Indication for Kyleena (levonorgestrel-releasing intrauterine system) 19.5 mg
Kyleena™ is indicated for the prevention of pregnancy for up to 5 years. Kyleena should be replaced after 5 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.
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.
IMPORTANT SAFETY INFORMATION ABOUT KYLEENA, MIRENA AND SKYLA
Who is not appropriate for Kyleena, Mirena and Skyla
Use of Kyleena, Mirena or Skyla 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 Kyleena, Mirena or Skyla.
Clinical considerations for use and removal of Kyleena, Mirena and Skyla
Use Kyleena, Mirena or Skyla 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 the threads are not visible or are significantly shortened they may have broken or retracted into the cervical canal or uterus. If Kyleena, Mirena or Skyla is displaced (e.g., expelled or perforated the uterus), remove it.
In addition, Kyleena and Skyla can be safely scanned with MRI only under specific conditions.
Pregnancy related risks with Kyleena, Mirena and Skyla
If pregnancy should occur with Kyleena, Mirena or Skyla 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 Kyleena, Mirena or Skyla.
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); Kyleena, Mirena, and Skyla do not protect against STIs, including HIV.
In clinical trials with:
- Kyleena and 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 Kyleena, Mirena, and Skyla
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 Kyleena, Mirena and Skyla 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:
- Kyleena – the most common adverse reactions (≥5%) were vulvovaginitis (24%), ovarian cyst (22%), abdominal/pelvic pain (21%), headache/migraine (15%), acne/seborrhea (15%), dysmenorrhea/uterine spasm (10%), breast pain/breast discomfort (10%), and increased bleeding (8%).
- Mirena – adverse reactions reported in ≥5% users were alterations of menstrual bleeding patterns [including unscheduled uterine bleeding (31.9%), decreased uterine bleeding (23.4%), increased scheduled uterine bleeding (11.9%), and female genital tract bleeding (3.5%)], abdominal/pelvic pain (22.6%),
amenorrhea (18.4%), headache/migraine (16.3%), genital discharge (14.9%), vulvovaginitis (10.5%), breast pain (8.5%), back pain (7.9%), benign ovarian cyst and associated complications (7.5%), acne (6.8%), depression/depressive mood (6.4%) and dysmenorrhea (6.4%).
- 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%).
Teach patients to recognize and immediately report signs or symptoms of the aforementioned conditions. Evaluate patients 4 to 6 weeks after insertion of Kyleena, Mirena or Skyla and then yearly or more often if clinically indicated.
For important information about Kyleena, please see the Full Prescribing Information.
For important information about Mirena, please see the Full Prescribing Information.
For important information about Skyla, please see the Full Prescribing Information.