Mirena Levonorgestrel 52 mg Intrauterine Device, 1 intrauterine — NDC 50419-423-01 (Billing 50419-0423-01)
This is a package of 1 intrauterine of Mirena Levonorgestrel 52 mg Intrauterine Device from Bayer HealthCare Pharmaceuticals Inc., marketed since Oct 2009 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 023725
- GCN: 11639
- GPI-14 (Medi-Span): 25200050005324
- HICL (First Databank): 007318
- AHFS class code: 68:12.00.00
- RxCUI (RxNorm): 804156
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Progestin class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It comes in two main types. The intrauterine systems (Mirena, Liletta, Kyleena, Skyla) prevent pregnancy for years, and Mirena and Liletta also treat heavy menstrual bleeding. The...
- Take it as soon as you can, within 72 hours (3 days) of unprotected sex. The sooner you take it, the better it works. If you vomit within 2 hours, call a healthcare professional to...
- How do I take the emergency contraceptive tablet?
- No. It's a backup method and isn't as effective as regular birth control. It also won't work if you're already pregnant, and it doesn't protect against HIV or other STDs.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Levonorgestrel — tap one for details:
Levonorgestrel may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $1,219.92 | $1,219.92 / 1 intrauterine |
| Medicare drug plans payPart D · Q2 2026 | $1,252.97 | $1,252.97 / 1 intrauterine |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 50419-0423-01 You're viewing this Main listing | 1 INTRAUTERINE DEVICE in 1 CARTON | 2014-05-30 | — | Active |
| 50419-0423-08 50419-423-08 | 1 INTRAUTERINE DEVICE in 1 CARTON | 2016-12-08 | — | Active |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 50419-0423-08?
What NDC number is used to bill for this package of Mirena Levonorgestrel 52 mg Intrauterine Device?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Mirena 52 mgthis 50419-0423-01 | Bayer | 1 intrauterine | — | — | FDA listed | — |
| Liletta 52 mg 00023-5858-01 | Allergan, | 1 intrauterine | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 11850182 ↗ | Method of use | U-3819 | Sep 14, 2029 |
| US 10561524 ↗ | Method of use | U-2948 | Sep 16, 2029 |
Is there a generic version of MIRENA 52 MG SYSTEM?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII 25BB7EKE2E
Barium sulfate is a white powder mineral compound used as a filler and opacifying agent in tablets and capsules. It adds bulk to the medicine and may be included in formulations for imaging purposes.
-
UNII 92RU3N3Y1O
Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
2 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE 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 )
1.1Contraception Mirena is indicated for prevention of pregnancy for up to 8 years; replace after the end of the eighth year.
1.2Heavy 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 and Administration ▾
2 DOSAGE AND ADMINISTRATION • 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 ) • To be inserted by a trained healthcare provider using strict aseptic technique. Follow insertion instructions exactly as described.
( 2.2 ) • Patient should be re-examined and evaluated 4 to 6 weeks after insertion; then, yearly or more often if clinically indicated. ( 2.3 )
2.1Dosing Over Time Mirena 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
2.2Insertion Instructions • Obtain a complete medical and social history to determine conditions that might influence the selection of a levonorgestrel-releasing intrauterine system (LNG IUS) for contraception . If indicated, perform a physical examination, and appropriate tests for any forms of genital or other sexually transmitted infections. [See Contraindications ( 4 ) and Warnings and Precautions ( 5.10 ).] Because irregular bleeding/spotting is common during the first months of Mirena use, exclude endometrial pathology (polyps or cancer) prior to the insertion of Mirena in women with persistent or uncharacteristic bleeding [see Warnings and Precautions ( 5.8 )]. • Follow the insertion instructions exactly as described to ensure proper placement and avoid premature release of Mirena from the inserter.
