The information contained on this website is intended for US healthcare professionals only. Click the appropriate link below.
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 is committed to the reproductive health of women, and we work hard to ensure every woman has access to effective contraception. Bayer may be able to help if your patients are uninsured or underinsured, or if they have high out-of-pocket costs.
The Confidence In Coverage program replaces IUDs at no cost for eligible patients who are denied coverage* by their plan after IUD insertion.
Does not apply for patients who have co-pay, insertion and removal costs, or any other costs.
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/
The Co-pay Savings Program for Mirena®
Have health insurance but still have high out-of-pocket costs for Mirena? The Co-pay Savings Program for Mirena may help! Eligible patients may be able to pay as little as $20 out of pocket for Mirena.*
OF PATIENTS HAD COVERAGE FOR A BAYER IUD WITH LOW OR NO OUT-OF-POCKET COSTS BASED ON BENEFIT INVESTIGATION SUBMISSIONS TO BAYER IN 20171
Other products costs may apply; N=291,664.
*Eligible patients may pay as little as $20 for the cost of the Mirena IUD. Benefit limitations apply. For full terms and conditions, please reference copayformirena.com. Patients who are enrolled in any type of government insurance or reimbursement programs are not eligible. As a condition precedent of the co-payment support provided under this program, e.g., co-pay refunds, participating patients and pharmacies are obligated to inform insurance companies and third-party payers of any benefits they receive and the value of this program, and may not participate if this program is prohibited by or conflicts with their private insurance policy, as required by contract or otherwise. Void where prohibited by law, taxed, or restricted. Patients enrolled in the Bayer US Patient Assistance Foundation are not eligible. Bayer may determine eligibility, monitor participation, equitably distribute product and modify or discontinue any aspect of the Co-pay Savings Program for Mirena at any time, including but not limited to this commercial co-pay assistance program.
WE’RE FOR HER is in line with Bayer’s goal to provide 100 million women across the world with access to contraception by 2030 through 2 key programs in the US:
Bayer US Patient Assistance Foundation
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 www.patientassistance.bayer.us to see if they might qualify for assistance.
Partnership with Direct Relief
In 2020, we committed to a partnership with the humanitarian medical organization Direct Relief to provide IUDs to health facilities caring for women in need across the country.*
Interested health facilities can learn more by visiting www.directrelief.org or by contacting Direct Relief at 1-805-964-4767.
IUD=intrauterine device; US=United States.
Bayer WHC Support Center
Go to WHC Support Center
Bayer WHC Specialty Pharmacy Program
Depending on a patient's insurance plan, offices can order Mirena through a Specialty Pharmacy.
Specialty Pharmacies may be able to bill the insurance company directly for Mirena. In this case, the office bills only for the clinical services related to insertion. The remaining share of the cost is billed by the Specialty Pharmacy.
Contacting your Specialty Pharmacy
CVS Specialty (in the Continental US)
CVS Specialty (in Hawaii-Neighbor Islands)
CVS Specialty (in Hawaii-Oahu)
AllianceRx Walgreens Pharmacy
CenterWell Specialty Pharmacy
HCPCS codes (Mirena J-code)
The alphanumeric codes are used to report drugs, supplies, and services. HCPCS codes starting with the letter “J” are used for products, supplies and services administered by the provider.
Note that some payers, including Tricare and Medicaid, require the 11-digit NDC format when billing for Mirena. Confirm NDC billing instructions with each payer, as requirements may vary.
HCPCS=healthcare common procedure coding system; NDC=national drug codes.
Mirena® (levonorgestrel-releasing intrauterine system) 52 mg is indicated for prevention of pregnancy for up to 8 years; replace after the end of the eighth 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.
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 through 8. By the end of Year 8 of use, amenorrhea and infrequent bleeding are experienced by 34% and 26% of users, respectively; irregular bleeding occurs in 10%, frequent bleeding in 3%, and prolonged bleeding in 3% of users. In this study, 9% 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.