MIRENA

AbsorptionLow doses of LNG are administered into the uterine cavity with the Mirena intrauterine delivery system. Estimated in vivo release rates for different points in time are provided in Table 5.

Table 5Estimated in vivo release rates for Mirena: Time Estimated in vivo release rate [μg/day] (rounded) 24 days after insertion 21 60 days after insertion 21 1 year after insertion 19 3 years after insertion 14 5 years after insertion 11 6 years after insertion 9 7 years after insertion 8 8 yea...

14.1 Clinical Trials on Contraception The safety and effectiveness of Mirena was studied in two clinical trials in Finland and Sweden. In these trials, 1,169 women 18 to 35 years of age at enrollment used Mirena for up to 5 years, for a total of 45,000 women-months of exposure. Of these, 5.6% (66) were nulliparous women. Subjects had previously been pregnant, had no history of ectopic pregnancy, had no history of pelvic inflammatory disease over the preceding 12 months, were predominantly White, and over 70% of the subjects had previously used IUDs (intrauterine devices). The reported 12-month...

The following serious or otherwise important adverse reactions are discussed in 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 ...

The use of Mirena 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 (P...

• Remove Mirena if pregnancy occurs with Mirena 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 Mirena, consider the risks of PID. ( 5.4 )
• Uterine perforatio...

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