Once released, Mirena cannot be re-loaded . • Check expiration date of Mirena prior to initiating insertion. • Mirena should be inserted by a trained healthcare provider. Healthcare providers should become thoroughly familiar with the insertion instructions before attempting insertion of Mirena. • Insertion may be associated with some pain and/or bleeding or vasovagal reactions (for example, syncope, bradycardia), or with seizure, especially in patients with a predisposition to these conditions. Consider administering analgesics prior to insertion.
Timing of Insertion Table 1: When to Insert 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 Mi… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 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. • One sterile intrauterine system consisting of a T-shaped polyethylene frame with a steroid reservoir containing 52 mg levonorgestrel packaged within a sterile inserter ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS 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 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • 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 )
5.1Risk 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.
5.2Risks 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.
5.3Sepsis 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.
5.4Pelvic 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 )].… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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.
6.1Clinical 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
6.4Other 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.
6.2Postmarketing 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. • Arteri… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS 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.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary The use of Mirena is contraindicated in pregnancy or with a suspected pregnancy and Mirena may cause adverse pregnancy outcomes [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 , 5.2 )]. 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 [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.
8.2Lactation Risk Summary Published studies report the presence of LNG in human milk. Small amounts of progestins (approximately 0.1% of the total maternal doses) were detected in the breast milk of nursing mothers who used Mirena, resulting in exposure of LNG to the breastfed infants. There are no reports of adverse effects in breastfed infants with maternal use of progestin-only contraceptives.
Isolated cases of decreased milk production have been reported with Mirena. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Mirena and any potential adverse effects on the breastfed child from Mirena or from the underlying maternal condition.
8.3Females and Males of Reproductive Potential Return to Fertility After Discontinuing Mirena In two studies, return to fertility was investigated in a total of 229 women who desired pregnancy after study discontinuation and provided follow-up information. The probability to conceive within 12 months after removal of Mirena was approximately 80%.
8.4Pediatric 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.
8.5Geriatric Use Mirena has not been studied in women over age 65 and is not approved for use in this population.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary The use of Mirena is contraindicated in pregnancy or with a suspected pregnancy and Mirena may cause adverse pregnancy outcomes [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 , 5.2 )]. 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 [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.
🧒 Pediatric Use ▾
8.4Pediatric 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.
🧓 Geriatric Use ▾
8.5Geriatric Use Mirena has not been studied in women over age 65 and is not approved for use in this population.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The local mechanism by which continuously released LNG contributes to the contraceptive effectiveness of Mirena has not been conclusively demonstrated. Studies of Mirena and similar LNG IUS prototypes have suggested several mechanisms that prevent pregnancy: thickening of cervical mucus preventing passage of sperm into the uterus, inhibition of sperm capacitation or survival, and alteration of the endometrium .
12.2Pharmacodynamics Mirena has mainly local progestogenic effects in the uterine cavity. The local concentrations of LNG lead to morphological changes including stromal pseudodecidualization, glandular atrophy, a leukocytic infiltration and a decrease in glandular and stromal mitoses. Ovulation is inhibited in some women using Mirena.
In a 1-year study, approximately 45% of menstrual cycles were ovulatory, and in another study after 4 years, 75% of cycles were ovulatory.
12.3Pharmacokinetics Absorption Low doses of LNG are administered into the uterine cavity with the Mirena intrauterine delivery system. Estimated in vivo release rates for different points in time are provided in Table 5. Table 5: Estimated in vivo release rates for Mirena: Time Estimated in vivo release rate [μg/day] (rounded) 24 days after insertion 21 60 days after insertion 21 1 year after insertion 19 3 years after insertion 14 5 years after insertion 11 6 years after insertion 9 7 years after insertion 8 8 years after insertion 7 Average over 1st year 20 Average over 3 years 18 Average over 5 years 15 Average over 8 years 13 After insertion of Mirena, LNG is detectable in serum/plasma after 1 hour.
