DESCRIPTION
ELIGARD® 7.5 mg is a sterile polymeric matrix formulation of leuprolide acetate for subcutaneous injection. It is designed to deliver 7.5 mg of leuprolide acetate at a controlled rate over a one month therapeutic period.
Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH or LH-RH) that, when given continuously, inhibits pituitary gonadotropin secretion and suppresses testicular and ovarian steroidogenesis. The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:
ELIGARD® 7.5 mg is prefilled and supplied in two separate, sterile syringes whose contents are mixed immediately prior to administration. The two syringes are joined and the single dose product is mixed until it is homogenous. ELIGARD® 7.5 mg is administered subcutaneously where it forms a solid drug delivery depot.
One syringe contains the ATRIGEL® Delivery System and the other contains leuprolide acetate. The ATRIGEL® Delivery System is a polymeric (non-gelatin containing) delivery system consisting of a biodegradable poly(DL-lactide-co-glycolide) (PLGH) polymer formulation dissolved in a biocompatible solvent, N -methyl-2-pyrrolidone (NMP). PLGH is a co-polymer with a 50:50 molar ratio of DL-lactide to glycolide containing carboxyl end groups. The second syringe contains leuprolide acetate and the constituted product is designed to deliver 7.5 mg of leuprolide acetate at the time of subcutaneous injection.
ELIGARD® 7.5 mg delivers 7.5 mg of leuprolide acetate (equivalent to approximately 7.0 mg leuprolide free base) dissolved in 160 mg N -methyl-2-pyrrolidone and 82.5 mg poly(DL-lactide-co-glycolide). The approximate weight of the administered formulation is 250 mg.
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