Important Safety Information

Who is not appropriate for Kyleena

Use of Kyleena is contraindicated in women with: known or suspected pregnancy and cannot be used for post-coital contraception; congenital or acquired uterine anomaly, including fibroids if they distort the uterine cavity; known or suspected breast cancer or other progestin-sensitive cancer, now or in the past; known or suspected uterine or cervical... Continue below

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Frequently Asked Questions (FAQs) About Kyleena®

If you have a question that is not covered here, please contact us directly. If your patients have questions, direct them to the Kyleena Patient FAQs page.

 

Go to questions regarding:

Kyleena indication and usage

    • Kyleena is indicated to prevent pregnancy for up to 5 years. The system should be replaced after 5 years if continued use is desired. Remember to check the expiration date of Kyleena prior to initiating insertion. The expiration date is etched on the carton and printed on the label. Insert Kyleena before the end of the month shown1
    • Yes. Kyleena has been studied in both parous and nulliparous women. Use of Kyleena before menarche is not indicated1
    • The clinical trials had no upper or lower weight or BMI limit. The weight range was 38 to 173 kg (mean weight: 68.7 kg) and mean BMI was 25.3 kg/m2 (range 15.2–57.6 kg/m2)1
    • The Kyleena steroid reservoir contains a total of 19.5 mg LNG, and is intended to provide an initial release rate of approximately 17.5 mcg/day of LNG 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 12.6 mcg/day over the first year and 9.0 mcg/day over a period of 5 years1

     

    LNG=levonorgestrel.

    • Depending on the patient’s prior method of contraception and when during the menstrual cycle Kyleena is being inserted, backup contraception may be appropriate1
    • If Kyleena is inserted during the first 7 days of the menstrual cycle or immediately after a first trimester abortion, backup contraception is not needed. If Kyleena is not inserted during the first 7 days of the menstrual cycle, a barrier method of contraception should be used or the patient should abstain from vaginal intercourse for 7 days to prevent pregnancy1

      Please see the full Prescribing Information for when backup contraception may be recommended.

      Click here for more information on insertion and removal instructions.
    • No, Kyleena is only indicated to prevent pregnancy for up to 5 years1

    Size of Kyleena and insertion

      Please see the table below for when to insert Kyleena:

       

      When to Insert Kyleena

      Starting Kyleena in women not currently using hormonal or intrauterine contraception

      • Kyleena can be inserted any time the provider can be reasonably certain the woman is not pregnant. Consider the possibility of ovulation and conception prior to initiation of this product.
      • If Kyleena 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 Kyleena 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 Kyleena from an oral, transdermal or vaginal hormonal contraceptive

      • Kyleena may be inserted 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 Kyleena insertion or until the end of the current treatment cycle.
      • If the woman was using continuous hormonal contraception, discontinue that method seven days after Kyleena insertion.

      Switching to Kyleena from an injectable progestin contraceptive

      • Kyleena may be inserted at any time; a back-up method of contraception (such as condoms or spermicide) should also be used for 7 days if Kyleena is inserted more than 3 months (13 weeks) after the last injection.

      Switching to Kyleena from a contraceptive implant or another IUS

      • Insert Kyleena on the same day the implant or IUS is removed.
      • Kyleena may be inserted at any time during the menstrual cycle.

      Inserting Kyleena after abortion or miscarriage

      First-trimester

      • Kyleena may be inserted immediately after a first-trimester abortion or miscarriage.

      Second-trimester

      • Do not insert Kyleena until a minimum of 6 weeks after second trimester abortion or miscarriage, or until the uterus is fully involuted. If involution is delayed, wait until involution is complete before insertion.
      • If the woman has not yet had a period, consider the possibility of ovulation and conception occurring prior to insertion of Kyleena.
      • If Kyleena is not inserted during the first 7 days of the menstrual cycle, a back-up method of contraception should be used or the patient should abstain from vaginal intercourse for 7 days to prevent pregnancy.

      Inserting Kyleena after Childbirth

      • Do not insert Kyleena until a minimum of 6 weeks after delivery, or until the uterus is fully involuted. If involution is delayed, wait until involution is complete before insertion.
      • If the woman has not yet had a period, consider the possibility of ovulation and conception occurring prior to insertion of Kyleena. Kyleena can be inserted any time the provider can be reasonably certain the woman is not pregnant.
      • If Kyleena is not inserted during the first 7 days of the menstrual cycle, a backup method of contraception should be used or the patient should abstain from vaginal intercourse for 7 days to prevent pregnancy.
      • There is an increased risk of perforation in lactating women.

      IUS=intrauterine system.

      Kyleena safety considerations

        • Risk of ectopic pregnancy1
          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 pregnancy1
          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. Advise her of isolated reports of virilization of the female fetus following local exposure to LNG during pregnancy with an LNG IUS in place. Follow her pregnancy closely and advise her to report immediately any symptom that suggests complications of the pregnancy.

         

        IUS=intrauterine system.

