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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

What to Expect

We’ve got some helpful information for you about what to expect at your Skyla® placement appointment and changes to your period that may occur after placement. You can also find out more about Skyla and insurance coverage.

What to expect at your placement appointment

How is Skyla placed?

Skyla is placed by your healthcare provider during an in-office visit. First, your healthcare provider will examine your pelvis to find the exact position of your uterus. Your healthcare provider will then clean your vagina and cervix with an antiseptic solution and slide a slim plastic tube containing Skyla into your uterus. Your healthcare provider will then remove the plastic tube, and leave Skyla in your uterus. Your healthcare provider will cut the threads to the right length. Placement takes only a few minutes.
 
You may experience pain, bleeding or dizziness during and after placement. If your symptoms do not pass within 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.

Do 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
    • 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 or iron oxide

Before having Skyla placed, tell your healthcare
provider 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

 

Changes to your period

With Skyla, your periods are likely to change.

For the first 3 to 6 months:

  • Your period may become irregular
  • 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 Skyla for a while:

  • The number of bleeding and spotting days is likely to lessen
  • For some women, periods will stop altogether

When Skyla is removed:

  • Your menstrual periods should return

What else should I know about effects on 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 should return.
  • 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.

After Placement

You should call your healthcare provider if you have any concerns about Skyla. Otherwise, you should return to your healthcare provider for a follow-up visit 4 to 6 weeks after Skyla is placed to make sure that Skyla is in the right position.

If Skyla 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.

Should I check that Skyla is in place?

Yes, you should check that Skyla is in proper position by feeling the removal threads. It is a good habit to do this 1 time a month. Your healthcare provider should teach you how to check that Skyla is in place. First, wash your hands with soap and water. You can check by reaching up to the top of your vagina with clean fingers to feel the removal threads. Do not pull on the threads. If you feel more than just the threads or if you cannot feel the threads, Skyla may not be in the right position and may not prevent pregnancy. Use non-hormonal back-up birth control (such as condoms and spermicide) and ask your healthcare provider to check that Skyla is still in the right place.

What if I want birth control for more than 3 years?

Skyla must be removed after 3 years. Your healthcare provider can place a new Skyla during the same office visit if you choose to continue using Skyla.

What if I want to stop using Skyla?

Skyla is intended for use up to 3 years but you can stop using Skyla at any time by asking your healthcare provider to remove it. You could become pregnant as soon as Skyla is removed, so you should use another method of birth control if you do not want to become pregnant. Talk to your healthcare provider about the best birth control methods for you, because your new method may need to be started 7 days before Skyla is removed to prevent pregnancy.

What if I change my mind about birth control and want to become pregnant in less than 3 years?

Your healthcare provider can remove Skyla at any time. You may become pregnant as soon as Skyla is removed. About 3 out of 4 women who want to become pregnant will become pregnant sometime in the first year after Skyla is removed.

Call your healthcare provider if you have any concerns about Skyla. 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 Skyla may have been expelled (came out)
  • 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 becomes HIV positive
  • Have severe vaginal bleeding or bleeding that concerns you
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INDICATION FOR SKYLA

Skyla® (levonorgestrel-releasing intrauterine system) is a hormone-releasing IUD that prevents pregnancy for up to 3 years.

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). 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.