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TEPEZZA Dosing Information

The importance of completing full treatment course

Infusion-Manual

8 IV Infusions

1 given every 3 weeks1

  • Infusion 1: 10 mg/kg – 90 min1
  • Infusion 2: 20 mg/kg – 90 min 
  • Infusions 3-8: 20 mg/kg – 60 min*
  • TEPEZZA dosing is based on the patient’s actual weight

*If not well tolerated, the minimum infusion duration should remain at 90 minutes.

Find your patient’s dose

The below charts are intended to provide dosing calculations for each infusion stage for patients ranging from 40 kg to 182 kg. The dosing values can also be downloaded as a PDF.

Dosing Calculations

Determine the dosing and infusion values for your patient1

  • Patients weighing 88 lbs to 168 lbs / 40 kg to 76 kg
    Patient Weight Infusion 1 (10 mg/kg) Infusions 2 to 8 (20 mg/kg)
    lb* kg* Dose (mg) Vials
    required (#)    		 Volume to
    withdraw (mL)†    		 Dose (mg) Vials
    required (#)    		 Volume to
    withdraw (mL)†
    884040018.0800216.8
    904141018.6820217.2
    934242018.8840217.6
    954343019.0860218.1
    974444019.2880218.5
    994545019.5900218.9
    1014646019.7920219.3
    1044747019.9940219.7
    10648480110.1960220.2
    10849490110.4980220.6
    11050500110.61000221.0
    11251510210.71020321.4
    11552520210.91040321.8
    11753530211.11060322.3
    11954540211.31080322.7
    12155550211.61100323.1
    12356560211.81120323.5
    12657570212.01140323.9
    12858580212.21160324.4
    13059590212.41180324.8
    13260600212.61200325.2
    13561610212.91220325.6
    13762620213.11240326.1
    13963630213.21260326.5
    14164640213.41280326.9
    14365650213.71300327.3
    14666660213.91320327.7
    14867670214.11340328.1
    15068680214.31360328.6
    15269690214.51380329.0
    15470700214.71400329.4
    15771710214.91420329.8
    15972720215.21440330.2
    16173730215.31460330.7
    16374740215.51480331.1
    16575750215.71500331.5
    16876760215.91520331.9
  • Patients weighing 170 lbs to 247 lbs / 77 kg to 112 kg
    Patient Weight Infusion 1 (10 mg/kg) Infusions 2 to 8 (20 mg/kg)
    lb* kg* Dose (mg) Vials required(#) Volume to withdraw (mL)† Dose (mg) Vials required(#) Volume to withdraw (mL)†
    170 77 770 2 16.2 1540 4 32.4
    172 78 780 2 16.4 1560 4 32.8
    174 79 790 2 16.6 1580 4 33.2
    176 80 800 2 16.8 1600 4 33.6
    179 81 810 2 17.0 1620 4 34.0
    181 82 820 2 17.2 1640 4 34.5
    183 83 830 2 17.4 1660 4 34.9
    185 84 840 2 17.6 1680 4 35.3
    187 85 850 2 17.9 1700 4 35.7
    190 86 860 2 18.1 1720 4 36.1
    192 87 870 2 18.3 1740 4 36.6
    194 88 880 2 18.5 1760 4 37.0
    196 89 890 2 18.7 1780 4 37.4
    198 90 900 2 18.9 1800 4 37.8
    201 91 910 2 19.1 1820 4 38.2
    203 92 920 2 19.3 1840 4 38.7
    205 93 930 2 19.5 1860 4 39.1
    207 94 940 2 19.7 1880 4 39.5
    209 95 950 2 20.0 1900 4 39.9
    212 96 960 2 20.2 1920 4 40.3
    214 97 970 2 20.4 1940 4 40.8
    216 98 980 2 20.6 1960 4 41.2
    218 99 990 2 20.8 1980 4 41.6
    221 100 1000 2 21.0 2000 4 42.0
    223 101 1010 3 21.2 2020 5 42.4
    225 102 1020 3 21.4 2040 5 42.9
    227 103 1030 3 21.6 2060 5 43.3
    229 104 1040 3 21.8 2080 5 43.7
    232 105 1050 3 22.1 2100 5 44.1
    234 106 1060 3 22.3 2120 5 44.5
