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

Efficacy

Mirena® provides pregnancy protection for up to 6 years

 
  • No daily, weekly, or monthly dosing routines

  • Remind her that she should check that Mirena is in place once a month by feeling for the threads

  • Evaluate patients 4 to 6 weeks after insertion and once a year thereafter, or more frequently if clinically indicated

Mirena is also approved to treat HMB for up to 5 years in patients who choose an IUD for contraception


In patients with heavy menstrual bleeding, Mirena rapidly and significantly decreased bleeding volume*

 

  • 80% decrease in median menstrual blood loss vs baseline at 3 months

  • >95% decrease at 6 months

  • 85% of women using Mirena experienced treatment success

Defined as end-of-study menstrual blood loss <80 mL and ≥50% decrease in menstrual blood loss from baseline to end of study

*The safety and efficacy of Mirena in the treatment of heavy menstrual bleeding (≥80 mL menstrual blood loss) were studied in a randomized, open-label, parallel-group, active-control trial comparing Mirena (n=79) to oral hormonal therapy with medroxyprogesterone acetate (MPA) (n=81), over 6 cycles. Women with organic or systemic conditions that can cause heavy uterine bleeding (except for small fibroids—total volume ≤5 mL) were excluded from the study.


Expect changes in bleeding patterns with Mirena

 

  • Tell patients that 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

  • Amenorrhea develops in approximately 20% of Mirena users by one year. 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, for example, 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.

Continuation of Contraception after Removal

  • If Mirena is removed and the patient does not want to become pregnant, she should use another method of birth control

  • Patients who do not want to become pregnant should be provided a new Mirena or another type of contraception

  • If a patient with regular cycles wants to start a different birth control method, remove Mirena during the first 7 days of the menstrual cycle and start the new method immediately thereafter or start the new method at least 7 days prior to removing Mirena if removal is to occur at other times during the cycle