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). ... Continue below

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Kyleena is a hormone-releasing IUD
that prevents pregnancy for up to 5 years.

What is an IUD?

right image An IUD (short for intrauterine device) is a small, T-shaped device that is made of soft, flexible plastic and is smaller than you think. Insertion of an IUD by your healthcare provider is a nonsurgical procedure, and it typically takes just a few minutes to place it in your uterus. Once in place, it can provide up to 5 years of continuous pregnancy prevention. IUDs are reversible, and can be removed by your healthcare provider at any time, so you can try to get pregnant right away.

With Kyleena, you get:

  • Birth control that’s over 99% effective for each year of use 98.5% effective over 5 years

  • The smallest 5-year IUD

  • Continuous low dose of hormones

  • Up to 5 years of nonstop pregnancy prevention

  • Birth control that can be used whether or not you’ve had a baby

  • No daily pills to think about taking

  • No monthly refills or trips to the pharmacy

You should make sure Kyleena is in place with a monthly thread check. Your healthcare provider can show you how. If you don't feel the threads or feel more than just the threads, call your healthcare provider. Kyleena may not be in the right position and may not prevent pregnancy. Use non-hormonal back-up birth control (such as condoms and spermicide) until your healthcare provider can check that Kyleena is still in the right place.

Kyleena is FDA-approved and is available by prescription only.

Where does Kyleena go?

Kyleena is placed in your uterus by your healthcare provider. Placement involves a nonsurgical procedure that takes just a few minutes. In 4 to 6 weeks, you should return to your healthcare provider for a follow-up visit.

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 provider will examine you to see if Kyleena needs to be removed or replaced.

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Kyleena is thought to work in several ways, which include:

  • Thinning the lining of the uterus
  • Thickening cervical mucus
  • Inhibiting sperm movement and reducing sperm survival

Highly effective but low in hormones

Kyleena works by giving you a continuous low dose of progestin—a hormone that acts primarily in the uterus. And Kyleena is estrogen-free.

Because Kyleena is in your uterus, not your vagina:

  • You and your partner should not feel Kyleena during intercourse.

  • Sometimes your partner may feel the threads. If this occurs, or if you or your partner experience pain during sex, talk with your healthcare provider.

If I can’t feel it, how do I know it’s working?

Kyleena is over 99% effective at preventing pregnancy for each year of use and 98.5% effective over 5 years. This was proven in a study of more than 1,400 women between the ages of 18 and 35. Some of these women already had children before the study, some did not. They also had a range of body weight—from 84 pounds to 381 pounds.

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 3–6 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 cysts will 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. Tell your healthcare provider if you have any side effect that bothers you or does not go away.

Some serious risk considerations about Kyleena

  • Although pregnancy while using Kyleena is uncommon (less than 1 in 100), it can be serious. Call your healthcare provider right away if you think you may be 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 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.

    For a full list of serious risk considerations about Kyleena, please click here.

HOW EFFECTIVE IS KYLEENA?

Kyleena® is one of the most effective methods of birth control. It’s over 99% effective at preventing pregnancy for each year of use, and 98.6% effective over 5 years.

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IUDs ARE RECOMMENDED AS EFFECTIVE, REVERSIBLE BIRTH CONTROL BY THE FOLLOWING ORGANIZATIONS:

  • The American College of Obstetricians and Gynecologists (ACOG)
  • American Medical Association (AMA)
  • Centers for Disease Control and Prevention (CDC)

Click here to learn more about safety considerations with Kyleena.

Did you know
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IUDs are reversible. They can be removed by a healthcare provider at any time, and you can try to get pregnant right away.

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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.