Mirena (Levonorgestrel)
Dosage & administration
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Mirena prescribing information
Mirena is a progestin-containing intrauterine system (IUS) indicated for:
• Prevention of pregnancy for up to 8 years ()1.1 ContraceptionMirena is indicated for prevention of pregnancy for up to 8 years; replace after the end of the eighth year.
• Treatment of heavy menstrual bleeding for women who choose to use intrauterine contraception as their method of contraception for up to 5 years. ()1.2 Heavy Menstrual BleedingMirena is indicated for the treatment of heavy menstrual bleeding for up to 5 years in women who choose to use intrauterine contraception as their method of contraception; replace after the end of the fifth year if continued treatment of heavy menstrual bleeding is needed.
• Release rate of levonorgestrel (LNG) is 21 mcg/day after 24 days; this rate is reduced to about 11 mcg/day after 5 years and 7 mcg/day after 8 years. ()2.1 Dosing Over TimeMirena contains 52 mg of levonorgestrel (LNG) released in vivo, at a rate of approximately 21 mcg/day after 24 days. This rate decreases progressively to approximately 11 mcg/day after 5 years and 7 mcg/day after 8 years.
For contraception, remove Mirena by the end of the eighth year and replace at the time of removal with a new Mirena if continued use is desired.
For treatment of heavy menstrual bleeding, replace Mirena by the end of the fifth year if continued use is needed because data on use in this indication beyond 5 years are limited.
Mirena is supplied in a sterile package within an inserter that enables single-handed loading (see Figure 1). Do not open the package until required for insertion
[see Description (11.2)].Do not use if the seal of the sterile package is broken or appears compromised. Use strict aseptic techniques throughout the insertion procedure[see Warnings and Precautions (5.3)].
Mirena and Inserter • To be inserted by a trained healthcare provider using strict aseptic technique. Follow insertion instructions exactly as described.• Patient should be re-examined and evaluated 4 to 6 weeks after insertion; then, yearly or more often if clinically indicated.
Mirena is a LNG-releasing IUS (a type of intrauterine device, or IUD) consisting of a T-shaped polyethylene frame with a steroid reservoir containing a total of 52 mg LNG.
The use of Mirena is contraindicated in pregnancy or with a suspected pregnancy and Mirena may cause adverse pregnancy outcomes
The use of Mirena is contraindicated when one or more of the following conditions exist:
• Pregnancy or suspicion of pregnancy[see Warnings and Precautions , Use in Specific Populations ]• For use as post-coital contraception (emergency contraception)• Congenital or acquired uterine anomaly including fibroids, that distorts the uterine cavity• Acute pelvic inflammatory disease (PID) or a history of PID unless there has been a subsequent intrauterine pregnancy[see Warnings and Precautions ]• Postpartum endometritis or infected abortion in the past 3 months• Known or suspected uterine or cervical malignancy• Known or suspected breast cancer or other progestin-sensitive cancer, now or in the past• Uterine bleeding of unknown etiology• Untreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections until infection is controlled• Acute liver disease or liver tumor (benign or malignant)• Conditions associated with increased susceptibility to pelvic infections[see Warnings and Precautions ]• A previously inserted intrauterine device (IUD) that has not been removed• Hypersensitivity to any component of this product[see Adverse Reactions (6.2) and Description ]
• Pregnancy or suspicion of pregnancy. Cannot be used for post-coital contraception (emergency contraception) .• Congenital or acquired uterine anomaly if it distorts the uterine cavity• Acute pelvic inflammatory disease (PID) or a history of PID unless there has been a subsequent intrauterine pregnancy• Postpartum endometritis or infected abortion in the past 3 months• Known or suspected uterine or cervical malignancy• Known or suspected breast cancer or other progestin-sensitive cancer• Uterine bleeding of unknown etiology• Untreated acute cervicitis or vaginitis or other lower genital tract infections• Acute liver disease or liver tumor (benign or malignant)• Increased susceptibility to pelvic infection• A previous intrauterine device (IUD) that has not been removed• Hypersensitivity to any component of Mirena
There have been isolated cases of virilization of the external genitalia of the female fetus following local exposure to LNG during pregnancy with an LNG IUS in place.
The use of Mirena is contraindicated when one or more of the following conditions exist:
• Pregnancy or suspicion of pregnancy[see Warnings and Precautions (), Use in Specific Populations (5.2 Risks with Intrauterine PregnancyIf pregnancy occurs while using Mirena, remove Mirena because leaving it in place may increase the risk of spontaneous abortion and preterm labor. Removal of Mirena or probing of the uterus may also result in spontaneous abortion. In the event of an intrauterine pregnancy with Mirena, consider the following:
Septic abortionIn patients becoming pregnant with an IUS in place, septic abortion - with septicemia, septic shock, and death - may occur.