    236 107 1070 3 22.5 2140 5 45.0
    238 108 1080 3 22.7 2160 5 45.4
    240 109 1090 3 22.9 2180 5 45.8
    243 110 1100 3 23.1 2200 5 46.2
    245 111 1110 3 23.3 2220 5 46.6
    247 112 1120 3 23.5 2240 5 47.1
  • Patients weighing 249 lbs to 326 lbs / 113 kg to 148 kg
    Patient Weight Infusion 5 (10 mg/kg) Infusions 2 to 8 (20 mg/kg)
    lb* kg* Dose (mg) Vials required (#) Volume to withdraw (mL)† Dose (mg) Vials required (#) Volume to withdraw (mL)†
    249 113 1130 3 23.7 2260 5 47.5
    251 114 1140 3 23.9 2280 5 47.9
    254 115 1150 3 24.2 2300 5 48.3
    256 116 1160 3 24.4 2320 5 48.7
    258 117 1170 3 24.6 2340 5 49.2
    260 118 1180 3 24.8 2360 5 49.6
    262 119 1190 3 25.0 2380 5 50.0
    265 120 1200 3 25.2 2400 5 50.4
    267 121 1210 3 25.4 2420 5 50.8
    269 122 1220 3 25.6 2440 5 51.3
    271 123 1230 3 25.8 2460 5 51.7
    273 124 1240 3 26.1 2480 5 52.1
    276 125 1250 3 26.3 2500 5 52.5
    278 126 1260 3 26.5 2520 6 52.9
    280 127 1270 3 26.7 2540 6 53.4
    282 128 1280 3 26.9 2560 6 53.8
    284 129 1290 3 27.1 2580 6 54.2
    287 130 1300 3 27.3 2600 6 54.6
    289 131 1310 3 27.5 2620 6 55.0
    291 132 1320 3 27.7 2640 6 55.5
    293 133 1330 3 27.9 2660 6 55.9
    295 134 1340 3 28.2 2680 6 56.3
    298 135 1350 3 28.4 2700 6 56.7
    300 136 1360 3 28.6 2720 6 57.1
    302 137 1370 3 28.8 2740 6 57.6
    304 138 1380 3 29.0 2760 6 58.0
    306 139 1390 3 29.2 2780 6 58.4
    309 140 1400 3 29.4 2800 6 58.8
    311 141 1410 3 29.6 2820 6 59.2
    313 142 1420 3 29.8 2840 6 59.7
    315 143 1430 3 30.0 2860 6 60.1
    318 144 1440 3 30.3 2880 6 60.5
    320 145 1450 3 30.5 2900 6 60.9
    322 146 1460 3 30.7 2920 6 61.3
    324 147 1470 3 30.9 2940 6 61.8
    326 148 1480 3 31.1 2960 6 62.2
  • Patients weighing 329 lbs to 401 lbs / 149 kg to 182 kg
    Patient Weight Infusion 1 (1.0 mg/kg) Infusions 2 to 8 (20 mg/kg)
    lb* kg* Dose (mg) Vials required(#) Volume to withdraw (mL)† Dose (mg) Vials required(#) Volume to withdraw (mL)†
    329 145 1490 3 31.1 2960 6 62.6
    331 150 1500 3 31.5 3000 6 63.0
    333 151 1510 4 31.7 3020 7 63.4
    335 152 1520 4 31.9 3040 7 63.9
    337 153 1530 4 32.1 3060 7 64.3
    340 154 1540 4 32.4 3080 7 64.7
    342 155 1550 4 32.6 3100 7 65.1
    344 156 1560 4 32.8 3120 7 65.5
    346 157 1570 4 33.0 3140 7 66.0
    348 158 1580 4 33.2 3160 7 66.4
    351 159 1590 4 33.4 3180 7 66.8
    353 160 1600 4 33.6 3200 7 67.2
    355 161 1610 4 33.8 3220 7 67.6
    357 162 1620 4 34.0 3240 7 68.1
    359 163 1630 4 34.2 3260 7 68.5
    362 164 1640 4 34.5 3280 7 68.9
    364 165 1650 4 34.7 3300 7 69.3
    366 166 1660 4 34.9 3320 7 69.7
    368 167 1670 4 35.1 3340 7 70.2
    370 168 1680 4 35.3 3360 7 70.6
    373 169 1690 4 35.5 3380 7 71.0
    375 170 1700 4 35.7 3400 7 71.4
    377 171 1710 4 35.9 3420 7 71.8
    379 172 1720 4 36.1 3440 7 72.3
    381 173 1730 4 36.3 3460 7 72.7
    384 174 1740 4 36.6 3480 7 73.1
    386 175 1750 4 36.8 3500 7 73.5
    388 176 1760 4 37.0 3520 8 73.9
    390 177 1770 4 37.2 3540 8 74.4
    392 178 1780 4 37.4 3560 8 74.8
    395 179 1790 4 37.6 3580 8 75.2
    397 180 1800 4 37.8 3600 8 75.6
    399 181 1810 4 38.0 3620 8 76.1
    401 182 1820 4 38.2 3640 8 76.5

*Rounded to the nearest whole number.

