KYLEENA SIDE EFFECTS
AND SAFETY INFORMATION
Kyleena® isn’t right for everyone. You and your healthcare provider will review your health history to determine if Kyleena is an option for you. An important part of your decision is making sure you’re aware of possible side effects. Keep reading to learn about the safety considerations for Kyleena. If you have questions or concerns, always talk to your healthcare provider.
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 unless you have had a normal pregnancy after the infection went away
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have an untreated genital infection now
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have had a serious pelvic infection 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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have bleeding from the vagina that has not been explained
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have liver disease or a 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 -
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
Before having Kyleena placed, tell your healthcare provider about all of your medical conditions including if you:
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have any of the conditions listed above
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have had a heart attack
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have had a stroke
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were born with heart disease or have problems with your heart valves
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have problems with blood clotting or take medicine to reduce clotting
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have high blood pressure
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recently had a baby or are breastfeeding
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have severe headaches or migraine headaches
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have AIDS, HIV, or any other sexually transmitted infection
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What if I become pregnant while using Kyleena?
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Call your healthcare provider 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.
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Ectopic pregnancy is a medical emergency that often requires surgery. Ectopic pregnancy can cause internal bleeding, infertility, and even death.
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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 provider may try to remove Kyleena, even though removing it may cause a miscarriage. If Kyleena cannot be removed, talk with your healthcare provider about the benefits and risks of continuing the pregnancy and possible effects of the hormone on your unborn baby.
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If you continue your pregnancy, see your healthcare provider regularly. Call your healthcare provider 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.
How will Kyleena change my periods?
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.
Is it safe to breastfeed while using Kyleena?
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 uterus is increased if Kyleena is inserted while you are breastfeeding.
What are the possible side effects of Kyleena?
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.
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Life‐threatening infection. Life‐threatening infection can occur within the first few days after Kyleena is placed. Call your healthcare provider 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 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 including the removal of the uterus (hysterectomy). In rare cases, infections that start as PID can even cause death. Tell your healthcare provider 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 provider. 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 provider 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 provider 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
In the clinical trials of 1,697 healthy women aged 18-41, the most common adverse reactions (occurring in ≥ 5% women) were vulvovaginitis (24%), ovarian cyst (22%), abdominal pain/pelvic pain (21%), headache/migraine (15%), acne/seborrhea (15%), dysmenorrhea/uterine spasm (10%), breast pain/breast discomfort (10%), and increased bleeding (8%).
These are not all of the possible side effects with Kyleena. For more information, ask your healthcare provider.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088). You may also report side effects to Bayer Healthcare Pharmaceuticals at 1-888-842-2937.
After Kyleena has been placed, when should I call my healthcare provider?
If Kyleena is accidentally removed and you had vaginal intercourse within the preceding week, you may be at risk of pregnancy, and you should talk to a healthcare provider.
Call your healthcare provider if you have any concerns about Kyleena. Be sure to call if you:
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think you are pregnant
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have pelvic pain, abdominal pain, or pain during sex
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have unusual vaginal discharge or genital sores
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have unexplained fever, flu-like symptoms, or chills
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might be exposed to sexually transmitted infections (STIs)
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are concerned that Kyleena may have been expelled (came out)
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cannot feel Kyleena's threads
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develop very severe or migraine headaches
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have yellowing of the skin or whites of the eyes. These may be signs of liver problems
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have had a stroke or heart attack
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become HIV positive, or your partner becomes HIV positive
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have severe vaginal bleeding or bleeding that concerns you
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 or 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, or excessive bleeding after placement tell your healthcare provider (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 through the wall of 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 use information about Kyleena, please see Full Prescribing Information.
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