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What is tesamorelin? Tesamorelin is used to red...

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What is tesamorelin? Tesamorelin is used to reduce excess stomach-area (abdominal) fat in HIV-infected adult patients with lipodystrophy. It is injected subcutaneously (under the skin) once a day. Tesamorelin is made with growth hormone-releasing factor (GRF). Tesamorelin for injection is the only medication approved in the U.S. for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy. It is available in 2 formulations, Egrifta SV and Egrifta WR. Egrifta WR is a new formulation that was FDA approved on March 25, 2025. It is injected daily, but only needs weekly reconstitution. Egrifta WR requires less than half the administration volume of Egrifta SV (approved October 19, 2019), which is reconstituted daily. These 2 formulations are not substitutable because they have differences in the dosage, the number of vials required to prepare a dose, reconstitution instructions, and storage requirements. Tesamorelin is not a weight-loss medication and should not be used to treat obesity. Dosing information Usual Adult Dose for Lipodystrophy (Egrifta SV): 1.4 mg (0.35 mL of the reconstituted solution) injected subcutaneously once daily. Usual Adult Dose for Lipodystrophy (Egrifta WR) 1.28 mg (0.16 mL of the reconstituted solution) subcutaneously once daily. Ingredients Active ingredient: tesamorelin Inactive ingredients (Egrifta SV): histidine, mannitol, polysorbate 20, sucrose. Hydrochloric acid may be used to adjust the pH. The pH of Egrifta SV is between 4.5 and 7.4. After reconstitution with 0.5 mL of Sterile Water for Injection, the resultant concentration is 2 mg/0.5 mL, and the solution is clear and colorless. Only 1.4 mg (0.35 mL) needs to be given for each dose. Inactive ingredients (Egrifta WR): hydrochloric acid, hydroxypropyl betadex, mannitol, sodium hydroxide. After reconstitution with 1.3 mL of Bacteriostatic Water for Injection, USP, the resultant concentration is 8 mg/mL, and the solution is clear and colorless. Bacteriostatic Water for Injection, USP contains benzyl alcohol as a preservative. Only 1.28 mg (0.16 mL) needs to be given for each dose. Tesamorelin Biosimilars Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
 2025-06-09T13:21:07

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