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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

      Depending on a patient's status, same day insertion could be appropriate if the provider can be reasonably certain the woman is not pregnant. Please see the full Prescribing Information for more details.

      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

         

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

        • Tell your patients that they may use Kyleena when they are breastfeeding. 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. The risk of Kyleena going into the wall of the uterus (becoming embedded) or going through the wall of the uterus is increased if Kyleena is inserted while breastfeeding
        • 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 a 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 condition
        • APEX IUD was a large US retrospective cohort study to assess the impact of breastfeeding and timing of postpartum IUD insertion on uterine perforation and IUD expulsion. Breastfeeding data were available in 94,817 insertions performed in women 52 weeks or less after delivery. Women who were breastfeeding at the time of insertion were at 33% higher risk of perforation (adjusted hazard ratio [HR]=1.33, 95% confidence interval [CI]: 1.07–1.64) compared to women who were not breastfeeding at the time of insertion. Progressively lower risk of uterine perforation was observed in postpartum time windows beyond 6 weeks, in both breastfeeding and not breastfeeding women. Women who were breastfeeding were at 28% lower risk of IUD expulsion (adjusted HR=0.72, 95% CI: 0.64-0.80) compared to women who were not breastfeeding at time of insertion.  For more information, please see section 6.2 Postmarketing Experience of the full Prescribing Information

         

        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 is increased with insertions immediately after delivery and appears to be increased with insertion after second-trimester abortion based on limited data. In a large postmarketing safety study conducted in the US, the risk of expulsion was lower with breastfeeding status1
        • Remove a partially expelled Kyleena. If expulsion has occurred, a new Kyleena can be inserted any time 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

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          Cost and Coverage Information

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          Important Safety Information

          View Important Safety Information for Kyleena.