New Long-Term IUD Kyleena Approved

The FDA has just approved Bayer's levonorgestrel-releasing intrauterine system (Kyleena), a long-term, progestin-containing intrauterine device (IUD) that will be available by prescription in October 2016.

The FDA has just approved Bayer’s levonorgestrel-releasing intrauterine system (Kyleena), a long-term, progestin-containing intrauterine device (IUD) that will be available by prescription in October 2016.

Kyleena is a small, flexible plastic T-shaped device containing 19.5 mg of levonorgestrel, which it releases into a woman’s uterus slowly, allowing small amounts of the hormone to enter the blood. The IUD is placed by a health care provider during an in-office visit and prevents pregnancy for up to 5 years, but it may be removed by a health care provider at any time.

“Data show that the use of effective, long-acting birth control methods including…IUDs have helped to reduce unintended pregnancies in the United States, but we still have a long way to go,” stated Anita L. Nelson, MD, professor and chair of Obstetrics and Gynecology at Western University of Health Sciences, in a press release. “Kyleena is highly effective at preventing pregnancy and may be an appropriate choice for women who want a low-dose non-daily birth control method.”

Kyleena’s efficacy in preventing pregnancy was established by a clinical trial involving 1452 women aged 18 to 35 years who received the IUD. The researchers excluded women fewer than 6 weeks postpartum, with a long history of ectopic pregnancy, with clinically significant ovarian cysts or HIV, or at high risk for sexually transmitted infections.

Kyleena’s contraceptive reliability was assessed through the pregnancy rate calculated as the Pearl Index, which was based on 28-day equivalent exposure cycles.

About 71% of 163 women who desired pregnancy after the trial conceived within 12 months after removal of Kyleena. Of the women who participated in the study, 22% discontinued due to an adverse reaction, 5% were lost to follow-up, 2.3% withdrew for unspecified reasons, 1.2% discontinued due to a protocol deviation, 0.9% discontinued due to pregnancy, and 20% discontinued due to other reasons.

Important safety information for Kyleena includes the following:

  • Don’t use Kyleena if you have a pelvic infection, get infections easily, or have certain cancers. Less than 1% of users get a serious pelvic infection called pelvic inflammatory disease.
  • If you experience persistent pelvic or stomach pain, or if Kyleena comes out, tell your health care provider. If Kyleena comes out, use alternative birth control. Kyleena can attach to or go through the uterus and cause problems.
  • Pregnancy while using Kyleena is rare but can be life threatening and may result in loss of pregnancy or fertility.
  • Ovarian cysts may occur but usually disappear. Bleeding and spotting my increase for the first 3 to 6 months and remain irregular. Periods over time usually become shorter, lighter, and may stop.