Levonorgestrel Intrauterine

DEA Class; Rx

Common Brand Names; Mirena, Skyla, Liletta, Kyleena

Indicated for routine contraception.

Pregnancy or suspicion of pregnancy; cannot be used for postcoital contraception (emergency contraception)

Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity

Acute pelvic inflammatory disease or a history of pelvic inflammatory disease unless there has been a subsequent intrauterine pregnancy

Postpartum endometritis or infected abortion in the past 3 months

Known or suspected uterine or cervical neoplasia

Known or suspected breast cancer or other progestin-sensitive cancer, now or in the past

Uterine bleeding of unknown etiology

Untreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections until infection is controlled

Acute liver disease or liver tumor (benign or malignant)

Conditions associated with increased susceptibility to pelvic infections

Previously inserted intrauterine device (IUD) that has not been removed

Hypersensitivity to any component of this product

• Unscheduled uterine bleeding (31.9%)
• Decreased uterine bleeding (23.4%)
• Abdominal/pelvic pain (22.6%)
• Amenorrhea (18.4%)
• Headache/migraine (16.3%)
• Genital discharge (14.9%)
• Increased scheduled uterine bleeding (11.9%)
• Vulvovaginitis (10.5%)
• Breast pain (8.5%)
• Back pain (7.9%)
• Benign ovarian cyst and associated complications (7.5%)
• Acne (6.8%)
• Dysmenorrhea (6.4%)
• Depression/depressive mood (6.4%)
• Female genital tract bleeding (3.5%)
• Angioedema
• Cervical perforation
• Failed insertion
• Sepsis
• Uterine bleeding
• Device breakage
• Pulmonary emboli
• Deep vein thrombosis and stroke
• Increased blood pressure

Evaluate women for ectopic pregnancy; ~50% of pregnancies that occur with IUD are likely to be ectopic; also consider possibility of ectopic pregnancy in case of lower abdominal pain, especially in association with missed menses or if an amenorrheic woman starts bleeding

Severe infection, including group A streptococcal sepsis reported

Bleeding pattern alterations may occur, including amenorrhea, infrequent bleeding, prolonged bleeding, or irregular bleeding

Perforation may occur, most often during insertion; an interim analysis from a large postmarketing safety study shows an increased risk of perforation in lactating women; perforation risk may be increased in women with fixed retroverted uteri, and during the postpartum period; perforation may also occur at any time during IUS use; perforation may reduce contraceptive efficacy and result in pregnancy; this may be associated with severe pain and continued bleeding

Inform women who use product about recognizing signs and symptoms of ectopic pregnancy and promptly reporting them to their healthcare professional, and about the associated risks of ectopic pregnancy (eg, loss of fertility)

Exclude underlying endometrial pathology (eg, polyps or cancer) prior to insertion of device in women with persistent or uncharacteristic bleeding; irregular bleeding/spotting is common during first months of use and may preclude adequate assessment after insertion

If the threads are not visible or are significantly shortened, they may have broken or retracted into cervical canal or uterus; consider possibility that IUS may have been displaced, (for example, expulsed or perforated the uterus); exclude pregnancy and verify location of device by an appropriate diagnostic method

Women who currently have or have had breast cancer, or have a suspicion of breast cancer, should not use hormonal contraception, because some breast cancers are hormone-sensitive

Product not intended for use in menopausal women

Women with symptomatic actinomycosis should have device removed and should receive antibiotics

Contraindicated in pregnancy or suspected pregnancy

If a females becomes pregnant with IUD in place, risk of ectopic pregnancy is increased as well as miscarriage, sepsis, premature labor, and premature delivery

Published studies report presence of LNG in human milk

Small amounts of progestins (~0.1% of the total maternal doses) were detected in the breast milk of nursing mothers who used other LNG-releasing IUSs, resulting in exposure of LNG to the breastfed infants