KYLEENA

AbsorptionLow doses of LNG are administered into the uterine cavity with the Kyleena intrauterine delivery system. The in vivo release rate is approximately 17.5 mcg/day after 24 days and is reduced to approximately 15.3 mcg/day after 60 days and to 9.8 mcg/day after 1 year. It then declines progressively to approximately 7.9 mcg/day after 3 years and 7.4 mcg/day after 5 years. The average LNG in vivo release rate is approximately 12.6 mcg/day over the first year and 9.0 mcg/day over the period...

The contraceptive efficacy of Kyleena was evaluated in a clinical trial that enrolled generally healthy women aged 18–35, of whom 1,452 received Kyleena. Of these, 40% (574) were nulliparous women, 870 (60%) women completed 3 years of the study, 707 (49%) elected to enroll in an extension phase up to a total of 5 years, and 550 (38%) completed 5 years of use. The trial was a multicenter, multi-national, randomized, open-label study conducted in 11 countries in Europe, Latin America, the US and Canada. Women less than six weeks postpartum, with a history of ectopic pregnancy, with clinically si...

The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling:

• Ectopic Pregnancy [see Warnings and Precautions ( 5.1 )]
• Intrauterine Pregnancy [see Warnings and Precautions ( 5.2 )]
• Group A Streptococcal Sepsis (GAS) [see Warnings and Precautions ( 5.3 )]
• Pelvic Inflammatory Disease [see Warnings and Precautions ( 5.4 )]
• Perforation [see Warnings and Precautions ( 5.5 )]
• Expulsion [see Warnings and Precautions ( 5.6 ]
• Ovarian Cysts [see Warn...

The use of Kyleena is contraindicated when one or more of the following conditions exist:

• Pregnancy or suspicion of pregnancy [see Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8.1 )]
• For use as post-coital contraception (emergency contraception)
• Congenital or acquired uterine anomaly, including fibroids, that distorts the uterine cavity
• Acute pelvic inflammatory disease ...

• Remove Kyleena if pregnancy occurs with Kyleena in place. 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 )
• Group A streptococcal infection has been reported following insertion of LNG IUS; strict aseptic technique is essential during insertion. ( 5.3 )
• Before using Kyleena, consider the risks of PID. ( 5.4 )
• Uterine perfora...

7 DRUG INTERACTIONS No drug-drug interaction studies have been conducted with Kyleena. Drugs or herbal products that induce or inhibit LNG metabolizing enzymes, including CYP3A4, may decrease or increase, respectively, the serum concentrations of LNG during the use of Kyleena. However, the contraceptive effect of Kyleena is mediated via the direct release of LNG into the uterine cavity and is unli...