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Consumer SitePrescribing Information

Important Safety Information About MIRENA®     Prescribing Information

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

Mirena® (levonorgestrel-releasing intrauterine system) - Keep Life Simple
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Insertion & Removal Instructions

You can access the Mirena® (levonorgestrel-releasing intrauterine system) insertion and removal instructions and watch the video provided or review the complete step-by-step instructions and illustrations found on this page. Please consult the full prescribing information for the complete insertion instructions.

Dosage and Administration

Mirena contains 52 mg of levonorgestrel (LNG). Initially, LNG is released at a rate of approximately 20 µg/day. This rate decreases progressively to half that value after 5 years.

Mirena is indicated for intrauterine contraception for up to 5 years. Thereafter, if continued contraception is desired, the system should be replaced.

Mirena is packaged sterile within an inserter. Information regarding insertion instructions, patient counseling and record keeping, patient follow-up, removal of Mirena, and continuation of contraception after removal is available.

How Supplied

Mirena, containing a total of 52 mg of LNG, is available in a carton of one sterile unit NDC# 50419-421-01. Each Mirena is packaged together with an inserter in a thermoformed blister package with a peelable lid.

Mirena is supplied sterile. Mirena is sterilized with ethylene oxide. Do not resterilize. For single use only. Do not use if the inner package is damaged or open. Insert before the end of the month shown on the label.

Only FDA-approved products are accompanied by verification holograms.1

Storage and Handling

Store at 25°C (77°F); with excursions permitted between 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].

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. Bayer HealthCare Pharmaceuticals Inc.

 


PLEASE READ!

The Prescribing Information for Mirena® (levonorgestrel-releasing intrauterine system) 52 mg on this site reflects the insertion instructions for the new Bayer Inserter for Mirena. The Bayer Inserter for Mirena will be available soon.

to continue on to the updated Prescribing Information for the new Bayer Inserter for Mirena.

to continue on to the insertion instructions for the currently available original inserter.

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)