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Indications of Tepezza
Tepezza is indicated for the treatment of thyroid eye disease.
Tepezza Dosage and Administration
Recommended Dosage
The recommended dose of Tepezza is an initial dose of 10 mg/kg as an intravenous infusion, followed by 20 mg/kg as an intravenous infusion every three weeks for a further 7 infusions.
Teprotumumab-trbw is an inhibitor of the insulin-like growth factor-1 receptor (IGF-1R) developed in Chinese hamster ovary (CHO-DG44) Fully human IgG1 monoclonal antibody produced in cells. Its molecular weight is 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 teprotumumab-trbw, L-histidine (7.45 mg), L-histidine hydrochloride monohydrate (31.8 mg), polysorbate 20(1 mg) and trehalose dihydrate (946 mg). Reconstitute with 10 mL of Sterile Water for Injection (USP) to give a final concentration of 47.6 mg/mL and a pH of 5.5.
What are the possible side effects of TEPEZZA?
The most common side effects of TEPEZZA include muscle spasms or spasms, nausea, hair loss, diarrhea, feeling tired, high blood sugar, hearing problems, changes in taste, headache, and dry skin.
TED is a severe, progressive, sight-threatening, rare autoimmune disease associated with proptosis (bulging eyeballs), double vision, blurred vision, pain, inflammation, and facial disfigurement. Tepezza is a fully human monoclonal antibody and insulin-like growth factor-1 receptor (IGF-1R) targeting agent that is injected every three weeks for a total of 8 injections.
It is worth mentioning that Tepezza is the first and only drug approved by the FDA to treat TED. Previously, the FDA has granted teprotumumab priority review, breakthrough drug designation, orphan drug designation, and fast track designation for the treatment of active TED. In December 2019, teprotumumab received unanimous (12-0) approval from the FDA’s Dermatology and Ophthalmology Drugs Advisory Committee (DODAC).