What Liletta is used for and how to use it
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Liletta ( lye- LET- uh) – Consumer Medicine Information

Manufacture: Actavis
Country: United States
Condition: Birth Control (Contraception)
Class: Contraceptives, Progestins
Form: Vaginal rings, Vaginal (e.g., douche, pessary, etc.)

( levonorgestrel- releasing intrauterine system )

LILETTA does not protect against HI V infection ( AI DS) and other sexually transmitted infections ( STI s).

Read this Patient Information carefully before you decide if LILETTA is right for you. This information does not take the place of talking with your gynecologist or other healthcare provider who specializes in women’s health. If you have any questions about LILETTA, ask your healthcare provider. You should also learn about other birth control methods to choose the one that is best for you.

What is Liletta?

  • LILETTA is a hormone-releasing system inserted in your uterus by your healthcare provider to prevent pregnancy for up to 3 years.
  • LILETTA can be removed by your healthcare provider at any time.
  • LILETTA can be used whether or not you have given birth to a child.

LILETTA is a small, flexible plastic T- shaped system that slowly releases a progestin hormone called levonorgestrel ( LNG) that is often used in birth control pills.

Because LILETTA releases LNG into your uterus, only small am ounts of the hormone enter your blood. LILETTA does not contain estrogen.

Two thin threads are attached to the stem ( lower end) of LILETTA. The threads are the only part of LILETTA you should feel when LILETTA is in your uterus; however, unlike a tamponstring, the threads do not extend outside your body.


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

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

What if I want to stop using Liletta?

LILETTA is intended for use up to 3 years, but you can stop using LILETTA at any time by asking your healthcare provider to remove it . You could become pregnant as soon as LILETTA is removed, so you should use another method of birth control if you do not want to become pregnant. Discuss your options with your healthcare provider, because certain methods should be started 7 days before LILETTA is removed to ensure continued birth control.

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

Your healthcare provider can remove LILETTA at any time. You could become pregnant as soon as LILETTA is removed. About 5 out of 6 women who want to become pregnant will become pregnant sometime in the first year after LILETTA is removed.

How does Liletta work?

LILETTA may work in several ways including by thickening cervicalmucus, inhibiting spermmovement, reducing sperm survival, and thinning the lining of your uterus. It is not known exactly how these actions work together to prevent pregnancy.


How well does Liletta work for contraception?

The following chart shows the chance of getting pregnant for women who use different control methods that are similar in effectivmethods of birth control. Each box on the chart contains a list of birtheness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.

LILETTA, an intrauterine system ( I US), is in the box at the top of the chart.


Who might use Liletta?

You might choose LILETTA if you:

  • want birth control that provides a low chance of getting pregnant ( less than 1 in 100)
  • want birth control that works continuously for up to a maximum of 3 years
  • want birth control that is reversible
  • want a birth control method that you do not need to take daily
  • are willing to use a birth control method that is inserted in the uterus
  • want birth control that does not contain estrogen

Who should not use Liletta?

Do not use LILETTA if you:

  • are or might be pregnant; LILETTA cannot be used as an emergency contraceptive
  • have had a serious pelvic infection called pelvic inflammatory disease ( PI D) 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 problems with your immune system
    • have multiplesexual partners or your partner has multiple sexual partners
    • use or 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 tum or
    • have breast cancer or any other cancer that is sensitive to progestin ( a female hormone), now or in the past
    • have an intrauterine system in your uterus already
    • have a condition of the uterus that changes the shape of the uterine cavity, such as large fibroidtumors
    • are allergic to levonorgestrel, silicone, polyethylene, or barium sulfate

    Before having LILETTA inserted, tell your healthcare provider if you:

    • have had a heart attack
    • have had a stroke
    • were born with heart disease or have problem s with your heart valves
    • have problems with blood clotting or take medicine to reduce clotting
    • have high blood pressure
    • recently had a baby or if you are breastfeeding
    • have severe migraine headaches
    • are or might be pregnant
    • have acute pelvic inflammatory disease or a history of pelvic inflam m atory disease
    • have AI DS, HI V, or any other sexually transmitted infection
    • have any other medical conditions

    Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements.

