SPL Set ID: 487f8a62-e142-457c-97cc-2e398fde7594

NEXPLANON is a radiopaque, progestin-only, soft, flexible implant preloaded in a sterile, disposable applicator for subdermal use. The implant is white/off-white, non-biodegradable and 4 cm in length with a diameter of 2 mm (see Figure 19 ). Each implant consists of an ethylene vinyl acetate (EVA) copolymer (28% vinyl acetate, 43 mg) core, containing 68 mg of the synthetic progestin etonogestrel, barium sulfate ((15 mg), radiopaque ingredient), and magnesium stearate (0.1 mg), surrounded by an EVA copolymer skin. Once inserted subdermally, the release rate is 60-75 mcg/day in week 5-6 and decreases to approximately 40-50 mcg/day at the end of the first year, and then to approximately 15-20 mcg/day at the end of the fifth year. NEXPLANON is a progestin-only contraceptive and does not contain estrogen. NEXPLANON is not made with natural rubber latex. Figure 19 (Not to scale) Etonogestrel [13-Ethyl-17-hydroxy-11-methylene-18,19-dinor-17α-pregn-4-en-20-yn-3-one], structurally derived from 19-nortestosterone, is the synthetic biologically active metabolite of the synthetic progestin desogestrel. It has a molecular weight of 324.46 and the following structural formula ( Figure 20 ). Figure 20 Figure 19 Figure 20