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...continue reading below
The failure rate for Skyla was 0.4% at year 1; 0.9% cumulative over 3 years*
Perforation or expulsion may lead to the reduction or loss of contraceptive efficacy and result in pregnancy
If pregnancy should occur with Skyla in place, remove Skyla 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. Also consider the possibility of ectopic pregnancy in the case of lower abdominal pain, especially in association with missed menses or if an amenorrheic woman starts bleeding. 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
To help ensure Skyla is in place
Reexamine patients 4 to 6 weeks after insertion and once a year thereafter, or more frequently if clinically indicated
Teach patients how to check that Skyla is in the proper position by feeling the removal threads. Counsel patients that it is a good habit to do this once per month
Studies suggest Skyla has several mechanisms that prevent pregnancy
The local mechanism by which continuously released LNG contributes to the contraceptive effectiveness of Skyla has not been conclusively demonstrated.
Inhibits the capacitation or survival of sperm that enter the uterus
Thickens cervical mucus to inhibit sperm movement
Thins the endometrium
Skyla acts mainly locally to prevent pregnancy
There is generally no change in ovulatory function, because the contraceptive effect of Skyla is mainly due to its local effects in the uterus
Skyla cannot be used for post-coital contraception
Skyla provides low LNG serum levels
Skyla releases a low dose of LNG in vivo at a rate of approximately 14 mcg/day after 24 days. This rate declines progressively to approximately 6 mcg/day after 1 year and to 5 mcg/day after 3 years. The average in vivo release rate of LNG is approximately 8 mcg/day over the first year of use and 6 mcg/day over the period of 3 years.
In a subset of 7 patients, maximum observed serum LNG concentration was (mean±SD) 192† ± 105 pg/mL after 2 days; over time, serum level concentration decreased to approximately 72‡ ± 29 pg/mL at 3
A population pharmacokinetic evaluation based on a broader database (>1000 patients) showed similar concentration data of 168 ± 46 pg/mL 7 days after placement. Thereafter, LNG serum concentrations decline slowly to 61 ± 19 pg/mL after 3 years
Skyla® (levonorgestrel-releasing intrauterine system) 13.5mg is indicated for the prevention of pregnancy for up to 3 years. Replace the system after 3 years if continued use is desired.
IMPORTANT SAFETY INFORMATION ABOUT SKYLA
Who is not appropriate for Skyla
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 Skyla.
Clinical considerations for use and removal of Skyla
Use 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 Skyla 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 Skyla is displaced (e.g., expelled or perforated the uterus), remove it. Skyla can be safely scanned with MRI only under specific conditions.
Pregnancy related risks with Skyla
If pregnancy should occur with Skyla in place, remove Skyla 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. Also consider the possibility of ectopic pregnancy in the case of lower abdominal pain, especially in association with missed menses or if an amenorrheic woman starts bleeding. 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
Skyla is contraindicated in the presence of known or suspected PID or in women with a history of PID, unless there has been a subsequent intrauterine pregnancy. IUDs have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion. Promptly examine users with complaints of lower abdominal pain or pelvic pain, odorous discharge, unexplained bleeding, fever, genital lesions or sores. 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 does not protect against STIs, including HIV. PID may be asymptomatic but still result in tubal damage and its sequelae.
In Skyla clinical trials, PID occurred more frequently within the first year and most often within the first month after insertion.
Expect changes in bleeding patterns
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.
Because irregular bleeding/spotting is common during the first months of Skyla use, exclude endometrial pathology (polyps or cancer) prior to the insertion of Skyla in women with persistent or uncharacteristic bleeding. If a significant change in bleeding develops during prolonged use, take appropriate diagnostic measures to rule out endometrial pathology.
Be aware of other serious complications and most common adverse reactions
Some serious complications with IUDs like Skyla are sepsis, perforation and expulsion. Severe infection, or sepsis, including Group A streptococcoal sepsis (GAS) have been reported following insertion of a LNG-releasing IUS. Aseptic technique during insertion of Skyla is essential in order to minimize serious infections, such as GAS.
Perforation (total or partial, including penetration/embedment of Skyla in the uterine wall or cervix) may occur, most often during insertion, although the perforation may not be detected until sometime later. Perforation may reduce contraceptive efficacy. If perforation occurs, locate and remove Skyla. Surgery may be required. Delayed detection or removal of Skyla in case of perforation may result in migration outside the uterine cavity, adhesions, peritonitis, intestinal perforations, intestinal obstruction, abscesses, and erosion of adjacent viscera. The risk of perforation may be increased if inserted when the uterus is not completely involuted or fixed retroverted. A postmarketing safety study over a 1-year observational period reported that lactation at the time of insertion of an IUS/IUD was associated with an increased risk of perforation. In this study, for users of another LNG-releasing IUS, the incidence of uterine perforation was reported as 6.3 per 1,000 insertions for lactating women, compared to 1.0 per 1,000 insertions for non-lactating women.
Partial or complete expulsion of Skyla may occur resulting in the loss of contraceptive protection. Delay insertion a minimum of six weeks or until uterine involution is complete following a delivery or a second trimester abortion. Remove a partially expelled Skyla. If expulsion has occurred, a new Skyla can be inserted any time the provider can be reasonably certain the woman is not pregnant.
Ovarian cysts may occur and are generally asymptomatic but may be accompanied by pelvic pain or dyspareunia. Evaluate persistent enlarged ovarian cysts.
The most common adverse reactions (≥5%) 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 and then yearly or more often if clinically indicated.
*Efficacy rate for year 1 (calculated using Pearl Index), based on 5 pregnancies that occurred within 7 days after Skyla removal or expulsion, was 0.41 with a 95% upper confidence limit of 0.96. The cumulative 3-year pregnancy rate (calculated using the Kaplan-Meier method), based on 10 pregnancies, was 0.9 with a 95% upper confidence limit of 1.7%.
†Median value ‡Arithmetic mean
LNG=levonorgestrel; IUD=intrauterine device