Transcription of HIGHLIGHTS OF PRESCRIBING INFORMATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION These HIGHLIGHTS do not include all the INFORMATION needed to use KYLEENA safely and effectively. See full PRESCRIBING INFORMATION for KYLEENA. KYLEENA (levonorgestrel-releasing intrauterine system) Initial Approval: 2000 ----------------------------RECENT MAJOR CHANGES-------------------------- Dosage and Administration, Timing of insertion ( ) 3/2018 --------------------------- INDICATIONS AND USAGE -------------------------- Kyleena is a progestin-containing intrauterine system (IUS) indicated for prevention of pregnancy for up to 5 years. (1) ---------------------- DOSAGE AND ADMINISTRATION ---------------------- Release rate of levonorgestrel (LNG) is mcg/day after 24 days and declines to mcg/day after 5 years; Kyleena must be removed or replaced after 5 years. (2) To be inserted by a trained healthcare provider using strict aseptic technique.
FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE Kyleena is indicated to prevent pregnancy for up to 5 years. Replace the system after 5 years if continued use is desired. 2 DOSAGE AND ADMINISTRATION Kyleena contains 19.5 mg of levonorgestrel (LNG) released in vivo at a rate of approximately 17.5 mcg/day after 24 days.
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