WHIPPANY, N.J., June 2, 2014 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. today announced Food and Drug Administration (FDA) approval of a new inserter for Mirena®. Bayer now offers the same inserter design and technique for both Mirena and Skyla® (levonorgestrel-releasing intrauterine system) 13.5 mg.
The innovative Bayer Inserter for Skyla and Mirena features a thin, flexible insertion tube. The inserter is preloaded with a small, rounded flexible T-body and enables single-handed loading. The diameter of the insertion tube for Skyla is 3.8 mm and 4.4 mm for Mirena.
"As a leading women's healthcare company, we are dedicated to providing innovative options for healthcare providers and their patients," said Edio Zampaglione, vice president, US Medical Affairs for Women's Healthcare, Bayer. "The launch of the Bayer Inserter for Mirena demonstrates our commitment to one of the leading contraceptive options available in the U.S."
Additional information and an instructional video are available at www.mirenalearningcenter.com
Indication for Skyla® (levonorgestrel-releasing intrauterine system) 13.5 mg
Skyla is indicated for the prevention of pregnancy for up to 3 years. Skyla should be replaced after 3 years if continued use is desired.
Indications for Mirena® (levonorgestrel-releasing intrauterine system) 52 mg
Mirena is indicated for intrauterine contraception for up to 5 years. Mirena is also indicated to treat heavy menstrual bleeding in women who choose to use intrauterine contraception as their method of contraception. Mirena is recommended for women who have had a child. Mirena should be replaced after 5 years if continued use is desired.
IMPORTANT SAFETY INFORMATION ABOUT SKYLA AND MIRENA
Who is not appropriate for Skyla and Mirena
Use of Skyla or Mirena is contraindicated in women with: known or suspected pregnancy and cannot be used for post-coital contraception; congenital or acquired uterine anomaly, including fibroids if they distort the uterine cavity; known or suspected breast cancer or other progestin-sensitive cancer, now or in the past; known or suspected uterine or cervical neoplasia; liver disease, including tumors; untreated acute cervicitis or vaginitis, including lower genital tract infections (eg, bacterial vaginosis) until infection is controlled; postpartum endometritis or infected abortion in the past 3 months; unexplained uterine bleeding; current IUD; acute pelvic inflammatory disease (PID) or history of PID (except with later intrauterine pregnancy); conditions increasing susceptibility to pelvic infection; or hypersensitivity to any component of Skyla or Mirena.
Clinical considerations for use and removal of Skyla and Mirena
Use Skyla or Mirena with caution after careful assessment in patients with coagulopathy or taking anticoagulants; migraine, focal migraine with asymmetrical visual loss, or other symptoms indicating transient cerebral ischemia; exceptionally severe headache; marked increase of blood pressure; or severe arterial disease such as stroke or myocardial infarction. Consider removing the intrauterine system if these or the following arise during use: uterine or cervical malignancy or jaundice. If Skyla or Mirena is displaced (e.g., expelled or perforated the uterus), remove it.
In addition, Skyla can be safely scanned with MRI only under specific conditions.
Pregnancy related risks with Skyla and Mirena
If pregnancy should occur with Skyla or Mirena in place, remove the intrauterine system because leaving it in place may increase the risk of spontaneous abortion and preterm labor. Removal or manipulation may result in pregnancy loss. Evaluate women for ectopic pregnancy because the likelihood of a pregnancy being ectopic is increased with Skyla or Mirena. Tell women about the signs of ectopic pregnancy and associated risks, including loss of fertility. Women with a history of ectopic pregnancy, tubal surgery, or pelvic infection carry a higher risk of ectopic pregnancy.
Educate her about PID
IUDs have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion. Inform women about the possibility of PID and that PID can cause tubal damage leading to ectopic pregnancy or infertility, or infrequently can necessitate hysterectomy, or cause death. PID is often associated with sexually transmitted infections (STIs); Skyla and Mirena do not protect against STIs, including HIV.
In clinical trials with:
- Skyla – PID occurred more frequently within the first year and most often within the first month after insertion.
- Mirena – upper genital infections, including PID, occurred more frequently within the first year. In a clinical trial with other IUDs and a clinical trial with an IUD similar to Mirena, the highest rate occurred within the first month after insertion.
Expect changes in bleeding patterns with Skyla and Mirena
Spotting and irregular or heavy bleeding may occur during the first 3 to 6 months. Periods may become shorter and/or lighter thereafter. Cycles may remain irregular, become infrequent, or even cease. Consider pregnancy if menstruation does not occur within 6 weeks of the onset of previous menstruation.
Be aware of other serious complications and most common adverse reactions
Some serious complications with IUDs like Skyla and Mirena are expulsion, sepsis, and perforation. Perforation may reduce contraceptive efficacy. The risk of perforation is higher if inserted in lactating women and may be higher if inserted in women who are postpartum or when the uterus is fixed retroverted.
Ovarian cysts may occur and are generally asymptomatic, but may be accompanied by pelvic pain or dyspareunia. Evaluate persistent enlarged ovarian cysts.
In clinical trials with:
- Skyla – the most common adverse reactions (>/=5% users) 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%).
- Mirena – the most common adverse reactions (>/=5% users) are uterine/vaginal bleeding alterations (51.9%), amenorrhea (23.9%), intermenstrual bleeding and spotting (23.4%), abdominal/pelvic pain (12.8%), ovarian cysts (12%), headache/migraine (7.7%), acne (7.2%), depressed/altered mood (6.4%), menorrhagia (6.3%), breast tenderness/pain (4.9%), vaginal discharge (4.9%) and IUD expulsion (4.9%).
Teach patients to recognize and immediately report signs or symptoms of the aforementioned conditions. Evaluate patients 4 to 6 weeks after insertion of Skyla or Mirena and then yearly or more often if clinically indicated.
For important information about Skyla, please see the full Prescribing Information.
For important information about Mirena, please see the full Prescribing Information.
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer Web site at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
The Bayer Cross, Bayer, and Mirena® are registered trademarks of Bayer.
SOURCE Bayer HealthCare Pharmaceuticals, Inc.