Important Safety Information

If you have a pelvic infection, get infections easily, or have certain cancers, don't use Kyleena. Less than 1% of users get a serious pelvic infection called pelvic inflammatory disease (PID). ... Continue below

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Frequently asked
questions about Kyleena

About IUDs

    An IUD (intrauterine device) is a small, T-shaped device that’s placed in your uterus by your healthcare professional to prevent pregnancy. Getting an IUD does not involve surgery and typically takes just a few minutes during a routine in-office visit. Once in place, it provides continuous, highly effective birth control.

     

    You may experience pain, bleeding, or dizziness during and after placement. If your symptoms do not pass within 30 minutes after placement, Kyleena may not have been placed correctly. Your healthcare professional will examine you to see if Kyleena needs to be removed or replaced.

     

    Getting Kyleena®

      You may experience pain, bleeding, or dizziness during and after placement. If your symptoms do not pass within 30 minutes after placement, Kyleena may not have been placed correctly. Your healthcare professional will examine you to see if Kyleena needs to be removed or replaced.

       

      If pain is a concern for you, ask your healthcare professional about taking over-the-counter pain medication before the procedure. 

       

      Find more information about the insertion process.

       

      No. Kyleena can be removed at any time by your healthcare professional. You could become pregnant as soon as Kyleena is removed, so you should use another method of birth control if you do not want to become pregnant.

      Safety considerations for Kyleena

        Kyleena is not right for everyone. Do not use Kyleena if you:

         

        • Are or might be pregnant; Kyleena cannot be used as an emergency contraceptive

        • Have had a serious pelvic infection called pelvic inflammatory disease (PID), unless you have had a normal pregnancy after the infection went away

        • Have an untreated pelvic infection now

        • Have had serious pelvic infections in the past 3 months after a pregnancy

        • Can get infections easily. For example, if you:

          • Have multiple sexual partners or your partner has multiple sexual partners

          • Have problems with your immune system

          • Abuse intravenous drugs

        • Have or suspect you might have cancer of the uterus or cervix

        • Have bleeding from the vagina that has not been explained

        • Have liver disease or liver tumor

        • Have breast cancer or any other cancer that is sensitive to progestin (a female hormone), now or in the past

        • Have an intrauterine device in your uterus already

        • Have a condition of the uterus that changes the shape of the uterine cavity, such as large fibroid tumors

        • Are allergic to levonorgestrel, silicone, polyethylene, silver, silica, barium sulfate, polypropylene, or copper phthalocyanine

        Kyleena can cause serious side effects, including:

         

        • Ectopic pregnancy and intrauterine pregnancy risks. There are risks if you become pregnant while using Kyleena (see “What if I become pregnant while using Kyleena?”).

        • Life‐threatening infection. Life­‐threatening infection can occur within the first few days after Kyleena is placed. Call your healthcare professional immediately if you develop severe pain or fever shortly after Kyleena is placed.

        • Pelvic inflammatory disease (PID). Some IUD users get a serious pelvic infection called pelvic inflammatory disease. PID is usually sexually transmitted. You have a higher chance of getting PID if you or your partner has sex with other partners. PID can cause serious problems such as infertility, ectopic pregnancy or pelvic pain that does not go away. PID is usually treated with antibiotics. More serious cases of PID may require surgery. A hysterectomy (removal of the uterus) is sometimes needed. In rare cases, infections that start as PID can even cause death. Tell your healthcare professional right away if you have any of these signs of PID: long-lasting or heavy bleeding, unusual vaginal discharge, low abdominal (stomach area) pain, painful sex, chills, or fever.

        • Perforation. Kyleena may become attached to (embedded) or go through the wall of the uterus. This is called perforation. If this occurs, Kyleena may no longer prevent pregnancy. If perforation occurs, Kyleena may move outside the uterus and can cause internal scarring, infection, or damage to other organs, and you may need surgery to have Kyleena removed. The risk of perforation is increased if Kyleena is inserted while you are breastfeeding.

         

        Common side effects of Kyleena include:

         

        • Pain, bleeding, or dizziness during and after placement. If these symptoms do not stop 30 minutes after placement, Kyleena may not have been placed correctly. Your healthcare professional will examine you to see if Kyleena needs to be removed or replaced.

        • Expulsion. Kyleena may come out by itself. This is called expulsion. Expulsion occurs in about 4 out of 100 women. You may become pregnant if Kyleena comes out. If you think that Kyleena has come out, use a back-up birth control method like condoms and spermicide, and call your healthcare professional.

        • Missed menstrual periods. About 12 out of 100 women stop having periods after 1 year of Kyleena use. If you do not have a period for 6 weeks during Kyleena use, call your healthcare professional. When Kyleena is removed, your menstrual periods should return.

        • Changes in bleeding. You may have bleeding and spotting between menstrual periods, especially during the first 3 to 6 months. Sometimes the bleeding is heavier than usual at first. However, the bleeding usually becomes lighter than usual and may be irregular. Call your healthcare professional if the bleeding remains heavier than usual or increases after it has been light for a while.

        • Cysts on the ovary. About 22 out of 100 women using Kyleena develop a cyst on the ovary. These cysts usually disappear on their own in two to three months. However, cysts can cause pain and sometimes need surgery.

         

        Other common side effects include:

         

        • Inflammation or infection of the outer part of your vagina (vulvovaginitis)

        • Abdomen or pelvic pain

        • Headache or migraine

        • Acne or greasy skin

        • Painful periods

        • Sore or painful breasts

         

        This is not a complete list of possible side effects with Kyleena. For more information, please see Full Prescribing Information or ask your healthcare professional.

        For the first 3 to 6 months, your period may become irregular and the number of bleeding days may increase. You may also have frequent spotting or light bleeding.

