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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. Once in place, it provides continuous, highly effective birth control.
You may experience pain, bleeding, or dizziness during and after placement. If you have any symptoms that are worrying or concerning you then please contact your healthcare professional.
Getting a Kyleena
You may experience pain, bleeding, or dizziness during and after placement. If you have any symptoms that are worrying or concerning you then please contact your healthcare professional.
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:
- are or might be pregnant; Kyleena cannot be used as an emergency contraceptive
- have a serious pelvic infection called pelvic inflammatory disease (PID) or have had PID in the past
- have an untreated genital infection now
- have had serious pelvic infections in the past 3 months after a pregnancy, abortion or miscarriage
- can get pelvic infections easily. For example, if you:
- sexually transmitted diseases
- diseases that lower your body’s ability to fight off infections, like advanced stages of HIV
- have or suspect you might have cancer of the uterus or cervix
- your latest smear test (cervical screening) results were abnormal
- have bleeding from the vagina that has not been explained
- have liver disease or a liver tumour
- have or have had breast cancer or any other cancer that is sensitive to progestin (a female hormone)
- 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 fibroids
- 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?”).
- Mental health problems - you have mood changes and depressive symptoms.
- Pelvic inflammatory disease (PID). Some IUS 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. 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, fever, genital lesions or sores.
- 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.
- Expulsion. Kyleena may come out by itself. This is called expulsion. Expulsion occurs in up to 1 in 10 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. It is also possible that Kyleena can fall out without you noticing it. 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 if you were overweight at the time of Kyleena insertion or have had heavy periods before.
Common side effects of Kyleena include:
- Pain, bleeding, or dizziness during and after placement. If you have any symptoms that are worrying or concerning you then please contact your healthcare professionals.
- 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.
- Missed menstrual periods. Changes in menstrual periods - some women may stop having their periods. This is usually normal. Your hormone levels usually remain normal. If you have Kyleena removed, you usually get your normal period again. If that does not happen, contact your healthcare professional.
- Cysts on the ovary. Women using Kyleena may develop a small fluid-filled sac on an ovary, known as an ovarian cyst. These cysts usually disappear on their own. However, cysts can cause pain and sometimes need surgery. If you think you may have a cyst, please contact your healthcare professional.
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
- sensitive or painful breasts
- depressed mood
- decreased libido
- hair loss
- genital discharge
- 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 a heavier period than usual at first. 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.
If you have any concerns about how your periods may have changed, please contact your healthcare professional.
Kyleena does not protect against HIV infection (AIDS) or any 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 professional.
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. 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 inserted 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 after it has been 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 fertilised egg 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.
There are also risks if you get pregnant while using Kyleena and the pregnancy is in the uterus. Miscarriage or premature delivery can occur with pregnancies that continue with Kyleena in place. Because of this, your healthcare professional will remove Kyleena, even though removing it may cause a miscarriage. If Kyleena cannot be removed, talk with your healthcare professional.
You can use Kyleena during breast-feeding. A small amount of hormone ends up in breast milk. However, Kyleena is not likely to affect the quality or amount of your breast milk or the growth and development of your nursing baby.
PP-KYL-GB-0200 January 2025
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.
