Source: FDA, National Drug Code (US) Revision Year: 2020
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.
| Dosage Forms and Strengths |
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For injection (intravenous infusion): 500 mg of teprotumumab as a white to off-white lyophilized powder in a single-dose vial for reconstitution and dilution. |
| How Supplied | ||
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TEPEZZA (teprotumumab-trbw) for injection is a sterile, preservative-free, white to off-white lyophilized powder available as follows:
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| Drug | Countries | |
|---|---|---|
| TEPEZZA | United States |
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