Continuation of pregnancyIf a woman becomes pregnant with Mirena in place and if Mirena cannot be removed or the woman chooses not to have it removed, warn her that failure to remove Mirena increases the risk of miscarriage, sepsis, premature labor and premature delivery. Advise her of isolated reports of virilization of the female fetus following local exposure to LNG during pregnancy with an LNG IUS in place
[see Use in Specific Populations (8.1)].Follow her pregnancy closely and advise her to report immediately any symptom that suggests complications of the pregnancy.)]8.1 PregnancyRisk SummaryThe use of Mirena is contraindicated in pregnancy or with a suspected pregnancy and Mirena may cause adverse pregnancy outcomes
[see Contraindications (If a woman becomes pregnant with Mirena in place, the likelihood of ectopic pregnancy is increased and there is an increased risk of miscarriage, sepsis, premature labor, and premature delivery4), Warnings and Precautions (5.1,5.2)]..Remove Mirena, if possible, if pregnancy occurs in a woman using Mirena. If Mirena cannot be removed, follow the pregnancy closely[see Warnings and Precautions (.5.1,5.2)]There have been isolated cases of virilization of the external genitalia of the female fetus following local exposure to LNG during pregnancy with an LNG IUS in place.
• For use as post-coital contraception (emergency contraception)• Congenital or acquired uterine anomaly including fibroids, that distorts the uterine cavity• Acute pelvic inflammatory disease (PID) or a history of PID unless there has been a subsequent intrauterine pregnancy[see Warnings and Precautions ()]5.4 Pelvic InfectionPromptly examine users with complaints of lower abdominal or pelvic pain, odorous discharge, unexplained bleeding, fever, genital lesions or sores. Remove Mirena in cases of recurrent endometritis or PID, or if an acute pelvic infection is severe or does not respond to treatment.
Pelvic Inflammatory Disease (PID)Mirena is 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
[see Contraindications (4)].IUDs have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion. In clinical trials, total combined upper genital infections were reported in 3.5% of Mirena users. More specifically, endometritis was reported in 2.1%, PID in 0.6%, and all other upper genital infections in ≤0.5% of women overall. These infections occurred more frequently within the first year. In a clinical trial with other IUDs1and a clinical trial with an IUD similar to Mirena, the highest rate occurred within the first month after insertion.Women at increased risk for PIDPID is often associated with a sexually transmitted infection (STI), and Mirena does not protect against STI. The risk of PID is greater for women who have multiple sexual partners, and also for women whose sexual partner(s) have multiple sexual partners. Women who have had PID are at increased risk for a recurrence or re-infection. In particular, ascertain whether the woman is at increased risk of infection (for example, leukemia, acquired immune deficiency syndrome [AIDS], intravenous drug abuse).
Subclinical PIDPID may be asymptomatic but still result in tubal damage and its sequelae.
Treatment of PIDFollowing a diagnosis of PID, or suspected PID, bacteriologic specimens should be obtained, and antibiotic therapy should be initiated promptly. Removal of Mirena after initiation of antibiotic therapy is usually appropriate.1
ActinomycosisActinomycosis has been associated with IUDs. Remove Mirena from symptomatic women and treat with antibiotics. The significance of actinomyces-like organisms on Pap smear in an asymptomatic IUD user is unknown, and so this finding alone does not always require Mirena removal and treatment. When possible, confirm a Pap smear diagnosis with cultures.
• Postpartum endometritis or infected abortion in the past 3 months• Known or suspected uterine or cervical malignancy• Known or suspected breast cancer or other progestin-sensitive cancer, now or in the past• Uterine bleeding of unknown etiology• Untreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections until infection is controlled• Acute liver disease or liver tumor (benign or malignant)• Conditions associated with increased susceptibility to pelvic infections[see Warnings and Precautions ()]5.4 Pelvic InfectionPromptly examine users with complaints of lower abdominal or pelvic pain, odorous discharge, unexplained bleeding, fever, genital lesions or sores. Remove Mirena in cases of recurrent endometritis or PID, or if an acute pelvic infection is severe or does not respond to treatment.