†Rounded to the nearest tenth.

DOWNLOAD
ALL DOSING INFORMATION

Please see Dosage and Administration in the TEPEZZA Prescribing Information (pdf).

Saline-bag

Saline bag size:

  • If dose is <1800 mg, use a 100-mL bag of normal saline (0.9% NaCl)1
  • If dose is ≥1800 mg, use a 250-mL bag of normal saline (0.9% NaCl)1

IV, intravenous.

In a post hoc analysis, 63% (n=15/24) of TEPEZZA patients who showed no proptosis improvement midway (12 weeks) through treatment ultimately did have a proptosis response after completing 8 infusions at 24 weeks from baseline.2

SEE THE DATA
Randi

"After the second infusion, my
symptoms seemed to decrease, and
that motivated me to continue."

—Randi C., 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

Nearly

OUT
OF

patients with TED would
prefer IV medicine before
trying eye surgery4

Based on a survey of 102 TED patients.

HCP
shield-tepezza

All TEPEZZA patients completing treatment had proptosis reduction3,*

Phase 3 study exploratory analysis: Change from baseline in proptosis over 24 weeks in individual patients

In a post hoc analysis, 63% (n=15/24) of TEPEZZA patients who showed no
proptosis improvement midway (12 weeks) through treatment ultimately did have
a proptosis response after completing 8 infusions at 24 weeks from baseline.2

*Analysis is exploratory and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn.

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.

