauthorization or an extension of your insurance coverage. Horizon Patient Services can provide additional information and assist with this process. You can also find additional information about insurance on TEPEZZAsupply.com.

7. If I’ve already had one or more TEPEZZA infusions, should I pick up where I left off or start over with the first infusion?

We suggest you speak with your doctor about how to best manage your specific situation. The data supporting the efficacy of TEPEZZA is from clinical studies in which TEPEZZA was given to patients once every three weeks for a total of eight infusions.

8. It is safe for me to start TEPEZZA infusions again after going more than three weeks since my last infusion?

The TEPEZZA clinical studies only evaluated TEPEZZA in patients who received TEPEZZA once every three weeks for a total of eight infusions. We suggest you speak with your doctor about how to best manage your specific situation.

9. If I’ve had some of my TEPEZZA infusions and am feeling better, do I need to complete the remaining infusions, or can I stop?

In clinical studies, TEPEZZA was given to patients once every three weeks for a total of eight infusions. Most patients who completed all eight infusions had reduced eye bulging; improved double vision; and less eye pain, redness and swelling. Some patients began to see less eye bulging in as few as six weeks, with improvements continuing for the full course of all eight infusions. To learn more about the efficacy of TEPEZZA, please visit TEPEZZA.com.

10. Will the production of TEPEZZA affect the availability of the COVID-19 vaccine?

No. The solution we put in place to manufacture enough TEPEZZA to meet the needs of the TED community does not affect the space available to make the COVID-19 vaccine.

11. How can I get in contact with Horizon?

You can call Horizon Patient Services at 1‐833‐583‐7399 Monday to Friday, 8 a.m. through 8 p.m. ET.

12. What is TEPEZZA?

TEPEZZA is the first and only medicine FDA-approved to treat TED. Unlike other medicines you and your doctor may have tried, TEPEZZA treats the cause of TED. When you have TED, a switch behind your eye, called a receptor, is turned on that causes redness and swelling. This can also make your eyes bulge. TEPEZZA is the only medicine that blocks this receptor to treat TED at its source. Learn more at TEPEZZA.com.

13. In what form is TEPEZZA made available?

TEPEZZA is an IV (intravenous) treatment given once every three weeks for a total of eight treatments. This means it is delivered through a needle that is placed in your arm. The first and second treatments will last about 90 minutes. The remaining six treatments will take about 60 minutes each but could be longer depending on how you respond to the medicine. Learn more at TEPEZZA.com.

14. What is Thyroid Eye Disease?

TED is a vision-threatening autoimmune disease that often occurs in people living with Graves’ disease; however, it is a different disease that must be managed separately. Common symptoms of TED include double vision, bulging eyes, dry eyes, eye pain, eyelid redness and swelling, teary eyes, light sensitivity and vision changes. Learn more at TEPEZZA.com.

15. Are any patient advocacy organizations available to provide support?

The following patient advocacy organizations can provide support:

16. Where can I find more information about the status of TEPEZZA production, as well as how to start or resume treatment with TEPEZZA?

For more information, please visit TEPEZZAsupply.com.

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 should 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.

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