Generic name: TESAMORELIN ACETATE
1mg in 1mL;
Dosage form: injection
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General Dosing Information
The recommended dose of EGRIFTA® is 2 mg injected subcutaneously once a day.
The recommended injection site is the abdomen. Injection sites should be rotated to different areas of the abdomen. Do not inject into scar tissue, bruises or the navel.
2.2 Reconstitution Procedure
Detailed instructions for reconstituting EGRIFTA® are provided in the INSTRUCTIONS FOR USE leaflet enclosed in the boxes containing EGRIFTA® and diluent.
Two vials of 1 mg of EGRIFTA® must be reconstituted with the diluent provided with the product.
Reconstitute the first 1 mg vial of EGRIFTA® with 2.2 mL of diluent. Mix by rolling the vial gently in your hands for 30 seconds. Do not shake. Reconstitute the second 1 mg vial of EGRIFTA® with the entire solution from the first vial. Mix by rolling the vial gently in your hands for 30 seconds. Do not shake.
Administer EGRIFTA® immediately following reconstitution and throw away any unused EGRIFTA® solution. If not used immediately, the reconstituted EGRIFTA® solution should be discarded. Do not freeze or refrigerate the reconstituted EGRIFTA® solution.
Reconstituted EGRIFTA® solution should always be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. EGRIFTA® must be injected only if the solution is clear, colorless and without particulate matter.
EGRIFTA® should be injected subcutaneously into the skin on the abdomen. Injection sites should be rotated to different areas of the abdomen. Do not inject into scar tissue, bruises or the navel.