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.
  2. 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.
  3. Douglas RS, Couch S, Wester ST, et al. A randomized, quadruple-masked, placebo-controlled, multicenter trial to evaluate the efficacy and safety of teprotumumab in patients with chronic (inactive/low CAS) Thyroid Eye Disease. Presented at: ENDO 2023; June 15-18, 2023; Chicago, IL. Poster SAT-459.
  4. Douglas RS. Teprotumumab, an insulin-like growth factor-1 receptor antagonist antibody, in the treatment of active Thyroid Eye Disease: a focus on proptosis. Eye (Lond). 2019;33(2):183-190.
  5. Data on File. Amgen, July 2023.
REFERENCES:
  1. Bahn RS. Graves' ophthalmopathy. N Engl J Med. 2010;362(8):726-738.
  2. Wang Y, Patel A, Douglas RS. Thyroid Eye Disease: how a novel therapy may change the treatment paradigm. Ther Clin Risk Manag. 2019;15:1305-1318.
  3. Patel A, Yang H, Douglas RS. A new era in the treatment of Thyroid Eye Disease. Am J Ophthalmol. 2019;208:281-288.
  4. Wang Y, Sharma A, Padnick-Silver L, et al. Physician-perceived impact of Thyroid Eye Disease on patient quality of life in the United States. Ophthalmol Ther. 2021;10(1):75-87.
  5. Dik WA, Virakul S, van Steensel L. Current perspectives on the role of orbital fibroblasts in the pathogenesis of Graves' ophthalmopathy. Exp Eye Res. 2016;142:83-91.
  6. Patel P, Khandji J, Kazim M. Recurrent Thyroid Eye Disease. Ophthal Plast Reconstr Surg. 2015;31(6):445-448.
  7. Douglas RS, Kahaly GJ, Ugradar S, et al. Teprotumumab efficacy, safety and durability in longer-duration Thyroid Eye Disease and re-treatment: OPTIC-X study. Ophthalmology. 2022;129(4):438-449.
  8. Bothun ED, Scheurer RA, Harrison AR, Lee MS. Update on Thyroid Eye Disease and management. Clin Ophthalmol.2009;3:543-551.
  9. Barrio-Barrio J, Sabater AL, Bonet-Farriol E, Velázquez-Villoria Á, Galofré JC. Graves' ophthalmopathy: VISA versus EUGOGO classification, assessment, and management. J Ophthalmol.2015;2015:249125.
  10. Thyroid Eye Disease. National Organization for Rare Disorders. 2020. Accessed December 8, 2022. https://rarediseases.org/rare-diseases/thyroid-eye-disease
  11. TEPEZZA (teprotumumab-trbw) [prescribing information] Amgen.
  12. Risk factors for the development of Thyroid Eye Disease in patients with Graves' disease. Clin Thyroidology for the Public. 2021;14(8):5-6.
  13. Verjee MA, Brissette AR, Starr CE. Dry eye disease: early recognition with guidance on management and treatment for primary care family physicians.Ophthalmol Ther. 2020;9:877-888.
  14. Burch HB, Perros P, Bednarczuk T, et al. Management of Thyroid Eye Disease: a consensus statement by the American Thyroid Association and the European Thyroid Association. Thyroid. 2022;32(12):1439-1470.
  15. Dolman PJ. Grading severity and activity in Thyroid Eye Disease. Ophthalmic Plast Reconstr Surg. 2018;34(4S supp 1):S34-S40.
  16. Ozzello DJ, Dallalzadeh LO, Liu CY. Teprotumumab for chronic Thyroid Eye Disease. Orbit. 2022;41(5):539-546.
  17. Ponto KA, Merkesdal S, Hommel G, Pitz S, Pfeiffer N, Kahaly GJ. Public health relevance of Graves' orbitopathy.J Clin Endocrinol Metab. 2013;98(1):145-152.
  18. McAlinden C. An overview of Thyroid Eye Disease. Eye Vis (Lond). 2014;1:9.
  19. Bartley GB, Fatourechi V, Kadrmas EF, et al. Clinical features of Graves' ophthalmopathy in an incidence cohort. Am J Ophthalmol. 1996;121(3):284-290.
  20. Terwee C, Wakelkamp I, Tan S, Dekker F, Prummel MF, Wiersinga W. Long-term effects of Graves' ophthalmopathy on health-related quality of life. Eur J Endocrinol. 2002;146(6):751-757.
  21. Bartley GB. The epidemiologic characteristics and clinical course of ophthalmopathy associated with autoimmune thyroid disease in Olmsted County, Minnesota. Trans Am Ophthalmol Soc. 1994;92(1):477-588.
  22. Neigel JM, Rootman J, Belkin RI, et al. Dysthyroid optic neuropathy. The crowded orbital apex syndrome.phthalmology. O1988;95(11):1515-1521.
  23. Cockerham KP, Padnick-Silver L, Stuertz N, Francis-Sedlak M, Holt RJ. Quality of life in patients with chronic Thyroid Eye Disease in the United States. Ophthalmol Ther. O 2021;10(4):975-987.
  24. Smith TJ, Kahaly GJ, Ezra DG, et al. Teprotumumab for thyroid-associated ophthalmopathy. N Engl J Med. 2017;376(18)(suppl):1748-1761.
  25. 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.
  26. Stan MN, Garrity JA, Bahn RS. The evaluation and treatment of Graves ophthalmopathy. Med Clin North Am. 2012;96(2):311-328.
