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You should 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

What if I become pregnant while using Kyleena?

  • Call your healthcare provider right away if you think you are pregnant. 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 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
  • 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
  • It is not known if Kyleena can cause long-term effects on the fetus if it stays in place during a pregnancy

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 among women using progestin-only birth control pills. The risk of Kyleena becoming attached to (embedded) or going through the wall of the uterus is increased when Kyleena is placed in breastfeeding women

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 (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 provider 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 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, 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 in breastfeeding women.

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 provider 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 provider.
  • 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 provider. 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 provider 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, ask your healthcare provider. Call your healthcare provider for medical advice about side effects. You may report side effects to the manufacturer at 1-­888-­842-­2937, or FDA at 1-­800-­FDA-­1088 or www.fda.gov/medwatch.

What are other serious risk considerations about Kyleena?

Other serious risk considerations about Kyleena include:

  • Sepsis (a rare, but 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 getting Kyleena.
  • Less than 1% of users get a serious pelvic infection called PID. 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.
  • Less than 0.1% of users experienced perforation (attaching to or going through the wall of the uterus) in clinical trials. 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 when Kyleena is placed in breastfeeding women.

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:

  • 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 provider (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.