Pronunciation:

tep-roe-TOOM-ue-mab - trbw

Brand Names:

• Tepezza

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Teprotumumab

Uses of This Medicine:

Teprotumumab-trbw injection is used to treat thyroid eye disease regardless of the disease activity or duration.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of teprotumumab-trbw injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of teprotumumab-trbw injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetes or
• Hyperglycemia (high blood sugar) or
• Inflammatory bowel disease—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

Precautions While Using This Medicine:

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control during treatment and for 6 months after your final dose to keep from getting pregnant. If you think you have become pregnant, tell your doctor right away.

This medicine may cause a rare but serious type of an allergic reaction called an infusion reaction, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a headache, dizziness, fast heartbeat, muscle pain, trouble breathing, chest tightness, swelling in your face or hands, fever, chills, itching or hives while you are receiving this medicine.

This medicine may cause inflammatory bowel disease. Call your doctor right away if you have diarrhea that may contain blood, severe stomach pain, or bleeding from the rectum.

This medicine may cause hyperglycemia (high blood sugar). Check with your doctor right away if you have blurred vision, dry mouth, fatigue, flushed, dry skin, fruit-like breath odor, increased hunger, increased thirst, increased urination, nausea, sweating, trouble breathing, unexplained weight loss, or vomiting.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Blurred vision

dry mouth

flushed, dry skin

fruit-like breath odor

increased hunger

increased thirst

increased urination

nausea

stomach pain

sweating

trouble breathing

unexplained weight loss

unusual tiredness or weakness

vomiting

Less common

Fast, pounding, or irregular heartbeat or pulse

feeling hot

headache

muscle pain

Incidence not known

Bleeding from the rectum

diarrhea that may contain blood

severe stomach pain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Change or loss of hearing

change or loss of taste

dry skin

hair loss or thinning of the hair

mild diarrhea

muscle spasms

unusual tiredness or weakness

Incidence not known

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.