Counseling

“She should be counseled about Mirena.”

She should know that Mirena does not protect against HIV infection (AIDS) and other sexually transmitted diseases (STDs)

Instruct the patient to contact her healthcare provider if she experiences any of the following:

A stroke or heart attack	Develops very severe or migraine headaches
Unexplained fever	Yellowing of the skin or whites of the eyes, as these may be signs of serious liver problems
She thinks she is pregnant	Pelvic pain or pain during sex
She or her partner becomes HIV positive	She might be exposed to sexually transmitted diseases (STDs)
Unusual vaginal discharge or genital sores	Severe vaginal bleeding or bleeding that lasts a long time, or if she misses a menstrual period
Cannot feel Mirena's threads

Prior to insertion, give the patient the Patient Information Booklet. She should be given the opportunity to read the information and discuss fully any questions she may have concerning Mirena as well as other methods of contraception and therapies for heavy menstrual bleeding. Also, advise the patient that the Prescribing Information is available to her upon request
Instruct the patient on how to check after her menstrual period to make certain that the threads still protrude from the cervix and caution her not to pull on the threads and displace Mirena. Inform her that there is no contraceptive protection if Mirena is displaced or expelled

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

After 1 year, women had fewer than 2 bleeding days per month¹
Expect spotting and irregular/heavy bleeding for 3-6 months, then shorter, lighter periods. Cycles may remain irregular and become infrequent and may cease

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

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 fibroidstotal volume ≤5 mL) were excluded from the study.

Mirena users with HMB saw a decrease in the mean number of bleeding and spotting days in a 6-month study^2†

Mirena causes thinning of the uterine lining, which results in less bleeding^3,4

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

Local delivery of LNG directly to the uterus initiates and maintains thinning of the uterine lining
Nearly one-quarter (23.9%) of women studied stopped having periods
Inform the patient that irregular or prolonged bleeding and spotting, and/or cramps may occur during the first few weeks after insertion. If her symptoms continue or are severe she should report them to her healthcare provider

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.

You are encouraged to report negative side effects or quality complaints of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1.800.FDA.1088.

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

References:

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.
Data on file. NDA21-225. Bayer HealthCare Pharmaceuticals Inc.
Nilsson CG, Luukkainen T, Arko H. Endometrial morphology of women using a D-norgestrel-releasing intrauterine device. Fertil Steril. 1978;29: 397-401.
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.

Important Safety Information About MIRENA® Prescribing Information