IMPORTANT SAFETY INFORMATION

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

Bayer Logo Bayer Logo Bayer Logo

Frequently Asked Questions (FAQs) About Mirena®

If you have a question that is not covered here, please contact us directly. If your patients have questions, direct them to the Mirena Patient FAQs page.

 

Go to questions regarding:

Mirena indication and usage

    • Mirena is indicated to prevent pregnancy for up to 7 years. The system should be replaced after Year 7 if continued use is desired. Mirena is indicated for the treatment of heavy menstrual bleeding for up to 5 years in women who choose to use intrauterine contraception. Mirena should be replaced after Year 5 if continued treatment of heavy menstrual bleeding is needed1
    • Remember to check the expiration date of Mirena prior to initiating insertion. The expiration date is etched on the carton and printed on the label. Insert Mirena before the end of the month shown
    • Yes. Mirena has been studied in both parous and nulliparous women. Use of Mirena before menarche is not indicated1
    • Patients in the clinical trials had a weight range between 38.5–163.5 kg with a mean BMI of 27.9 kg/m² 1
    • The Mirena steroid reservoir contains a total of 52 mg LNG, and is intended to provide an initial release rate of approximately 20 mcg/day of LNG. This rate decreases progressively to approximately 10 mcg/day after 5 years and 8 mcg/day after 7 years1

     

    LNG=levonorgestrel.

    • Depending on the patient’s prior method of contraception and when during the menstrual cycle Mirena is being inserted, backup contraception may be appropriate1
    • If Mirena is inserted during the first 7 days of the menstrual cycle or immediately after a first trimester abortion, backup contraception is not needed. If Mirena is not inserted during the first 7 days of the menstrual cycle, a barrier method of contraception should be used or the patient should abstain from vaginal intercourse for 7 days to prevent pregnancy1

     

    Please see the full Prescribing Information for when backup contraception may be recommended.


    Click here for more information on insertion and removal instructions.

    • Mirena is indicated for the treatment of HMB for up to 5 years in women who choose to use intrauterine contraception as their method of contraception; replace after the end of the fifth year if continued treatment of HMB is needed1

     

    Click here for more information about the impact of Mirena on HMB.

    Size of Mirena and insertion

      • The Mirena IUD measures 32 mm long by 32 mm wide1

       

      Click here for more information about the size of Mirena and inserter.

       

      IUD=intrauterine device.

      • Mirena is supplied in a sterile package within an inserter that enables single-handed loading1


      Click here for more information about the Mirena insertion process.

      • Once released, Mirena cannot be reloaded. Follow the insertion instructions exactly as described to ensure proper placement and avoid premature release of Mirena from the inserter1


      Click here for more information about the Mirena insertion process.

      Mirena safety considerations

      For more information on Mirena safety considerations, please click here or see the Full Prescribing Information.

       

        • Risk of ectopic pregnancy1

          Evaluate women for ectopic pregnancy if they become pregnant with Mirena in place because the likelihood of a pregnancy being ectopic is increased with Mirena. Approximately one-half of pregnancies that occur with Mirena in place are likely to be ectopic. Also consider the possibility of ectopic pregnancy in the case of lower abdominal pain, especially in association with missed menses or if an amenorrheic woman starts bleeding.   

           

          The incidence of ectopic pregnancy in clinical trials with Mirena, which excluded women with a history of ectopic pregnancy, was approximately 0.1% per year. The risk of ectopic pregnancy in women who have a history of ectopic pregnancy and use Mirena is unknown. Women with a previous history of ectopic pregnancy, tubal surgery or pelvic infection carry a higher risk of ectopic pregnancy. Ectopic pregnancy may result in loss of fertility


        • Risks with intrauterine pregnancy1
          If pregnancy occurs while using Mirena, remove Mirena because leaving it in place may increase the risk of spontaneous abortion and preterm labor. Removal of Mirena or probing of the uterus may also result in spontaneous abortion. In the event of an intrauterine pregnancy with Mirena, consider the following:  

          Septic abortion

          In patients becoming pregnant with an IUS in place, septic abortion—with septicemia, septic shock, and death—may occur.

