Source: FDA, National Drug Code (US) Revision Year: 2023
EGRIFTA SV contains tesamorelin (as the acetate salt), a human growth hormone-releasing factor (GRF) analog. The peptide precursor of tesamorelin acetate is produced synthetically and is comprised of the 44 amino acid sequence of human GRF. Tesamorelin acetate is made by attaching a hexenoyl moiety, a C6 chain with a double bond at position 3, to the tyrosine residue at the N-terminal part of the molecule. The molecular formula of tesamorelin acetate is C221H366N72O67S • x C2H4O2 (x ≈ 7) and its molecular weight (free base) is 5135.9 Daltons.
The structural formula of tesamorelin acetate is:
EGRIFTA SV is a sterile, white to off-white, preservative-free lyophilized powder for subcutaneous injection. After reconstitution with the supplied diluent (Sterile Water for Injection, USP), the solution is clear and colorless. Each single-dose vial of EGRIFTA SV contains 2 mg of tesamorelin acetate and the following inactive ingredients: 20 mg mannitol, USP, 10 mg sucrose, NF, 0.78 mg histidine, USP and 0.05 mg polysorbate 20, NF.
| Dosage Forms and Strengths |
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EGRIFTA SV for injection is supplied in a single-dose 2 mg vial as a white to off-white lyophilized powder and a diluent of 10 mL of Sterile Water for Injection, USP. |
| How Supplied |
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EGRIFTA SV for injection is supplied as a white to off-white lyophilized powder in a 2 mg single-dose vial with a diluent of 10 mL vial of Sterile Water for Injection, USP. EGRIFTA SV (NDC 62064-241-30) is available in a package comprised of two boxes, containing 30 (thirty) 2 mg single-dose vials of EGRIFTA SV in the Medication Box and 30 single-dose 10 mL bottles of Sterile Water for Injection, USP diluent with a 30-day supply of disposable syringes and needles in the Injection Box. Distributed by: Theratechnologies Inc., Montréal, Québec, Canada H3A 1T8 |
| Drug | Countries | |
|---|---|---|
| EGRIFTA | Canada, United States |
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