Counsel your patients that they may experience shorter, lighter periods after the first 3 to 6 months with Kyleena®

Mean Number of Bleeding and Spotting Days Over the Course of 5 Years

Safety data with Kyleena<sup>®</sup> (levonorgestel-releasing intrauterine system) 19.5mg

Cycles become more consistent over time

  • Minimal fluctuations in bleeding and spotting after first 6 months1

    • Bleeding: Mean number of days overall did not fluctuate more than 1.3 days per 28-day cycle

    • Spotting: Mean number of days overall did not fluctuate more than 1.4 days per 28-day cycle

Over 5 years, some patients experienced amenorrhea and infrequent bleeding

Bleeding-patterns (by 90 days reference periods)

  • Kyleena
  • Amenorrhea*
  • Infrequent bleeding
  • Frequent bleeding
  • Prolonged bleeding§
  • Irregular bleeding||
  • End of year 5 N=530
  • 23%
  • 26%
  • 2%
  • 1%
  • 9%
  • *Defined as subjects with no bleeding/spotting throughout the 90-day reference period.
  • Defined as subjects with 1 or 2 bleeding/spotting episodes in the 90-day reference period.
  • Defined as subjects with more than 5 bleeding/spotting episodes in the 90-day reference period.
  • §Defined as subjects with bleeding/spotting episodes lasting more than 14 days in the 90-day reference period. Subjects with prolonged bleeding may also be included in one of the other categories (excluding amenorrhea).
  • ||Defined as subjects with 3 to 5 bleeding/spotting episodes and less than 3 bleeding/spotting-free intervals of 14 or more days.

The release of LNG progressively decreases over time

  • Kyleena contains 19.5 mg of levonorgestrel (LNG) released in vivo at a rate of approximately 17.5 mcg/day after 24 days. This rate decreases progressively to 9.8 mcg/day after 1 year and to 7.4 mcg/day after 5 years

  • The average in vivo release rate of LNG is approximately 12.6 mcg/day over the first year and 9.0 mcg/day over a period of 5 years

Only Kyleena releases the lowest dose of hormones available in a 5-year IUD

LNG=levonorgestrel; IUD=intrauterine device