American Thyroid Association (ATA) Product Theater:
TEPEZZA® (teprotumumab-trbw): The First and Only FDA-Approved Treatment for Thyroid Eye Disease (TED)
Presented by Horizon Therapeutics
September 22, 2020
7:00 pm – 8:00 pm ET / 6:00 pm – 7:00 pm CT / 4:00 pm – 5:00 pm PT
Presented by:
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Gary J. Lelli, Jr, MD
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Terry J. Smith, MD Frederick G.L. Huetwell Professor Ophthalmology and Visual Sciences Professor of Internal Medicine University of Michigan Medical School Ann Arbor, MI |
Program Description:
This program will focus on TEPEZZA, the first and only FDA-approved treatment for TED, a serious, vision-threatening autoimmune disease with debilitating consequences for patients. Come learn about the novel mechanism of action and how TEPEZZA is shifting the paradigm of TED management. The program will also highlight the clinical efficacy and safety of TEPEZZA and practical applications of treatment.
This presentation is intended for US healthcare professionals.
Learning Objectives
INDICATION
TEPEZZA is indicated for the treatment of Thyroid Eye Disease.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Infusion Reactions: TEPEZZA may cause infusion reactions. Infusion reactions have been reported in approximately 4% of patients treated with TEPEZZA. Reported infusion reactions have usually been mild or moderate in severity. Signs and symptoms may include transient increases in blood pressure, feeling hot, tachycardia, dyspnea, headache, and muscular pain. Infusion reactions may occur during an infusion or within 1.5 hours after an infusion. In patients who experience an infusion reaction, consideration should be given to premedicating with an antihistamine, antipyretic, or corticosteroid and/or administering all subsequent infusions at a slower infusion rate.
Preexisting Inflammatory Bowel Disease: TEPEZZA may cause an exacerbation of preexisting inflammatory bowel disease (IBD). Monitor patients with IBD for flare of disease. If IBD exacerbation is suspected, consider discontinuation of TEPEZZA.
Hyperglycemia: Increased blood glucose or hyperglycemia may occur in patients treated with TEPEZZA. In clinical trials, 10% of patients (two-thirds of whom had preexisting diabetes or impaired glucose tolerance) experienced hyperglycemia. Hyperglycemic events should be managed with medications for glycemic control, if necessary. Monitor patients for elevated blood glucose and symptoms of hyperglycemia while on treatment with TEPEZZA. Patients with preexisting diabetes should be under appropriate glycemic control before receiving TEPEZZA.
Adverse Reactions
The most common adverse reactions (incidence ≥5% and greater than placebo) are muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, hearing impairment, dysgeusia, headache, and dry skin.
For additional information on TEPEZZA, please see Full Prescribing Information at TEPEZZAhcp.com.
NOTE: The ATA has external financial and business relationships with partners in the pharmaceutical and medical industry, which are important for its mission. ATA does not endorse any company, program or service provided by our partners. This information is provided for informational purposes and does not necessarily reflect the viewpoints of the ATA.
To learn more about upcoming ATA programs or to become an ATA Partner, visit the ATA website at www.thyroid.org.