|January 2013 · Vol. 25, No. 1
New IUD approved by FDA
Skyla™ (levonorgestrel-releasing intrauterine system) 13.5 mg, is a new hormone-releasing system placed in the uterus for up to 3 years of pregnancy prevention
Bayer HealthCare Pharmaceuticals recently announced US Food and Drug Administration (FDA) approval of Skyla™ (levonorgestrel-releasing intrauterine system) 13.5 mg. This new hormone-releasing system is for the prevention of pregnancy for up to three years.1
The intrauterine (IUD) device is constructed of flexible plastic, is small (28 mm x 30 mm) and T-shaped. Skyla contains 13.5 mg of the progestin levonorgestrel, which is slowly released into the uterus.1
The approval of Skyla is supported by data from a Phase 3 trial that included 1,432 women aged 18 to 35 years, of which 38.8% (n = 556) had not yet had a child. The multicenter, multinational, randomized open-label study was conducted in 11 countries in Europe, Latin America, the US, and Canada. Excluded from the study were women who were less than 6 weeks’ postpartum, those with a history of ectopic pregnancy, those with clinically significant ovarian cysts, and those with HIV or otherwise at high risk for sexually transmitted infections. The cumulative 3-year pregnancy rate, based on 10 pregnancies, was 0.9%, with a 95% upper confidence limit of 1.7%.1
Of Skyla-treated women, 21.9% discontinued treatment due to an adverse event. Most common adverse reactions were vulvovaginitis (20.2%), abdominal/pelvic pain (18.9%), acne/seborrhea (15.0%), ovarian cyst (13.2%), headache (12.4%), dysmenorrhea (8.6%), breast pain/discomfort (8.6%), increased bleeding (7.8%) and nausea (5.5%). Other serious adverse reactions were also observed, including ectopic/intrauterine pregnancy, life-threatening infections, pelvic inflammatory disease (PID), perforation and expulsion.1
Other serious adverse reactions were also observed, including ectopic/intrauterine pregnancy, life-threatening infections, pelvic inflammatory disease (PID), perforation and expulsion.
Skyla 13.5 mg will be available by prescription the week of February 11, 2013. Full prescribing information can be accessed at www.skyla-us.com.
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1. Bayer Healthcare Pharmaceuticals Inc. US FDA approves Bayer’s SKYLA™ (levonorgestrel-releasing intrauterine system) 13.5 mg for prevention of pregnancy for up to three years [news release]. http://www.multivu.com/mnr/58310-u-s-fda-approves-skyla-for-prevention-of-pregnancy-for-up-to-three-years. Published January 10, 2013. Accessed January 11, 2013.More NEWS FOR YOUR PRACTICE…
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