ZOLADEX

11 DESCRIPTION ZOLADEX (goserelin implant) is a GnRH agonist.‍‍‍‍‍‍​​​‍​​​​​​ Goserelin acetate is chemically described as an acetate salt of [D-Ser(Bu t ) 6 ,Azgly 10 ]. Its chemical structure is pyro-Glu-His-Trp-Ser-Tyr-D-Ser(Bu t )-Leu-Arg-Pro-Azgly-NH 2 acetate [C 59 H 84 N 18 O 14· (C 2 H 4 O 2 ) x where x = 1 to 2.4]. Goserelin acetate is an off-white powder with a molecular weight of 1269 Daltons (free base). It is freely soluble in glacial acetic acid. It is soluble in water, 0.1M hydrochloric acid, 0.1M sodium hydroxide, dimethylformamide and dimethyl sulfoxide. Goserelin acetate is practically insoluble in acetone, chloroform and ether. ZOLADEX is supplied as a sterile, biodegradable product containing 3.8 mg goserelin acetate, equivalent to 3.6 mg of goserelin. ZOLADEX is designed for subcutaneous injection with continuous release over a 28-day period. Goserelin acetate, containing up to 12% goserelin-related substances, is dispersed in a matrix of D,L-lactic and glycolic acids copolymer (to a total implant weight of 18.0 mg, containing less than 2.5% total acetic acid) and presented as a sterile, white to cream colored 1-mm diameter cylinder, preloaded in a special single use syringe with a 16-gauge x 36 +/- 0.5 mm siliconized needle with protective needle sleeve (SafeSystem ® Syringe) in a sealed, light- and moisture-proof, aluminum foil laminate pouch containing a desiccant capsule. Studies of the D,L-lactic and glycolic acids copolymer have indicated that it is completely biodegradable and has no demonstrable antigenic potential.