The maximum concentration is reached within 2 weeks after insertion and amounts to about 180 ng/L (CV 38%). In correspondence with the declining release rate, the geometric mean serum/plasma concentration of levonorgestrel declines continuously: Table 6: Estimated Total LNG Mean Plasma Concentrations Time after insertion Total LNG plasma concentrations [ng/L] (geometric CV%) 24 days 175 (37.6) 2 months 169 (37.1) 1 year 159 (37.4) 3 years 139 (37.8) 5 years 123 (38.2) 8 years 100 (39.9) Distribution LNG is bound non-specifically to serum albumin and specifically to the Sex hormone-binding globulin (SHBG.) Less than 2% of the circulating LNG is present as free steroid.
Levonorgestrel binds with high affinity to SHBG. Accordingly, changes in the concentration of SHBG in serum result in an increase (at higher SHBG concentrations) or in a decrease (at lower SHBG concentrations) of the total levonorgestrel concentration in serum. The concentration of SHBG declined on average by about 20% during the two months after insertion of Mirena and remained stable during thereafter, increasing only slightly until the end of the 8 years of use.
The apparent volume of distribution of LNG is reported to be approximately
1.8L/kg. Elimination Following intravenous administration of 0.09 mg LNG to healthy volunteers, the total clearance of LNG is approximately 1 mL/min/kg and the elimination half-life is approximately 20 hours. Metabolic clearance rates may differ among individuals by several-fold, and this may account in part for wide individual variations in LNG concentrations seen in individuals using LNG–containing contraceptive products.
Metabolism Following absorption, LNG is extensively metabolized. The most important metabolic pathways are the reduction of the Δ4-3-oxo group and hydroxylations at positions 2α, 1β and 16β, followed by conjugation. Significant amounts of conjugated and unconjugated 3α, 5β-tetra-hydrolevonorgestrel are also present in serum, along with much smaller amounts of 3α, 5α-tetrahydrolevonorgestrel and 16β-hydroxylevonorgestrel.
CYP3A4 is the main enzyme involved in the oxidative metabolism of LNG. Excretion LNG and its phase I metabolites are excreted primarily as glucuronide conjugates. About 45% of LNG and its metabolites are excreted in the urine and about 32% are excreted in feces, mos… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action The local mechanism by which continuously released LNG contributes to the contraceptive effectiveness of Mirena has not been conclusively demonstrated. Studies of Mirena and similar LNG IUS prototypes have suggested several mechanisms that prevent pregnancy: thickening of cervical mucus preventing passage of sperm into the uterus, inhibition of sperm capacitation or survival, and alteration of the endometrium .
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Mirena (levonorgestrel-releasing intrauterine system), containing a total of 52 mg LNG, is available in a carton of one sterile unit NDC# 50419-423-01. Mirena is supplied sterile. Mirena is sterilized with ethylene oxide.
Do not resterilize. For single use only. Do not use if the inner package is damaged or open.
Insert before the end of the month shown on the label. Store at 25°C (77°F); with excursions permitted between 15–30°C (59–86°F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Mirena (levonorgestrel-releasing intrauterine system) contains 52 mg of LNG, a progestin, and is intended to provide an initial release rate of LNG of approximately 21 mcg/day after 24 days. Levonorgestrel USP, (-)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one, the active ingredient in Mirena, has a molecular weight of 312.4, a molecular formula of C 21 H 28 O 2 , and the following structural formula:
11.1Mirena Mirena consists of a T-shaped polyethylene frame (T-body) with a steroid reservoir (hormone elastomer core) around the vertical stem. The white T-body has a loop at one end of the vertical stem and two horizontal arms at the other end. The reservoir consists of a white or almost white cylinder, made of a mixture of LNG and silicone (polydimethylsiloxane), containing a total of 52 mg LNG.
The reservoir is covered by a semi-opaque silicone membrane, composed of polydimethylsiloxane and colloidal silica. The T-body is 32 mm in both the horizontal and vertical directions. The polyethylene of the T-body is compounded with barium sulfate, which makes it radiopaque.
A monofilament brown polyethylene removal thread is attached to a loop at the end of the vertical stem of the T-body. The polyethylene of the removal thread contains iron oxide as a colorant (see Figure 10 ). The components of Mirena, including its packaging, are not manufactured using natural rubber latex.
Figure 10: Mirena Mirena IUD
11.2Inserter Mirena is packaged sterile within an inserter. The inserter (Figure 11), which is used for insertion of Mirena into the uterine cavity, consists of a symmetric two-sided body and slider that are integrated with flange, lock, pre-bent insertion tube and plunger. The outer diameter of the insertion tube is 4.4 mm.
The vertical stem of Mirena is loaded in the insertion tube at the tip of the inserter. The arms are pre-aligned in the horizontal position. The removal threads are contained within the insertion tube and handle.
Once Mirena has been placed, the inserter is discarded. Figure 11: Diagram of Inserter Mirena Inserter Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information) • Sexually Transmitted Infections: Advise the patient that this product does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs). • Risk of Ectopic Pregnancy: Advise the patient about the risks of ectopic pregnancy, including the loss of fertility. Teach her to recognize and report to her healthcare provider promptly any symptoms of ectopic pregnancy. [See Warnings and Precautions ( 5.1 ).] • Risks of Intrauterine Pregnancy: Advise the patient to contact her healthcare provider if she thinks she might be pregnant.
Inform the patient about the risks of intrauterine pregnancy while using Mirena, including the risks of leaving Mirena in place and the risks of removing Mirena or probing of the uterus. If Mirena cannot be removed in a pregnant patient, advise her to report immediately any symptom that suggests complications of the pregnancy. 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 Warnings and Precautions ( 5.2 ) and Use in Special Populations ( 8.1 ).] • Sepsis: Counsel the patient that severe infection or sepsis, including Group A streptococcal sepsis (GAS), can occur within the first few days after Mirena is inserted.
Instruct her to contact a healthcare provider immediately if she develops severe pain or fever shortly after Mirena is inserted. [See Warnings and Precautions ( 5.3 ).] • Pelvic Infection: Advise the patient about the possibility of pelvic infections, including PID, and that these infections can cause tubal damage leading to ectopic pregnancy or infertility, or infrequently can necessitate hysterectomy, or cause death. Teach patients to recognize and report to their healthcare provider promptly any symptoms of pelvic infection.
These symptoms include development of menstrual disorders (prolonged or heavy bleeding), unusual vaginal discharge, abdominal or pelvic pain or tenderness, dyspareunia, chills, and fever. [See Warnings and Precautions ( 5.4 ).] • Perforation and Expulsion: Advise the patient that the IUS may be expelled from or perforate the uterus and instruct her on how she can check that the threads still protrude from the cervix. Inform her that excessive pain or vaginal bleeding during Mirena placement, worsening pain or bleeding after placement, or the inability to feel Mirena strings may occur with Mirena perforation and expulsion.
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. Instruct the patient to contact her healthcare provider if she cannot feel the threads and to avoid intercourse or use a non-hormonal back-up birth control (such as condoms or spermicide) until the location of Mirena has been confirmed.
Advise her that if perforation occurs, Mirena will have to be located and removed; surgery may be required. [See Warnings and Precautions ( 5.5 , 5.6 , 5.10 ).] • Ovarian Cysts: Advise the patient regarding the risk of ovarian cysts and that cysts can cause clinical symptoms including pelvic pain, abdominal pain or dyspareunia. Advise the patient to contact her healthcare provider if she experiences these symptoms. [ See Warnings and Precautions ( 5.7 ).] • Bleeding Pattern Alterations: Advise the patient that irregular or prolonged bleeding and spotting, and/or cramps may occur during the first few weeks after insertion.
Inform the patient that, 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. If her symptoms continue or are severe, she should report them to her healthcare provider. [See Warnings and Precautions ( 5.8 ).] • Clinical Considerations for Use and Removal: Advise the patient to contact her healthcare provider if she experiences any of the… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption Low doses of LNG are administered into the uterine cavity with the Mirena intrauterine delivery system. Estimated in vivo release rates for different points in time are provided in Table 5. Table 5: Estimated in vivo release rates for Mirena: Time Estimated in vivo release rate [μg/day] (rounded) 24 days after insertion 21 60 days after insertion 21 1 year after insertion 19 3 years after insertion 14 5 years after insertion 11 6 years after insertion 9 7 years after insertion 8 8 years after insertion 7 Average over 1st year 20 Average over 3 years 18 Average over 5 years 15 Average over 8 years 13 After insertion of Mirena, LNG is detectable in serum/plasma after 1 hour.
The maximum concentration is reached within 2 weeks after insertion and amounts to about 180 ng/L (CV 38%). In correspondence with the declining release rate, the geometric mean serum/plasma concentration of levonorgestrel declines continuously: Table 6: Estimated Total LNG Mean Plasma Concentrations Time after insertion Total LNG plasma concentrations [ng/L] (geometric CV%) 24 days 175 (37.6) 2 months 169 (37.1) 1 year 159 (37.4) 3 years 139 (37.8) 5 years 123 (38.2) 8 years 100 (39.9) Distribution LNG is bound non-specifically to serum albumin and specifically to the Sex hormone-binding globulin (SHBG.) Less than 2% of the circulating LNG is present as free steroid.
Levonorgestrel binds with high affinity to SHBG. Accordingly, changes in the concentration of SHBG in serum result in an increase (at higher SHBG concentrations) or in a decrease (at lower SHBG concentrations) of the total levonorgestrel concentration in serum. The concentration of SHBG declined on average by about 20% during the two months after insertion of Mirena and remained stable during thereafter, increasing only slightly until the end of the 8 years of use.
The apparent volume of distribution of LNG is reported to be approximately
1.8L/kg. Elimination Following intravenous administration of 0.09 mg LNG to healthy volunteers, the total clearance of LNG is approximately 1 mL/min/kg and the elimination half-life is approximately 20 hours. Metabolic clearance rates may differ among individuals by several-fold, and this may account in part for wide individual variations in LNG concentrations seen in individuals using LNG–containing contraceptive products.
Metabolism Following absorption, LNG is extensively metabolized. The most important metabolic pathways are the reduction of the Δ4-3-oxo group and hydroxylations at positions 2α, 1β and 16β, followed by conjugation. Significant amounts of conjugated and unconjugated 3α, 5β-tetra-hydrolevonorgestrel are also present in serum, along with much smaller amounts of 3α, 5α-tetrahydrolevonorgestrel and 16β-hydroxylevonorgestrel.
CYP3A4 is the main enzyme involved in the oxidative metabolism of LNG. Excretion LNG and its phase I metabolites are excreted primarily as glucuronide conjugates. About 45% of LNG and its metabolites are excreted in the urine and about 32% are excreted in feces, mostly as glucuronide conjugates.
Specific Populations Pediatric: Safety and efficacy of Mirena have been established in women of reproductive age. Use of this product before menarche is not indicated . Geriatric: Mirena has not been studied in women over age 65 and is not currently approved for use in this population .
Race: No studies have evaluated the effect of race on the pharmacokinetics of Mirena. Hepatic Impairment: No studies were conducted to evaluate the effect of hepatic disease on the disposition of Mirena . Renal Impairment: No formal studies were conducted to evaluate the effect of renal disease on the disposition of Mirena.
Drug-Drug Interactions No drug-drug interaction studies were conducted with Mirena [see Drug Interactions ( 7 )] .
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Mirena has mainly local progestogenic effects in the uterine cavity. The local concentrations of LNG lead to morphological changes including stromal pseudodecidualization, glandular atrophy, a leukocytic infiltration and a decrease in glandular and stromal mitoses. Ovulation is inhibited in some women using Mirena.
In a 1-year study, approximately 45% of menstrual cycles were ovulatory, and in another study after 4 years, 75% of cycles were ovulatory.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Clinical 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% (66) 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%.
