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Ophthalmology

Teprotumumab

Teprotumumab is a newly approved medication to manage active, moderate to severe thyroid eye disease. Teprotumumab has been approved by the U.S. Food and Drug Administration (FDA) for treating thyroid orbitopathy, under breakthrough therapy designation, as an Orphan Drug. It is an insulin-like growth factor-1 receptor (IGF-1R) inhibitor in the class of biological therapy. This activity describes the indications and evidence supporting each indication, action, and contraindications for teprotumum

v1 · Reviewed Nov 8, 2026 by Automated Clinical Reviewer (Strict Verbatim v1)
  • Active Moderate to Severe Thyroid Eye Disease
  • Dysthyroid Optic Neuropathy (DON)
  • Teprotumumab is indicated for DON when conventional therapies have failed, and patients are considered poor surgical candidates for orbital decompression.
  • orbital magnetic resonance imaging (MRI)
  • orbital echography
  • Complete ophthalmologic examination (including visual acuity, color vision, exophthalmometry, extraocular motility, anterior segment, and fundus examination).
  • Standard clinical laboratory evaluation (e.g., complete blood count, liver function tests, fasting blood glucose, and hemoglobin A1c).
  • Objective audiology testing (if available).
Clinical Activity Score (CAS)
defined as having a Clinical Activity Score (CAS) of 4 or more out of 7 points
Clinical Activity Score (CAS)
A response was defined as having a ≥ 2-point reduction in the CAS and a ≥ 2mm reduction in proptosis.
Gorman diplopia score
Secondary outcomes were assessed by the improvement of diplopia by the Gorman diplopia score
Graves' orbitopathy-Quality of Life (GO-QOL) score
and quality of life by Graves' orbitopathy-Quality of Life (GO-QOL) score by 24 weeks.
  • The drug may be considered first-line therapy for patients with clinically significant ophthalmopathy.
Teprotumumab
intravenous infusion
Adult
initial dose of 10 mg/kg (over 90 minutes) followed by 20 mg/kg (over 90 minutes for infusion 2 and over 60 minutes for infusions 3 to 8), at a 3-week interval.
Renal
Not specified in source
Duration
Not specified in source
  • Teprotumumab has no listed contraindications on the label.
  • warnings and precautions are for poorly controlled diabetics, pregnant or breastfeeding women, and prepubertal children.
  • Based on its mechanism of action, it is likely that teprotumumab will have teratogenic effects during pregnancy.
  • Therefore, it is recommended that women of child-bearing age use adequate contraception before starting therapy, during the course of treatment, and for six months following the last dose of teprotumumab.
  • Teprotumumab for thyroid eye disease should be used cautiously in patients with IBD.
  • It can be considered in selected patients; however, co-management with a gastroenterologist is strongly recommended.
  • Simultaneous use of teprotumumab with another biological agent is strongly discouraged.
  • Rituximab-treated patients may have depleted B-cell counts for six months following their last treatment; hence a 6-month break between the last rituximab dose and the start of teprotumumab is strongly advised.
  • A thorough history (in particular, a history of diabetes and IBD).
  • Physical examination (e.g., measurement of weight and blood pressure).
  • Complete ophthalmologic examination (including visual acuity, color vision, exophthalmometry, extraocular motility, anterior segment, and fundus examination).
  • Standard clinical laboratory evaluation (e.g., complete blood count, liver function tests, fasting blood glucose, and hemoglobin A1c).
  • Objective audiology testing (if available).
  • Patients with diabetes who receive teprotumumab are advised to have monitoring of blood glucose and glycated hemoglobin levels and should be co-managed with an endocrinologist.
  • Routine audiograms with teprotumumab therapy have been suggested.
  • Given the ototoxicity potential, baseline audiometry and tympanometry with repeat audiology testing during the course of teprotumumab are recommended for early detection and management of otologic symptoms.
  • review
    Teprotumumab. StatPearls [Internet] — Camille Yvon, Jwu Jin Khong, Raman Malhotra, Bhupendra C. Patel — StatPearls Publishing, 2023

Decision support only. Verify against local protocols and current labeling. Source: www.ncbi.nlm.nih.gov