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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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Counseling

“She should be counseled about Mirena.”


The contraceptive trial showed a change in bleeding to be the most common adverse event1

Effect of Mirena on bleeding and spotting days1*

Effect of Mirena on bleeding and spotting days

*Open, randomized, multicenter study (N=2758) comparing Mirena with a copper-releasing intrauterine device during 5 years of contraceptive use.1


 

The HMB trial also showed a change in bleeding pattern as the most common adverse event2

Mirena reduced bleeding and spotting days

Mirena reduced bleeding and spotting days

Randomized, open-label, parallel-group, active-control trial comparing the safety and efficacy of Mirena (n=79) to oral hormonal therapy with medroxyprogesterone acetate (MPA) (n=81), in the treatment of heavy menstrual bleeding (≥80 mL menstrual blood loss). Women with organic or systemic conditions that can cause heavy uterine bleeding (except for small fibroids—total volume ≤5 mL) were excluded from the study.


 

Mirena causes thinning of the uterine lining, which results in less bleeding3,4

Mirena causes thinning of the uterine lining, which results in less bleeding

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. Andersson K, Odlind V, Rybo G. Levonorgestrel-releasing and copper-releasing (Nova T) IUDs during five years of use: a randomized comparative trial. Contraception. 1994;49(6):56-72.
  2. Data on file. NDA21-225. Bayer HealthCare Pharmaceuticals Inc.
  3. Nilsson CG, Luukkainen T, Arko H. Endometrial morphology of women using a D-norgestrel-releasing intrauterine device. Fertil Steril. 1978;29: 397-401.
  4. Hidalgo MM, Hidalgo-Regina C, Bahamondes MV, Monteiro I, Petta CA, Bahamondes L. Serum levonorgestrel levels and endometrial thickness during extended use of the levonorgestrel-releasing intrauterine system. Contraception. 2009;80(1):84-89.