Mirena Drug Information

Generic name: LEVONORGESTREL

Progestin [EPC] Progestin-containing Intrauterine System [EPC]

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Uses of Mirena

  • Mirena is a progestin-containing intrauterine system (IUS) indicated for:
  • Prevention of pregnancy for up to 8 years ( 1.1 )
  • 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 ) 1.1 Contraception Mirena is indicated for prevention of pregnancy for up to 8 years; replace after the end of the eighth year. 1.2 Heavy Menstrual Bleeding Mirena 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.

Dosage & Administration of Mirena

Starting Mirena in women not currently using hormonal or intrauterine contraception
  • Insert Mirena any time there is reasonable certainty that the woman is not pregnant. Consider the possibility of ovulation and conception prior to initiation of this product [see Contraindications (4)].
  • If Mirena is inserted during the first seven days of the menstrual cycle or immediately after a first trimester abortion, back-up contraception is not needed.
  • If Mirena is not inserted during the first seven days of the menstrual cycle, a barrier method of contraception should be used, or the patient should abstain from vaginal intercourse for seven days to prevent pregnancy.
Switching to Mirena from an oral, transdermal, or vaginal hormonal contraceptive
  • Insert Mirena at any time, including during the hormone-free interval of the previous method.
  • If inserted during active use of the previous method, continue that method for 7 days after Mirena insertion or until the end of the current treatment cycle.
  • If the woman was using continuous hormonal contraception, discontinue that method seven days after Mirena insertion.
Switching to Mirena from an injectable progestin contraceptive
  • Insert Mirena at any time; a non-hormonal back-up birth control (such as condoms or spermicide) should also be used for 7 days if Mirena is inserted more than 3 months (13 weeks) after the last injection.
Switching to Mirena from a contraceptive implant or another IUS
  • Insert Mirena on the same day the implant or IUS is removed.
  • Insert Mirena at any time during the menstrual cycle.
Inserting Mirena after first-trimester abortion or miscarriage
  • Insert Mirena immediately after a first-trimester abortion or miscarriage, unless it is a septic abortion [see Contraindications (4)].
Inserting Mirena after childbirth or second-trimester abortion or miscarriage
  • Immediate insertion after childbirth or second-trimester abortion or miscarriage
  • Insert Mirena after removal of the placenta. Back-up contraception is not needed. [See Contraindications (4), Warnings and Precautions (5.5, 5.6), Adverse Reactions (6.2)].
Interval insertion following complete involution of the uterus
  • Wait a minimum of 6 weeks or until the uterus is fully involuted before inserting Mirena [see Warnings and Precautions (5.5, 5.6), Adverse Reactions (6.2)].
  • Insert Mirena any time there is reasonable certainty the woman is not pregnant.
  • If Mirena is not inserted during the first 7 days of the menstrual cycle, a back-up method of contraception should be used, or the woman should abstain from vaginal intercourse for 7 days to prevent pregnancy [see Contraindications (4), Warnings and Precautions (5.2)].

