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KYLEENA ® (levonorgestrel-releasing intrauterine system) 19.5 mg Kyleena Important Safety Information MIRENA ® (levonorgestrel-releasing intrauterine system) 52 mg Mirena Important Safety Information SKYLA ® (levonorgestrel-releasing intrauterine system) 13.5 mg Skyla Important Safety Information Important Safety Information Full Prescribing Information Sign Up Consumer Site 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 Toggle navigation Important Safety Information Full Prescribing Information About Mirena Who Is Right for Mirena? Efficacy Mechanism of Action (MOA) Bleeding Data Insertion & Removal Insertion & Removal Video Insertion Instructions Ordering & Reimbursement Resources Safety Request A Rep Prescribing Information Patient Information Contact Us Site Map Terms of Use Privacy Policy Mirena is the #1 prescribed intrauterine device (IUD) in the U.S.*1 *Supported by 2014-2016 SHS data. Mirena® is a highly effective, low-maintenance contraceptive option for your appropriate patients Counsel patients to check their threads once a month. Reexamine and evaluate patients 4 to 6 weeks after insertion and once a year thereafter, or more frequently if clinically indicated. Learn more about Mirena Mirena is the #1 prescribed intrauterine device (IUD) in the U.S.* 1 *Supported by 2015-2016 SHS data. Highly effective Provides high contraceptive efficacy over 5 years Learn more > Contraception and Heavy Menstrual Bleeding (HMB) First IUD birth control that is FDA approved to treat heavy menstrual bleeding in women who chose an IUD for contraception Learn more > Non-daily No daily, weekly, or monthly dosing routines. After insertion, make sure patient checks that Mirena is in place once a month by feeling for the threads Learn more > Reversible Mirena can be removed at any time during the 5 years if a patient decides she wants to try to become pregnant Fertility is rapidly restored once Mirena is removed About 80% of women wishing to become pregnant conceived within 12 months after removal of Mirena Safety Please see Important Safety Information for Mirena Learn more > Inserting Mirena The single-handed Bayer inserter for Mirena has the same innovative inserter design and insertion technique as the other Bayer IUDs (with varying insertion tube diameters for each IUD). Watch instructional video on how to properly insert Mirena Ordering and Reimbursement Information for Mirena For more information about accessing Mirena, contact the Women's Healthcare (WHC) Support Center: call 1-866-647-3646 1-866-647-3646 . Go to WHC Support Center Back to top INDICATIONS FOR MIRENA ® Mirena ® (levonorgestrel-releasing intrauterine system) 52 mg 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 should be replaced after 5 years if continued use is desired. 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 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 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. 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. 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. 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...