Teprotumumab

Teprotumumab-trbw's mechanism of action in patients with Thyroid Eye Disease has not been fully characterized. Teprotumumab-trbw binds to IGF-1R and blocks its activation and signaling.

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

• None.contraindicated

Initiate dosing with 10 mg/kg for first infusion, followed by 20 mg/kg every 3 weeks for 7 additional infusions ( 2.1 ) Administer TEPEZZA by intravenous infusion over 60 to 90 minutes ( 2.3 ) 2.1 Recommended Dosing The recommended dose of TEPEZZA is an intravenous infusion of 10 mg/kg for the initial dose followed by an intravenous infusion of 20 mg/kg every three weeks for 7 additional infusions. 2.2 Reconstitution and Preparation Step 1: Calculate the dose (mg) and determine the number of vials needed for the 10 or 20 mg/kg dosage based on patient weight. Each TEPEZZA vial contains 500 mg of the teprotumumab antibody. Step 2: Using appropriate aseptic technique, reconstitute each TEPEZZA vial with 10 mL of Sterile Water for Injection, USP. Ensure that the stream of diluent is not directed onto the lyophilized powder, which has a cake-like appearance. Do not shake, but gently swirl the solution by rotating the vial until the lyophilized powder is dissolved. The reconstituted solution has a total volume of 10.5 mL. Withdraw 10.5 mL of reconstituted solution to obtain 500 mg. After reconstitution, the final concentration is 47.6 mg/mL. Step 3: The reconstituted TEPEZZA solution must be further diluted in 0.9% Sodium Chloride Injection, USP prior to infusion. To prepare the diluted solution, use 100 mL infusion bags for a dose less than 1800 mg, and 250 mL infusion bags for a dose equal to or greater than 1800 mg.

Infusion Reactions : If an infusion reaction occurs, interrupt or slow the rate of infusion and use appropriate medical management ( 5.1 ) Inflammatory Bowel Disease (IBD) : Monitor patients; for signs and symptoms of disease, including patients without a history of IBD; discontinue TEPEZZA if IBD exacerbation is suspected ( 5.2 ) Hyperglycemia : 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 ( 5.3 ) 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 ( 5.4 ) 5.1 Infusion Reactions TEPEZZA may cause infusion reactions. Infusion reactions have been reported in approximately 4% of patients treated with TEPEZZA. Signs and symptoms of infusion-related reactions include transient increases in blood pressure, feeling hot, tachycardia, dyspnea, headache and muscular pain. Infusion reactions may occur during any of the infusions or within 1.5 hours after an infusion. Reported infusion reactions are usually mild or moderate in severity and can usually be successfully managed with corticosteroids and antihistamines.

The following clinically significant adverse reactions are described elsewhere in the labeling: Infusion Reactions [see Warnings and Precautions (5.1) ] Inflammatory Bowel Disease [see Warnings and Precautions (5.2) ] Hyperglycemia [see Warnings and Precautions (5.3) ] Hearing Impairment Including Hearing Loss [see Warnings and Precautions (5.4) ] Most common adverse reactions (incidence greater than 5%) are muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, hearing impairment, dry skin, dysgeusia, headache, weight decreased, and nail disorder ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of TEPEZZA was evaluated in two premarketing randomized, double-masked, placebo-controlled clinical trials (Study 1 [NCT01868997] and Study 2 [NCT03298867]) consisting of 170 patients with Thyroid Eye Disease (84 received TEPEZZA and 86 received placebo). Patients were treated with TEPEZZA (10 mg/kg for first infusion and 20 mg/kg for the remaining 7 infusions) or placebo given as an intravenous infusion every 3 weeks for a total of 8 infusions. The majority of patients completed 8 infusions (89% of TEPEZZA patients and 93% of placebo patients).

Females of Reproductive Potential: Appropriate forms of contraception should be implemented prior to initiation, during treatment and for 6 months following the last dose of TEPEZZA ( 8.3 ) 8.1 Pregnancy Risk Summary Based on findings in animals and its mechanism of action inhibiting insulin-like growth factor-1 receptor (IGF-1R) signaling, TEPEZZA may cause fetal harm when administered to a pregnant woman. Adequate and well-controlled studies with TEPEZZA have not been conducted in pregnant women. There are insufficient data with TEPEZZA use in pregnant women to inform any drug associated risks for adverse developmental outcomes. Cynomolgus monkeys dosed once weekly with teprotumumab during pregnancy resulted in placental changes, decreased fetal growth during pregnancy, decreased fetal size and weight, and multiple external and skeletal abnormalities in offspring. Teprotumumab exposure may lead to an increase in fetal loss [see Data ] . Therefore, TEPEZZA should not be used in pregnancy, and appropriate forms of contraception should be implemented prior to initiation, during treatment and for 6 months following the last dose of TEPEZZA. Women of childbearing age should have a pregnancy test performed by their doctor before starting treatment with TEPEZZA.

