SKYLA

AbsorptionLow doses of LNG are administered into the uterine cavity with the Skyla intrauterine delivery system. The in vivo release rate is approximately 14 mcg/day after 24 days and is reduced to approximately 10 mcg/day after 60 days and then declines progressively to approximately 6 mcg/day after 1 year and 5 mcg/day after 3 years. The average LNG in vivo release rate is approximately 8 mcg/day over the first year of use and 6 mcg/day over the period of 3 years. In a subset of 7 subjects, t...

The contraceptive efficacy of Skyla was evaluated in a clinical trial that enrolled generally healthy women aged 18–35, 1,432 of whom received Skyla. Of these, 38.8 % (556) were nulliparous women, and 819 women completed 3 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 significant ovarian cysts or with HIV or otherwise at high risk for sexually transmitted infections were excluded. A total of 54...

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 War...

The use of Skyla 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 (PI...

• Remove Skyla if pregnancy occurs with Skyla in place. If a 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 Skyla, consider the risks of PID. ( 5.4 )
• Uterine perforation...

7 DRUG INTERACTIONS No drug-drug interaction studies have been conducted with Skyla. 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 Skyla. However, the contraceptive effect of Skyla is mediated via the direct release of LNG into the uterine cavity and is unlikely t...