Teprotumumab

Pronunciation: TEP-roe-TOOM-ue-mab
Generic name: teprotumumab-trbw
Brand name: Tepezza
Dosage form: injection (500 mg lyophilized powder in a single-dose vial for reconstitution)
Drug class: Growth hormone receptor blockers

Medically reviewed by Melisa Puckey, BPharm. Last updated on Oct 10, 2024.

What is teprotumumab?

Teprotumumab is used for thyroid eye disease (TED) to help reduce eye bulging (proptosis), improve redness, pain, and swelling of the eyes, and improve double vision (diplopia). Teprotumumab infusion treats the cause of TED, not just the symptoms, by decreasing inflammation, preventing muscle and fat tissue remodeling, and preventing tissue expansion behind the eye. Teprotumumab brand name is Tepezza by Horizon Therapeutics.

Improvement in eye bulging started as early as 6 weeks and continued to improve over 24 weeks in the OPTIC trial for teprotumumab which was reported in the NEJM.  It is given as an infusion into a vein, usually every 3 weeks, for a total of 8 doses; each infusion takes 60 to 90 minutes to complete.

Thyroid eye disease (TED) is an autoimmune disorder in which the immune system attacks tissues around the eyes, resulting in symptoms such as dry or watery eyes, eye redness, bulging eyes, vision problems, and difficulty closing the eyes. TED is sometimes called Graves' Eye Disease, as it often occurs in people living with Graves’ disease or hyperthyroidism.

A protein called insulin-like growth factor I receptor (IGF-IR) plays a central role in causing the symptoms of TED. Teprotumumab mechanism of action is thought to be by binding to IGF-1R, which blocks its activation and signaling to help improve symptoms. Teprotumumab-trbw  is an insulin-like growth factor-1 receptor inhibitor (IGF-1R) and a fully human monoclonal antibody (mAb). 

Teprotumumab FDA approval was received on January 21, 2020, for treating thyroid eye disease, regardless of TED activity or duration, for the Tepezza brand. The approval was based on positive results from OPTIC teprotumumab clinical trials.

Teprotumumab side effects

Common teprotumumab side effects

Common teprotumumab side effects may include muscle spasms, nausea, diarrhea, headache, tiredness, high blood sugar, hair loss, hearing problems, dry skin, or an altered sense of taste.

Serious teprotumumab side effects

Get emergency medical help if you have signs of an allergic reaction to this medicine, such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

Some serious side effects may occur during an injection or within 1.5 hours afterward. Tell your caregiver if you feel hot, anxious, or short of breath, or if you have a headache, muscle pain, or fast heartbeats.

Call your doctor at once if you have:

• diarrhea (with or without blood);
• stomach cramps;
• bowel movements that occur suddenly;
• loss of bowel control;
• a feeling of not completely emptying your bowels;
• rectal bleeding; or
• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor.

Teprotumumab infusion may cause side effects of infusion reactions, worsening of inflammatory bowel disease, high blood sugar, and hearing loss or impairment. See Warning Section for more details of these side effects.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Warnings

Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Infusion reactions can occur with this medicine. Infusion reactions may occur during any of the infusions or within 1.5 hours after an infusion. Infusion reactions that have been reported are usually mild or moderate in severity and can usually be successfully managed with corticosteroids and antihistamines.

Preexisting inflammatory bowel disease (IBD) may be exacerbated with this medicine. Patients who have IBD should be monitored for flare-ups. If a flare-up is suspected, consider stopping this medicine.

High blood sugar levels (hyperglycemia). This medicine may cause an increase in blood glucose levels. Monitor blood glucose levels and symptoms of hyperglycemia before infusion and while on treatment. Patients who have hyperglycemia or pre-existing diabetes should be under appropriate glycemic control before and while receiving this infusion.

Teprotumumab hearing loss or hearing impairment may be a side effect. This medicine may cause severe hearing impairment including hearing loss, which, in some cases may be permanent. Patients’ hearing should be assessed before, during, and after treatment with this infusion. Weigh up the benefit-risk ratio of treatment before treatment.

Before taking this medicine

To make sure teprotumumab is safe for you, tell your doctor if you have:

• inflammatory bowel disease;
• diabetes or hyperglycemia (high blood sugar);

Pregnancy

This medicine may harm an unborn baby. Use effective birth control to prevent pregnancy while you are receiving the infusion and for at least 6 months after your last dose. Tell your doctor if you become pregnant.

Breastfeeding

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

How will I receive this medicine?

Teprotumumab is given as an infusion into a vein, which can take 60 to 90 minutes to complete. It is usually given once every 3 weeks for a total of 8 doses.

A healthcare provider will give you this injection.

Teprotumumab Dosing information

Usual Adult teprotumumab Dose for Thyroid Eye Disease

Initial dose: 10 mg/kg intravenous infusion
Maintenance dose: 20 mg/kg intravenous infusion every 3 weeks for 7 additional infusions.

Teprotumumab (Tepezza) is available as a 500 mg lyophilized powder in a single-dose vial for reconstitution.

Related/similar drugs

Tepezza, teprotumumab

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your infusion.

What happens if I overdose?

Since this infusion is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving this medicine?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect this medicine?

Other drugs may affect teprotumumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Click on the Interactions link below for more interactions information.

Teprotumumab Package Insert

Review the Teprotumumab Package Insert (Tepezza Package Insert) for more detailed information about this medicine. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

Storage

Single dose vial
Refrigerate at 2°C to 8°C (36°F to 46°F) in original carton until time of use to protect from light. Do not freeze.

Reconstituted Tepezza solution in the vial and the diluted solution in the infusion bag containing 0.9% Sodium Chloride Injection.

The combined storage time of reconstituted Tepezza solution in the vial and the diluted solution in the infusion bag containing 0.9% Sodium Chloride Injection, USP is a total of 4 hours at room temperature 20°C to 25°C (68°F to 77°F) or up to 48 hours under refrigerated conditions 2°C to 8°C (36°F to 46°F) protected from light. If refrigerated prior to administration, allow the diluted solution to reach room temperature prior to infusion.

Tepezza Company

Tepezza (teprotumumab) manufactured by Horizon Therapeutics Ireland DAC Dublin, Ireland U.S. License No. 2022.

Distributed by: Horizon Therapeutics USA, Inc. Deerfield, IL 60015

Teprotumumab Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for teprotumumab.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer