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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Ordering and Reimbursement

Cost and insurance coverage

Bayer is committed to the reproductive health of women, and we work hard to ensure every woman has access to effective contraception. Bayer may be able to help if your patients are uninsured or underinsured, or if they have high out-of-pocket costs.

 

 

    The Confidence In Coverage program replaces IUDs at no cost for eligible patients who are denied coverage* by their plan after IUD insertion.

    *Does not apply for patients who have co-pay, insertion and removal costs, or any other costs.

    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/

    The Kyleena® Co-Pay Savings Program may help eligible commercially insured patients to pay as little as $20 for Kyleena.*

    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 20171

    Other products costs may apply; N=291,664.

    *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.

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    We’re for health.
    We’re for access.
    WE’RE FOR HER.

    We're for Her

    • CONTRACEPTIVE ACCESS through the donation of more than 277,000 IUDs in the US for women in need since 2001
    • COLLABORATION in the form of funding to Direct Relief
    • EDUCATIONAL TOOLS for healthcare professionals who provide care to women in underserved communities

     

    WE’RE FOR HER is in line with Bayer’s goal to provide 100 million women across the world with access to contraception by 2030 through 2 key programs in the US:

    Bayer US Patient Assistance Foundation

    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 at www.patientassistance.bayer.us to see if they might qualify for assistance.

    Partnership with Direct Relief

    In 2020, we committed to a partnership with the humanitarian medical organization, Direct Relief, to provide IUDs to health facilities caring for women in need across the country.*

     

    *Interested health facilities can learn more by visiting www.directrelief.org or by contacting Direct Relief at 1-805-964-4767.

    IUD=intrauterine device; US=United States.

    There are 2 ways to order Kyleena

      Bayer WHC Support Center

       

      • Place orders online, by phone, or by fax
      • Check account status and track orders
      • Access 24-hour online support 

       

      Go to WHC Support Center

      Bayer WHC Specialty Pharmacy Program

       

      Depending on a patient's insurance plan, offices can order Kyleena through a Specialty Pharmacy.

       

      Specialty Pharmacies may be able to bill the insurance company directly for Kyleena. In this case, the office bills only for the clinical services related to insertion. The remaining share of the cost is billed by the Specialty Pharmacy.

       

      Contacting your Specialty Pharmacy
      CVS Specialty (in the Continental US)
      (866) 638-8312

       

      CVS Specialty (in Hawaii-Neighbor Islands)
      (800) 896-1464

       

      CVS Specialty (in Hawaii-Oahu)
      (808) 254-2727

       

      AllianceRx Walgreens Prime
      Phone: 1-877-686-4633
      Fax: 1-800-830-5292

       

      Cigna Specialty Pharmacy Services
      (800) 351-3606

       

      Humana Specialty Pharmacy
      (800) 486-2668

       

      Magellan Rx
      Phone: 1-866-554-2673
      Fax: 1-866-364-2673

      Visit the Bayer WHC Support Center for additional ordering resources and support

      Coding and reimbursement

        HCPCS codes (Kyleena J-code)
        The alphanumeric codes are used to report drugs, supplies, and services. HCPCS codes starting with the letter “J” are used for products, supplies and services administered by the provider.

         

        Table of HCPCs codes for Kyleena®, Mirena® and Skyla®

         

        NDC codes
        Note that some payers, including Tricare and Medicaid, require the 11-digit NDC format when billing for Kyleena. Confirm NDC billing instructions with each payer, as requirements may vary.

         

        Table of NDC codes for Kyleena®, Mirena® and Skyla®

        HCPCS=healthcare common procedure coding system; NDC=national drug codes.

         

        Request a Rep

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

         

        Download the Compass Guide

        Ordering, billing, and reimbursement resources for your staff.

         

        Download Resources

        Search resources for you, your staff, and your patients.

         

        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.

        Reference: 1. Data on file. Benefit verification—service removal plan overview; 2018.