Side Effects of Mirena

  • The following serious or otherwise important adverse reactions are discussed in elsewhere in the labeling:
  • Ectopic Pregnancy [see Warnings and Precautions ( 5.1 )]
  • Intrauterine Pregnancy [see Warnings and Precautions ( 5.2 )]
  • Group A Streptococcal Sepsis (GAS) [see Warnings and Precautions ( 5.3 )]
  • Pelvic Inflammatory Disease [see Warnings and Precautions ( 5.4 )]
  • Perforation [see Warnings and Precautions ( 5.5 )]
  • Expulsion [see Warnings and Precautions ( 5.6 )]
  • Ovarian Cysts [see Warnings and Precautions ( 5.7 )]
  • Bleeding Pattern Alterations [see Warnings and Precautions ( 5.8 )] The most common adverse reactions (≥10% users) are alterations of menstrual bleeding patterns, abdominal/pelvic pain, amenorrhea, headache/migraine, genital discharge, and vulvovaginitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The data provided in Table 2 reflect the experience with the use of Mirena in the adequate and well-controlled studies as well as in the supportive and uncontrolled studies for contraception and heavy menstrual bleeding (n=5,091). The data cover more than 12,101 women-years of exposure up to 5 years of use, mainly in the contraception studies (11,761 women-years). The frequencies of reported adverse drug reactions represent crude incidences. The most common adverse reactions (≥10% users) are alterations of menstrual bleeding patterns [including unscheduled uterine bleeding (31.9%), decreased uterine bleeding (23.4%), increased scheduled uterine bleeding (11.9%), and female genital tract bleeding (3.5%)], abdominal/pelvic pain (22.6%), amenorrhea (18.4%), headache/migraine (16.3%), genital discharge (14.9%), and vulvovaginitis (10.5%). Adverse reactions reported in ≥ 5% of users are shown in Table 2. Table 2: Adverse Reactions ≥ 5% Reported in Clinical Trials with Mirena System Organ Class Adverse Reactions % (N= 5,091) Reproductive system and breast disorders alteration of menstrual bleeding pattern, including: unscheduled uterine bleeding decreased uterine bleeding increased scheduled uterine bleeding female genital tract bleeding 31.9 23.4 11.9 3.5 amenorrhea 18.4 genital discharge 14.9 vulvovaginitis 10.5 breast pain 8.5 benign ovarian cyst and associated complications 7.5 dysmenorrhea 6.4 Gastrointestinal disorders abdominal/pelvic pain 22.6 Nervous system disorders headache/migraine 16.3 Musculoskeletal and connective tissue disorders back pain 7.9 Skin and subcutaneous tissue disorders acne 6.8 Psychiatric disorders depression/depressive mood 6.4 Other adverse reactions occurring in <5% of subjects include alopecia, (partial and complete) device expulsion, hirsutism, nausea, and PID/endometritis. A separate study with 362 women who have used Mirena for more than 5 years showed a consistent adverse reaction profile in Years 6 through 8 as shown in Table 2. By the end of Year 8 of use, amenorrhea and infrequent bleeding are experienced by 34% and 26% of users, respectively; irregular bleeding occurs in 10%, frequent bleeding in 3%, and prolonged bleeding in 3% of users. In this study, 9% of women reported the adverse event of weight gain; it is unknown if the weight gain was caused by Mirena. 6.2 Postmarketing Experience Adverse Reactions from Postmarketing Spontaneous Reports The 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 Studies Assessment of Perforation and Expulsion of Intrauterine Devices (APEX IUD) Study APEX 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 insertion Not breastfeeding at time of insertion Postpartum interval at time of insertion Number of events/ insertions Uterine perforation rate per 1,000 insertions Number of events/ insertions Uterine perforation rate per 1,000 insertions 0 to 3 days 8/1,896 4.22 0/277 0.00 4 days to ≤ 6 weeks 120/10,735 11.18 28/2,377 11.78 > 6 to ≤ 14 weeks 268/29,677 9.03 80/12,011 6.66 > 14 to ≤ 52 weeks 43/6,139 7.00 22/9,089 2.42 > 52 weeks or no delivery no 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 insertion Not breastfeeding at time of insertion Postpartum interval at time of insertion Number of events/ insertions Expulsion rate per 1,000 insertions Number of events/ insertions Expulsion rate per 1,000 insertions 0 to 3 days 187/1,896 98.63 12/277 43.32 4 days to ≤ 6 weeks 185/10,735 17.23 52/2,377 21.88 > 6 to ≤ 14 weeks 421/29,677 14.19 306/12,011 25.48 > 14 to ≤ 52 weeks 120/6,139 19.55 273/9,089 30.04 > 52 weeks or no delivery no data available 5,481/184,733 29.67 1 Expulsion includes both complete and partial expulsion

