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Drug Description

(levonorgestrel-releasing) intrauterine system


Kyleena (levonorgestrel-releasing intrauterine system) contains 19.5 mg of LNG, a progestin, and is intended to provide an initial release rate of approximately17.5 mcg/day of LNG after 24 days.

Levonorgestrel USP, (-)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one, the active ingredient in Kyleena, has a molecular weight of 312.4, a molecular formula of C21H28O2, and the following structural formula:

Kyleena (levonorgestrel) - Structural Formula Illustration


Kyleena 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 whitish or pale yellow cylinder, made of a mixture of LNG and silicone (polydimethylsiloxane), containing a total of 19.5 mg LNG. The reservoir is covered by a semi-opaque silicone membrane, composed of polydimethylsiloxane and colloidal silica. A ring composed of 99.95% pure silver is located at the top of the vertical stem close to the horizontal arms and is visible by ultrasound. The polyethylene of the T-body is compounded with barium sulfate, which makes it radiopaque. A monofilament blue polypropylene removal thread is attached to a loop at the end of the vertical stem of the T-body. The polypropylene of the removal thread contains < 0.5% phthalocyaninato(2-) copper as a colorant (see Figure 10).

The components of Kyleena, including its packaging, are not manufactured using natural rubber latex.

Figure 10:Kyleena

Components of Kyleena - Illustration


Kyleena is packaged sterile within an inserter. The inserter (Figure 11), which is used for insertion of Kyleena 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 3.8 mm. The vertical stem of Kyleena 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 Kyleena has been placed, the inserter is discarded.

Figure 11:Diagram of Inserter

Diagram of Inserter - Illustration
Indications & Dosage


Kyleena is indicated to prevent pregnancy for up to 5 years. Replace the system after 5 years if continued use is desired.


Kyleena contains 19.5 mg of levonorgestrel (LNG) released in vivo at a rate of approximately 17.5 mcg/day after 24 days. This rate decreases progressively to 9.8 mcg/day after 1 year and to 7.4 mcg/day after 5 years. The average in vivo release rate of LNG is approximately 9 mcg/day over a period of 5 years. [See CLINICAL PHARMACOLOGY]

Kyleena must be removed by the end of the fifth year and can be replaced at the time of removal with a new Kyleena if continued contraceptive protection is desired.

Kyleena can be distinguished from other intrauterine systems (IUSs) by the combination of the visibility of the silver ring on ultrasound and the blue color of the removal threads.

Kyleena 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]. 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].

KYLEENA and inserter - Illustration

Insertion 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 and WARNINGS AND PRECAUTIONS]
  • Follow the insertion instructions exactly as described to ensure proper placement and avoid premature release of Kyleena from the inserter. Once released, Kyleena cannot be re-loaded.
  • Check expiration date of Kyleena prior to initiating insertion.
  • Kyleena should be inserted by a trained healthcare provider. Healthcare providers should become thoroughly familiar with the insertion instructions before attempting insertion of Kyleena.
  • 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
  • Insert Kyleena into the uterine cavity during the first seven days of the menstrual cycle or immediately after a first trimester abortion. Back-up contraception is not needed when Kyleena is inserted as directed.
  • Postpone postpartum insertion and insertions following second trimester abortions a minimum of six weeks or until the uterus is fully involuted. If involution is delayed, wait until involution is complete before insertion. [See WARNINGS AND PRECAUTIONS]
Tools For Insertion


  • Gloves
  • Speculum
  • Sterile uterine sound
  • Sterile tenaculum
  • Antiseptic solution, applicator


  • Sterile gloves
  • Kyleena with inserter in sealed package
  • Instruments and anesthesia for paracervical block, if anticipated
  • Consider having an unopened backup Kyleena available
  • Sterile, sharp curved scissors
Preparation For Insertion
  • Exclude pregnancy and confirm that there are no other contraindications to the use of Kyleena.
  • Ensure that the patient understands the contents of the Patient Information Booklet and obtain the signed patient informed consent located on the last page of the Patient Information Booklet.
  • With the patient comfortably in lithotomy position, do a bimanual exam to establish the size, shape and position of the uterus.
  • Gently insert a speculum to visualize the cervix.
  • Thoroughly cleanse the cervix and vagina with a suitable antiseptic solution.
  • Prepare to sound the uterine cavity. Grasp the upper lip of the cervix with a tenaculum forceps and gently apply traction to stabilize and align the cervical canal with the uterine cavity. Perform a paracervical block if needed. If the uterus is retroverted, it may be more appropriate to grasp the lower lip of the cervix. The tenaculum should remain in position and gentle traction on the cervix should be maintained throughout the insertion procedure.
  • Gently insert a uterine sound to check the patency of the cervix, measure the depth of the uterine cavity in centimeters, confirm cavity direction, and detect the presence of any uterine anomaly. If you encounter difficulty or cervical stenosis, use dilatation, and not force, to overcome resistance. If cervical dilatation is required, consider using a paracervical block.
Insertion Procedure

Proceed with insertion only after completing the above steps and ascertaining that the patient is appropriate for Kyleena. Ensure use of aseptic technique throughout the entire procedure.

Step 1-Opening of the package

  • Open the package (Figure 1). The contents of the package are sterile.

Figure 1: Opening the Kyleena Package

Kyleena Package - Illustration
  • Using sterile gloves, lift the handle of the sterile inserter and remove from the sterile package.

Step 2-Load Kyleena into the insertion tube

  • Push the slider forward as far as possible in the direction of the arrow, thereby moving the insertion tube over the Kyleena T-body to load Kyleena into the insertion tube (Figure 2). The tips of the arms will meet to form a rounded end that extends slightly beyond the insertion tube.

Figure 2: Move slider all the way to the forward position to load Kyleena

Move slider all the way to the forward position to load Kyleena - Illustration
  • Maintain forward pressure with your thumb or forefinger on the slider. DO NOT move the slider downward at this time as this may prematurely release the threads of Kyleena. Once the slider is moved below the mark, Kyleena cannot be re-loaded.

Step 3-Setting the Flange

  • Holding the slider in this forward position, set the upper edge of the flange to correspond to the uterine depth (in centimeters) measured during sounding (Figure 3).

Figure 3: Setting the flange

Setting the flange - Illustration

Step 4 - Kyleena is now ready to be inserted

  • Continue holding the slider in this forward position. Advance the inserter through the cervix until the flange is approximately 1.5-2 cm from the cervix and then pause (Figure 4).

Figure 4: Advancing insertion tube until flange is 1.5 to 2 cm from the cervix

Advancing insertion tube until flange is 1.5 to 2 cm from the cervix - Illustration

Do not force the inserter. If necessary, dilate the cervical canal.

Step 5 - Open the arms

  • While holding the inserter steady, move the slider down to the mark to release the arms of Kyleena (Figure 5). Wait 10 seconds for the horizontal arms to open completely.

Figure 5: Move the slider back to the mark to release and open the arms

Move the slider back to the mark to release and open the arms - Illustration

Step 6 - Advance to fundal position

Advance the inserter gently towards the fundus of the uterus until the flange touches the cervix. If you encounter fundal resistance do not continue to advance. Kyleena is now in the fundal position (Figure 6). Fundal positioning of Kyleena is important to prevent expulsion.

Figure 6: Move Kyleena into the fundal position

Move Kyleena into the fundal position - Illustration

Step 7-Release Kyleena and withdraw the inserter

  • Holding the entire inserter firmly in place, release Kyleena by moving the slider all the way down (Figure 7).

Figure 7: Move the slider all the way down to release Kyleena from the insertion tube

Move the slider all the way down to release Kyleena from the insertion tube - Illustration
  • Continue to hold the slider all the way down while you slowly and gently withdraw the inserter from the uterus.
  • Using a sharp, curved scissor, cut the threads perpendicular, leaving about 3 cm visible outside of the cervix [cutting threads at an angle may leave sharp ends (Figure 8)]. Do not apply tension or pull on the threads when cutting to prevent displacing Kyleena.

Figure 8: Cutting the threads

Cutting the threads - Illustration

Kyleena insertion is now complete. Prescribe analgesics, if indicated. Keep a copy of the Consent Form with lot number for your records.

Important Information To Consider During Or After Insertion
  • If you suspect that Kyleena is not in the correct position, check placement (for example, using transvaginal ultrasound). Remove Kyleena if it is not positioned completely within the uterus. Do not reinsert a removed Kyleena.
  • If there is clinical concern, exceptional pain or bleeding during or after insertion, take appropriate steps (such as physical examination and ultrasound) immediately to exclude perforation.

Patient Follow-up

  • Reexamine and evaluate patients 4 to 6 weeks after insertion and once a year thereafter, or more frequently if clinically indicated.

