VYLEESI Solution for injection Ref.[9967] Active ingredients:

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

VYLEESI (bremelanotide injection) contains bremelanotide, a melanocortin receptor agonist for subcutaneous administration via an autoinjector. Bremelanotide acetate is a synthetic, cyclic heptapeptide with a free acid at the carboxyl terminus and an acetylated amino group at the amino terminus of the peptide with the following structure:

Ac-Nle-cyclo-(Asp-His-D-Phe-Arg-Trp-Lys-OH) ● xCH3COOH

The molecular formula of bremelanotide acetate is C50H68N14O10 ● xCH3COOH (1≤ x ≤2) and the molecular weight is 1025.2 (free base).

VYLEESI (bremelanotide injection) is supplied as a sterile, clear solution in a pre-filled syringe contained in a single-dose autoinjector for subcutaneous administration. Each pre-filled syringe contains 1.75 mg of bremelanotide (equivalent to 1.89 mg bremelanotide acetate) in 0.3 mL solution. Inactive ingredients consist of 2.5% glycerin, sterile water for injection, and hydrochloric acid or sodium hydroxide added to adjust the pH.

Dosage Forms and Strengths

Subcutaneous injection: 1.75 mg/0.3 mL clear solution in a single-dose autoinjector.

How Supplied

VYLEESI (bremelanotide) is supplied as: 1.75 mg bremelanotide in 0.3 mL solution in a single-dose, disposable prefilled autoinjector (NDC 80064-141-01) provided in a carton of 4 autoinjectors (NDC 80064-141-04), carton of 2 autoinjectors (NDC 80064-141-02).

Drugs

Drug Countries
VYLEESI United States

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