Mirena® (levonorgestrel-releasing intrauterine system) 52 mg
IMPORTANT SAFETY INFORMATION ABOUT MIRENA

Who is not appropriate for Mirena

Use of Mirena is contraindicated in women with: known or suspected pregnancy and cannot be used for post-coital contraception; congenital or acquired uterine anomaly, including fibroids if they distort... Continue below

Bleeding Data

Counsel your patients that they may experience shorter, lighter periods with Mirena®

  • Spotting and irregular or heavy bleeding may occur during the first 3 to 6 months. Periods may become shorter and/or lighter thereafter. Cycles may remain irregular, become infrequent, or even cease. Consider pregnancy if menstruation does not occur within 6 weeks of the onset of previous menstruation

  • Because irregular bleeding/spotting is common during the first months of Mirena use, exclude endometrial pathology (polyps or cancer) prior to the insertion of Mirena in women with persistent or uncharacteristic bleeding. If a significant change in bleeding develops during prolonged use, take appropriate diagnostic measures to rule out endometrial pathology

  • The possibility of pregnancy should be considered if menstruation does not occur within six weeks of the onset of previous menstruation. Once pregnancy has been excluded, repeated pregnancy tests are generally not necessary in amenorrheic women unless indicated by other signs of pregnancy or by pelvic pain

  • In most women with heavy menstrual bleeding, the number of bleeding and spotting days may also increase during the initial months of therapy but usually decrease with continued use; the volume of blood loss per cycle progressively becomes reduced

  • A separate study with 362 women who have used Mirena for more than 5 years showed a consistent adverse reaction profile in Year 6. By the end of Year 6 of use, amenorrhea and infrequent bleeding are experienced by 24% and 31% of users, respectively; irregular bleeding occurs in 15%, and prolonged bleeding in 2% of users.

The total number of bleeding and bleeding/spotting days in patients with HMB*1
Clinical trial comparing the safety and efficacy of Mirena to oral hormone therapy with medroxyprogesterone acetate
  • The number of bleeding and spotting days may also increase during the initial months of therapy but usually decreases with continued use