KYLEENA

What it is

Kyleena is an intrauterine delivery system containing 19.5 mg levonorgestrel as the active ingredient. It consists of a whitish or pale yellow drug core covered with a semi-opaque membrane, which is mounted on the vertical stem of a T-body. The vertical stem contains a silver ring located close to the horizontal arms, the T-body has a loop at one end of the vertical stem and two horizontal arms at the other end, and blue coloured removal threads are attached to the loop.

Approved indications

— Contraception for up to 5 years.

Dosing overview

Kyleena is inserted into the uterine cavity and is effective for up to five years. The in vivo release rate is approximately 17.5 μg/24 hours after 24 days and is reduced to approximately 15.3 μg/24 hours after 60 days and to 9.8 μg/24 hours after one year, then declines progressively to 7.4 μg/24 hours after five years, with an average levonorgestrel release rate of approximately 12.6 μg/24 hours over the first year and 9.0 μg/24 hours over five years. Kyleena is to be inserted into the uterine cavity within seven days of the onset of menstruation. The system should be removed no later than by the end of the fifth year.

Key safety warnings

Although Kyleena and the inserter are sterile, they may become a vehicle for microbial transport in the upper genital tract due to bacterial contamination during insertion. Pelvic infection has been reported during use of any intrauterine system or device, and in clinical trials pelvic inflammatory disease was observed more frequently at the beginning of Kyleena use, consistent with published data where the highest rate occurs during the first 3 weeks after insertion and decreases thereafter. Pelvic infections such as pelvic inflammatory disease may have serious consequences and may impair fertility and increase the risk of ectopic pregnancy. Perforation or penetration of the uterine corpus or cervix may occur, most often during insertion although it may not be detected until sometime later and may decrease the effectiveness of Kyleena. Excessive pain or bleeding during insertion or while Kyleena is in situ may be indicative of a perforation. 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. Risk of expulsion is increased in women with history of heavy menstrual bleeding and women with greater than normal BMI at the time of insertion, where this risk increases gradually with increasing BMI. Irregular bleeding and spotting are common in the first months of therapy with all levonorgestrel intrauterine systems including Kyleena. If bleeding becomes heavier and/or more irregular over time, appropriate diagnostic measures should be taken as irregular bleeding may be a symptom of endometrial polyps, hyperplasia or cancer. Kyleena does not protect against HIV infection (AIDS) and other sexually transmitted infections. The woman should be advised that additional measures such as condoms are needed to prevent the transmission of sexually transmitted infections.

Contraindications

Contraindications include pregnancy; acute or recurrent pelvic inflammatory disease or conditions associated with increased risk for pelvic infections; lower genital tract infection; postpartum endometritis or infected abortion during the past three months; cervicitis; cervical intraepithelial neoplasia; uterine or cervical malignancy; confirmed or suspected hormone dependent tumours including breast cancer; abnormal uterine bleeding of unknown aetiology; congenital or acquired uterine anomaly including fibroids which would interfere with insertion and/or retention of the intrauterine system; acute liver disease or liver tumour; and hypersensitivity to the active substance or to any of the excipients.

PBS listing

Kyleena 19.5 mg intrauterine drug delivery system has 1 PBS item listed with restriction, with an ex-manufacturer price of A$144.67.

Regulatory history

Kyleena (levonorgestrel 19.5 mg intrauterine drug delivery system) was first listed on the Australian Register of Therapeutic Goods on 18 January 2017. The TGA approved Kyleena for contraception for up to 5 years based on a positive evaluation of quality, nonclinical, and clinical data, which supported the product's safety and efficacy. The pivotal Phase III study demonstrated an overall Pearl Index of 0.29 (95% confidence interval: 0.16, 0.50) for contraception over 5 years, meeting efficacy guidelines.