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 8 years.

• 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); PID occurs in less than 1% of users
  • Have an untreated lower genital infection now
  • Have had a serious pelvic infection after an abortion or pregnancy within the last 3 months
  • Can get infections easily; for example, if you:
  • Have problems with your immune system
  • Have multiple sexual partners or your partner has multiple sexual partners
  • Have a history of PID
  • 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 contraceptive 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 may be 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 or foul-smelling vaginal discharge, low abdominal or pelvic pain, painful sex, genital lesions or sores, 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 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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

Please also see full Prescribing Information.