Warnings & Cautions for Mirena

  • 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 , 5.2 )
  • Group A streptococcal infection has been reported following insertion of LNG IUS; strict aseptic technique is essential during insertion. ( 5.3 )
  • Before using Mirena, consider the risks of PID. ( 5.4 )
  • 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)
  • Partial or complete expulsion may occur, which can be unnoticed, leading to loss of contraceptive efficacy. ( 5.6 )
  • Evaluate persistent enlarged ovarian follicles or ovarian cysts. ( 5.7 )
  • Bleeding patterns become altered, may remain irregular and amenorrhea may ensue. ( 5.8 ) 5.1 Risk of Ectopic Pregnancy Evaluate 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 Pregnancy If 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 abortion In patients becoming pregnant with an IUS in place, septic abortion - with septicemia, septic shock, and death - may occur. Continuation of pregnancy If 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. 5.3 Sepsis Severe 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. 5.4 Pelvic Infection Promptly 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 IUDs 1 and a clinical trial with an IUD similar to Mirena, the highest rate occurred within the first month after insertion. Women at increased risk for PID PID 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 PID PID may be asymptomatic but still result in tubal damage and its sequelae. Treatment of PID Following 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 Actinomycosis Actinomycosis 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. 5.5 Perforation Perforation (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. 5.6 Expulsion Partial 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. 5.7 Ovarian Cysts Because 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. 5.8 Bleeding Pattern Alterations Mirena can alter the bleeding pattern and result in spotting, irregular bleeding, heavy bleeding, oligomenorrhea and amenorrhea. During the first 3–6 months of Mirena use, the number of bleeding and spotting days may be higher and bleeding patterns may be irregular. Thereafter the number of bleeding and spotting days usually decreases but bleeding may remain irregular. If bleeding irregularities develop during prolonged treatment, appropriate diagnostic measures should be taken to rule out endometrial pathology. Amenorrhea develops in approximately 20% of Mirena users by one year. If a significant change in bleeding develops during prolonged use, take appropriate diagnostic measures to rule out endometrial pathology. Consider the possibility of pregnancy if menstruation does not occur within six weeks of the onset of previous menstruation. Once pregnancy has been excluded, repeated pregnancy tests are generally not necessary in amenorrheic women unless indicated, for example, by other signs of pregnancy or by pelvic pain [see Clinical Studies ( 14.1 )]. In most women with heavy menstrual bleeding, the number of bleeding and spotting days may also increase during the initial months of therapy but usually decrease with continued use; the volume of blood loss per cycle progressively becomes reduced [see Clinical Studies ( 14.2 )]. 5.9 Breast Cancer Women who currently have or have had breast cancer, or have a suspicion of breast cancer, should not use hormonal contraception, including Mirena, because some breast cancers are hormone-sensitive [see Contraindications ( 4 )]. Spontaneous reports of breast cancer have been received during postmarketing experience with Mirena. Observational studies of the risk of breast cancer with use of a LNG-releasing IUS do not provide conclusive evidence of increased risk. 5.10 Clinical Considerations for Use and Removal Use Mirena with caution after careful assessment if any of the following conditions exist, and consider removal of the system if any of them arise during use:
  • Coagulopathy or use of anticoagulants
  • Migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia
  • Exceptionally severe headache
  • Marked increase of blood pressure
  • Severe arterial disease such as stroke or myocardial infarction In addition, consider removing Mirena if any of the following conditions arise during use [see Contraindications ( 4 )] :
  • Uterine or cervical malignancy
  • Jaundice If the threads are not visible or are significantly shortened, they may have broken or retracted into the cervical canal or uterus. Consider the possibility that the system may have been displaced (for example, expelled or perforated the uterus) [see Warnings and Precautions ( 5.5 , 5.6 )]. Exclude pregnancy and verify the location of Mirena, for example, by sonography, X-ray, or by gentle exploration of the cervical canal with a suitable instrument. If Mirena is displaced, remove it. A new Mirena may be inserted at that time or during the next menses if it is certain that conception has not occurred. If Mirena is in place with no evidence of perforation, no intervention is indicated.

Drug Interactions with Mirena

No drug-drug interaction studies have been conducted with Mirena. Drugs or herbal products that induce or inhibit LNG metabolizing enzymes, including CYP3A4, may decrease or increase, respectively, the serum concentrations of LNG during the use of Mirena. However, the contraceptive effect of Mirena is mediated via the direct release of LNG into the uterine cavity and is unlikely to be affected by drug interactions via enzyme induction or inhibition.

Pregnancy Safety for Mirena

Pregnancy Risk Summary The use of Mirena is contraindicated in pregnancy or with a suspected pregnancy and Mirena may cause adverse pregnancy outcomes. 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 delivery. Remove Mirena, if possible, if pregnancy occurs in a woman using Mirena.

If Mirena cannot be removed, follow the pregnancy closely . 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.

Pediatric Use of Mirena

Pediatric Use Safety and efficacy of Mirena have been established in women of reproductive age. Efficacy is expected to be the same for postpubertal females under the age of 18 as for users 18 years and older. Use of this product before menarche is not indicated.

