Tepezza
Generic name: teprotumumab
Dosage form: infusion
Drug class: Growth hormone receptor blockers
What is Tepezza?
Tepezza infusion 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). Tepezza 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. Improvement in eye bulging started as early as 6 weeks and continued to improve over 24 weeks in clinical trials. 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.
Tepezza is an insulin-like growth factor-1 receptor inhibitor (IGF-1R) and a fully human monoclonal antibody (mAb). Tepezza's mechanism of action is not fully understood.
Tepezza (teprotumumab) received FDA approval on January 21, 2020, and is indicated for treating thyroid eye disease, regardless of TED activity or duration.
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.
Tepezza side effects
Common Tepezza 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.
Get emergency medical help if you have signs of an allergic reaction to this medicine, such as hives, difficult 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.
Tepezza 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.
Hearing impairment including hearing loss may be caused by Tepezza. 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 Tepezza 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?
Tepezza 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.
Tepezza Dosing information
Usual Tepezza Adult 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.
Tepezza is available as a 500 mg lyophilized powder in a single-dose vial for reconstitution.
Related/similar drugs
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 Tepezza, 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.
Tepezza Package Insert
Review the 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.
Company
Manufactured by: Horizon Therapeutics Ireland DAC Dublin, Ireland U.S. License No. 2022.
Distributed by: Horizon Therapeutics USA, Inc. Deerfield, IL 60015
Tepezza 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 Tepezza.
Tepezza (teprotumumab-trbw) - Horizon Therapeutics Ireland DAC
| Formulation type | Strength |
|---|---|
| Single-Dose Vial | 500 mg |
Popular FAQ
Does Tepezza cause weight gain?
Weight gain or weight loss is not a known side effect with Tepezza, a prescription medicine used for the treatment of Thyroid Eye Disease (TED). Thyroid eye disease, also known as Graves' ophthalmopathy, commonly affects people with hyperthyroidism (overproduction of thyroid hormones) due to Graves' disease. Studies have shown that treatment of hyperthyroidism with anti-thyroid drug therapy or radioactive iodine therapy frequently leads to weight gain.
What are monoclonal antibodies?
Monoclonal antibodies (mAbs) are man-made proteins that mimic the natural antibodies produced by our immune systems. Monoclonal antibodies can be formulated into medicines to treat various types of illnesses, such as cancer, rheumatoid arthritis or psoriasis. Continue reading
How does Tepezza work, what's the mechanism of action?
Tepezza (teprotumumab) is an inhibitor of insulin-like growth factor-1 receptor (IGF-1R) used to treat Thyroid Eye Disease (TED). It is a monoclonal antibody that blocks IGF-1R activation and signaling. Tepezza decreases eye bulging (proptosis) by decreasing inflammation, preventing muscle and fat tissue remodeling, and preventing tissue expansion behind the eye. Continue reading
Tepezza before and after, what should I expect?
After treatment, Tepezza has been shown in 24-week long clinical studies to reduce the eye bulging, double vision, eye pain, redness and swelling that may occur before treatment with TED. Some patients may have improvement in symptoms as early as 6 weeks. In addition, an improvement in vision (such as reading or watching TV) and in the patient’s appearance was also seen. Continue reading
How long does it take Tepezza to work?
In studies with Tepezza (teprotumumab-trbw), some patients began to see less eye bulging and double vision by 6 weeks (after the first 2 treatments). By 24 weeks, 8 out of 10 (80%) of patients saw less eye bulging compared to 10 of 100 (10%) of patients taking a placebo. Continue reading
How long does Tepezza stay in your system?
Tepezza stays in your system approximately 100 days after the last dose. This is calculated by looking at the average half-life of Tepezza which is 20 days. The half-life is the time it takes for 50% of a medicine to be eliminated from the body. Research has shown that it takes 4 to 5 half-lives for a medicine to be fully cleared from the body which calculates out to 80 to 100 days or 11 to 14 weeks for Tepezza. Continue reading
Is Tepezza a chemotherapy drug?
No, Tepezza is not used for chemotherapy or to treat any form of cancer. Tepezza is used to treat Thyroid Eye Disease, an autoimmune disease. An autoimmune disease is a condition that causes your body's immune system to mistakenly attack healthy cells in your body instead of foreign substances. Continue reading
Is Tepezza used to treat Graves disease?
Tepezza (teprotumumab-trbw) is a prescription medicine used to treat Thyroid Eye Disease (TED). TED often occurs in people living with Graves’ disease (too much thyroid hormone). TED and Graves’ disease are both autoimmune disorders, but are different conditions and are treated differently. Continue reading
Tepezza and COVID vaccine, what should I know?
People with Thyroid Eye Disease (TED) prescribed Tepezza should be vaccinated against COVID-19 as soon as possible but there are no guidelines regarding preference for one COVID-19 vaccination over another or for the timing of vaccine administration. There is no evidence that people with TED are at more risk of severe COVID-19 or if Tepezza increases the risk of infection with the SARS-CoV-2 virus. There is no guidance regarding the best time to get a COVID-19 vaccination if you are on Tepezza; however, the product information states that Tepezza should not be infused at the same time as other medicines. Because Tepezza is given as a series of 8 injections every 3 weeks, and there is a risk of infusion reactions occurring with Tepezza, it may be best to allow at least 24 to 48hours between an infusion of Tepezza and a COVID-19 vaccine since, if a reaction or a side effect was to occur, it may be challenging to work out which injection was to blame. There is no reason to stop Tepezza until you complete the course of the COVID-19 vaccinations. Continue reading
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