TEPEZZA is a prescription medication administered via infusion.

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A full course of treatment with TEPEZZA is 8 infusions, given once every 3 weeks.1 TEPEZZA may be administered at an infusion center, your practice, a hospital, or your patient’s home.

Before beginning TEPEZZA, be aware that insurance payors may require the Clinical Activity Score (CAS),*† thyroid labs, and/or documentation of previously tried medications (such as steroids) for treatment approval. It is recommended that you download the Clinical Documentation Tearpad to appropriately document inflammatory signs and symptoms of TED, such as CAS. It is important to ask patients if they have, or have ever had, any of these CAS symptoms. A CAS ≥4 on a 7-point scale indicates inflammatory TED. A lower score indicates fewer signs of inflammation.2-4†

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Things to remember before starting your patients on TEPEZZA:

  • TEPEZZA is a specialty medicine and will require prior authorization by insurance
  • TEPEZZA is an intravenous medicine, and a full course of treatment is 8 infusions1
  • While many patients experience a reduction in proptosis, redness, pain, and swelling as early as 6 weeks after start of treatment with TEPEZZA, it is recommended that patients receive the full course of treatment, as improvement continues across all 8 infusions1,5

*Clinical Activity Score (CAS) is a 7-point composite score measuring spontaneous orbital pain, gaze-evoked orbital pain, eyelid swelling, eyelid erythema, conjunctival redness, chemosis, and inflammation of caruncle or plica. A lower score indicates fewer symptoms.4

The CAS is a composite score with equal weighting of a number of factors. However, the factors may not be of equal clinical weight to patients or to physicians treating these patients.


Steps to help start a patient on TEPEZZA

1 Gather clinical information on patient’s Thyroid Eye Disease (TED) diagnosis. Download and review the prior authorization (PA) form and requirements from the payor website.

2 Initiate patient enrollment. Complete the PDF or DocuSign® option of the Patient Enrollment Form (PEF) to get your patient started on TEPEZZA. To complete the PEF, both a physician signature and a patient signature are required.

3 Review patient’s benefits investigation and payor requirements, then complete the Clinical Documentation Tearpad to appropriately document inflammatory signs and symptoms of TED, such as CAS. Once completed, identify a site of care (SOC).

4 Coordinate submission of prior authorization with SOC.

5 Confirm your patient has scheduled their first infusion appointment after prior authorization approval.

Download the TEPEZZA Access Roadmap, or speak with your Horizon Representative, for more
detailed information on the steps to get your patients started on TEPEZZA.

HORIZON BY YOUR SIDE icon

Support for patients on TEPEZZA

Horizon believes cost should never stop someone from getting the medicine they need. Support for your patients is available from Horizon By Your Side.

Key considerations when starting a patient on TEPEZZA1:

key-considerations
  • Patient’s glucose levels should be monitored for hyperglycemic reactions1
  • Patients with preexisting diabetes or impaired glucose tolerance should be under appropriate glycemic control before receiving TEPEZZA1
  • Educate and counsel females of reproductive potential about the need to use effective contraception prior to initiation, during treatment with TEPEZZA, and for 6 months after the last dose1

TEPEZZA may improve the signs and symptoms of TED, including
physical appearance and functional vision1,6-9

TEPEZZA patients often talk about how TEPEZZA worked for them.

During treatment with TEPEZZA, my eye bulging became less and less. My double vision went away. The redness was gone. And the pain and swelling under my eyes improved.

Jeanne T., real TEPEZZA patient10

INDICATION

TEPEZZA is indicated for the treatment of Thyroid Eye Disease regardless of Thyroid Eye Disease activity or duration.

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 controlled with medications for glycemic control, if necessary. Assess patients for elevated blood glucose and symptoms of hyperglycemia prior to infusion and continue to monitor while on treatment with TEPEZZA. Ensure patients with hyperglycemia or preexisting diabetes are under appropriate glycemic control before and while receiving TEPEZZA.

Hearing Impairment Including Hearing Loss: TEPEZZA may cause severe hearing impairment including hearing loss, which in some cases may be permanent. Assess patients’ hearing before, during, and after treatment with TEPEZZA and consider the benefit-risk of treatment with patients.

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, dry skin, weight decreased, nail disorders, and menstrual disorders.

Please see Full Prescribing Information or visit TEPEZZAhcp.com for more information.

P-TEP-US-01064-2 07/23

INDICATION

TEPEZZA is indicated for the treatment of Thyroid Eye Disease regardless of Thyroid Eye Disease activity or duration.

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 controlled with medications for glycemic control, if necessary. Assess patients for elevated blood glucose and symptoms of hyperglycemia prior to infusion and continue to monitor while on treatment with TEPEZZA. Ensure patients with hyperglycemia or preexisting diabetes are under appropriate glycemic control before and while receiving TEPEZZA.

Hearing Impairment Including Hearing Loss: TEPEZZA may cause severe hearing impairment including hearing loss, which in some cases may be permanent. Assess patients’ hearing before, during, and after treatment with TEPEZZA and consider the benefit-risk of treatment with patients.

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, dry skin, weight decreased, nail disorders, and menstrual disorders.

Please see Full Prescribing Information or visit TEPEZZAhcp.com for more information.

P-TEP-US-01064-2 07/23

  1. TEPEZZA (teprotumumab-trbw) [prescribing information] Horizon. 
  2. Smith TJ, Kahaly GJ, Ezra DG, et al. Teprotumumab for thyroid-associated ophthalmopathy. N Engl J Med. 2017;376(18)(suppl):1748-1761. https://www.nejm.org/doi/suppl/10.1056/NEJMoa1614949/suppl_file/nejmoa1614949_appendix.pdf
  3. Smith TJ, Kahaly GJ, Ezra DG, et al. Teprotumumab for thyroid-associated ophthalmopathy. N Engl J Med. 2017;376(18)(protocol):1748-1761. https://www.nejm.org/doi/suppl/10.1056/NEJMoa1614949/suppl_file/nejmoa1614949_protocol.pdf
  4. European Group on Graves’ Orbitopathy (EUGOGO); Wiersinga WM, Perros P, Kahaly GJ, et al. Clinical assessment of patients with Graves’ orbitopathy: the European Group on Graves’ Orbitopathy recommendations to generalists, specialists and clinical researchers. Eur J Endocrinol. 2006;155(3):387-389. 
  5. Smith TJ, Kahaly GJ, Ezra DG, et al. Teprotumumab for thyroid-associated ophthalmopathy. N Engl J Med. 2017;376(18):1748-1761. 
  6. Patel A, Yang H, Douglas RS. A new era in the treatment of thyroid eye disease. Am J Ophthalmol. 2019;208:281-288. 
  7. Douglas RS, Kahaly GJ, Patel A, et al. Teprotumumab for the treatment of active thyroid eye disease. N Engl J Med. 2020;382(4):341-352. 
  8. Smith TJ, Hoa N. Immunoglobulins from patients with Graves’ disease induce hyaluronan synthesis in their orbital fibroblasts through the self-antigen, insulin-like growth factor-I receptor. J Clin Endocrinol Metab. 2004;89:5076-5080. 
  9. Kahaly GJ, Douglas RS, Holt RJ, Sile S, Smith TJ. Teprotumumab for patients with active thyroid eye disease: a pooled data analysis, subgroup analyses, and off-treatment follow-up results from two randomised, double-masked, placebo-controlled, multicentre trials. Lancet Diabetes Endocrinol. 2021;9(6):360-372. 
  10. Data on File. Horizon, May 2022.