“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*
- After 1 year, women had fewer than 2 bleeding days per month1
- 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
The HMB trial also showed a change in bleeding pattern as the most common adverse event2
Mirena reduced bleeding and spotting days
- Mirena users with HMB saw a decrease in the mean number of bleeding and spotting days in a 6-month study2†
Mirena causes thinning of the uterine lining, which results in less bleeding3,4
- 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
Indications for Mirena (levonorgestrel-releasing intrauterine system) 52 mg
Mirena 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. Mirena should be replaced after 5 years if continued use is desired.
IMPORTANT SAFETY INFORMATION ABOUT MIRENA
Who is not appropriate for Mirena
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
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 Mirena if these or the following arise during use: uterine or cervical malignancy or jaundice. 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 Mirena 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. 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
IUDs have been associated with an increased risk of PID most likely due to organisms being introduced into the uterus during 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 infections (STIs); Mirena does not protect against STIs, including HIV. 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
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.
Be aware of other serious complications and most common adverse reactions
Some serious complications with IUDs like Mirena are expulsion, sepsis, and perforation. Perforation may reduce contraceptive efficacy. 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 cysts.
The most common adverse reactions (≥5% users) are uterine/vaginal bleeding alterations (51.9%), amenorrhea (23.9%), intermenstrual bleeding and spotting (23.4%), abdominal/pelvic pain (12.8%), ovarian cysts (12%), headache/migraine (7.7%), acne (7.2%), depressed/altered mood (6.4%), menorrhagia (6.3%), breast tenderness/pain (4.9%), vaginal discharge (4.9%) and IUD expulsion (4.9%).
Teach patients to recognize and immediately report signs or symptoms of the aforementioned conditions. Evaluate patients 4 to 6 weeks after insertion and then yearly or more often if clinically indicated.
For important information about Mirena, please see the full Prescribing Information.
- 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.