Indicated for:

Contraception:

• Prevention of pregnancy for up to 7 years; replace after the end of the seventh year.

Heavy Menstrual Bleeding:

• 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.

Mirena is recommended for women who have had at least one child.

Mirena contains 52 mg of levonorgestrel (LNG). Initially, LNG is released at a rate of approximately 20 mcg/day. This rate decreases progressively to approximately 10 mcg/day after 5 years and 8 mcg/day after 7 years.

For contraception, remove Mirena by the end of the seventh year and replace at the time of removal with a new Mirena if continued use is desired.

For treatment of heavy menstrual bleeding, replace Mirena by the end of the fifth year if continued use is needed because data on use in this indication beyond 5 years are limited.

Reexamine and evaluate patients 4 to 6 weeks after insertion and once a year thereafter, or more frequently if clinically indicated.

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.

Actinomycosis has been associated with IUDs. Remove Mirena from symptomatic women and treat with antibiotics.

If pregnancy is not desired, remove Mirena during the first 7 days of the menstrual cycle, provided the woman is still experiencing regular menses. If removal will occur at other times during the cycle or the woman does not experience regular menses, she is at risk of pregnancy; start a new contraceptive method a week prior to removal for these women.

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.

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

Severe infection or sepsis, including Group A streptococcal sepsis (GAS), have been reported following insertion of Mirena. IUDs have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion. These infections occurred more frequently within the first year. PID may be asymptomatic but still result in tubal damage and its sequelae.

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.

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.

Ovarian cysts have been reported in approximately 8% of women using Mirena.

Mirena can alter the bleeding pattern and result in spotting, irregular bleeding, heavy bleeding, oligomenorrhea and amenorrhea. During the first 3–6 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 pathology.

Women who currently have or have had breast cancer, or have a suspicion of breast cancer, should not use hormonal contraception, including Mirena, because some breast cancers are hormone-sensitive. Spontaneous reports of breast cancer have been received during postmarketing experience with Mirena.

The use of Mirena is contraindicated when one or more of the following conditions exist:

• Pregnancy or suspicion of pregnancy
• For use as post-coital contraception (emergency contraception)
• Congenital or acquired uterine anomaly, including fibroids, that distorts the uterine cavity
• Acute pelvic inflammatory disease (PID) or a history of PID unless there has been a subsequent intrauterine pregnancy
• Postpartum endometritis or infected abortion in the past 3 months
• Known or suspected uterine or cervical malignancy
• Known or suspected breast cancer or other progestin-sensitive cancer, now or in the past
• Uterine bleeding of unknown etiology
• Untreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections until infection is controlled
• Acute liver disease or liver tumor (benign or malignant)
• Conditions associated with increased susceptibility to pelvic infections
• A previously inserted intrauterine device (IUD) that has not been removed

Use Mirena with caution after careful assessment if any of the following conditions exist, and consider removal of the system if any of them arise during use:

• Coagulopathy or use of anticoagulants
• Migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia
• Exceptionally severe headache
• Marked increase of blood pressure
• Severe arterial disease such as stroke or myocardial infarction
• Uterine or cervical malignancy
• Jaundice

Drugs or herbal products that may decrease the serum concentration of LNG include barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, nevirapine, oxcarbazepine, phenytoin, rifabutin, rifampin, st. john’s wort, and topiramate.

Significant changes (increase or decrease) in the serum concentrations of the progestin have been noted in some cases of co-administration with HIV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors. CYP3A4 inhibitors such as itraconazole or ketoconazole may increase plasma hormone levels.

The use of Mirena is contraindicated in pregnancy or with a suspected pregnancy and Mirena may cause adverse pregnancy outcomes.

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.

GoToSource

 • Supplement estrogen replacement therapy, for uterine fibroids, endometriosis, adenomyosis, endometrial hyperplasia and as an alternative to hysterectomy. GoToSource

• Hyperplastic polyps. GoToSource

Ectopic pregnancy. GoToSource

Sepsis. GoToSource

Perforation or penetration of the uterine wall or cervix. GoToSource

Ovarian cysts. GoToSource

Breast cancer GoToSource

Venous thromboembolic events. GoToSource

Acne, menstrual disorder, pelvic pain, seborrhoeic dermatitis and acute urticaria (hives). GoToSource

Intracranial hypertension (increased pressure in brain). GoToSource

Edema (fluid retention). GoToSource 

Pelvic inflammatory disease. GoToSource

Lawsuits filed for uterine perforation, infertility, ectopic pregnancy, miscarriage, pelvic inflammatory disease and peritonitis.