Tepezza
Generic name: teprotumumab
Drug class: Growth hormone receptor blockers
What is Tepezza?
Tepezza is an insulin-like growth factor-1 receptor inhibitor (IGF-1R).
Tepezza 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.
Description
Teprotumumab-trbw, an insulin-like growth factor-1 receptor inhibitor (IGF-1R), is a fully human IgG1 monoclonal antibody produced in Chinese hamster ovary (CHO-DG44) cells. It has a molecular weight of approximately 148 kilodaltons.
TEPEZZA (teprotumumab-trbw) for injection is supplied as a sterile, preservative-free, white to off-white, lyophilized powder for intravenous infusion. Each single-dose vial contains 500 mg of teprotumumab-trbw, L-histidine (7.45 mg), L-histidine hydrochloride monohydrate (31.8 mg), polysorbate 20 (1 mg), and trehalose dihydrate (946 mg). After reconstitution with 10 mL of Sterile Water for Injection, USP, the final concentration is 47.6 mg/mL with a pH of 5.5.
Mechanism Of Action
Teprotumumab-trbw’s mechanism of action in patients with Thyroid Eye Disease has not been fully characterized. Teprotumumab-trbw binds to IGF-1R and blocks its activation and signaling.
Warnings
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.
Before taking this medicine
To make sure Tepezza is safe for you, tell your doctor if you have:
- inflammatory bowel disease;
- diabetes or hyperglycemia (high blood sugar);
Tepezza may harm an unborn baby. Use effective birth control to prevent pregnancy while you are receiving Tepezza 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.
How is Tepezza given?
Tepezza is given as an infusion into a vein. A healthcare provider will give you this injection.
Tepezza 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.
Dosing information
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
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your Tepezza.
What happens if I overdose?
Since Tepezza is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What should I avoid while receiving Tepezza?
Follow your doctor’s instructions about any restrictions on food, beverages, or activity.
Tepezza side effects
Get emergency medical help if you have signs of an allergic reaction to Tepezza: 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.
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 Tepezza side effects 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.
What other drugs will affect Tepezza?
Other drugs may affect Tepezza, 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.
Label
- NDC-75987-130-15
- TEPEZZA®
(teprotumumab-trbw)
for Injection - 500 mg/vial
- For Intravenous Infusion Only
Reconstitute and Further Dilute Prior to Use - Single-dose vial. Discard unused portion.
- Rx Only
SRC: NLM .