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Find answers to commonly asked questions about topics such as coverage and insurance, dosing, administration, efficacy, clinical trial data, and more.
Clinical Trial Data & Efficacy
TEPEZZA is indicated for the treatment of TED, regardless of activity or duration.1 Explore the clinical data of TEPEZZA.
In the Phase 3 clinical trial, 83% (n=34/41) of TEPEZZA patients achieved a significant proptosis reduction of ≥2 mm vs 10% with placebo (n=4/42) at Week 24 (P<0.001) in patients with high disease activity and short-duration TED.2 Take a closer look at how TEPEZZA impacted patients with proptosis.
Observed follow-up analysis was done of patients who responded to TEPEZZA treatment at Week 24 of Phase 2/3 studies and had available data at Week 72, to explore maintenance of response across key endpoints.3 Explore the full clinical outcomes of TEPEZZA.
TEPEZZA was studied in a wide patient population. In the Phase 3 trial, TEPEZZA was studied in patients with high disease activity, short-duration, and with a clinical activity score (CAS) ≥4.2 In Phase 4, TEPEZZA was studied in patients with long-duration and low disease activity.4 See how TEPEZZA has helped real patients here.
In the Phase 3 and Phase 4 TEPEZZA clinical trials, mean change in proptosis was measured across trial visits from baseline through Week 24, and some patients had a TEPEZZA response as early as Week 6.2,4
In the Phase 3 study, as early as Week 6, TEPEZZA patients achieved a mean change from baseline in proptosis of -2.00 mm (n=41) vs -0.38 mm with placebo (n=42). At Week 24, the mean change from baseline in proptosis was -3.32 mm vs -0.53 mm with placebo.2
In the Phase 4 study, as early as Week 6, TEPEZZA patients achieved a mean change from baseline in proptosis of -1.17 mm (n=42) vs -0.63 mm with placebo (n=20). At Week 24, the mean change from baseline in proptosis was -2.41 mm vs -0.92 mm with placebo.4
Find out how quickly patients responded to TEPEZZA throughout this period.
Insurance
TEPEZZA has [98%] coverage across commercial and government insurance types.5 With commercial insurance, patients may be eligible to pay as little as $0* out-of-pocket through the Amgen Commercial Co-Pay Program. Government insurance support may be available.
Amgen By Your Side can offer support for your practice with the prior authorization process. Initiate your patient’s enrollment in Amgen By Your Side by submitting the Patient Enrollment Form (PEF) and see how you can help your patients get started today.
*Eligibility criteria and program maximums apply. Visit https://www.tepezzahcp.com/starting-patients for full terms and conditions. Patients who are residents of Massachusetts or Rhode Island are not eligible for administration support.
Safety & 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.1 Most adverse events were mild or moderate, manageable and resolved during or after treatment. 9 out of 10 patients completed a full course of treatment with TEPEZZA.6 Learn more about the TEPEZZA safety profile here.
In the Phase 2/3 study (N=84), with high disease activity, short-duration patients with CAS ≥4, 10% of patients (n=8/84) experienced a hearing impairment event. Of those cases, 88% (n=7/8) resolved either during the double-masked period or the follow-up period (48 weeks). The majority of events were mild or moderate and managed without interrupting therapy. In a Phase 4 study of patients with CAS ≤1 with a TED diagnosis for 2-10 years at baseline, 22% (n=9/41) experienced a hearing impaired event. Of those cases, 33% (n=3/9) resolved or were resolving by the end of the 30-day follow-up period.
The PI recommends assessing hearing before, during, and after treatment.
Hearing impairment does not necessarily mean total hearing loss. Hearing may be unclear, distorted, or limited to certain sound ranges (eg, difficulty discerning higher-pitched noises). Learn more about TEPEZZA and hearing loss here.
Dosing & Administration
TEPEZZA is 8 IV infusions, 1 given every 3 weeks.1 Infusions can be administered at a variety of locations, including infusion centers, other clinics or physicians offices, hospitals, or at home. Over 25,000 patients† have been treated with TEPEZZA across 3,126 sites of care.9,10 See what preparation and administration steps need to be taken to infuse TEPEZZA.
†Based on 25,062 individual patients enrolled in Amgen By Your Side who received at least 1 dose of TEPEZZA from 02/05/2020 – 11/14/2025. TED diagnosis is assumed based on initiation of TEPEZZA.
TEPEZZA is 8 IV infusions, 1 given every 3 weeks.1 The first and second infusions are 90 minutes at minimum; with subsequent infusions ~60 minutes, if well tolerated. If not well tolerated, minimum time should remain at 90 minutes, and premedication is recommended.1 Learn about dosing calculations for each infusion stage.
Start, Monitor, and Manage TEPEZZA
While each situation will depend on a patient’s individual circumstances, know that 92% of insured patients have no CAS threshold requirement.11 Also be sure to provide patient education on the infusion process, warnings, precautions, and potential side effects of TEPEZZA.
Amgen By Your Side matches patients with a Patient Access Liaison (PAL), who can help support them through benefits verification, understand their coverage, and answer financial support questions. Share this valuable resource with them to get them started on their TEPEZZA journey and educate on site-of-care options.
