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Important Safety Information

If you have a pelvic infection, get infections easily, or have certain
cancers, don’t use Skyla.
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 Skyla comes out, tell your healthcare
provider (HCP)... continue reading below

Safety Considerations

Skyla® isn't right for everyone. Prior to placement, you should review your health history with your healthcare provider and be aware of some serious but uncommon side effects that are associated with Skyla. You should also be aware of the possible common side effects that may occur after placement. For more information, talk to your healthcare provider and read the information below.

Who should not use Skyla?

You should not use Skyla if you:

  • Are or might be pregnant; Skyla 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
    • Problems with your immune system
    • Abused/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 tumors
  • 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 any components of Skyla, which include levonorgestrel, silicone, polyethylene, silver, silica, barium sulfate or iron oxide

What if I become pregnant while using Skyla?

  • Call your healthcare provider right away if you think you are pregnant. If you get pregnant while using Skyla, 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 Skyla 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 Skyla, even though removing it may cause a miscarriage. If Skyla 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 Skyla can cause long-term effects on the fetus if it stays in place during a pregnancy

What are the possible side effects of Skyla?

Skyla can cause serious side effects, including:

  • 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 have 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
  • Life-threatening infection. Life-threatening infection can occur within the first few days after Skyla is placed. Call your healthcare provider immediately if you develop severe pain or fever shortly after Skyla is placed
  • Perforation. Skyla may become attached to (embedded) or go through the wall of the uterus. This is called perforation. If this occurs, Skyla may no longer prevent pregnancy. If perforation occurs, Skyla may move outside the uterus and can cause internal scarring, infection, or damage to other organs, and you may need surgery to have Skyla removed. The risk of perforation is increased if Skyla is inserted while you are breastfeeding

Common side effects of Skyla include:

  • Pain, bleeding, or dizziness during and after placement. If these symptoms do not stop 30 minutes after placement, Skyla may not have been placed correctly. Your healthcare provider will examine you to see if Skyla needs to be removed or replaced
  • Expulsion. Skyla may come out by itself. This is called expulsion. Expulsion occurs in about 3 out of 100 women. You may become pregnant if Skyla comes out. If you think that Skyla has come out, use a backup birth control method like condoms and spermicide and call your healthcare provider
  • Missed menstrual periods. About 1 out of 16 women stop having periods after 1 year of Skyla use. If you do not have a period for 6 weeks during Skyla use, call your healthcare provider. When Skyla is removed, your menstrual periods will come back
  • 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 14 out of 100 women using Skyla develop a cyst on the ovary. These cysts usually disappear on their own in a month or two. However, cysts can cause pain and sometimes cysts will need surgery

This is not a complete list of possible side effects with Skyla. 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.

After Skyla has been placed, when should I call my healthcare provider?

Call your healthcare provider if you have any concerns about Skyla. Be sure to call if you:

  • Think you are pregnant
  • Have pelvic 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)
  • Cannot feel Skyla'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 does
  • Have severe vaginal bleeding or bleeding that lasts a long time
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Skyla® (levonorgestrel-releasing intrauterine system) is a hormone-releasing IUD that prevents pregnancy for up to 3 years.

  • If you have a pelvic infection, get infections easily, or have certain cancers, don't use Skyla. 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 Skyla comes out, tell your healthcare provider (HCP). If Skyla comes out, use back-up birth control. Skyla may attach to or go through the uterus and cause other problems.
  • Pregnancy while using Skyla 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.

Skyla does not protect against HIV or STDs.

Only you and your HCP can decide if Skyla is right for you. Skyla is available by prescription only.

For important risk and use information about Skyla, please see the Full Prescribing Information.