SPL Set ID: 2c311700-edf4-4f2a-a468-9875489a6cc7

FENSOLVI for injectable suspension is a sterile polymeric matrix formulation of leuprolide acetate, a GnRH agonist, for subcutaneous use. It is designed to deliver leuprolide acetate at a controlled rate over a six-month therapeutic period. Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone. 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: FENSOLVI is supplied as a pre-connected syringe system. Immediately prior to administration, the content of the pre-connected syringe system are mixed until homogenous. FENSOLVI is administered subcutaneously, where it forms a solid drug delivery depot. Syringe A contains the in situ polymeric extended release technology consisting of a biodegradable poly (DL-lactide-co-glycolide) (PLG) polymer formulation dissolved in a biocompatible solvent, N -methyl-2pyrrolidone (NMP) and syringe B contains the leuprolide acetate. Refer to Table 2 for the delivery system composition and reconstituted product formulation for FENSOLVI product. Table 2: FENSOLVI Delivery System Composition and Reconstituted Product Formulation In situ polymeric extended release technology Polymer PLG Polymer description Copolymer with hexanediol Polymer DL-lactide to glycolide molar ratio 85:15 Reconstituted Product Polymer delivered 165 mg NMP delivered 165 mg Leuprolide acetate delivered 45 mg Approximate leuprolide free base equivalent 42 mg Approximate administered formulation weight 375 mg Approximate injection volume 0.375 mL structure