Tepezza

Tepezza (teprotumumab-trbw) infusion is a prescription medication used to treat thyroid eye disease (TED), an autoimmune condition that can cause eye bulging (proptosis), double vision, swelling, redness, pain, and pressure behind the eyes.

Tepezza belongs to a class of medicines called insulin-like growth factor-1 receptor (IGF-1R) inhibitors. It is also a fully human monoclonal antibody. By blocking IGF-1R, Tepezza helps reduce the inflammatory processes involved in TED.

Tepezza is given by intravenous infusion, usually once every 3 weeks for a total of 8 doses. The first two infusions take at least 90 minutes, and subsequent infusions may take 60 minutes.

Thyroid eye disease is often associated with Graves’ disease, although not everyone with TED has the same thyroid history. Tepezza received its initial U.S. FDA approval in 2020, after positive results in the OPTIC trial (NCT03298867).

Tepezza works by blocking the insulin-like growth factor-1 receptor (IGF-1R), which plays an important role in the development of thyroid eye disease. IGF-1R is found in higher levels in the tissues around the eyes in people with TED, where it contributes to inflammation and tissue changes.

When IGF-1R is activated, it can lead to swelling, inflammation, and expansion of the muscles and fatty tissues behind the eye. This is what causes many of the most noticeable TED symptoms, including eye bulging, double vision, redness, irritation, tearing, and discomfort.

By targeting and blocking IGF-1R, Tepezza helps reduce inflammation and limit tissue expansion behind the eyes to help improve the eye changes and symptoms associated with thyroid eye disease.

The Phase 3 confirmatory clinical study OPTIC (NCT03298867) demonstrated:

• 83% of Tepezza patients had a significant improvement in eye bulging (proptosis) compared to 10% for patients using placebo treatment at week 24.
• 68% of Tepezza patients had improved double vision (diplopia) baseline scores by at least one grade, compared to 29% of patients receiving a placebo treatment in Week 24.
• Improvement in eye-bulging started as early as 6 weeks and continued to improve over 24 weeks in clinical trials

Tepezza is given as an infusion into a vein. The first two infusions take at least 90 minutes to complete, and subsequent infusions may take 60 minutes. It is usually given once every 3 weeks for a total of 8 doses.

A healthcare provider will give you this injection.

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.

Inflammatory bowel disease (IBD). There is an increased risk of IBD in patients with or without a previous diagnosis. Contact your healthcare provider immediately if there are symptoms of diarrhea with or without blood or rectal bleeding, associated with abdominal pain or cramping/colic, fecal urgency, persistent urge to empty bowels even when empty (tenesmus), or incontinence.

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.

Tepezza hearing loss. 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.

Encephalopathy. Cases of encephalopathy have been reported in patients treated with this medicine. Seek immediate medical attention if you experience signs or symptoms suggestive of encephalopathy.

To make sure this infusion 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.

Your doctor should perform a pregnancy test before you start treatment. 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.

Common Tepezza side effects

Common Tepezza side effects may include muscle spasms, nausea, diarrhea, headache, tiredness, high blood sugar, hair loss, hearing problems, dry skin, altered sense of taste, weight loss, and nail problems.

Serious Tepezza side effects

Get emergency medical help if you have signs of an allergic reaction to Tepezza: hives; difficult breathing; 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.

Other serious side effects can occur. 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
• hearing problems or hearing loss
• signs or symptoms of encephalopathy (a brain disorder).

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.

These common side effects occurred in 5% or more of patients in two randomized, double-masked, placebo-controlled clinical studies: Study 1 (NCT:01868997) and Study 2 (NCT:03298867).

For more information on the side effects of hearing loss, see the warning section below.

Usual Tepezza Adult Dose for Thyroid Eye Disease:

Initial dose: 10 mg/kg intravenous infusionMaintenance 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.

Tepezza J code is J3241 (10 mg, injection)

J codes are used for medicines that are not taken orally and include injections, inhalations chemotherapies. J codes are important accurate and consistent coding for billing and reimbursement purposes.

Your physician will need the J code when filling out forms for your treatment.

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

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

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

Other drugs may affect this medicine, 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.

HCPs and patients often use the Tepezza Package Insert for more detailed information about this medicine. The Package Insert contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interactions, and more. Discuss any medical questions you have with your doctor or other health care professional. 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.

The Package Insert is sometimes called Prescribing Information (PI) or FDA label.

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

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

The combined storage time of the reconstituted 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.

Manufactured by: Horizon Therapeutics Ireland DAC, Dublin, Ireland, U.S. License No. 2022.

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