        • Non-clinical testing has demonstrated that Kyleena is MR Conditional. A patient with Kyleena can be safely scanned in an MR system meeting the following conditions1:
          • Static magnetic field of 3.0 T or less
          • Maximum spatial field gradient of 36,000 gauss/cm (360 T/m)
          • Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4 W/kg (First Level Controlled Operating Mode)
        • Under the scan conditions defined above, the Kyleena IUS is expected to produce a maximum temperature rise of less than 2ºC after 15 minutes of continuous scanning1
        • In non-clinical testing, the image artifact caused by the IUS extended up to 5 mm from the IUS when imaged with a gradient echo pulse sequence and a 3.0 T MRI system1

         

        MRI=magnetic resonance imaging; MR=magnetic resonance; IUS=intrauterine system.

        • Clinical trials with Kyleena excluded breastfeeding women. A large postmarketing safety study conducted in Europe over a 1-year observational period reported that lactation at the time of insertion of an IUD/IUS was associated with an increased risk of perforation. For users of another LNG-releasing IUS, the incidence of uterine perforation was reported as 6.3 per 1000 insertions for lactating women, compared to 1.0 per 1000 insertions for non-lactating women1
        • Tell your patients that they can breastfeed if more than 6 weeks have passed since delivery. Kyleena is not likely to affect the quality or amount of breast milk or the health of the nursing baby. However, isolated cases of decreased milk production have been reported among women using progestin. The risk of Kyleena becoming attached to (embedded) or going through the wall of the uterus is increased if Kyleena is inserted while the patient is breastfeeding1

         

        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 other LNG-releasing IUSs, 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 another LNG-releasing IUS. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Kyleena and any potential adverse effects on the breastfed child from Kyleena or from the underlying maternal condition1

         

        IUD=intrauterine device; IUS=intrauterine system; LNG=levonorgestrel.

        • Kyleena can alter the bleeding pattern and result in spotting, irregular bleeding, heavy bleeding, oligomenorrhea, and amenorrhea. During the first 3 to 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 irregular1
        • 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 1697 (4.8%) discontinued due to uterine bleeding complaints1
        • 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 6 weeks of the onset of a 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 pain1

          Click here for more information on bleeding data for Kyleena.
        • In clinical trials, a 5-year expulsion rate of 3.5% (59 out of 1690 subjects) was reported1
        • 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. Consider further diagnostic imaging, such as x-ray, if expulsion is suspected based on ultrasound. The risk of expulsion may be increased when the uterus is not completely involuted1
        • Delay Kyleena insertion a minimum of 6 weeks or until uterine involution is complete following a delivery or a second trimester abortion. Remove a partially expelled Kyleena. If expulsion has occurred, a new Kyleena can be inserted anytime the provider can be reasonably certain the woman is not pregnant1

        Kyleena cost and coverage

          • Kyleena offers a co-pay card savings program for your patients. Eligible commercially insured patients may pay as little as $20 for the Kyleena IUD.* Other costs may still be incurred by the patient
          • 95% of patients had coverage for a Bayer IUD with low or no out-of-pocket costs based on benefit investigation submissions to Bayer in 2017 (other products costs may apply; N=291,664)2

           

          *Eligible patients may pay as little as $20 and save up to $999. Patients who are enrolled in any type of government insurance or reimbursement programs are not eligible. As a condition precedent of the co-payment support provided under this program, e.g., co-pay refunds, participating patients and pharmacies are obligated to inform insurance companies and third-party payers of any benefits they receive and the value of this program, and may not participate if this program is prohibited by or conflicts with their private insurance policy, as required by contract or otherwise. Void where prohibited by law, taxed, or restricted. Patients enrolled in the Bayer US Patient Assistance Foundation are not eligible. Bayer may determine eligibility, monitor participation, equitably distribute product and modify or discontinue any aspect of the Co-pay Savings Program for Kyleena at any time, including but not limited to this commercial co-pay assistance program.  

           

          Click here for more information on Kyleena co-pay card savings program.

           

          IUD=intrauterine device.

          • Yes, the Bayer US Patient Assistance Foundation is a charitable organization that helps eligible patients get their Bayer prescription medicine at no cost. Please have your patient contact the program at 1-866-2BUSPAF (228-7723), Monday to Friday, 9 AM to 6 PM EST, or visit the foundation website https://www.patientassistance.bayer.us/
          • State Medicaid programs offer coverage for contraceptives. However, state Medicaid program eligibility guidelines may vary and could restrict access to Kyleena for some women. As with private payers, offices should verify coverage prior to treatment. Among women enrolled in Medicaid managed care organizations (Medicaid MCOs), coverage will be based on the specific Medicaid MCOs’ policies for Kyleena

          Request a Rep

          Stay up to date with clinical information and virtual trainings for Kyleena.

           

          Cost and Coverage Information

          Review helpful information for ordering Kyleena.

           

          Important Safety Information

          View Important Safety Information for Kyleena.

           

          INDICATION FOR KYLEENA

          Kyleena® (levonorgestrel-releasing intrauterine system) 19.5 mg is indicated for the prevention of pregnancy for up to 5 years. Replace the system after 5 years if continued use is desired.