Contraindications for Mirena

  • The use of Mirena is contraindicated when one or more of the following conditions exist:
  • Pregnancy or suspicion of pregnancy [see Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8.1 )]
  • 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 )]
  • 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 )]
  • 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 ( 11.1 )]
  • Pregnancy or suspicion of pregnancy. Cannot be used for post-coital contraception (emergency contraception) ( 4 ).
  • Congenital or acquired uterine anomaly if it distorts the uterine cavity ( 4 )
  • Acute pelvic inflammatory disease (PID) or a history of PID unless there has been a subsequent intrauterine pregnancy ( 4 )
  • Postpartum endometritis or infected abortion in the past 3 months ( 4 )
  • Known or suspected uterine or cervical malignancy ( 4 )
  • Known or suspected breast cancer or other progestin-sensitive cancer ( 4 )
  • Uterine bleeding of unknown etiology ( 4 )
  • Untreated acute cervicitis or vaginitis or other lower genital tract infections ( 4 )
  • Acute liver disease or liver tumor (benign or malignant) ( 4 )
  • Increased susceptibility to pelvic infection ( 4 )
  • A previous intrauterine device (IUD) that has not been removed ( 4 )
  • Hypersensitivity to any component of Mirena ( 4 )

Clinical Studies of Mirena

Clinical Trials on Contraception

The safety and effectiveness of Mirena was studied in two clinical trials in Finland and Sweden. In these trials, 1,169 women 18 to 35 years of age at enrollment used Mirena for up to 5 years, for a total of 45,000 women-months of exposure. Of these, 5.6% were nulliparous women.

Subjects had previously been pregnant, had no history of ectopic pregnancy, had no history of pelvic inflammatory disease over the preceding 12 months, were predominantly White, and over 70% of the subjects had previously used IUDs (intrauterine devices). The reported 12-month pregnancy rates were less than or equal to 0.2 per 100 women (0.2%) and the cumulative 5-year pregnancy rate was approximately 0.7 per 100 women (0.7%). The contraceptive efficacy of Mirena during extended use beyond 5 years was studied in the Mirena Extension Trial (NCT02985541), a multi-center, open-label, uncontrolled study conducted in the United States. The trial enrolled women 18 to 35 years of age who had been using Mirena for not less than 4.5 years and not more than 5 years at enrollment. The population consisted of 362 women using Mirena.

Of these 47.2% were nulliparous. The women were predominantly White (75.4%); 14.1% of the women were Black/African American, and 2.5% were Asian; 11.3 % were Hispanic. The weight range was 38.5–163.5 kg (mean weight: 75.6 kg) and mean BMI was 27.9 kg/m 2 (range: 15.4–57.7 kg/m 2 ). The pregnancy rate calculated as the Pearl Index (PI) was the primary efficacy endpoint used to assess contraceptive efficacy.

The PI was based on 28-day equivalent exposure cycles; evaluable cycles excluded those in which back-up contraception was used unless a pregnancy occurred in that cycle. The PI for the 6th year of use based on the 1 pregnancy that occurred during Year 6 and within 7 days after Mirena removal or expulsion and 3,870 evaluable cycles was 0.34 with a 95% upper confidence limit of 1.88, and the PI for the 7th year of use based on the 1 pregnancy that occurred during Year 7 and within 7 days after Mirena removal or expulsion and 3,232 evaluable cycles was 0.40 with a 95% upper confidence limit of 2.25. The PI for the 8th year of use based on no pregnancies occurring during Year 8 and within 7 days after Mirena removal or expulsion and 2,534 evaluable cycles was 0.00 with a 95% upper confidence limit of 1.90. The cumulative 3-year pregnancy rate for Years 6, 7 and 8 was estimated by the Kaplan-Meier method. Based on 2 pregnancies (1 in Year 6 and 1 in Year 7) and 10,216 exposure cycles, the cumulative pregnancy rate at the end of the 3-year period of extended use (Years 6, 7 and 8) was 0.68% with a 95% upper confidence limit of 2.71%.

Clinical Trial on Heavy Menstrual Bleeding

The efficacy of Mirena in the treatment of heavy menstrual bleeding was studied in a randomized, open-label, active-control, parallel-group trial comparing Mirena (n=79) to an approved therapy, medroxyprogesterone acetate (MPA) (n=81), over 6 cycles. The subjects included reproductive-aged women in good health, with no contraindications to the drug products and with confirmed heavy menstrual bleeding (≥ 80 mL menstrual blood loss ) determined using the alkaline hematin method. Excluded were women with organic or systemic conditions that may cause heavy uterine bleeding (except small fibroids, with total volume not > 5 mL). Treatment with Mirena showed a statistically significantly greater reduction in MBL (see Figure 12) and a statistically significantly greater number of subjects with successful treatment (see Figure 13). Successful treatment was defined as proportion of subjects with end-of-study MBL < 80 mL and a ≥ 50% decrease in MBL from baseline to end-of-study.

Figure 12: Median Menstrual Blood Loss (MBL) by Time and Treatment Figure 13: Proportion of Subjects with Successful Treatment MBL Figure fig 13Proportion of Subjects with Successful Treatment

Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.

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