          Continuation of pregnancy

          If a woman becomes pregnant with Mirena in place and if Mirena cannot be removed or the woman chooses not to have it removed, warn her that failure to remove Mirena increases the risk of miscarriage, sepsis, premature labor and premature delivery. Advise her of isolated reports of virilization of the female fetus following local exposure to LNG during pregnancy with an LNG IUS in place. Follow her pregnancy closely and advise her to report immediately any symptom that suggests complications of the pregnancy.   

           

          IUS=intrauterine system.

        • Tell your patients that they may use Mirena when they are breastfeeding. Mirena is not likely to affect the quality or amount of breast milk or the health of the nursing baby. However, isolated cases of decreased milk production have been reported. The risk of Mirena going into the wall of the uterus (becoming embedded) or going through the wall of the uterus is increased if Mirena is inserted while breastfeeding
        • Published studies report the presence of LNG in human milk. Small amounts of progestins (approximately 0.1% of the total maternal doses) were detected in the breast milk of nursing mothers who used Mirena, resulting in exposure of LNG to the breastfed infants. There are no reports of adverse effects in breastfed infants with maternal use of progestin-only contraceptives. Isolated cases of decreased milk production have been reported with Mirena. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Mirena and any potential adverse effects on the breastfed child from Mirena or from the underlying maternal condition
        • APEX IUD was a large US retrospective cohort study to assess the impact of breastfeeding and timing of postpartum IUD insertion on uterine perforation and IUD expulsion. Breastfeeding data were available in 94,817 insertions performed in women 52 weeks or less after delivery. Women who were breastfeeding at the time of insertion were at 33% higher risk of perforation (adjusted hazard ratio [HR]=1.33, 95% confidence interval [CI]: 1.07–1.64) compared to women who were not breastfeeding at the time of insertion. Progressively lower risk of uterine perforation was observed in postpartum time windows beyond 6 weeks, in both breastfeeding and not breastfeeding women. Women who were breastfeeding were at 28% lower risk of IUD expulsion (adjusted HR=0.72, 95% CI: 0.64-0.80) compared to women who were not breastfeeding at time of insertion. For more information, please see section 6.2 Postmarketing Experience of the full Prescribing Information

        IUD=intrauterine device; LNG=levonorgestrel.

        • Mirena can alter the bleeding pattern and result in spotting, irregular bleeding, heavy bleeding, oligomenorrhea, and amenorrhea. During the first 3 to 6 months of Mirena use, the number of bleeding and spotting days may be higher and bleeding patterns may be irregular. Thereafter the number of bleeding and spotting days usually decreases but bleeding may remain irregular. If bleeding irregularities develop during prolonged treatment, appropriate diagnostic measures should be taken to rule out endometrial pathology1
        • Amenorrhea develops in approximately 20% of Mirena users by 1 year
        • If a significant change in bleeding develops during prolonged use, take appropriate diagnostic measures to rule out endometrial pathology. Consider the possibility of pregnancy 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

         


        Click here for more information on bleeding data for Mirena.

        • Partial or complete expulsion of Mirena may occur resulting in the loss of efficacy. Expulsion may be associated with symptoms of bleeding or pain, or it may be asymptomatic and go unnoticed. Mirena typically decreases menstrual bleeding over time; therefore, an increase of menstrual bleeding may be indicative of an expulsion. Consider further diagnostic imaging, such as x-ray, if expulsion is suspected based on ultrasound. In clinical trials, a 4.5% expulsion rate was reported over the 5-year study duration1
        • The risk of expulsion is increased with insertions immediately after delivery and appears to be increased with insertion after second-trimester abortion based on limited data. In a large postmarketing safety study conducted in the US, the risk of expulsion was lower with breastfeeding status. Remove a partially expelled Mirena. If expulsion has occurred, a new Mirena can be inserted any time the provider can be reasonably certain the woman is not pregnant1

        Mirena cost and coverage

          • The wholesale acquisition costs of Mirena before discounts is $999.282
          • Bayer offers discount programs for providers and support programs for patients


          Click here for more information on Bayer IUD support programs.

