Teprotumumab is used to treat thyroid eye disease (sometimes called Graves Eye Disease).

Thyroid eye disease is an autoimmune disorder in which the immune system attacks tissues around the eyes. Symptoms include dry or watery eyes, eye redness, bulging eyes, vision problems, and difficulty closing the eyes.

Teprotumumab may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Teprotumumab is given as an infusion into a vein. A healthcare provider will give you this injection.

Teprotumumab is usually given once every 3 weeks for a total of 8 doses.

This medicine must be given slowly, and the infusion can take 60 to 90 minutes to complete.

Usual Adult Dose for Graves' Ophthalmopathy:

Initial dose: 10 mg/kg intravenously
Maintenance dose: 20 mg/kg intravenously every 3 weeks for 7 additional infusions

Use: Treatment of thyroid eye disease

Tell your doctor if you have ever had:

• inflammatory bowel disease;

• diabetes or hyperglycemia (high blood sugar);

Teprotumumab may harm an unborn baby. Use effective birth control to prevent pregnancy while you are receiving teprotumumab and for at least 6 months after your last dose. Tell your doctor if you become pregnant.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Call your doctor for instructions if you miss an appointment for your teprotumumab injection.

Since teprotumumab 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.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some 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.

Teprotumumab may cause serious side effects. 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.

Common side effects of teprotumumab may include:

• muscle spasms;

• nausea, diarrhea;

• headache, tiredness;

• high blood sugar;

• hair loss;

• hearing problems;

• dry skin; or

• altered sense of taste.

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 FDA at 1-800-FDA-1088.

Other drugs may affect teprotumumab, 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.