What is Tepezza (teprotumumab-trbw) for?

Tepezza (teprotumumab-trbw) is an inhibitor of the insulin-like growth factor-1 receptor (IGF-1R) indicated for the treatment of active thyroid eye disease (TED), which is also known as Grave’s eye disease.^[1]

It is available as intravenous powder for injection containing 500 mg teprotumumab-trbw.^[1]

How does Tepezza (teprotumumab-trbw) work?

TED is an autoimmune disease in which the immune cells attack the thyroid gland. As a result, this gland starts producing an excess of thyroid hormone, which causes the fat and muscle tissue of the thyroid gland to become swollen. This can cause symptoms like eye bulging, double vision, eye pain, and redness.^[2]

The insulin-like growth factor-1 receptor (IGF-1R) plays a role in the development of TED, but how exactly is not yet known. Teprotumumab-trbw can bind to IGF-1R and block its activation and signaling, thereby reducing fat and muscle swelling and improving TED symptoms.^[1,2]

Where has Tepezza (teprotumumab-trbw) been approved?

Tepezza (teprotumumab-trbw) was approved for the treatment of TED by:

• The Food and Drug Administration (FDA), USA, on January 21, 2020.^[3]

Tepezza (teprotumumab-trbw) is the first medicine that has been approved for the treatment of TED.^[3]

The medicine received Priority Review, Orphan Drug, Fast Track and Breakthrough Therapy designations from the FDA.^[3]

In December 2016, the Paediatric Committee of the European Medicines Agency (EMA) granted a product specific waiver for the use of teprotumumab in TED, without the obligation to obtain additional data.^[4]

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Tepezza (teprotumumab-trbw) taken?

The standard dosage is:^[1]

• 10 mg/kg body weight for the first dose
• Followed by 20 mg/kg body weight every three weeks for 7 additional infusions

A dose of Tepezza (teprotumumab-trbw) is given as an intravenous infusion (drip) into a vein.^[1]

Complete information about Tepezza (teprotumumab-trbw) dosage and administration can be found in the official prescribing information listed in our references section.^[1]

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Tepezza (teprotumumab-trbw)?

Common adverse reactions

The most common side effects (≥5% of patients) listed in the prescribing information include:^[1]

• Muscle cramps or spasms
• Nausea
• Hair loss
• Diarrhea
• Feeling tired
• High blood sugar
• Hearing problems
• Taste changes
• Headache
• Dry skin

Use in a specific population

Tepezza (teprotumumab-trbw) can cause fetal harm when administered to a pregnant woman, it is advised to avoid pregnancies and breastfeeding.^[1]

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.^[1]

References

1. Full prescribing information [FDA]: Tepezza (teprotumumab-trbw) [PDF] Horizon, Jan 21, 2020

2. How TEPEZZA Works
Horizon Therapeutics press release, cited on Nov 6, 2020

3. FDA Approves TEPEZZA (TM) (teprotumumab-trbw) for the Treatment of Thyroid Eye Disease (TED)
Horizon Therapeutics press release, Jan 21, 2020

4. European Medicines Agency decision
EMA, Dec 2, 2016