Removal Of Kyleena

Timing Of Removal
  • Kyleena should not remain in the uterus after 5 years.
  • If pregnancy is not desired, the removal should be carried out during the first 7 days of the menstrual cycle, provided the woman is still experiencing regular menses. If removal will occur at other times during the cycle, start a new contraceptive method a week prior to removal. If removal occurs at other times during the cycle and the woman has had intercourse in the week prior to removal, she is at risk of pregnancy. [See Continuation of Contraception after Removal]
Tools For Removal


  • Gloves
  • Speculum


  • Sterile forceps

Removal Procedure

  • Remove Kyleena by applying gentle traction on the threads with forceps (Figure 9).

Figure 9: Removal of Kyleena

Removal of Kyleena - Illustration
  • If the threads are not visible, determine location of Kyleena by ultrasound [see WARNINGS AND PRECAUTIONS].
  • If Kyleena is found to be in the uterine cavity on ultrasound exam, it may be removed using a narrow forceps, such as an alligator forceps. This may require dilation of the cervical canal. After removal of Kyleena, examine the system to ensure that it is intact.
  • Removal may be associated with some pain and/or bleeding or vasovagal reactions (for example, syncope, bradycardia) or seizure, especially in patients with a predisposition to these conditions.

Continuation Of Contraception After Removal

  • If pregnancy is not desired and if a woman wishes to continue using Kyleena, a new system can be inserted immediately after removal any time during the cycle.
  • If a patient with regular cycles wants to start a different contraceptive method, time removal and initiation of the new method to ensure continuous contraception. Either remove Kyleena during the first 7 days of the menstrual cycle and start the new method immediately thereafter or start the new method at least 7 days prior to removing Kyleena if removal is to occur at other times during the cycle.
  • If a patient with irregular cycles or amenorrhea wants to start a different contraceptive method, start the new method at least 7 days before removal.


Dosage Forms And Strengths

Kyleena 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 19.5 mg LNG.

Storage And Handling

Kyleena (levonorgestrel-releasing intrauterine system), containing a total of 19.5 mg LNG, is available in a carton of one sterile unit.

NDC# 50419-424-01

Kyleena is supplied sterile. Kyleena 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].

Manufactured for: Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981 Manufactured in Finland © 2016, Bayer HealthCare Pharmaceuticals Inc. Revised: Sep 2016


Choosing Your Birth Control Method See Slideshow
Side Effects & Drug Interactions


The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling:

  • Ectopic Pregnancy [see WARNINGS AND PRECAUTIONS]
  • Intrauterine Pregnancy [see WARNINGS AND PRECAUTIONS]
  • Group A Streptococcal Sepsis (GAS) [see WARNINGS AND PRECAUTIONS]
  • Pelvic Inflammatory Disease [see WARNINGS AND PRECAUTIONS]
  • Perforation [see WARNINGS AND PRECAUTIONS]
  • Ovarian Cysts [see WARNINGS AND PRECAUTIONS]
  • Bleeding Pattern Alterations [see WARNINGS AND PRECAUTIONS]

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 described below reflect exposure of 1,697 healthy 18 to 41-year-old women (mean age 27.8 ± 5.2 years) to Kyleena. These data come from two multi-center contraceptive trials: A phase 2 study with a 3-year duration was conducted in Europe, enrolling generally healthy, 21 to 41-year old women; 217 subjects were exposed to Kyleena for one year and 174 completed three years. The data in this trial cover approximately 8,000 cycles of exposure. A phase 3 study with a 3-year duration and an optional extension of Kyleena use up to 5 years was conducted in the United States (US), Canada, Europe, and Latin America. The population was generally healthy, 18 to 35-year old women. A total of 1,208 subjects were exposed to Kyleena for at least one year; 707 women entered the optional extension phase after 3 years and 550 completed five years. The data in this trial cover approximately 60,000 cycles.

In total for both studies, 1,425 subjects were exposed for at least 1 year, and 550 subjects completed 5 years of use. Of the total of 1,697 subjects exposed to Kyleena, 563 were from the US and 1,134 were from Europe, Canada and Latin America; 623 (37%) were nulliparous (mean age 24.6 ± 4.5 years) and 1,074 (63%) were parous (mean age 29.7 ± 4.7 years). Most women who received Kyleena were Caucasian (83%) or Black/African American (4.4%); 9.4% of women were of Hispanic ethnicity. The clinical trials had no upper or lower weight or body mass index (BMI) limit. Mean BMI of Kyleena subjects was 25.2 kg/m²(range 15.2 - 57.6 kg/m²); 16% had a BMI ≥ 30 kg/m², and 2.0% had a BMI ≥ 40 kg/m². The frequencies of reported adverse drug reactions represent crude incidences.