    How is Liletta inserted?

    LILETTA is inserted by your healthcare provider during an in- office visit .

    First, your healthcare provider will exam ine 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 LILETTA into your uterus. Your healthcare provider will then remove the plastic tube, and leave LILETTA in your uterus. Your healthcare provider will trim the threads to the right length. Insertion takes only a few minutes.

    You may experience pain, bleeding, or dizziness during and after insertion. If your symptoms do not pass within 30 minutes after insertion, LILETTA may not have been inserted correctly. Your healthcare provider will examine you to see if LILETTA needs to be removed or replaced.

    Should I check that Liletta is in place?

    Yes, you should check that LILETTA is in proper position by feeling the threads. It is a good habit to do this 1 time a month. Your healthcare provider should teach you how to check that LILETTA 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 threads. Do not pull on the threads.

    If you feel more than just the threads or if you cannot feel the threads, LILETTA may not be in the right position and may not prevent pregnancy. Use non-hormonal back- up birth control ( such as condom s and sperm icide) and ask your healthcare provider to check that LILETTA is still in the right place.

    If LILETTA is accidentally removed and you had vaginal intercourse within the preceding 24 hours, you may be at risk of pregnancy, and should talk to a healthcare provider.

    How soon after insertion of Liletta should I return to my healt hcare provider?

    Call your healthcare provider if you have any questions or concerns ( see “ When should I call my healthcare provider?” ) . Otherwise, you should return to your healthcare provider for a follow- up visit 4 to 6 weeks after LILETTA is inserted to m ake sure that LILETTA is in the right position.

    Can I use tampons w ith Liletta?

    Tampons maybe used with LILETTA.

    What if I become pregnant while using Liletta?

    Call your healthcare provider right away if you think you are pregnant. If you get pregnant while using LILETTA, you may have an ectopic pregnancy. This meansthat the pregnancy is not in the uterus. Unusual vaginal bleeding or abdominal pain maybe 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 LILETTA and the pregnancy is in the uterus. Severe infection, miscarriage, premature delivery, and even death can occur with pregnancies that continue with an intrauterine system ( I US). Because of this, your healthcare provider may try to remove LILETTA, even though removing it may cause a mscarriage. If LILETTA 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, cram ping, pain, bleeding, vaginal discharge, or fluid leaking from your vagina. These may be signs of infection.

    I t is not known if LILETTA can cause long- term effects on the fetus if it stays in place during a pregnancy.

    How will Liletta 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 tim e. After you have used LILETTA for a while, the number of bleeding and spotting days is likely to lessen. For some women, menstrual periods will stop altogether. When LILETTA is removed, your menstrual periods will likely return to their form er pattern.

    If you have any concerns that you may be pregnant while using LILETTA, do a urine pregnancy test or call your healthcare provider.

    Is it safe to breastfeed while using Liletta?

    You may use LILETTA when you are breastfeeding if more than 6 weeks have passed since you had your baby. If you are breastfeeding, LILETTA is not likely to affect the quality or am ount of your breast milk or the health of your nursing baby. However, isolated cases of decreased milk production have been reported am ong women using progestin-only birth control pills.

    Will Liletta interfere with sexual intercourse?

    You and your partner should not feel LILETTA during intercourse. LILETTA is inserted in the uterus, not in the vagina. In some cases, your partner may feel the threads. If this occurs, or if you or your partner experience pain during sex, talk with your healthcare provider.

    Can I have an MRI with Liletta in place?

    LILETTA is MR Safe. It is safe to have an MRI following LILETTA insertion.

    What are the possible side effects of Liletta?

