These highlights do not include all the information needed to use LILETTA® safely and effectively. See full prescribing information for LILETTA.
LILETTA (levonorgestrel-releasing intrauterine system)
Initial U.S. Approval: 1968 (norgestrel)
RECENT MAJOR CHANGES
Indications and Usage (1) 10/2019
Dosage and Administration (2.1) 10/2019
INDICATIONS AND USAGE
LILETTA is a progestin-containing intrauterine system indicated for prevention of pregnancy for up to 6 years. (1)
DOSAGE AND ADMINISTRATION
The initial release rate of levonorgestrel (LNG) is approximately 20 mcg/day and declines progressively to approximately 8.6 mcg/day after 6 years; LILETTA can be removed at any time but must be removed by the end of the sixth year. (2)
To be inserted into the uterine cavity with the provided inserter by a trained healthcare professional using strict aseptic technique. Follow insertion instructions exactly as described. (2.3)
Patients should be re-examined and evaluated 4 to 6 weeks after insertion and once a year thereafter, or more frequently if clinically indicated. (2.5)
DOSAGE FORMS AND STRENGTHS
One intrauterine system consisting of a T-shaped polyethylene frame with a drug reservoir containing 52 mg LNG, packaged within a sterile inserter. (3)
CONTRAINDICATIONS
Pregnancy (4)
Use for post-coital contraception (emergency contraception) (4)
Congenital or acquired uterine anomaly that distorts the uterine cavity and would be incompatible with correct IUS placement (4)
Acute pelvic inflammatory disease (PID) or endometritis or a history of PID unless there has been a subsequent intrauterine pregnancy (4)
Infected abortion in the past 3 months (4)
Known or suspected uterine or cervical neoplasia (4)
Known or suspected breast cancer or other hormone-sensitive cancer (4)
Uterine bleeding of unknown etiology (4)
Untreated acute cervicitis or vaginitis or other lower genital tract infections (4)
Acute liver disease or liver tumor (benign or malignant) (4)
Increased susceptibility to pelvic infections (4)
A previously inserted IUS that has not been removed (4)
Hypersensitivity to any component of LILETTA (4)
WARNINGS AND PRECAUTIONS
Remove LILETTA if pregnancy occurs with LILETTA in place and LILETTA is in the uterus. If pregnancy occurs, there is increased risk of ectopic pregnancy (including loss of fertility), pregnancy loss, septic abortion (including septicemia, shock and death) and premature labor and delivery. (5.1, 5.2)
Severe infection or sepsis, including Group A streptococcal sepsis (GAS), have been reported following insertion of LNG-releasing IUSs; strict aseptic technique is essential during insertion. (5.3)
Before using LILETTA, consider the risks of pelvic infection. (5.4)
Perforation may occur and reduce contraceptive effectiveness. Risk is increased if inserted in women with fixed retroverted uteri, during lactation, or postpartum. (5.5)
Partial or complete expulsion may occur. (5.6)
Evaluate persistent enlarged ovarian follicles or ovarian cysts. (5.7)
Bleeding patterns can become altered, may remain irregular and amenorrhea may ensue. (5.8)
ADVERSE REACTIONS
The most common adverse reactions reported in clinical trials (> 10% users) are vulvovaginal mycotic infections, vaginal bacterial infections, acne, and nausea or vomiting. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 10/2019