The most common adverse reactions (occurring in ≥ 5% users) were vulvovaginitis (24%), ovarian cyst (22%), abdominal pain/pelvic pain (21%), headache/migraine (15%), acne/seborrhea (15%), dysmenorrhea/uterine spasm (10%), breast pain/breast discomfort (10%), and increased bleeding (8%).

In the combined studies, 22% discontinued prematurely due to an adverse reaction. The most common adverse reactions ( > 1%) leading to discontinuation were increased bleeding (4.5%), abdominal pain/pelvic pain (4.2%), device expulsion (3.1%), acne/seborrhea (2.3%), and dysmenorrhea/uterine spasm (1.3%).

Common adverse reactions (occurring in ≥ 1% users) are summarized in Table 3 (presented as crude incidences).

Table 3: Adverse reactions that occurred in at least 1% of Kyleena users in clinical trials by System Organ Class (SOC)

System Organ Class Adverse Reaction Incidence (%)
Reproductive System and Breast Disorders Vulvovaginitis 24.3
Ovarian cysta 22.2
Dysmenorrhea/uterine spasm 8.0/2.4
Increased bleedingb 7.9
Breast pain/discomfort 7.1/3.5
Genital discharge 4.5
Device expulsion (complete and partial) 3.5
Upper genital tract infection 1.5
Gastrointestinal Disorders Abdominal pain/pelvic pain 13.3/8.2
Nausea 4.7
Skin and Subcutaneous Tissue Disorders Acne/Seborrhea 14.1/1.8
Alopecia 1.0
Nervous System Disorders Headache/Migraine 12.9/3.3
Psychiatric Disorders Depression/ Depressed mood 4.4/0.2
a Ovarian cysts were reported as adverse events if they were abnormal, non-functional cysts and/or had a diameter > 3 cm on ultrasound examination
b Not all bleeding alterations were captured as adverse reactions [see WARNINGS AND PRECAUTIONS].

In the clinical trials, serious adverse reactions occurring in more than a single subject included: ectopic pregnancy/ruptured ectopic pregnancy (10 subjects); pelvic inflammatory disease (6 subjects); missed abortion/incomplete spontaneous abortion/spontaneous abortion (4 subjects); ovarian cyst (3 subjects); abdominal pain (4 subjects); depression/affective disorder (4 subjects); and uterine perforation/embedded device (myometrial perforation) (3 subjects).

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of LNG-releasing IUSs. 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


No drug-drug interaction studies have been conducted with Kyleena.

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 Kyleena. However, the contraceptive effect of Kyleena 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.

Warnings & Precautions


Included as part of the PRECAUTIONS section.


Risk Of Ectopic Pregnancy

Evaluate women for ectopic pregnancy if they become pregnant with Kyleena in place because the likelihood of a pregnancy being ectopic is increased with Kyleena. Approximately one-half of pregnancies that occur with Kyleena 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 Kyleena, which excluded women with a history of ectopic pregnancy, was approximately 0.2% per year. The risk of ectopic pregnancy in women who have a history of ectopic pregnancy and use Kyleena 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.

Risks With Intrauterine Pregnancy

If pregnancy occurs while using Kyleena, remove Kyleena because leaving it in place may increase the risk of spontaneous abortion and preterm labor. Removal of Kyleena or probing of the uterus may also result in spontaneous abortion. In the event of an intrauterine pregnancy with Kyleena, 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 Kyleena in place and if Kyleena cannot be removed or the woman chooses not to have it removed, warn her that failure to remove Kyleena increases the risk of miscarriage, sepsis, premature labor and premature delivery. Follow her pregnancy closely and advise her to report immediately any symptom that suggests complications of the pregnancy.


Severe infection or sepsis, including Group A streptococcal sepsis (GAS), have been reported following insertion of a LNG-releasing IUS. 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 Kyleena is essential in order to minimize serious infections such as GAS.

Pelvic Infection

Promptly examine users with complaints of lower abdominal or pelvic pain, odorous discharge, unexplained bleeding, fever, genital lesions or sores. Remove Kyleena in cases of recurrent endometritis or pelvic inflammatory disease, or if an acute pelvic infection is severe or does not respond to treatment.

