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Important Safety Information About MIRENA®

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 neoplasia; 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. Continue reading below

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Mirena and the Affordable Care Act: What it means for you and your patients

More insurance plans are covering Mirena at $0 cost to patients1

For the majority of patients, these national plans, plus the majority of Blue Cross Blue Shield-affiliated plans, have already adopted $0 cost for Mirena1:

To learn more about which plans may cover Mirena at $0 cost in your state,
please contact your Bayer Sales Consultant or call 1-888-84-BAYER

Through the Affordable Care Act, patients' insurance plans may now cover the cost of Mirena, including product cost as well as insertion and removal appointments, without co-pays, deductibles, or out-of-pocket expenses.2 The details of insurance plans vary, and some plans may have limitations or may be exempt. Continue to verify patients' insurance benefits through your own methods and procedures or through Bayer support services, such as www.whcsupport.com or your Specialty Pharmacy.

Indications for Mirena (levonorgestrel-releasing intrauterine system) 52 mg

Mirena is indicated for intrauterine contraception for up to 5 years. Mirena is also indicated to treat heavy menstrual bleeding in women who choose to use intrauterine contraception as their method of contraception. Mirena is recommended for women who have had a child. Mirena should be replaced after 5 years if continued use is desired.

IMPORTANT SAFETY INFORMATION ABOUT MIRENA

Who is not appropriate for Mirena

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 neoplasia; 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

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 Mirena if these or the following arise during use: uterine or cervical malignancy or jaundice. 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 Mirena because leaving it in place may increase the risk of spontaneous abortion and preterm labor. 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. 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

IUDs have been associated with an increased risk of PID most likely due to organisms being introduced into the uterus during insertion. 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. 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

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.

Be aware of other serious complications and most common adverse reactions

Some serious complications with IUDs like Mirena are expulsion, sepsis, and perforation. Perforation may reduce contraceptive efficacy. The risk of perforation is higher if inserted in lactating women and may be higher if inserted in women who are postpartum or when the uterus is fixed retroverted.

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 (≥5% users) are uterine/vaginal bleeding alterations (51.9%), amenorrhea (23.9%), intermenstrual bleeding and spotting (23.4%), abdominal/pelvic pain (12.8%), ovarian cysts (12%), headache/migraine (7.7%), acne (7.2%), depressed/altered mood (6.4%), menorrhagia (6.3%), breast tenderness/pain (4.9%), vaginal discharge (4.9%) and IUD expulsion (4.9%).

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


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


Reference:

  1. Data on file. HealthLeaders Interstudy 2012. Bayer HealthCare Pharmaceuticals Inc.
  2. Women’s Preventive Services Guidelines. US Department of Health and Human Services.
    http://www.hrsa.gov/womensguidelines. Accessed January 6, 2014.

For the proper insertion and removal instructions,
choose which Mirena® product you are using.

NDC 50419-421-01
NDC 50419-423-01

PLEASE READ!

This video features the insertion instructions for the original inserter for
Mirena ® (levonorgestrel-releasing intrauterine system) 52 mg (NDC# 50419-421-01)

To view the updated Prescribing Information for the Bayer Inserter for Mirena (NDC# 50419-423-01)

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