Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Kyleena Contraceptive Device

Bayer news release; 2016 Sep 19

The FDA has approved Kyleena (levonorgestrel-releasing intrauterine system) 19.5 mg, a progestin-containing intrauterine system (IUS) for the prevention of pregnancy for up to 5 years.

Indications: Kyleena is a progestin-containing intrauterine system (IUS) indicated for prevention of pregnancy for up to 5 years.

Dosage and administration:

• Release rate of levonorgestrel (LNG) is 17.5 mcg/day after 24 days and declines to 7.4 mcg/day after 5 years; Kyleena must be removed or replaced after 5 years.

• To be inserted by a trained healthcare provider using strict aseptic technique. Follow insertion instructions exactly as described.

• Patient should be re-examined and evaluated 4 to 6 weeks after insertion; then yearly or more often if clinically indicated.

Safety and efficacy: The contraceptive efficacy of Kyleena was evaluated in a clinical trial that enrolled generally healthy women aged 18 to 35, of whom 1,452 received Kyleena. About 71% of 163 women who desired pregnancy after study discontinuation and provided follow-up information, conceived within 12 months after removal of Kyleena.

Adverse reactions: The most common adverse reactions reported (≥5% users) were vulvovaginitis, ovarian cysts, abdominal pain/pelvic pain, headache/migraine, acne/seborrhea, dysmenorrhea/uterine spasm, breast pain/breast discomfort, and increased bleeding.


FDA approves Bayer’s Kyleena (levonorgestrel-releasing intrauterine system) 19.5 mg for prevention of pregnancy for up to five years. [news release]. Whippany, NJ; Bayer; September 19, 2016: Accessed September 21, 2016.