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Consumer SitePrescribing Information

Important Safety Information About MIRENA®     Prescribing Information

Mirena is contraindicated in women with known or suspected: pregnancy; congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity; breast carcinoma; uterine or cervical neoplasia; unresolved, abnormal Pap smear; liver disease including tumors; untreated acute cervicitis or vaginitis, including lower genital tract infections (e.g., bacterial vaginosis) until infection is controlled; postpartum endometritis or infected abortion in past 3 months; unexplained vaginal bleeding; current IUD; acute pelvic inflammatory disease (PID) or history of PID (except with later intrauterine pregnancy); or conditions increasing susceptibility to pelvic infections. Continue reading below

Mirena® (levonorgestrel-releasing intrauterine system) - Keep Life Simple
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Single Payment Option Available for Patients

Approximately 3 out of 4 women with health insurance have coverage for Mirena. For those who don't, there is an option available. 1,2

Single Payment Option Available for Patients

Contact your Specialty Pharmacy to learn more about single payment opportunities.

CVS Caremark:
In the continental US
Phone: 1-866-638-8312

In Hawaii (Neighbor Islands)
Phone: 1-800-896-1464

In Hawaii (Oahu)
Phone: 1-808-254-2727

Walgreens:
Phone: 1-877-686-4633

Prime Therapeutics:
Phone: 1-877-627-6337
Fax: 1-877-684-8854

The above methods for ordering Mirena are void where prohibited. It is your responsibility to comply with any requirements imposed by any third party payer, public or private, through the operation law, contract, or otherwise, with regard to submitting claims for reimbursement for Mirena.

*By participating in this program, a patient must certify that she is not reimbursed, nor will she submit a claim for reimbursement, nor will she seek to have any portion of this prescription counted toward her out-of-pocket costs (eg, TrOOP) under any federal, state, or private programs for this or other prescriptions for Mirena to which this offer may apply.

Know who is appropriate for Mirena

Mirena (levonorgestrel-releasing intrauterine system) 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.

Know who is not appropriate for Mirena

Mirena is contraindicated in women with known or suspected: pregnancy; congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity; breast carcinoma; uterine or cervical neoplasia; unresolved, abnormal Pap smear; liver disease including tumors; untreated acute cervicitis or vaginitis, including lower genital tract infections (e.g., bacterial vaginosis) until infection is controlled; postpartum endometritis or infected abortion in past 3 months; unexplained vaginal bleeding; current IUD; acute pelvic inflammatory disease (PID) or history of PID (except with later intrauterine pregnancy); or conditions increasing susceptibility to pelvic infections.

Use with caution in patients with certain conditions

In patients with certain types of valvular or congenital heart disease and surgically constructed systemic-pulmonary shunts, Mirena increases risk of infective endocarditis and may be a source of septic emboli. Give appropriate antibiotics at insertion and removal to patients with known congenital heart disease who may have higher risk. Monitor for infections any patient on chronic corticosteroid therapy or insulin for diabetes.

Use Mirena with caution 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.

In the event of pregnancy

If pregnancy should occur with Mirena in place, Mirena should be removed. Removal or manipulation may result in pregnancy loss. Up to half the pregnancies that occur with Mirena in place are ectopic. Tell women about the risks of ectopic pregnancy 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

Prior to 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 diseases (STDs); Mirena does not protect against STDs, including HIV. The highest risk of PID occurs shortly after insertion (usually within the first 20 days).

Expect changes in bleeding patterns

Expect spotting and irregular/heavy bleeding for 3-6 months, then shorter, lighter periods. Cycles may remain irregular and become infrequent and may 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, myometrial embedment and uterine or cervical perforation. 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 follicles.

The most common adverse reactions (>10%) are uterine/vaginal bleeding alterations (51.9%), amenorrhea (23.9%), intermenstrual bleeding and spotting (23.4%), abdominal/pelvic pain (12.8%) and ovarian cysts (12%).

Teach patients to recognize and immediately report signs or symptoms of the aforementioned conditions. Evaluate patients 4-12 weeks after insertion and then yearly or more often if clinically indicated.


For important risk and use information, please see the Full Prescribing Information.


References:

  1. Data on file. Bayer HealthCare Pharmaceuticals Inc.
  2. Data on file. TheraCom, based on calls to the benefit verification services of the Mirena Support Center. Bayer HealthCare Pharmaceuticals Inc.