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Consumer SitePrescribing Information

Important Safety Information About MIRENA® and SKYLA®
(levonorgestrel-releasing intrauterine system) 13.5 mg

Use of Mirena or Skyla 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 or Skyla. Continue reading below

Mirena® (levonorgestrel-releasing intrauterine system) - Keep Life Simple
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Bayer

The Bayer Inserter for Mirena®

The single-handed inserters for Mirena and Skyla® have the same
inserter design and insertion technique.* The insertion tube diameters
differ for Mirena and Skyla (4.4 mm for Mirena and 3.8 mm for Skyla)

Thin and flexible insertion tube (4.4 mm)
Small, rounded T-body design (32 mm x 32 mm)
Single-handed inserter
REMOVAL THREADS - Unlike the original inserter, the threads are fully contained within the insertion tube and handle.
HANDLE - Mechanism within the handle automatically locks and releases the threads. This allows for single-handed loading.
SLIDER - Unlike the original inserter, once you pull the slider below the mark, Mirena is released and CANNOT be reloaded.
*Review the preparatory steps to ensure that the patient is appropriate for Mirena or Skyla.
Click here to learn more about insertion and removal of Mirena

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INDICATIONS FOR MIRENA

Mirena® (levonorgestrel-releasing intrauterine system) 52 mg 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.

INDICATION FOR SKYLA

Skyla® (levonorgestrel-releasing intrauterine system) 13.5 mg is indicated for the prevention of pregnancy for up to 3 years. Skyla should be replaced after 3 years if continued use is desired.

IMPORTANT SAFETY INFORMATION ABOUT MIRENA AND SKYLA

Who is not appropriate for Mirena and Skyla

Use of Mirena or Skyla 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 or Skyla.

Clinical considerations for use and removal of Mirena and Skyla

Use Mirena or Skyla 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 or Skyla is displaced (e.g., expelled or perforated the uterus), remove it.

In addition, Skyla can be safely scanned with MRI only under specific conditions.

Pregnancy related risks with Mirena and Skyla

If pregnancy should occur with Mirena or Skyla in place, remove the intrauterine system 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 or Skyla. 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 and Skyla are 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 and Skyla do not protect against STIs, including HIV. PID may be asymptomatic but still result in tubal damage and its sequelae.

In clinical trials with:

  • Mirena — 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.
  • Skyla — PID occurred more frequently within the first year and most often within the first month after insertion.

Expect changes in bleeding patterns with Mirena and Skyla

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.

Because irregular bleeding/spotting is common during the first months of Mirena or Skyla use, exclude endometrial pathology (polyps or cancer) prior to the insertion of Mirena or Skyla in women with persistent or uncharacteristic bleeding. 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 and Skyla are sepsis, perforation and expulsion. Severe infection, or sepsis, including Group A streptococcal sepsis (GAS) have been reported following insertion of a LNG-releasing IUS. Aseptic technique during insertion of the IUD is essential in order to minimize serious infections, such as GAS.

Perforation (total or partial, including penetration/embedment of Mirena or Skyla in the uterine wall or cervix) may occur, most often during insertion, although the perforation may not be detected until sometime later. Perforation may reduce contraceptive efficacy. If perforation occurs, locate and remove the intrauterine system. Surgery may be required. Delayed detection or removal of the intrauterine system in case of perforation may result in migration outside the uterine cavity, adhesions, peritonitis, intestinal perforations, intestinal obstruction, abscesses, and erosion of adjacent viscera. The risk of perforation may be increased if inserted when the uterus is not completely involuted or fixed retroverted. A postmarketing safety study over a 1-year observational period reported that lactation at the time of insertion of an IUS/IUD was associated with an increased risk of perforation. In this study, for Mirena users, the incidence of uterine perforation was reported as 6.3 per 1,000 insertions for lactating women, compared to 1.0 per 1,000 insertions for non-lactating women.

Partial or complete expulsion of Mirena or Skyla may occur resulting in the loss of contraceptive protection. Delay insertion a minimum of six weeks or until uterine involution is complete following a delivery or a second trimester abortion. Remove a partially expelled IUD. If expulsion has occurred, Mirena or Skyla may be replaced within 7 days after the onset of a menstrual period after pregnancy has been ruled out.

Ovarian cysts may occur and are generally asymptomatic, but may be accompanied by pelvic pain or dyspareunia. Evaluate persistent enlarged ovarian cysts.

In clinical trials with:

  • Mirena — adverse reactions reported in ≥5% of users were alterations of menstrual bleeding patterns [including unscheduled uterine bleeding (31.9%), decreased uterine bleeding (23.4%), and increased uterine bleeding (11.9%)], 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%).
  • Skyla — the most common adverse reactions (≥5% users) were vulvovaginitis (20.2%), abdominal/pelvic pain (18.9%), acne/seborrhea (15.0%), ovarian cyst (13.2%), headache (12.4%), dysmenorrhea (8.6%), breast pain/discomfort (8.6%), increased bleeding (7.8%), and nausea (5.5%).

Teach patients to recognize and immediately report signs or symptoms of the aforementioned conditions. Evaluate patients 4 to 6 weeks after insertion of Mirena or Skyla and then yearly or more often if clinically indicated.

For important information about Mirena, please see the Prescribing Information.

For important information about Skyla, please see the Prescribing Information.



For the proper insertion and removal instructions,
choose which Mirena® product you are using.

NDC 50419-421-01
NDC 50419-423-01

PLEASE READ!

This video features the insertion instructions for the original inserter for
Mirena ® (levonorgestrel-releasing intrauterine system) 52 mg (NDC# 50419-421-01)

To view the updated Prescribing Information for the Bayer Inserter for Mirena (NDC# 50419-423-01)

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