           

          IMPORTANT SAFETY INFORMATION

          Who is not appropriate for Kyleena

          Use of Kyleena is contraindicated in women with: known or suspected pregnancy and cannot be used for post-coital contraception; congenital or acquired uterine anomaly, including fibroids if they distort the uterine cavity; known or suspected breast cancer or other progestin-sensitive cancer, now or in the past; known or suspected uterine or cervical neoplasia; liver disease, including tumors; untreated acute cervicitis or vaginitis, including lower genital tract infections (e.g., bacterial vaginosis) until infection is controlled; postpartum endometritis or infected abortion in the past 3 months; unexplained uterine bleeding; current IUD; acute pelvic inflammatory disease (PID) or history of PID (except with later intrauterine pregnancy); conditions increasing susceptibility to pelvic infection; or hypersensitivity to any component of Kyleena.

           

          Clinical considerations for use and removal of Kyleena

          Use Kyleena with caution after careful assessment in patients with coagulopathy or taking anticoagulants; migraine, focal migraine with asymmetrical visual loss, or other symptoms indicating transient cerebral ischemia; exceptionally severe headache; marked increase of blood pressure; or severe arterial disease such as stroke or myocardial infarction. Consider removing the intrauterine system if these or the following arise during use: uterine or cervical malignancy or jaundice. If the threads are not visible or are significantly shortened they may have broken or retracted into the cervical canal or uterus. If Kyleena is displaced (e.g., expelled or perforated the uterus), remove it. Kyleena can be safely scanned with MRI only under specific conditions.

           

          Pregnancy related risks with Kyleena

          If pregnancy should occur with Kyleena in place, remove the intrauterine system because leaving it in place may increase the risk of spontaneous abortion and preterm labor. Advise her of isolated reports of virilization of the female fetus following local exposure to LNG during pregnancy with an LNG IUS in place. Removal or manipulation may result in pregnancy loss. Evaluate women for ectopic pregnancy because the likelihood of a pregnancy being ectopic is increased with Kyleena. Also consider the possibility of ectopic pregnancy in the case of lower abdominal pain, especially in association with missed menses or if an amenorrheic woman starts bleeding. Tell women about the signs of ectopic pregnancy and associated risks, including loss of fertility. Women with a history of ectopic pregnancy, tubal surgery, or pelvic infection carry a higher risk of ectopic pregnancy.

           

          Educate her about PID

          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. IUDs have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion. Promptly examine users with complaints of lower abdominal pain or pelvic pain, odorous discharge, unexplained bleeding, fever, genital lesions or sores. Inform women about the possibility of PID and that PID can cause tubal damage leading to ectopic pregnancy or infertility, or infrequently can necessitate hysterectomy, or cause death. PID is often associated with sexually transmitted infections (STIs). Kyleena does not protect against STIs, including HIV. PID may be asymptomatic but still result in tubal damage and its sequelae.

           

          In clinical trials with Kyleena PID occurred more frequently within the first year and most often within the first month after insertion.

           

          Expect changes in bleeding patterns with Kyleena

          Spotting and irregular or heavy bleeding may occur during the first 3 to 6 months. Periods may become shorter and/or lighter thereafter. Cycles may remain irregular, become infrequent, or even cease. Consider pregnancy if menstruation does not occur within 6 weeks of the onset of previous menstruation.

           

          If a significant change in bleeding develops during prolonged use, take appropriate diagnostic measures to rule out endometrial pathology.

           

          Be aware of other serious complications and most common adverse reactions

          Some serious complications with IUDs like Kyleena are sepsis, perforation and expulsion. Severe infection or sepsis, including Group A streptococcal sepsis (GAS), have been reported following insertion of a LNG-releasing IUS. Aseptic technique during insertion of Kyleena is essential in order to minimize serious infections, such as GAS.

           

          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. 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. The risk of perforation may be increased if inserted when the uterus is not completely involuted or fixed retroverted. A postmarketing safety study over a 1-year observational period reported that lactation at the time of insertion of an IUS/IUD was associated with an increased risk of perforation. In this study, for users of another LNG-releasing IUS, the incidence of uterine perforation was reported as 6.3 per 1,000 insertions for lactating women, compared to 1.0 per 1,000 insertions for non-lactating women.

           

          Partial or complete expulsion of Kyleena may occur resulting in the loss of contraceptive protection. Delay insertion a minimum of six weeks or until uterine involution is complete following a delivery or a second trimester abortion. Remove a partially expelled IUD. If expulsion has occurred, a new Kyleena can be inserted any time the provider can be reasonably certain the woman is not pregnant.

           

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

           

          In clinical trials with Kyleena the most common adverse reactions (≥5%) were vulvovaginitis (24%), ovarian cyst (22%), abdominal/pelvic pain (21%), headache/migraine (15%), acne/seborrhea (15%), dysmenorrhea/uterine spasm (10%), breast pain/breast discomfort (10%), and increased bleeding (8%).

           

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

           

          For important information about Kyleena, please see the Full Prescribing Information.

          References: 1. Kyleena [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals; 2021. 2. Data on file. Bayer HealthCare Pharmaceuticals. Risk benefit verification, 2017-2018.