    LILETTA can cause serious side effects, including:

    • ectopic pregnancy . If you get pregnant while using LILETTA, you might have an ectopic pregnancy. This means that the pregnancy is not in the uterus. Unusual vaginal bleeding or abdom inal pain maybe 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.
    • intrauterine pregnancy risks. There are also risks if you get pregnant while using LILETTA and the pregnancy is in the uterus. Severe infection, m iscarriage, prem ature delivery, and even death can occur with pregnancies that continue with an int rauterine system ( I US). Because of this, your healthcare provider may try to remove LILETTA, even though removing it may cause a m iscarriage. If LILETTA cannot be removed, talk with your healthcare provider about the benefits and risks of continuing the pregnancy. If, after seeing your healthcare provider, you choose to continue your pregnancy, see your healthcare provider regularly. Call your healthcare provider right away if you get flu-like symptoms, fever, chills, cram ping, pain, bleeding, vaginal discharge, or fluid leaking from your vagina. These may be signs of infection. It is not known if LILETTA can cause long- term effects on the fetus if it stays in place during a pregnancy.
    • life- threatening infection . Life-threatening infection can occur within the first few days after LILETTA is inserted. Call your healthcare provider immediately if you develop severe pain or fever shortly after LILETTA is inserted.
    • pelvic inflammatory disease ( PI D ). Some I US users get a serious pelvic infection called pelvic inflammatory disease ( PI D). PI D is usually sexually transmitted. You have a higher chance of getting PI D if you or your partner has sex with other partners. PI D can cause serious problem s such as infertility, ectopic pregnancy or pelvic pain that does not go away. PI D is usually treated with antibiotics. More serious cases of PI D may require surgery. Removal of the uterus ( hysterectom y) is som et im es needed. In rare cases, infections that start as PI D can even cause death.
    • Tell your healthcare provider right away if you have any of these signs of PI D: long- lasting or heavy bleeding, unusual vaginal discharge, low abdom inal pain, painful sex, chills, or fever.

    • perforation . LILETTA may become attached to ( embedded) or go through the wall of the uterus. This is called perforation ( or embedment). If this occurs, LILETTA may no longer prevent pregnancy. If perforation occurs, LILETTA may move outside the uterus and can cause internal scarring, infection, or dam age to other organs. You may need surgery to have LILETTA removed if perforation or embedment occurs. The risk of perforation is increased in breastfeeding women.
    • expulsion . LILETTA may come out of your uterus. This is called expulsion. Expulsion occurs in about 3 out of 100 women. You may become pregnant if LILETTA comes out. If you think that LILETTA has come out, use another birth control method like condoms and spermicide or do not have sex (vaginal intercourse) until you are seen by a healthcare provider.

    The most common side effects of LILETTA include:

    • vaginal infection
    • infection of the outer part of your vagina ( vulvovaginal)
    • acne
    • headache
    • nausea/ vomiting
    • pain during sex
    • abdom inal pain
    • breast pain
    • pelvic pain
    • depression
    • m ood changes
    • Pain, bleeding, or dizziness during and after insertion. If these symptoms do not stop within 30 minutes after insertion, LILETTA may not have been inserted correctly. Your healthcare provider will examine you to see if LILETTA needs to be removed or replaced.
    • Missed menstrual periods. About 1 out of 5 women stop having periods after 1 year of LILETTA use. If you have any concerns that you maybe pregnant while using LILETTA, do a urine pregnancy test or call your healthcare provider. When LILETTA is removed, your m enstrual periods will usually return to your previous pattern.
    • 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 maybe 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. Some women using LILETTA develop a painful cyst on the ovary. These cysts usually disappear on their own in 2 to 3 months. However, a cyst can cause pain and sometimes cysts will need surgery.

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

    These are not all the possible side effects of LILETTA. For more information, ask your healthcare provider or pharmacist.

    Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1- 800- FDA- 1088.

    You may also report side effects to Actavis at ( 800) 272- 5525.

    After Liletta has been inserted, when should I call my healthcare provider?

    Call your healthcare provider if you have any concerns about LILETTA. 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 ( STI s)
    • are concerned that the I US may have been expelled ( came out)
    • cannot feel LILETTA's threads
    • develop very severe or migraine headaches
    • have yellowing of the skin or whites of the eyes. These maybe signs of liver problems.
    • have had a stroke or heart attack
    • you or your partner becomes HI V positive
    • have severe vaginal bleeding or bleeding that concerns you

    General inform ation aboutt he safe and effective use of Liletta.

    Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

    This leaflet summarizes the most im portant information about LILETTA. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about LILETTA that is written for health professionals.

    For more information, go to www.LILETTA. com or call 1- 855- LILETTA ( 1- 855- 545- 3882).