Tepezza

Thyroid Eye Disease

Tepezza is used to treat thyroid eye disease (TED), which is also known as Graves' ophthalmopathy. This is an autoimmune condition where the immune system attacks the muscles and fatty tissues behind the eyes, leading to inflammation and physical changes in the eye area.

Symptoms Addressed

This medication is prescribed to help reduce the specific symptoms of TED, including:

• Eye bulging: Also known as proptosis, where the eyes are pushed forward due to swelling behind them.
• Double vision: A condition called diplopia that occurs when the eye muscles are affected.
• Eye pain and inflammation: This includes redness, swelling of the eyelids, and general discomfort or pressure behind the eyes.

Tepezza is the first medication approved by the FDA specifically for the treatment of thyroid eye disease. It is intended for use in adults and is designed to target the underlying biological processes that cause the disease to progress.

Mechanism of Action

Tepezza is a monoclonal antibody designed to target and block the insulin-like growth factor-1 receptor (IGF-1R). This receptor is found on the surface of various cells throughout the body, including the cells behind the eyes.

How it Affects Thyroid Eye Disease

In people with thyroid eye disease (TED), the immune system mistakenly attacks the muscles and fatty tissues located behind the eyes. This process involves cells called fibroblasts, which have an unusually high number of IGF-1R proteins. When these receptors are activated, they cause the fibroblasts to produce inflammation and lead to the buildup of extra tissue and fat.

Tepezza works by attaching itself to the IGF-1R. By doing so, it acts like a shield that prevents other proteins from activating the receptor. This blocking action helps to:

• Reduce inflammation: It calms the immune response in the eye socket.
• Decrease tissue growth: It stops the overproduction of fat and muscle tissue behind the eye.
• Relieve pressure: By reducing the volume of tissue, it helps the eyes move back into a more natural position and eases pressure on the optic nerve.

By addressing the underlying biological pathway of the disease, Tepezza helps improve symptoms such as eye bulging (proptosis), double vision, and eye pain.

Common Side Effects

Many people using Tepezza experience mild to moderate side effects. These may include:

• Muscle spasms or cramps
• Nausea
• Hair loss
• Diarrhea
• Feeling tired or fatigued
• Dry skin
• Headache
• Changes in taste
• Changes in menstrual periods

Serious Side Effects

Some side effects can be serious and require immediate medical attention. Contact your healthcare provider right away if you notice:

• Hearing changes: This includes ringing in the ears (tinnitus), a feeling of fullness in the ears, or muffled hearing. Some hearing loss may be permanent.
• High blood sugar: Symptoms may include excessive thirst, frequent urination, or blurred vision. This is especially important for patients with diabetes or pre-diabetes.
• Infusion reactions: These can occur during or shortly after the injection and may include high blood pressure, fast heart rate, feeling hot, or difficulty breathing.
• Inflammatory bowel disease (IBD) flare-ups: If you have IBD, Tepezza may worsen your condition. Watch for increased diarrhea, stomach pain, or blood in your stool.

Infusion Reactions

Infusion-related reactions can occur during or within 24 hours after receiving Tepezza. Symptoms may include increased blood pressure, rapid heart rate, shortness of breath, headache, or muscle pain. Healthcare providers typically monitor patients during and after the infusion.

Worsening of Inflammatory Bowel Disease

Tepezza may worsen symptoms in people who already have inflammatory bowel disease (IBD), such as Crohn’s disease or ulcerative colitis. It is important to monitor for new or worsening diarrhea, rectal bleeding, or abdominal pain while receiving this medication.

High Blood Sugar (Hyperglycemia)

This medication can cause high blood sugar levels or worsen existing diabetes. Blood glucose levels are usually monitored before and during treatment. Patients with diabetes may need adjustments to their glucose-lowering medications.

Hearing Impairment

Tepezza has been linked to hearing problems, including hearing loss, ringing in the ears (tinnitus), or a feeling of fullness in the ears. In some instances, these changes may be permanent. Hearing should be assessed before, during, and after treatment.

Pregnancy and Fertility

Based on its mechanism of action, Tepezza may cause harm to an unborn baby. Females who can become pregnant should use effective contraception during treatment and for at least six months after the final dose.

Pregnancy

Tepezza can cause harm to a developing fetus. Healthcare providers typically recommend a pregnancy test before starting treatment to ensure the patient is not pregnant. If you are pregnant or planning to become pregnant, discuss the potential risks and benefits with your doctor.

Individuals who can become pregnant should use effective birth control during treatment and for at least 6 months after the final dose of Tepezza. If you become pregnant while receiving this medication, notify your healthcare provider immediately.

Breastfeeding

It is currently unknown whether Tepezza passes into human breast milk or if it could affect a breastfeeding child. Because the risks are not fully understood, it is important to talk with a healthcare professional about the best way to feed your baby while receiving this treatment.

Dosage Forms

Tepezza is available as a sterile, preservative-free powder. It is provided in a vial and requires reconstitution and dilution before it can be used.

Administration

This medication is given as an intravenous infusion. It is administered by a healthcare provider in a medical setting, such as a doctor's office or infusion center.

FDA Approval and Indications

The U.S. Food and Drug Administration (FDA) approved Tepezza in January 2020. It was the first medication approved specifically for the treatment of Thyroid Eye Disease, a condition where the immune system attacks the muscles and fat behind the eyes, causing inflammation and bulging.

The medication is indicated for adults with Thyroid Eye Disease regardless of the disease activity or duration.

Regulatory History and Safety Updates

Tepezza was granted several special designations by the FDA during its development, including Orphan Drug, Fast Track, and Breakthrough Therapy designations, to expedite the availability of a treatment for this rare condition.

In 2023, the FDA approved a labeling update for Tepezza to include information regarding the risk of severe hearing loss. While hearing problems were known at the time of initial approval, the updated labeling reflects reports that these issues, including deafness, may be permanent in some patients.

There are currently no boxed warnings or Risk Evaluation and Mitigation Strategies (REMS) required for this medication.

Factors Influencing Cost

Because Tepezza is a specialized biologic medication administered via intravenous (IV) infusion, its total cost is influenced by several variables:

• Dosage: The amount of medication required for each session is calculated based on the patient's body weight.
• Number of Treatments: A standard course of treatment typically involves eight infusions given every three weeks.
• Administration Fees: Costs associated with the infusion center, nursing staff, and medical supplies are usually billed separately from the drug itself.

Insurance Coverage

Most insurance providers, including Medicare, may cover Tepezza for the treatment of thyroid eye disease. However, many plans require prior authorization, a process where a doctor must demonstrate that the medication is medically necessary before the insurer agrees to cover the cost. Out-of-pocket expenses like deductibles and co-insurance will vary depending on the specific insurance plan.

Financial Assistance Programs

Financial support may be available to help manage the costs of Tepezza. The manufacturer often provides patient support services that include:

• Co-pay Assistance: Programs designed to help patients with commercial insurance reduce their out-of-pocket costs.
• Patient Assistance Programs: Support for individuals who are uninsured or underinsured and meet specific financial eligibility requirements.

Patients are encouraged to work with their healthcare provider and insurance company to understand their financial responsibility before starting treatment.