What to Know About Tepezza (Teprotumumab)

For people with thyroid eye disease, a new FDA-approved injectable drug known as Tepezza (teprotumumab) has become the first nonsurgical treatment for this condition. This medication can interrupt activity that could otherwise lead to the bulging of eyes associated with Graves' disease.

Tepezza, which functions as an insulin-like growth factor receptor inhibitor, has the distinction of being the first in this class of drugs. This medication is delivered through an IV at an outpatient infusion center.

The way it helps is by targeting the inflammation and swelling underlying thyroid eye disease, which can cause the eye to bulge. Tepezza can be particularly effective for those at the beginning stages of the disease, but can also still help somewhat during the later stages.

Uses

This drug has been FDA-approved for the treatment of thyroid eye disease. It works to possibly resolve related symptoms such as:

• Eye bulging
• Double vision
• Dryness
• Redness
• Pain

People with thyroid eye disease often seek to alleviate such symptoms and enhance their cosmetic appearance in keeping with what it was before symptoms.

Before Tepezza, surgery was needed to try to make this happen. However, even when done repeatedly, surgery did not necessarily restore appearance or fully improve visual function. In studies, improvement in eye-bulging has been seen in as little as six weeks in some cases.

Before Taking

While there are no contraindications for taking Tepezza, this medication has been found to make some other conditions potentially worse. Those with preexisting inflammatory bowel disease (IBD) should understand that they will likely have to be monitored for any potential flare-ups of that condition.

Likewise, those with diabetes or glucose resistance may find they experience hyperglycemia while taking the medication. While this can occur in about two-thirds of patients predisposed to it, the good news is that medication can be used to control hyperglycemia if necessary.

You should alert your healthcare provider if you are pregnant or trying to become pregnant, or currently breastfeeding. Make any prior allergies to Tepezza or any other medicines, dyes, preservatives, or even foods known to the prescriber.

Also, be sure to talk to your healthcare provider about any other medications, vitamins, or other supplements you may currently be taking. While some drugs pose minor interaction risks, others may outright contraindicate use or prompt careful consideration of whether the pros of treatment outweigh the cons in your case.

Dosage

Tepezza will be administered at a health facility by an experienced professional. Keep in mind that this does take a little time, especially in the beginning. The initial two infusions of this medication will each be done over a 90-minute period. After that, the infusion takes just 60 minutes.

Tepezza is given every three weeks, with a total of eight infusions. If you are delayed in taking a dose, discuss this with your healthcare provider.

How to Take and Store

This medication, which is stored under refrigerated conditions, will be given to you at a clinic by a professional by infusion into a vein.

Be aware that some people may experience a reaction to the infusion. This happens in about 4% of cases and may occur during the infusion itself or take place up to 1.5 hours afterward. Signs of such a reaction include:

• A rise in blood pressure
• Difficulty breathing
• Headache
• Feeling hot
• Muscle pain

If you experience these symptoms, tell your healthcare provider. In most cases, corticosteroids and antihistamines can be used to manage such reactions successfully. You may even be asked to use such medications before subsequent infusions.

Anyone who has a reaction should keep in mind that this does not necessarily mean you cannot take the medication. Adjustments can be made to make this easier for you to tolerate. For example, the infusions can be given a little more slowly if this is necessary.

Those who have diabetes should discuss with their healthcare provider possibly adjusting any medication being used to control their sugar levels since this can put patients at risk of hyperglycemia. About 10% of patients in the clinical trials experienced hyperglycemia while on Tepezza.

Tepezza can harm a fetus, and people who are pregnant or planning to become pregnant should not take this medication. If you can become pregnant, it's important to use contraception before beginning Tepezza and remain on it for up to six months after receiving the last dose.

Side Effects

While Tepezza can help alleviate some of the problematic symptoms of thyroid eye disease, it may cause some side effects, which you should be aware can occur. For those taking Tepezza, some common side effects can include:

• Diarrhea
• Dry skin
• Fatigue
• Hair loss
• Hearing problems
• Muscle cramping or spasms
• Nausea
• Taste changes

Alert your healthcare provider if you are experiencing any of these common symptoms.

Anyone with inflammatory bowel disease should immediately alert their healthcare provider if they experience signs such as diarrhea, stomach pain, incontinence, or losing bowel control. If this causes a flare-up of the bowel disease, it may be necessary to discontinue the medication.

Be aware that if you are having difficulty breathing or are experiencing swelling of your tongue, face, or throat area, this is an allergic reaction. You should immediately contact emergency services.

Warnings and Interactions

Currently, Tepezza has not been evaluated to determine if there are any drug interactions. There is also no information on whether this may affect a nursing child or impact a mother's milk production. Anyone who is pregnant should not take this medication since it may cause harm to the fetus.

While the safety and efficacy of Tepezza have not yet been established for children, this medication has been found useful for older people. This older group has fared as well as younger patients with Tepezza in studies and can successfully take this medication.

In those with mild-to-moderate kidney impairment, Tepezza has been found to function the same as in other populations. However, the effect of liver impairment is currently unknown.