Transcription of HIGHLIGHTS OF PRESCRIBING INFORMATION • These …
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HIGHLIGHTS OF PRESCRIBING INFORMATION • These …
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.
vulvovaginitis, ovarian cysts, abdominal pain/pelvic pain, headache/migraine, acne/seborrhea, dysmenorrhea/uterine spasm, breast pain/breast discomfort, and increased bleeding. (6) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-800-
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