Metabolism

The pharmacokinetics of teprotumumab-trbw was described by a two compartment population PK model based on data from 40 patients with Thyroid Eye Disease receiving an initial intravenous infusion of 10 mg/kg, followed by infusions of 20 mg/kg TEPEZZA every 3 weeks in one clinical trial. Following this regimen, the mean (± standard deviation) estimates for steady-state area under the concentration curve (AUC), peak (C max ), and trough (C trough ) concentrations of teprotumumab-trbw were 138 (± 34) mg∙hr/mL, 632 (± 139) mcg/mL, and 176 (± 56) mcg/mL, respectively.

No information is available for patients who have received an overdosage.

• Jan 21, 2020BLABLA761143Horizon Therapeutics Ireland

1. 1Muscle Spasms1,04520%
2. 2Fatigue73514%
3. 3Tinnitus57111%
4. 4Headache4618.7%
5. 5Hypoacusis4488.4%
6. 6Diarrhoea4328.1%
7. 7Nausea4227.9%
8. 8Blood Glucose Increased4177.8%
9. 9Alopecia4117.7%
10. 10Pain3516.6%
11. 11Anxiety3366.3%
12. 12Diplopia3105.8%
13. 13Drug Ineffective2945.5%
14. 14Weight Decreased2905.5%
15. 15Endocrine Ophthalmopathy2815.3%

The 10 most recently updated of 24 ClinicalTrials.gov registrations naming Teprotumumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Teprotumumab N01 Versus Methylprednisolone After Urgent Orbital Decompression for Dysthyroid Optic Neuropathy
  Not yet recruiting · Phase 2 · Interventional · 60 enrolled · Sun Yat-sen University
  NCT07594912updated 2026-05-19
• A Study to Evaluate the Efficacy and Safety of LASN01 in Patients With Thyroid Eye Disease
  Completed · Phase 2 · Interventional · 41 enrolled · Lassen Therapeutics Inc.
  NCT06226545updated 2026-03-09
• A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Teprotumumab (AMG 632) Administered Intravenously in Healthy Chinese Participants
  Completed · Phase 1 · Interventional · 20 enrolled · Amgen
  NCT07142642updated 2026-02-27
• Evaluating the Efficacy and Safety of Teprotumumab N01 in Patients With Thyroid Eye Disease.
  Recruiting · Interventional · 50 enrolled · Peking University Third Hospital
  NCT07423013updated 2026-02-20
• A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease
  Active not recruiting · Phase 3 · Interventional · 89 enrolled · Amgen
  NCT06248619updated 2026-01-28
• TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement Study
  Completed · Phase 4 · Interventional · 313 enrolled · Amgen
  NCT05002998updated 2026-01-15
• Comparison of the Efficacy and Safety of 4 vs. 8 Treatments With Tepezza (Teprotumumab) for Thyroid Eye Disease
  Not yet recruiting · Phase 4 · Interventional · 40 enrolled · Sheba Medical Center
  NCT07308964updated 2025-12-30
• Safety and Efficacy Evaluation of Anti IGF-1R Monoclonal Antibody Combined With Anti-PD-1 Monoclonal Antibody in Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer
  Active not recruiting · Early phase 1 · Interventional · 7 enrolled · Shanghai Changzheng Hospital
  NCT06866548updated 2025-12-04
• A Study of Teprotumumab N01 in Subjects With Active Thyroid Eye Disease
  Not yet recruiting · Phase 4 · Interventional · 92 enrolled · Innovent Biologics (Suzhou) Co. Ltd.
  NCT07265258updated 2025-12-04
• A Clinical Study to Evaluate the Efficacy and Safety of IBI311 in Subjects With Inactive Thyroid Eye Disease
  Recruiting · Phase 3 · Interventional · 111 enrolled · Innovent Biologics (Suzhou) Co. Ltd.
  NCT07113262updated 2025-11-17

Frequently asked questions

How does Teprotumumab work?

Teprotumumab-trbw's mechanism of action in patients with Thyroid Eye Disease has not been fully characterized. Teprotumumab-trbw binds to IGF-1R and blocks its activation and signaling.

What is Teprotumumab used for?

According to FDA labeling, Teprotumumab carries indications including: TEPEZZA is indicated for the treatment of Thyroid Eye Disease regardless of Thyroid Eye Disease activity or duration.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Teprotumumab?

Teprotumumab is classified as Monoclonal antibodies, Insulin-like Growth Factor-1 Receptor Inhibitor, Antibody-Receptor Interactions, Insulin-like Growth Factor-1 Receptor Inhibitors.

What are the brand names for Teprotumumab?

Teprotumumab is marketed under brand names including Tepezza.

What are the contraindications for Teprotumumab?

Teprotumumab labeling lists contraindications including: None.. Always consult the full prescribing information and a clinician.