  27. 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.
  28. Ross DS, Burch HB, Cooper DS, et al. 2016 American Thyroid Association guidelines for diagnosis and management of hyperthyroidism and other causes of thyrotoxicosis. Thyroid. 2016;26(10):1343-1421.
REFERENCES:
  1.  TEPEZZA (teprotumumab-trbw) [prescribing information] Amgen. 
  2. Patel A, Yang H, Douglas RS. A new era in the treatment of Thyroid Eye Disease. Am J Ophthalmol. 2019;208:281-288. 
  3. Bahn RS. Graves' ophthalmopathy. N Engl J Med. 2010;362(8):726-738. 
  4. Douglas RS. Teprotumumab, an insulin-like growth factor-1 receptor antagonist antibody, in the treatment of active Thyroid Eye Disease: a focus on proptosis. Eye (Lond). 2019;33(2):183-190. 
  5. 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.
  6. Dik WA, Virakul S, van Steensel L. Current perspectives on the role of orbital fibroblasts in the pathogenesis of Graves' ophthalmopathy. Exp Eye Res. 2016;142:83-91.
  7. Ugradar S, Kang J, Kossler AL, et al. Teprotumumab for the treatment of chronic Thyroid Eye Disease. Eye (Lond). 2022;36(8):1553-1559.
  8. Data on File. Amgen, November 2020.
REFERENCES:
  1.  TEPEZZA (teprotumumab-trbw) [prescribing information] Amgen.  
  2. Patel A, Yang H, Douglas RS. A new era in the treatment of Thyroid Eye Disease. Am J Ophthalmol. 2019;208:281-288. 
  3. 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.
  4. Douglas RS. Teprotumumab, an insulin-like growth factor-1 receptor antagonist antibody, in the treatment of active Thyroid Eye Disease: a focus on proptosis. Eye (Lond). 2019;33(2):183-190.
  5. 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. 2021;9(6):360-372.
  6. Data on File. Amgen, April 2023.
  7. Smith TJ, Kahaly GJ, Ezra DG, et al. Teprotumumab for thyroid-associated ophthalmopathy.N Engl J Med. 2017;376(18):1748-1761.
  8. Data on File. Amgen, May 2022.
  9. 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.
  10. Bothun ED, Scheurer RA, Harrison AR, Lee MS. Update on Thyroid Eye Disease and management. Clin Ophthalmol.2009;3:543-551.
  11. Rollet J. Symptoms, quality of life improve with teprotumumab for adults with Thyroid Eye Disease.Endocrine Today. October 31, 2019. Accessed September 11, 2021.
    https://www.healio.com/news/endocrinology/20191031/symptoms-quality-of-life-improve-with-teprotumumab-for-adults-with-thyroid-eye-disease
REFERENCES:
  1. Douglas RS, Couch S, Wester ST, et al. A randomized, quadruple-masked, placebo-controlled, multicenter trial to evaluate the efficacy and safety of teprotumumab in patients with chronic (inactive/low CAS) Thyroid Eye Disease. Presented at: ENDO 2023; June 15-18, 2023; Chicago, IL. Poster SAT-459.
  2. Data on File. Amgen, April 2023.
  3. TEPEZZA (teprotumumab-trbw) prescribing information Amgen.
REFERENCES:
  1. TEPEZZA (teprotumumab-trbw) [prescribing information] Amgen.
  2. Smith TJ, Kahaly GJ, Ezra DG, et al. Teprotumumab for thyroid-associated ophthalmopathy. N Engl J Med. 2017;376(18):1748-1761.
  3. 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.
REFERENCES:
  1. Diniz SB, Cohen LM, Roelofs KA, Rootman DB. Early experience with the clinical use of teprotumumab in a heterogenous Thyroid Eye Disease population. Ophthalmic Plast Reconstr Surg. 2021;37(6):583-591
  2. Ugradar S, Kang J, Kossler AL, et al. Teprotumumab for the treatment of chronic Thyroid Eye Disease.Eye (Lond) . 2022;36(8):1553-1559.
  3. 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. 
  4. TEPEZZA (teprotumumab-trbw) [prescribing information] Amgen.
  5. Data on File. Amgen, January 2020.
  6. Ozzello DJ, Dallalzadeh LO, Liu CY. Teprotumumab for chronic Thyroid Eye disease. Orbit. 2022;41(5):539-546.
  7. Douglas RS, Kahaly GJ, Ugradar S, et al. Teprotumumab efficacy, safety and durability in longer duration Thyroid Eye Disease and retreatment: OPTIC-X study.Ophthalmol. 2022:129(4):438-449.
REFERENCES:
  1. TEPEZZA (teprotumumab-trbw) [prescribing information] Amgen.
  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. 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. 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.
  7. 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-1 receptor.J Clin Endocrinol Metab. 2004;89:5076-5080.
  8. 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. 2021;9(6):360-372.
  9. Data on File. Amgen, May 2022.
REFERENCES:
  1. TEPEZZA (teprotumumab-trbw) [prescribing information] Amgen.
  2. Data on File. Amgen, April 2022.
REFERENCES:
  1. TEPEZZA (teprotumumab-trbw) [prescribing information] Amgen.
REFERENCES:
  1. TEPEZZA (teprotumumab-trbw) [prescribing information] Amgen.
  2. Data on File. Amgen, May 2022.
REFERENCES:
  1. Ross DS, Burch HB, Cooper DS, et al. 2016 American Thyroid Association guidelines for diagnosis and management of hyperthyroidism and other causes of thyrotoxicosis. Thyroid. 2016;26(10):1343-1421.
  2. Barrio-Barrio J, Sabater AL, Bonet-Farriol E, Velázquez-Villoria Á, Galofré JC. Graves’ ophthalmopathy: VISA versus EUGOGO classification, assessment, and management. J Ophthalmol. 2015;2015:249125.
REFERENCES:
  1. TEPEZZA (teprotumumab-trbw) [prescribing information] Horizon.
  2. Patel A, Yang H, Douglas RS. A new era in the treatment of thyroid eye disease. Am J Ophthalmol. 2019;208:281-288.
  3. 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.
  4. Douglas RS. Teprotumumab, an insulin-like growth factor-1 receptor antagonist antibody, in the treatment of active thyroid eye disease: a focus on proptosis. Eye (Lond). 2019;33(2):183-190.
  5. Douglas RS, Couch S, Wester ST, et al. A randomized, quadruple-masked, placebo-controlled, multicenter trial to evaluate the efficacy and safety of teprotumumab in patients with chronic (inactive/low CAS) thyroid eye disease. Presented at: ENDO 2023; June 15-18, 2023; Chicago, IL. Poster SAT-459.
  6. Diniz SB, Cohen LM, Roelofs KA, Rootman DB. Early experience with the clinical use of teprotumumab in a heterogenous thyroid eye disease population. Ophthalmic Plast Reconstr Surg. 2021;37(6):583-591.
  7. Ugradar S, Kang J, Kossler AL, et al. Teprotumumab for the treatment of chronic thyroid eye disease. Eye (Lond). 2022;36(8):1553-1559.
  8. Wang Y, Patel A, Douglas RS. Thyroid eye disease: how a novel therapy may change the treatment paradigm. Ther Clin Risk Manag. 2019;15:1305-1318.
  9. Estcourt S, Hickey J, Perros P, Dayan C, Vaidya B. The patient experience of services for thyroid eye disease in the United Kingdom: results of a nationwide survey. Eur J Endocrinol. 2009;161(3):483-487.
  10. Konuk O, Anagnostis P. Diagnosis and differential diagnosis of Graves’ orbitopathy. In: Wiersinga WM, Kahaly GJ, eds. Graves’ Orbitopathy: A Multidisciplinary Approach - Questions and Answers. 3rd ed. S Karger AG; 2017:74-92.
  11. Ross DS, Burch HB, Cooper DS, et al. 2016 American Thyroid Association guidelines for diagnosis and management of hyperthyroidism and other causes of thyrotoxicosis. Thyroid. 2016;26(10):1343-1421.
  12. Barrio-Barrio J, Sabater AL, Bonet-Farriol E, Velázquez-Villoria Á, Galofré JC. Graves’ ophthalmopathy: VISA versus EUGOGO classification, assessment, and management. J Ophthalmol. 2015;2015:249125.
  • REFERENCES:
    1. TEPEZZA (teprotumumab-trbw) [prescribing information] Amgen. 2. Douglas RS, Couch S, Wester ST, et al. Efficacy and safety of teprotumumab in patients with thyroid eye disease of long duration and low disease activity. J Clin Endocrinol Metab. 2024;109(1):25-35. 3. Kahaly GJ, Petrak F, Hardt J, et al. Psychosocial morbidity of Graves’ orbitopathy. Clin Endocrinol (Oxf). 2005;63(4):395-402. 4. Estcourt S, Vaidya B, Quinn A, et al. The impact of thyroid eye disease upon patients’ wellbeing: a qualitative analysis. Clin Endocrinol (Oxf). 2008;68(4):635-639. 5. Smith TJ, Hegedüs L, Lesser I, et al. How patients experience thyroid eye disease. Front Endocrinol (Lausanne). 2023;14:1283374. 6. Kahaly GJ, Douglas RS, Holt RJ, et al. Teprotumumab for patients with active thyroid eye disease: a pooled data analysis, subgroup analyses, and off-treatment follow-up results from two randomized double-masked placebo-controlled multicenter trials. Lancet Diabetes Endocrinol. 2021;9(6):360-372. 7. Supplement to: 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 randomized double-masked placebo-controlled multicenter trials. Lancet Diabetes Endocrinol. 2021;9(6):360-372. 8. Smith TJ, Kahaly GJ, Ezra DG, et al. Teprotumumab for thyroid-associated ophthalmopathy. N Engl J Med. 2017;376(18):1748-1761. 9. 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. 10. Data on File. Amgen, October 2024. 11. Douglas RS, Kahaly GJ, Ugradar S, et al. Teprotumumab efficacy, safety and durability in longer-duration thyroid eye disease and re-treatment: OPTIC-X study. Ophthalmology. 2022;129(4):438-449. 12. US Food and Drug Administration. FDA approves first treatment for thyroid eye disease. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-thyroid-eyedisease

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