what should i expect
after liletta insertion?

After LILETTA is inserted, your healthcare provider will explain how you can check the threads, once a month, to make sure LILETTA is still in place. Schedule a follow-up appointment with your healthcare provider 4 to 6 weeks after placement and at least once per year thereafter.

After your healthcare provider inserts LILETTA, you must be aware of a few key factors. Aside from understanding the Important Risk Information, you may have the following questions:

WHAT SHOULD
I EXPECT AFTER
LILETTA
INSERTION?

After LILETTA is inserted, your healthcare provider will explain how you can check the threads, once a month, to make sure LILETTA is still in place. Schedule a follow-up appointment with your healthcare provider 4 to 6 weeks after placement and at least once per year thereafter.

After your healthcare provider inserts LILETTA, you must be aware of a few key factors. Aside from understanding the Important Risk Information, you may have the following questions:

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 condoms and spermicide) and ask your healthcare provider to check that LILETTA is still in the right place.

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

Will LILETTA change my periods?

For the first 3 to 6 months, your period may become a little unpredictable and you may bleed more than usual. You may also have frequent spotting or light bleeding and cramping. Some women have heavy bleeding during this time.

After you have used LILETTA for a while, the number of days you experience bleeding and spotting is likely to lessen. For some women, menstrual periods may stop altogether. When LILETTA is removed, your menstrual periods will likely return to their former pattern.

Will LILETTA interfere with sexual intercourse?

You and your partner should not feel LILETTA during intercourse. LILETTA is placed 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.

What if I become pregnant while using LILETTA?

Call your healthcare provider right away if you think you are pregnant. If possible, also do a urine pregnancy test. If you get pregnant while using LILETTA, you may have an ectopic pregnancy. This means that the pregnancy is not in the uterus. Unusual vaginal bleeding or abdominal pain especially with missed periods 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 LILETTA and the pregnancy is in the uterus. Severe infection, miscarriage, premature labor, premature delivery, and even death can occur with pregnancies that continue with an intrauterine system (IUS). Because of this, your healthcare provider may try to remove LILETTA, even though removing it may cause a miscarriage. 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, cramping, 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.

When should I call my healthcare provider regarding my use of LILETTA?

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 (STIs)
are concerned that LILETTA 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 may be signs of liver problems
have had a stroke or heart attack
you or your partner becomes HIV positive
have severe vaginal bleeding, bleeding that lasts a long time, or you miss your period

Call your healthcare provider if you have any concerns about LILETTA after it is inserted.

What I Need to know about insertion:

Before

During

After

LILETTA^® (levonorgestrel-releasing intrauterine system) 52 mg is a hormone-releasing system placed in your uterus to prevent pregnancy for as long as you want for up to 6 years.

Important Risk Information

Do not use LILETTA if you:
- Are or might be pregnant; LILETTA cannot be used as an emergency contraceptive
- Have a serious pelvic infection called pelvic inflammatory disease (PID) or endometritis unless you have had a normal pregnancy after the infection went away (PID occurs in less than 1% of users)
- Have an untreated lower genital infection now
- Have had an infection from an abortion within the last 3 months
- Can get infections easily; for example, if you:
- Have or suspect you might have cancer of the uterus or cervix
- Have bleeding from the vagina that has not been explained
- Have short-term (acute) 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 system (IUS) 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, or barium sulfate
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, which means the pregnancy is not in the uterus. Unusual vaginal bleeding or abdominal pain especially with missed periods may be a sign of ectopic pregnancy. Ectopic pregnancy can cause internal bleeding. There are also risks if you get pregnant while using LILETTA and the pregnancy is in the uterus. Severe infection and premature labor or delivery can occur with pregnancies that continue with an IUS
Although uncommon, pregnancy while using LILETTA can be life threatening and may result in loss of pregnancy or fertility
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
Life-threatening infection can occur within the first few days after LILETTA is placed. Call your healthcare provider immediately if you develop severe pain or fever shortly after LILETTA is placed
Some IUS users get a serious pelvic infection called pelvic inflammatory disease (PID) or endometritis. These are usually sexually transmitted. You have a higher chance of getting PID or endometritis if you or your partner has sex with other partners. PID or endometritis can cause serious problems such as infertility, ectopic pregnancy or pelvic pain that does not go away. More serious cases of PID or endometritis may require surgery. Removal of the uterus (hysterectomy) is sometimes needed. In rare cases, infections that start as PID or endometritis can even cause death. Tell your healthcare provider right away if you have any of these signs of PID or endometritis: long-lasting or heavy bleeding, unusual vaginal discharge, low abdominal pain, painful sex, chills, or fever
LILETTA may partially go into (become embedded) or go completely through (perforate) the wall of the uterus. If perforation occurs, LILETTA may move outside the uterus and can cause internal scarring, infection, or damage to other organs. You may need surgery to have LILETTA removed if it is embedded or perforation occurs. Risk of perforation is increased in breastfeeding women
LILETTA may come out of your uterus (expulsion). Expulsion occurs in about 4 out of 100 women, most often in the first year of use. 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
Ovarian cysts may occur but usually disappear

LILETTA does not protect against HIV or STDs.

Available by prescription only.

Please also see full Prescribing Information.