14.2Clinical 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 [MBL]) 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 (1) end-of-study MBL < 80 mL and (2) 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
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility [See Warnings and Precautions ( 5.9 )]
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility [See Warnings and Precautions ( 5.9 )]
📚 References ▾
15 REFERENCES 1 http://www.cdc.gov/std/tg2015/pid.htm . Accessed August 22, 2016.
📄 Patient Package Insert ▾
Patient Package Insert Patient Information MIRENA ® (mur-ā-nah) (levonorgestrel-releasing intrauterine system) Read this Patient Information carefully before you decide if MIRENA is right for you. This information does not take the place of talking with your gynecologist or other healthcare provider who specializes in women's health. If you have any questions about MIRENA, ask your healthcare provider.
You should also learn about other birth control methods to choose the one that is best for you. MIRENA does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs). What is MIRENA? • MIRENA is a hormone-releasing system placed in your uterus by your healthcare provider to prevent pregnancy for up to 8 years. • MIRENA can also be used to decrease menstrual blood loss for up to 5 years in women who have heavy menstrual flow and who also want to use a birth control method that is placed in the uterus to prevent pregnancy. • MIRENA can be removed by your healthcare provider at any time. • MIRENA can be used whether or not you have given birth to a child.
MIRENA is a small flexible plastic T-shaped system that slowly releases a progestin hormone called levonorgestrel (LNG) that is often used in birth control pills. Because MIRENA releases LNG into your uterus, only small amounts of the hormone enter your blood. MIRENA does not contain estrogen.
Two thin threads are attached to the stem (lower end) of MIRENA. The threads are the only part of MIRENA you can feel when MIRENA is in your uterus; however, unlike a tampon string, the threads do not extend outside your body. MIRENA is small and flexible What if I need birth control for more than 8 years?
MIRENA must be removed after 8 years. Your healthcare provider can place a new MIRENA during the same office visit if you choose to continue using MIRENA. What if I need treatment for heavy menstrual flow for more than 5 years?
For continued treatment of heavy menstrual flow after 5 years, your healthcare provider can remove MIRENA and place a new MIRENA during the same office visit. What if I want to stop using MIRENA? MIRENA is intended for use up to 8 years, but you can stop using MIRENA at any time by asking your healthcare provider to remove it.
You could become pregnant as soon as MIRENA is removed, so you should use another method of birth control if you do not want to become pregnant. Talk to your healthcare provider about the best birth control methods for you, because your new method may need to be started 7 days before MIRENA is removed to prevent pregnancy. What if I change my mind about birth control and want to become pregnant in less than 8 years?
Your healthcare provider can remove MIRENA at any time. You may become pregnant as soon as MIRENA is removed. About 8 out of 10 women who want to become pregnant will become pregnant sometime in the first year after MIRENA is removed.
How does MIRENA work? MIRENA may work in several ways including thickening cervical mucus, inhibiting sperm movement, reducing sperm survival, and thinning the lining of your uterus. It is not known exactly how these actions work together to prevent pregnancy.
MIRENA can cause your menstrual bleeding to be less by thinning the lining of the uterus. How well does MIRENA work for contraception? The following chart shows the chance of getting pregnant for women who use different methods of birth control.
Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.
MIRENA, an intrauterine device (IUD), also known as an intrauterine system (IUS), is in the box at the top of the chart. How well does MIRENA work for heavy menstrual bleeding? In the clinical trial performed in women with heavy menstrual bleeding and treated with MIRENA, almost 9… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 52 mg Intrauterine System Carton NDC 50419-423-01 1 Sterile Unit Rx only IMPORTANT: To be inserted in the uterus by a trained healthcare provider. Mirena cannot be reloaded. See physician insert for detailed instructions for use. Contains single-handed inserter with no visible removal threads. Mirena ® (levonorgestrel-releasing intrauterine system) 52 mg PRINCIPAL DISPLAY PANEL - 52 mg Intrauterine System Carton
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