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Patient information leaflet and adverse event reporting information can be found at the bottom of the page
Frequently asked
questions about Kyleena
About Kyleena
An IUS (intrauterine system) is a small, T-shaped device that’s placed in your uterus by your healthcare professional to prevent pregnancy. Getting an IUS does not involve surgery, but instead, can be placed during a routine appointment or immediately after giving birth. 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 a 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, speak to your healthcare professional before the procedure.
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:
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are or might be pregnant; Kyleena cannot be used as an emergency contraceptive
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have a serious pelvic infection called pelvic inflammatory disease (PID) or have had PID in the past
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have an untreated genital infection now
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have had serious pelvic infections in the past 3 months after a pregnancy
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can get infections easily. For example, if you:
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have multiple sexual partners or your partner has multiple sexual partners
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have problems with your immune system
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use or abuse intravenous drugs
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have or suspect you might have cancer of the uterus or cervix
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currently have cell abnormalities in the cervix
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have bleeding from the vagina that has not been explained
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have liver disease or liver tumor
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have breast cancer or any other cancer that is sensitive to progestin (a female hormone), now or in the past
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have an intrauterine device in your uterus already
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have a condition of the uterus that changes the shape of the uterine cavity, such as large fibroid tumors
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are allergic to levonorgestrel, silicone, polyethylene, silver, silica, barium sulfate, polypropylene, or copper phthalocyanine
Kyleena can cause serious side effects, including:
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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?”).
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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.
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Pelvic inflammatory disease (PID). Some IUD users get a serious pelvic infection called pelvic inflammatory disease. PID is usually caused by a sexually transmitted infection. 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 including removal of the uterus (hysterectomy). 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, fever, genital lesions or sores.
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Perforation. Kyleena may go into the wall of the uterus (become 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. Excessive pain or vaginal bleeding during placement of Kyleena, pain or bleeding that gets worse after placement, or not being able to feel the threads may happen with perforation. The risk of perforation is increased if Kyleena is inserted while you are breastfeeding, or if you have recently given birth.
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Expulsion. Kyleena may come out by itself. This is called expulsion. Expulsion occurs in about 4 out of 100 women. Excessive pain or vaginal bleeding during placement of Kyleena, pain or bleeding that gets worse after placement, or not being able to feel the threads may happen with expulsion. You may become pregnant if Kyleena comes out. If you think that Kyleena has come out, avoid intercourse or use a non-hormonal back-up birth control (such as condoms or spermicide) and call your healthcare professional. The risk of expulsion is increased with insertion right after delivery or second-trimester abortion.
Common side effects of Kyleena include:
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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.
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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.
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Missed menstrual periods. About 12 out of 100 women stop having periods after 1 year of Kyleena use. If you have any concerns that you may be pregnant while using Kyleena, do a urine pregnancy test and call your healthcare provider. If you do not have a period for 6 weeks during Kyleena use, call your healthcare provider. When Kyleena is removed, your menstrual periods should return.
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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 2 to 3 months. However, cysts can cause pain and sometimes need surgery.
Other common side effects include:
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inflammation or infection of the outer part of your vagina (vulvovaginitis)
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abdomen or pelvic pain
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headache or migraine
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acne or greasy skin
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painful periods
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sore or painful breasts
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depressed mood
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decreased libido
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dizziness
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nausea
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hair loss
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genital tact infection
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genital discharge
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increased weight
These are not all of the possible side effects with Kyleena. For more information, please see Patient information leaflet 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. You may also have cramping during the first few weeks. 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 (AIDS) and other sexually transmitted infections (STIs).
Kyleena can be 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 system (IUS), in place.
After getting Kyleena
Yes, tampons or menstrual cups may be used with Kyleena. Change tampons or menstrual cups with care to avoid pulling the threads of Kyleena. If you think you may have pulled Kyleena out of place, avoid intercourse or use a non-hormonal back-up birth control (such as condoms or spermicide), and contact your healthcare provider.
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. Avoid intercourse or use non-hormonal back-up birth control (such as condoms or 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. 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.
Pregnancy and Kyleena
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 system (IUS). 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 and possible effects of the hormone on your unborn baby.
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.
You may use Kyleena when 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 going into the wall of the uterus (becoming embedded) or going through the wall of the uterus is increased if Kyleena is inserted while you are breastfeeding. Small amounts of hormone (about 0.1%) pass into the breast milk in nursing mothers.
PP-KYL-GB-0132 January 2023
INDICATION FOR KYLEENA
Kyleena® (levonorgestrel-releasing intrauterine system) is a hormone-releasing IUS that prevents pregnancy for up to 5 years.
IMPORTANT SAFETY INFORMATION
- If you have an untreated genital 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, excessive bleeding after placement or if Kyleena comes out, tell your healthcare professional (HCP). If Kyleena comes out, call your HCP and avoid intercourse or use non-hormonal back-up birth control (such as condoms or spermicide). Kyleena may go into 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 STIs.
Only you and your HCP can decide if Kyleena is right for you. Kyleena is available by prescription only.
For important risk and usage information about Kyleena, please see Patient information leaflet
Reporting adverse events and quality complaints
If you get any side effects talk to your doctor, pharmacist, nurse or healthcare professional. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at https://yellowcard.mhra.gov.uk or search for MHRA Yellow Card in Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. Please report information of when Kyleena was inserted and removed, as applicable.
