Kyleena® isn’t right for everyone. You and your healthcare professional 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 professional.
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 a serious pelvic infection 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 a 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
Before having Kyleena placed, tell your healthcare professional if you:
Have any of the conditions listed above
Have had a heart attack
Have had a stroke
Were born with heart disease or have problems with your heart valves
Have problems with blood clotting or take medicine to reduce clotting
Have high blood pressure
Recently had a baby or are breastfeeding
Have severe migraine headaches
What if I become pregnant while using Kyleena?
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.
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. 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 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 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:
Ectopic pregnancy and intrauterine pregnancy risks. There are risks if you 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
Sore or painful breasts
This is not a complete list of possible side effects with Kyleena. For more information, ask your healthcare professional. Tell your healthcare professional if you have any side effect that bothers you or does not go away.
Call your healthcare professional for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088), or visit www.fda.gov/medwatch. You may also report side effects to the manufacturer at 1-888-842-2937.
After Kyleena has been placed, when should I call my healthcare professional?
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 professional.
Call your healthcare professional if you have any concerns about Kyleena. Be sure to call if you:
Think you are pregnant
Have pelvic pain, abdominal pain, or pain during sex
Have unusual vaginal discharge or genital sores
Have unexplained fever, flu-like symptoms, or chills
Might be exposed to sexually transmitted infections (STIs)
Are concerned that Kyleena may have been expelled (came out)
Cannot feel Kyleena's threads
Develop very severe or migraine headaches
Have yellowing of the skin or whites of the eyes. These may be signs of liver problems
Have had a stroke or heart attack
Become HIV positive, or your partner becomes HIV positive
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 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.