Tuesday, October 4, 2016

FDA Approves Kyleena Contraceptive Device Bayer news release;

  
 

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.


Kyleena delivers a lower dose of hormones per day (17.5 micrograms per day) compared to Mirena (20 micrograms per day), explains Yesmean Wahdan, MD associate medical director, Bayer Women’s Healthcare. "[Also,] Kyleena can be used whether or not a woman has given birth to a child," says Dr. Wahdan. "Mirena...is recommended for women who have given birth, and is also indicated for heavy menstrual bleeding in women who choose an IUD."

Along with the implant, IUDs fall into the category of long-acting reversible contraception (LARCs). These are considered to be some of the most effective birth control options largely because, unlike taking the pill, you don't really have to do anything for them to work (other than the initial insertion, of course). Other options include the three-year Liletta and the non-hormonal copper ParaGard IUDs.

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