         

        Some women have heavy bleeding during this time. After you have used Kyleena for a while, the number of bleeding and spotting days is likely to lessen. For some women, periods will stop altogether.

         

        When Kyleena is removed, your menstrual periods should return.

        Kyleena does not protect against HIV infection (the virus that causes AIDS) and other sexually transmitted infections (STIs).

        Kyleena can be safely scanned with magnetic resonance imaging (MRI) only under specific conditions. Before you have an MRI, tell your healthcare professional that you have Kyleena, an intrauterine device (IUD), in place.

        After getting Kyleena

          Yes. Because Kyleena is in your uterus, not your vagina, you can still use tampons.

          You and your partner should not feel Kyleena during intercourse. Kyleena is placed in the uterus, not in the vagina. Sometimes your partner may feel the threads. If this occurs, or if you or your partner experience pain during sex, talk with your healthcare professional.

          It depends on whether you were using hormonal birth control prior to getting Kyleena and also when Kyleena is placed during your menstrual cycle. Your healthcare professional will confirm if you need to use back-up birth control after Kyleena is placed.

          Yes, you should check that Kyleena is in the proper position by feeling the removal threads. It is a good habit to do this once a month. Your healthcare professional should teach you how to check that Kyleena is in place. First, wash your hands with soap and water. You can check by reaching up to the top of your vagina with clean fingers to feel the removal threads. Do not pull on the threads. If you feel more than just the threads or if you cannot feel the threads, Kyleena may not be in the right position and may not prevent pregnancy. Use non-hormonal back-up birth control (such as condoms and spermicide), and ask your healthcare professional to check that Kyleena is still in the right place.

          Call your healthcare professional if you have any questions or concerns (see “When should I call my healthcare professional?” ). Otherwise, you should return to your healthcare professional for a follow-up visit 4 to 6 weeks after Kyleena is placed to make sure that Kyleena is in the right position.

          Getting pregnant and new moms

            Kyleena can be removed at any time by your healthcare professional, and you can try getting pregnant right away. About 7 out of 10 women who tried to become pregnant conceived within a year of having Kyleena removed.

            Call your healthcare professional right away if you think you are pregnant. If possible, also do a urine pregnancy test. If you get pregnant while using Kyleena, you may have an ectopic pregnancy. This means that the pregnancy is not in the uterus. Unusual vaginal bleeding or abdominal pain may be a sign of ectopic pregnancy. Ectopic pregnancy is a medical emergency that often requires surgery. Ectopic pregnancy can cause internal bleeding, infertility, and even death.

             

            There are also risks if you get pregnant while using Kyleena and the pregnancy is in the uterus. Severe infection, miscarriage, premature delivery, and even death can occur with pregnancies that continue with an intrauterine device (IUD). Because of this, your healthcare professional may try to remove Kyleena, even though removing it may cause a miscarriage. If Kyleena cannot be removed, talk with your healthcare professional about the benefits and risks of continuing the pregnancy.

             

            If you continue your pregnancy, see your healthcare professional regularly. Call your healthcare professional right away if you get flu-like symptoms, fever, chills, cramping, pain, bleeding, vaginal discharge, or fluid leaking from your vagina. These may be signs of infection.

             

            It is not known if Kyleena can cause long-term effects on the fetus if it stays in place during a pregnancy.

             

            You may use Kyleena when you are breastfeeding if more than 6 weeks have passed since you had your baby. If you are breastfeeding, Kyleena is not likely to affect the quality or amount of your breast milk or the health of your nursing baby. However, isolated cases of decreased milk production have been reported. The risk of Kyleena becoming attached to (embedded) or going through the wall of the uterus is increased if Kyleena is inserted while you are breastfeeding.

            Cost and insurance coverage

              Follow these steps to check if Kyleena is covered by your insurance. If Kyleena isn’t covered or if you don’t have insurance, Bayer may be able to help

              If you do not have health insurance, or if Kyleena® is not covered by your insurance, the cost of Kyleena is $953.51. Learn more about how to pay for Kyleena.

              Yes, the Co-pay Savings Program for Kyleena may help if you have health insurance but still have high out-of-pocket costs for Kyleena.

               

              Eligible patients may be able to pay as little as $20 out of pocket for Kyleena.*

               

              Enroll now >

               

              *Eligible patients may pay as little as $20 and save up to $950. 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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              About Kyleena

              How small is Kyleena? Take a closer look. 

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              Prep for your visit

              Choose questions to ask your healthcare professional. 

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              What to expect

              Get the lowdown on getting a Kyleena IUD.

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              INDICATION FOR KYLEENA

              Kyleena® (levonorgestrel-releasing intrauterine system) is a hormone-releasing IUD that prevents pregnancy for up to 5 years.

               

              IMPORTANT SAFETY INFORMATION

              • If you have a pelvic infection, get infections easily, or have certain cancers, don't use Kyleena. Less than 1% of users get a serious pelvic infection called pelvic inflammatory disease (PID).
              • If you have persistent pelvic or stomach pain or if Kyleena comes out, tell your healthcare professional (HCP). If Kyleena comes out, use back-up birth control. Kyleena may attach to or go through the uterus and cause other problems.
              • Pregnancy while using Kyleena is uncommon but can be life threatening and may result in loss of pregnancy or fertility.
              • Ovarian cysts may occur but usually disappear.
              • Bleeding and spotting may increase in the first 3 to 6 months and remain irregular. Periods over time usually become shorter, lighter, or may stop.

               

              Kyleena does not protect against HIV or STDs.

               

              Only you and your HCP can decide if Kyleena is right for you. Kyleena is available by prescription only.

               

              For important risk and use information about Kyleena, please see Full Prescribing Information.