          • Yes, the Bayer US Patient Assistance Foundation is a charitable organization that helps eligible patients get their Bayer prescription medicine at no cost. Please have your patient contact the program at 1-866-2BUSPAF (228-7723), Monday to Friday, 9 AM to 6 PM EST, or visit the foundation website at https://www.patientassistance.bayer.us/

           

          US=United States.

          • State Medicaid programs offer coverage for contraceptives. However, state Medicaid program eligibility guidelines may vary and could restrict access to Mirena for some women. As with private payers, offices should verify coverage prior to treatment. Among women enrolled in Medicaid managed care organizations (Medicaid MCOs), coverage will be based on the specific Medicaid MCOs' policies for Mirena

          Request a Rep

          Bayer offers virtual trainings for inserting Mirena.

           

          Cost and Coverage Information

          Review helpful information for ordering Mirena. 

           

          Important Safety Information

          Important Safety Information for Mirena. 

           

          INDICATIONS FOR MIRENA®

          Mirena® (levonorgestrel-releasing intrauterine system) 52 mg is indicated for prevention of pregnancy for up to 7 years; replace after the end of the seventh year. Mirena is indicated for the treatment of heavy menstrual bleeding for up to 5 years in women who choose to use intrauterine contraception as their method of contraception; replace after the end of the fifth year if continued treatment of heavy menstrual bleeding is needed.

           

          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 the uterine cavity; known or suspected breast cancer or other progestin-sensitive cancer, now or in the past; known or suspected uterine or cervical malignancy; liver disease, including tumors; untreated acute cervicitis or vaginitis, including lower genital tract infections (eg, bacterial vaginosis) until infection is controlled; postpartum endometritis or infected abortion in the past 3 months; unexplained uterine bleeding; current IUD; acute pelvic inflammatory disease (PID) or history of PID (except with later intrauterine pregnancy); conditions increasing susceptibility to pelvic infection; or hypersensitivity to any component of Mirena.

           

          Clinical considerations for use and removal of Mirena

          Use Mirena with caution after careful assessment in patients with coagulopathy or taking anticoagulants; migraine, focal migraine with asymmetrical visual loss, or other symptoms indicating transient cerebral ischemia; exceptionally severe headache; marked increase of blood pressure; or severe arterial disease such as stroke or myocardial infarction.

           

          Consider removing the intrauterine system if these or the following arise during use: uterine or cervical malignancy or jaundice. If the threads are not visible or are significantly shortened they may have broken or retracted into the cervical canal or uterus. If Mirena is displaced (e.g., expelled or perforated the uterus), remove it.

           

          Pregnancy related risks with Mirena

          If pregnancy should occur with Mirena in place, remove the intrauterine system because leaving it in place may increase the risk of spontaneous abortion and preterm labor. Advise her of isolated reports of virilization of the female fetus following local exposure to LNG during pregnancy with an LNG IUS in place. Removal or manipulation may result in pregnancy loss. Evaluate women for ectopic pregnancy because the likelihood of a pregnancy being ectopic is increased with Mirena. Also consider the possibility of ectopic pregnancy in the case of lower abdominal pain, especially in association with missed menses or if an amenorrheic woman starts bleeding. Tell women about the signs of ectopic pregnancy and associated risks, including loss of fertility. Women with a history of ectopic pregnancy, tubal surgery, or pelvic infection carry a higher risk of ectopic pregnancy.

           

          Educate her about PID

          Mirena is contraindicated in the presence of known or suspected PID or in women with a history of PID unless there has been a subsequent intrauterine pregnancy. IUDs have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion. Promptly examine users with complaints of lower abdominal pain or pelvic pain, odorous discharge, unexplained bleeding, fever, genital lesions or sores. Inform women about the possibility of PID and that PID can cause tubal damage leading to ectopic pregnancy or infertility, or infrequently can necessitate hysterectomy, or cause death. PID is often associated with sexually transmitted infections (STIs); Mirena does not protect against STIs, including HIV. PID may be asymptomatic but still result in tubal damage and its sequelae.