Pelvic Inflammatory Disease (PID)

Kyleena 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]. 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, PID was observed in 0.5% of women overall and occurred more frequently within the first year and most often within the first month after insertion of Kyleena.

Women at increased risk for PID

PID is often associated with a sexually transmitted infection (STI), and Kyleena 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 Kyleena after initiation of antibiotic therapy is usually appropriate.1


Actinomycosis has been associated with IUDs. Remove Kyleena 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 Kyleena removal and treatment. When possible, confirm a Pap smear diagnosis with cultures.


Perforation (total or partial, including penetration/embedment of Kyleena in the uterine wall or cervix) may occur most often during insertion, although the perforation may not be detected until sometime later. Perforation may reduce contraceptive efficacy and result in pregnancy. The incidence of perforation during clinical trials was < 0.1%.

If perforation occurs, locate and remove Kyleena. Surgery may be required. Delayed detection or removal of Kyleena in case of perforation may result in migration outside the uterine cavity, adhesions, peritonitis, intestinal perforations, intestinal obstruction, abscesses and erosion of adjacent viscera.

Clinical trials with Kyleena excluded breast-feeding women. An analysis from a large postmarketing safety study with another LNG-releasing IUS and copper IUDs shows an increased risk of perforation in lactating women. The risk of perforation may be increased if Kyleena is inserted when the uterus is fixed retroverted or not completely involuted during the postpartum period. Delay Kyleena insertion a minimum of six weeks or until involution is complete following a delivery or a second trimester abortion.


Partial or complete expulsion of Kyleena may occur resulting in the loss of contraceptive protection. Expulsion may be associated with symptoms of bleeding or pain, or it may be asymptomatic and go unnoticed. Kyleena typically decreases menstrual bleeding over time; therefore, an increase of menstrual bleeding may be indicative of an expulsion. The risk of expulsion may be increased when the uterus is not completely involuted. In clinical trials, a 5-year expulsion rate of 3.5% (59 out of 1,690 subjects) was reported.

Delay Kyleena insertion a minimum of six weeks or until uterine involution is complete following a delivery or a second trimester abortion. Remove a partially expelled Kyleena. If expulsion has occurred, Kyleena may be replaced within 7 days after the onset of a menstrual period after pregnancy has been ruled out.

Ovarian Cysts

Because the contraceptive effect of Kyleena is mainly due to its local effects within the uterus, ovulatory cycles with follicular rupture usually occur in women of fertile age using Kyleena. Ovarian cysts (reported as adverse reactions if they were abnormal, non-functional cysts and/or had a diameter > 3 cm on ultrasound examination) were reported at least once over the course of clinical trials in 22% of women using Kyleena, and 0.6% of subjects discontinued because of an ovarian cyst. Most ovarian 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 Pattern Alterations

Kyleena can alter the bleeding pattern and result in spotting, irregular bleeding, heavy bleeding, oligomenorrhea and amenorrhea. During the first 3-6 months of Kyleena 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.

In Kyleena clinical trials, amenorrhea developed by the end of the first year of use in approximately 12% of Kyleena users. A total of 81 subjects out of 1,697 (4.8%) discontinued due to uterine bleeding complaints. Table 1 shows the bleeding patterns as documented in the Kyleena clinical trials based on 90-day reference periods. Table 2 shows the number of bleeding and spotting days based on 28-day cycle equivalents.

Table 1: Bleeding Patterns Reported with Kyleena in Contraception Studies (by 90-day reference periods)

Kyleena First 90 days
Second 90 days
End of year 1
End of year 3
End of year 5
Amenorrhea1 < 1% 5% 12% 20% 23%
Infrequent bleeding2 10% 20% 26% 26% 26%
Frequent bleeding3 25% 10% 4% 2% 2%
Prolonged bleeding4 57% 14% 6% 2% 1%
Irregular bleeding5 43% 25% 17% 10% 9%
1Defined as subjects with no bleeding/spotting throughout the 90-day reference period
2Defined as subjects with 1 or 2 bleeding/spotting episodes in the 90-day reference period
3Defined as subjects with more than 5 bleeding/spotting episodes in the 90-day reference period
4Defined as subjects with bleeding/spotting episodes lasting more than 14 days in the 90-day reference period. Subjects with prolonged bleeding may also be included in one of the other categories (excluding amenorrhea)
5Defined as subjects with 3 to 5 bleeding/spotting episodes and less than 3 bleeding/spotting-free intervals of 14 or more days

Table 2: Mean number of Bleeding and Spotting Days per 28-day Cycle Equivalent

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