Levonorgestrel intrauterine device (Kyleena)


FDA Approved Indication:
  • Indicated for prevention of pregnancy for up to 5 years
Prior authorization criteria:
  • Female patients for use for the prevention of pregnancy for up to 5 years, AND
  • Patient has none of the following: has not had acute pelvic inflammatory disease (PID) or a history of PID unless there has been a subsequent intrauterine pregnancy; postpartum endometritis or infected abortion in the past 3 months; known or suspected uterine or cervical neoplasia; known or suspected breast cancer or other progestin-sensitive cancer; uterine bleeding of unknown etiology; untreated acute cervicitis or vaginitis or other lower genital tract infections; acute liver disease or liver tumor; increased susceptibility to pelvic infection; a previous intrauterine device (IUD) that has not been removed
  • Kyleena's release rate of levonorgestrel is 17.5 mcg/day after 24 days and declines to 7.4 mcg/day after 5 years
  • Kyleena must be removed or replaced after 5 years
  • Kyleena is inserted by a trained healthcare provider using strict aseptic technique
  • Patient should be re-examined and evaluated 4 to 6 weeks after insertion, then yearly or more often if clinically indicated
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