Eligard 7.5 mg, 22.5 mg, 30 mg, 45 mg (leuprolide acetate for injectable suspension) product information
HERO ID
3974837
Reference Type
Technical Report
Year
2017
Language
English
| HERO ID | 3974837 |
|---|---|
| Year | 2017 |
| Title | Eligard 7.5 mg, 22.5 mg, 30 mg, 45 mg (leuprolide acetate for injectable suspension) product information |
| Authoring Organization | Sanofi-Aventis U.S. LLC |
| Publisher Text | Sanofi-Aventis U.S. LLC |
| City | Bridgewater, NJ |
| Abstract | ELIGARD® is a sterile polymeric matrix formulation of leuprolide acetate for subcutaneous injection. It is designed to deliver leuprolide acetate at a controlled rate over a one-, three-, four or six-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-Lhistidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula: ELIGARD® 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® is administered subcutaneously, where it forms a solid drug delivery depot. One syringe contains the ATRIGEL® Delivery System and the other contains leuprolide acetate. ATRIGEL® is a polymeric (non-gelatin containing) delivery system consisting of a biodegradable poly (DL-lactide-co-glycolide) (PLGH or PLG) polymer formulation dissolved in a biocompatible solvent, N-methyl-2-pyrrolidone (NMP). |
| Report Number | 2301-NMP-24 |
| Is Certified Translation | No |
| Dupe Override | No |
| Number Of Pages | 26 |
| Comments | ICF NOTE: 2301-NMP-24.pdf |
| Is Public | No |
| Language Text | English |