teprotumumab-trbw 500 mg intravenous solution

Generic name:
Teprotumumab - injection

Pronunciation
(TEP-roe-TOOM-ue-mab)

Brand name(s)
Tepezza

This medication is used to treat thyroid eye disease, also known as Graves' eye disease. Teprotumumab belongs to a class of drugs known as monoclonal antibodies. It is not known exactly how it works, but it may help improve symptoms such as a feeling of irritation or grittiness in the eyes, redness or swelling of the white part of the eyeball (conjunctiva), excessive tearing or dry eyes, swelling of the eyelids, sensitivity to light, bulging of the eyes, or double vision.

This medication is given by injection into a vein by a healthcare professional as directed by your doctor, usually every 3 weeks for 8 doses. The injection is usually given over 60 to 90 minutes. The dosage is based on your medical condition, weight, and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

Tell your doctor if your condition does not get better or if it gets worse.

Muscle spasms, nausea, tiredness, weakness, change in how food tastes, or dry skin may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Injection reaction symptoms such as increased blood pressure, fast heartbeat, feeling hot, headache, and muscle pain may also occur. Tell your doctor right away if you have any of these symptoms. Your doctor may direct you to take other medications (such as acetaminophen, antihistamines) before each dose to decrease the risk of side effects.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• bowel problems (such as diarrhea, bloody stools, abdominal pain/cramps, or incontinence)
• hearing problems (such as ringing in the ears, hearing loss)
• menstrual period changes (such as missed/stopped periods, spotting)

This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar, such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using teprotumumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• bowel problems (such as inflammatory bowel disease-IBD)
• diabetes

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using teprotumumab. Teprotumumab may harm an unborn baby. Ask about reliable forms of birth control before and while using this medication and for 6 months after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as eye exams, hearing tests, blood sugar) may be done before you start using this medication and while you are using it. Keep all medical and lab appointments.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a hospital or clinic or doctor's office and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.