Essential information

Kyleena^® product description: Kyleena^® is a levonorgestrel-releasing intrauterine system (IUS) containing 19.5 mg of levonorgestrel.

Indication: Contraception for up to 5 years.

Contraindications: Pregnancy; acute or recurrent pelvic inflammatory disease or conditions associated with increased risk for pelvic infections; acute cervicitis or vaginitis; postpartum endometritis or infected abortion during the past three months; cervical intraepithelial neoplasia until resolved; uterine or cervical malignancy; progestogen-sensitive tumors, e.g. breast cancer; abnormal uterine bleeding of unknown etiology; congenital or acquired uterine anomaly including fibroids which would interfere with insertion and/or retention of the intrauterine system (i.e. if they distort the uterine cavity); acute liver disease or liver tumor; hypersensitivity to the active substance or to any of the excipients.

Special warnings and precautions for use: Kyleena^® should be used with caution after specialist consultation, or removal of the system should be considered if any of the following conditions exist or arise for the first time: migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia; exceptionally severe headache; jaundice; marked increase of blood pressure; severe arterial disease such as stroke or myocardial infarction. Low dose levonorgestrel may affect glucose tolerance, and the blood glucose concentration should be monitored in diabetic users of Kyleena^®. However, there is generally no need to alter the therapeutic regimen in diabetics using levonorgestrel IUS.

Ectopic pregnancy: In clinical trials, the overall incidence of ectopic pregnancy with Kyleena^® was approximately 0.20 per 100 women ­years. Approximately half of the pregnancies that occur during Kyleena^® use are likely to be ectopic. Women considering Kyleena^® should be counselled on the signs, symptoms and risks of ectopic pregnancy. For women who become pregnant while using Kyleena^®, the possibility of an ectopic pregnancy must be considered and evaluated. Women with a previous history of ectopic pregnancy, tubal surgery or pelvic infection carry an increased risk of ectopic pregnancy. The possibility of ectopic pregnancy should be considered in the case of lower abdominal pain, especially in connection with missed periods or if an amenorrheic woman starts bleeding. Because an ectopic pregnancy may impact future fertility, the benefits and risks of using Kyleena^® should be carefully evaluated on an individual woman basis.

Pelvic infection: Pelvic infection has been reported during use of any IUS or IUD. While Kyleena^® and the inserter are sterile they may, due to bacterial contamination during insertion, become a vehicle for microbial transport in the upper genital tract. In clinical trials, pelvic inflammatory disease (PID) was observed more frequently at the beginning of Kyleena^® use, which is consistent with published data for copper IUDs, where the highest rate of PID occurs during the first 3 weeks after insertion and decreases thereafter. Before electing use of Kyleena^®, patients should be fully evaluated for risk factors associated with pelvic infection (e.g. multiple sexual partners, sexually transmitted infections, prior history of PID). Pelvic infections such as PID may have serious consequences and may impair fertility and increase the risk of ectopic pregnancy. As with other gynecological or surgical procedures, severe infection or sepsis (including group A streptococcal sepsis) can occur following IUD insertion, although this is extremely rare. If a woman experiences recurrent endometritis or PID or if an acute infection is severe or does not respond to treatment, Kyleena^® must be removed. Bacteriological examinations are indicated and monitoring is recommended, even with discrete symptoms indicative of infections.

Expulsion: In clinical trials with Kyleena^®, the incidence of expulsion was low and in the same range as that reported for other IUDs and IUSs. Symptoms of the partial or complete expulsion of Kyleena^® may include bleeding or pain. However, partial or complete expulsion can occur without the woman noticing it, leading to decrease or loss of contraceptive protection. As Kyleena^® typically decreases menstrual bleeding over time, an increase of menstrual bleeding may be indicative of an expulsion. A partially expelled Kyleena^® should be removed. A new system can be inserted at that time provided pregnancy has been excluded. A woman should be advised how to check the threads of Kyleena^® and to contact her healthcare professional if the threads cannot be felt.

Perforation: Perforation or penetration of the uterine corpus or cervix by an intrauterine contraceptive may occur, most often during insertion, although it may not be detected until sometime later, and may decrease the effectiveness of Kyleena^®. In case of a difficult insertion and/or exceptional pain or bleeding during or after insertion, appropriate steps should be taken immediately to exclude perforation, such as physical examination and ultrasound. Such a system must be removed; surgery may be required. In a large prospective comparative non-interventional cohort study in users of other IUDs (N=61,448 women) with a 1-year observational period, the incidence of perforation was 1.3 (95% CI: 1.1–1.6) per 1,000 insertions in the entire study cohort; 1.4 (95% CI: 1.1–1.8) per 1,000 insertions in the cohort of another levonorgestrel IUS and 1.1 (95% CI: 0.7–1.6) per 1,000 insertions in the copper IUD cohort. The study showed that both breastfeeding at the time of insertion and insertion up to 36 weeks after giving birth were associated with an increased risk of perforation (see Table 1). Both risk factors were independent of the type of IUD inserted.