Pelvic Inflammatory Disease (PID)Mirena is 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
[see Contraindications (4)].IUDs have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion. In clinical trials, total combined upper genital infections were reported in 3.5% of Mirena users. More specifically, endometritis was reported in 2.1%, PID in 0.6%, and all other upper genital infections in ≤0.5% of women overall. These infections occurred more frequently within the first year. In a clinical trial with other IUDs1and a clinical trial with an IUD similar to Mirena, the highest rate occurred within the first month after insertion.Women at increased risk for PIDPID is often associated with a sexually transmitted infection (STI), and Mirena does not protect against STI. The risk of PID is greater for women who have multiple sexual partners, and also for women whose sexual partner(s) have multiple sexual partners. Women who have had PID are at increased risk for a recurrence or re-infection. In particular, ascertain whether the woman is at increased risk of infection (for example, leukemia, acquired immune deficiency syndrome [AIDS], intravenous drug abuse).
Subclinical PIDPID may be asymptomatic but still result in tubal damage and its sequelae.
Treatment of PIDFollowing a diagnosis of PID, or suspected PID, bacteriologic specimens should be obtained, and antibiotic therapy should be initiated promptly. Removal of Mirena after initiation of antibiotic therapy is usually appropriate.1
ActinomycosisActinomycosis has been associated with IUDs. Remove Mirena from symptomatic women and treat with antibiotics. The significance of actinomyces-like organisms on Pap smear in an asymptomatic IUD user is unknown, and so this finding alone does not always require Mirena removal and treatment. When possible, confirm a Pap smear diagnosis with cultures.
• A previously inserted intrauterine device (IUD) that has not been removed• Hypersensitivity to any component of this product[see Adverse Reactions () and Description ]6.2 Postmarketing ExperienceAdverse Reactions from Postmarketing Spontaneous ReportsThe following adverse reactions have been identified during post approval use of Mirena. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Arterial thrombotic and venous thromboembolic events, including cases of pulmonary embolism, deep vein thrombosis and stroke• Device breakage• Hypersensitivity (including rash, urticaria and angioedema)• Increased blood pressure
Reported Adverse Reactions from Postmarketing StudiesAssessment of Perforation and Expulsion of Intrauterine Devices (APEX IUD) StudyAPEX IUD was a large US retrospective cohort study to assess the impact of breastfeeding and timing of postpartum IUD insertion on uterine perforation and IUD expulsion. The analyses included a total of 326,658 insertions, 30% (97,824 insertions) of which were performed in women with a delivery in the previous 12 months. For insertions performed in women who had delivered ≤ 52 weeks before IUD insertion, the majority of postpartum insertions, 57.3% (56,047 insertions) occurred between 6 and 14 weeks postpartum. Breastfeeding data were available in 94,817 insertions performed in women 52 weeks or less after delivery.
The study results indicated that the risk of uterine perforation was highest in women with IUD insertion ≤ 6 weeks postpartum. Immediate postpartum insertion (0–3 days) findings are limited due to the relatively small number of insertions occurring within this time interval. Women who were breastfeeding at the time of insertion were at 33% higher risk of perforation (adjusted hazard ratio [HR]=1.33, 95% confidence interval [CI]: 1.07–1.64) compared to women who were not breastfeeding at the time of insertion. Progressively lower risk of uterine perforation was observed in postpartum time windows beyond 6 weeks, in both breastfeeding and not breastfeeding women. Table 3 presents the uterine perforation rates for LNG IUS stratified by breastfeeding status and postpartum interval.
Table 3: Uterine Perforation1 rates for LNG IUS, by Breastfeeding Status and Postpartum Interval Breastfeeding at time of insertionNot breastfeeding at time of insertionPostpartum interval at time of insertionNumber of events/ insertions
Uterine perforation rate per 1,000 insertions
Number of events/ insertions
Uterine perforation rate
per 1,000 insertions0 to 3 days8/1,896
4.22
0/277
0.00
4 days to ≤ 6 weeks120/10,735
11.18
28/2,377
11.78
> 6 to ≤ 14 weeks268/29,677
9.03
80/12,011
6.66
> 14 to ≤ 52 weeks43/6,139
7.00
22/9,089
2.42
> 52 weeks or no deliveryno data available
243/184,733
1.32
Risk of expulsion was variable over the postpartum intervals through 52 weeks. Women who were breastfeeding were at 28% lower risk of IUD expulsion (adjusted HR=0.72, 95% CI: 0.64-0.80) compared to women who were not breastfeeding at time of insertion. Table 4 presents the IUD expulsion rates for LNG IUS stratified by breastfeeding status and postpartum interval.