           

          In Mirena clinical trials, upper genital infections, including PID, occurred more frequently within the first year. In a clinical trial with other IUDs and a clinical trial with an IUD similar to Mirena, the highest rate occurred within the first month after insertion.

           

          Expect changes in bleeding patterns 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.

           

          If a significant change in bleeding develops during prolonged use take appropriate diagnostic measures to rule out endometrial pathology.

           

          Be aware of other serious complications and most common adverse reactions

          Some serious complications with IUDs like Mirena are sepsis, perforation and expulsion. Severe infection, or sepsis, including Group A streptococcal sepsis (GAS) have been reported following insertion of Mirena. Aseptic technique during insertion of Mirena is essential in order to minimize serious infections, such as GAS.

           

          Perforation (total or partial, including penetration/embedment of Mirena in the uterine wall or cervix) may occur, most often during insertion, although the perforation may not be detected until sometime later. The risk of uterine perforation is increased in women who have recently given birth, and in women who are breastfeeding at the time of insertion. In a large US retrospective, postmarketing safety study of IUDs, the risk of uterine perforation was highest when insertion occurred within ≤6 weeks postpartum, and also higher with breastfeeding at the time of insertion. The risk of perforation may be increased if Mirena is inserted when the uterus is fixed, retroverted or not completely involuted. If perforation occurs, locate and remove Mirena. Surgery may be required. Delayed detection or removal of Mirena in case of perforation may result in migration outside the uterine cavity, adhesions, peritonitis, intestinal perforations, intestinal obstruction, abscesses, and erosion of adjacent viscera. In addition, perforation may reduce contraceptive efficacy and result in pregnancy.

           

          Partial or complete expulsion of Mirena may occur resulting in the loss of contraceptive protection. The risk of expulsion is increased with insertions immediately after delivery and appears to be increased with insertion after second-trimester abortion based on limited data. In the same postmarketing study, the risk of expulsion was lower with breastfeeding status. Remove a partially expelled Mirena. If expulsion has occurred, a new Mirena can be inserted any time the provider can be reasonably certain the woman is not pregnant.

           

          Ovarian cysts may occur and are generally asymptomatic, but may be accompanied by pelvic pain or dyspareunia. Evaluate persistent enlarged ovarian cysts.

           

          The most common adverse reactions reported in ≥5% of users were alterations of menstrual bleeding patterns [including unscheduled uterine bleeding (31.9%), decreased uterine bleeding (23.4%), increased scheduled uterine bleeding (11.9%), and female genital tract bleeding (3.5%)], abdominal/pelvic pain (22.6%), amenorrhea (18.4%), headache/migraine (16.3%), genital discharge (14.9%), vulvovaginitis (10.5%), breast pain (8.5%), back pain (7.9%), benign ovarian cyst and associated complications (7.5%), acne (6.8%), dysmenorrhea (6.4%), and depression/depressive mood (6.4%).

           

          A separate study with 362 women who have used Mirena for more than 5 years showed a consistent adverse reaction profile in Years 6 and 7. By the end of Year 7 of use, amenorrhea and infrequent bleeding are experienced by 28% and 26% of users, respectively; irregular bleeding occurs in 12%, frequent bleeding in 8%, and prolonged bleeding in 2% of users. In this study, 6% of women reported the adverse event of weight gain, it is unknown if the weight gain was caused by Mirena.

           

          Teach patients to recognize and immediately report signs or symptoms of the aforementioned conditions. Evaluate patients 4 to 6 weeks after insertion of Mirena and then yearly or more often if clinically indicated.

           

          For important information about Mirena, please see the accompanying Full Prescribing Information.

          References: 1. Mirena [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals; 2021. 2. Important update: Updated pricing for Kyleena®, Mirena®, and Skyla®. Bayer Women's HealthCare Support Center website. https://www.whcsupport.com/sites/g/files/vrxlpx6926/files/2021-01/Bayer%20IUS%20WAC%20Adjustment%20Letter.pdf. Accessed January 25, 2021.