Low-dose Kyleena® prevents pregnancy for up to 5 years

Kyleena<sup>®</sup> levonorgestel-releasing intrauterine system) 19.5mg efficacy after 1 year

*Year 1: Pearl Index of 0.16; 95% upper confidence limit (CL) of 0.58; cumulative 5-year pregnancy rate, based on 13 pregnancies, estimated by the KM method was 1.4%; 95% upper CL of 2.5%.

    • 98.6% cumulative efficacy over 5 years

    • The cumulative 5-year pregnancy rate, based on 13 pregnancies (KM estimate), was 1.45 per 100 women or 1.45%, with a 95% upper confidence limit of 2.53%

    • The efficacy of Kyleena over 5 years was studied in parous and nulliparous women across a broad range of ages and body mass index (BMI)

    • Ages in the clinical trial subjects ranged from 18 to 35

    • The weight range for Kyleena-treated women was 38 kg to 173 kg (84 lbs to 381 lbs)

    • Mean BMI was 25.3 kg/m2 (range 15.2-57.6 kg/m2)

Reversibility

Fertility is rapidly restored once hormone-releasing IUDs like Kyleena are removed1

In a study of 1452 parous and nulliparous women aged 18-35 years:

  • About 71% of 163 women wishing to become pregnant conceived within 12 months after removal of Kyleena

  • If Kyleena is removed and the patient does not want to become pregnant, she should use another method of birth control

  • Patients who do not want to become pregnant should be provided a new Kyleena or another type of contraception

  • If a patient with regular cycles wants to start a different birth control method, remove Kyleena during the first 7 days of the menstrual cycle and start the new method immediately thereafter or start the new method at least 7 days prior to removing Kyleena if removal is to occur at other times during the cycle

KM=Kaplan Meier; IUDs=intrauterine devices