Table 4: Expulsion1 Rates for LNG IUS, by Breastfeeding Status and Postpartum Interval Breastfeeding at time of insertionNot breastfeeding at time of insertionPostpartum interval at time of insertionNumber of events/ insertions
Expulsion rate
per 1,000 insertionsNumber of events/ insertions
Expulsion rate
per 1,000 insertions0 to 3 days187/1,896
98.63
12/277
43.32
4 days to ≤ 6 weeks185/10,735
17.23
52/2,377
21.88
> 6 to ≤ 14 weeks421/29,677
14.19
306/12,011
25.48
> 14 to ≤ 52 weeks120/6,139
19.55
273/9,089
30.04
> 52 weeks or no deliveryno data available
5,481/184,733
29.67
1Expulsion includes both complete and partial expulsion
• Remove Mirena if pregnancy occurs with Mirena in place. If pregnancy occurs, there is increased risk of ectopic pregnancy including loss of fertility, pregnancy loss, septic abortion (including septicemia, shock and death), and premature labor and delivery. (,5.1 Risk of Ectopic PregnancyEvaluate women for ectopic pregnancy if they become pregnant with Mirena in place because the likelihood of a pregnancy being ectopic is increased with Mirena. Approximately one-half of pregnancies that occur with Mirena in place are likely to be ectopic. 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.
The incidence of ectopic pregnancy in clinical trials with Mirena, which excluded women with a history of ectopic pregnancy, was approximately 0.1% per year. The risk of ectopic pregnancy, in women who have a history of ectopic pregnancy and use Mirena is unknown. Women with a previous history of ectopic pregnancy, tubal surgery or pelvic infection carry a higher risk of ectopic pregnancy. Ectopic pregnancy may result in loss of fertility.
)5.2 Risks with Intrauterine PregnancyIf pregnancy occurs while using Mirena, remove Mirena because leaving it in place may increase the risk of spontaneous abortion and preterm labor. Removal of Mirena or probing of the uterus may also result in spontaneous abortion. In the event of an intrauterine pregnancy with Mirena, consider the following:
Septic abortionIn patients becoming pregnant with an IUS in place, septic abortion - with septicemia, septic shock, and death - may occur.
Continuation of pregnancyIf a woman becomes pregnant with Mirena in place and if Mirena cannot be removed or the woman chooses not to have it removed, warn her that failure to remove Mirena increases the risk of miscarriage, sepsis, premature labor and premature delivery. Advise her of isolated reports of virilization of the female fetus following local exposure to LNG during pregnancy with an LNG IUS in place
[see Use in Specific Populations (8.1)].Follow her pregnancy closely and advise her to report immediately any symptom that suggests complications of the pregnancy.• Group A streptococcal infection has been reported following insertion of LNG IUS; strict aseptic technique is essential during insertion. ()5.3 SepsisSevere infection or sepsis, including Group A streptococcal sepsis (GAS), have been reported following insertion of Mirena. In some cases, severe pain occurred within hours of insertion followed by sepsis within days. Because death from GAS is more likely if treatment is delayed, it is important to be aware of these rare but serious infections. Aseptic technique during insertion of Mirena is essential in order to minimize serious infections such as GAS.
• Before using Mirena, consider the risks of PID. ()5.4 Pelvic InfectionPromptly examine users with complaints of lower abdominal or pelvic pain, odorous discharge, unexplained bleeding, fever, genital lesions or sores. Remove Mirena in cases of recurrent endometritis or PID, or if an acute pelvic infection is severe or does not respond to treatment.
Pelvic Inflammatory Disease (PID)Mirena is 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
[see Contraindications (4)].IUDs have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion. In clinical trials, total combined upper genital infections were reported in 3.5% of Mirena users. More specifically, endometritis was reported in 2.1%, PID in 0.6%, and all other upper genital infections in ≤0.5% of women overall. These infections occurred more frequently within the first year. In a clinical trial with other IUDs1and a clinical trial with an IUD similar to Mirena, the highest rate occurred within the first month after insertion.Women at increased risk for PIDPID is often associated with a sexually transmitted infection (STI), and Mirena does not protect against STI. The risk of PID is greater for women who have multiple sexual partners, and also for women whose sexual partner(s) have multiple sexual partners. Women who have had PID are at increased risk for a recurrence or re-infection. In particular, ascertain whether the woman is at increased risk of infection (for example, leukemia, acquired immune deficiency syndrome [AIDS], intravenous drug abuse).
Subclinical PIDPID may be asymptomatic but still result in tubal damage and its sequelae.
