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Setting Patient Expectations

Counseling patients throughout the course of treatment can help keep them on track with TEPEZZA
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Before they start treatment

  • Help patients define their goals with TEPEZZA, based on how they look and feel

  • Have an open conversation about their disease burden in terms of daily activities and emotional well-being

  • Provide information about TED and TEPEZZA—share TEPEZZA.com as an educational resource

  • Clarify the treatment process, including when treatment may start, the length of each IV infusion, and the importance of completing the entire treatment course of 8 IV infusions

  • Discuss potential adverse events and what to look for during and after treatment, including disease flare-ups

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After every infusion

  • Ask patients about their results with TEPEZZA and ask them to show you pictures of what they looked like before treatment

  • Provide resources to monitor their progress, improving symptoms, and side effects

  • Encourage patients to take selfies to track their progress and share with their care team

  • Continue to have an open dialogue about the TEPEZZA treatment process and encourage the completion of all 8 IV infusions

Lily

"After the 3rd infusion, I started seeing steady improvement, and my eyes were feeling more comfortable."

—Lily Z., real TEPEZZA patient

In the Phase 3 study, improvement of proptosis as measured by mean change from baseline was observed as early as 6 weeks and continued to improve through Week 24.1

Important patient counseling information

Infusion-reactions
Infusion reactions
  • Reported in ~4% of patients on TEPEZZA—most reactions were mild or moderate
  • Advise patients that TEPEZZA may cause infusion reactions that can occur at any time or within 1.5 hours after an infusion. Instruct patients to recognize the signs and symptoms of infusion reaction and to contact their healthcare provider immediately for signs or symptoms of potential infusion-related reactions
Exacerbation
Exacerbation of preexisting inflammatory bowel disease (IBD)
  • Monitor patients for disease flare; if exacerbation is suspected, consider discontinuing TEPEZZA
  • Advise patients on the risk of IBD and to seek medical advice immediately if they experience diarrhea, with or without blood or rectal bleeding, associated with abdominal pain or cramping/colic, urgency, tenesmus, or incontinence
Hyperglycemia
Hyperglycemia
  • In clinical trials, 10% of patients (two-thirds of whom had preexisting diabetes or impaired glucose tolerance) experienced hyperglycemia
  • Assess patients for elevated blood glucose and hyperglycemia symptoms before and during treatment
  • Ensure patients with hyperglycemia or preexisting diabetes are under appropriate glycemic control before and during treatment
Hearing
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
  • Instruct patients to contact their healthcare provider if they experience any signs or symptoms of hearing impairment or any changes in hearing
Pregnancy
Pregnancy
  • Advise women of childbearing potential that TEPEZZA can cause harm to a fetus and to inform their healthcare provider of a known or suspected pregnancy
  • Women of childbearing potential need to use effective contraception before, during, and for 6 months after last dose
adverse
Most common adverse reactions
  • Incidence ≥5% and greater than placebo: muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, hearing impairment, dysgeusia, headache, dry skin, weight decreased, nail disorders, and menstrual disorders
Kim

"To see myself now after this treatment, it’s been uplifting because I don’t think about my eyes every day anymore. I can go about my day being confident and people aren’t asking me about my eyes or staring at my eyes.”

—Kim E., real TEPEZZA patient

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.

Inflammatory Bowel Disease: TEPEZZA may cause an exacerbation of inflammatory bowel disease (IBD). IBD has been reported in some patients without a prior diagnosis of IBD. Monitor patients for signs and symptoms of IBD. If IBD exacerbation is suspected, discontinue use 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, ear discomfort, weight decreased, nail disorders, and menstrual disorders.

INDICATION

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

Please see Full Prescribing Information for more information.
REFERENCES:

1. TEPEZZA (teprotumumab-trbw) [prescribing information] Amgen.