Treatment of PIDFollowing a diagnosis of PID, or suspected PID, bacteriologic specimens should be obtained, and antibiotic therapy should be initiated promptly. Removal of Mirena after initiation of antibiotic therapy is usually appropriate.1
ActinomycosisActinomycosis has been associated with IUDs. Remove Mirena from symptomatic women and treat with antibiotics. The significance of actinomyces-like organisms on Pap smear in an asymptomatic IUD user is unknown, and so this finding alone does not always require Mirena removal and treatment. When possible, confirm a Pap smear diagnosis with cultures.
• Uterine perforation may occur and may reduce contraceptive effectiveness or require surgery. Risk is increased if inserted in lactating women and may be increased if inserted in women with fixed retroverted uteri or postpartum. (5.5 PerforationPerforation (total or partial, including penetration/embedment of Mirena in the uterine wall or cervix) may occur most often during insertion, although the perforation may not be detected until sometime later. The incidence of perforation during clinical trials, which excluded breast-feeding women, was < 0.1%.
The risk of uterine perforation is increased in women who have recently given birth, and in women who are breastfeeding at the time of insertion. In a large postmarketing safety study conducted in the US, the risk of uterine perforation was highest when insertion occurred within ≤ 6 weeks postpartum, and also higher with breastfeeding at the time of insertion
[see Adverse Reactions (6.2)].The risk of perforation may be increased if Mirena is inserted when the uterus is fixed, retroverted or not completely involuted.
If perforation occurs, locate and remove Mirena. Surgery may be required. Delayed detection or removal of Mirena in case of perforation may result in migration outside the uterine cavity, adhesions, peritonitis, intestinal perforations, intestinal obstruction, abscesses and erosion of adjacent viscera. In addition, perforation may reduce contraceptive efficacy and result in pregnancy.
• Partial or complete expulsion may occur, which can be unnoticed, leading to loss of contraceptive efficacy. ()5.6 ExpulsionPartial or complete expulsion of Mirena may occur resulting in the loss of efficacy. Expulsion may be associated with symptoms of bleeding or pain, or it may be asymptomatic and go unnoticed. Mirena typically decreases menstrual bleeding over time; therefore, an increase of menstrual bleeding may be indicative of an expulsion. Consider further diagnostic imaging, such as x-ray, if expulsion is suspected based on ultrasound [see Warnings and Precautions (5.10)]. In clinical trials, a 4.5% expulsion rate was reported over the 5-year study duration.
The risk of expulsion is increased with insertions immediately after delivery and appears to be increased with insertion after second-trimester abortion based on limited data. In a large postmarketing safety study conducted in the US, the risk of expulsion was lower with breastfeeding status
[see Adverse Reactions (6.2)].Remove a partially expelled Mirena. If expulsion has occurred, a new Mirena can be inserted any time the provider can be reasonably certain the woman is not pregnant.
• Evaluate persistent enlarged ovarian follicles or ovarian cysts. ()5.7 Ovarian CystsBecause the contraceptive effect of Mirena is mainly due to its local effects within the uterus, ovulatory cycles with follicular rupture usually occur in women of fertile age using Mirena. Ovarian cysts have been reported in approximately 8% of women using Mirena. Most cysts are asymptomatic, although some may be accompanied by pelvic pain or dyspareunia.
In most cases the ovarian cysts disappear spontaneously during two to three months observation. Evaluate persistent ovarian cysts. Surgical intervention is not usually required.
• Bleeding patterns become altered, may remain irregular and amenorrhea may ensue. ()5.5 PerforationPerforation (total or partial, including penetration/embedment of Mirena in the uterine wall or cervix) may occur most often during insertion, although the perforation may not be detected until sometime later. The incidence of perforation during clinical trials, which excluded breast-feeding women, was < 0.1%.
The risk of uterine perforation is increased in women who have recently given birth, and in women who are breastfeeding at the time of insertion. In a large postmarketing safety study conducted in the US, the risk of uterine perforation was highest when insertion occurred within ≤ 6 weeks postpartum, and also higher with breastfeeding at the time of insertion
[see Adverse Reactions (6.2)].The risk of perforation may be increased if Mirena is inserted when the uterus is fixed, retroverted or not completely involuted.
If perforation occurs, locate and remove Mirena. Surgery may be required. Delayed detection or removal of Mirena in case of perforation may result in migration outside the uterine cavity, adhesions, peritonitis, intestinal perforations, intestinal obstruction, abscesses and erosion of adjacent viscera. In addition, perforation may reduce contraceptive efficacy and result in pregnancy.