What Is Skyla®?

Skyla is a highly effective, low-dose LNG-releasing IUD that prevents pregnancy for up to 3 years.

  • Over 99% contraceptive efficacy that lasts for up to 3 years
  • No daily pill to remember–or forget
    • Counsel patients to check Skyla threads once a month
  • Small T-body with a thin insertion tube. To learn how to use the Skyla inserter, click here
  • Studied in ~40% nulliparous and ~60% parous women
    • Learn more about who may be right for Skyla here
  • Upon removal, patients can try to become pregnant right away
    • In the pivotal clinical trial, about 77% of women became pregnant within 1 year of removal. Read more about the Skyla clinical trial here
  • Acts mainly locally to prevent pregnancy

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, but beware that 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
  • Tell patients about the risks of ectopic pregnancy, including loss of fertility, and teach them to recognize and promptly report the symptoms of ectopic pregnancy, including: unusual vaginal bleeding, lower abdominal pain (especially in association with missed periods), and bleeding in amenorrheic women
  • 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

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Skyla features

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How does Skyla work?

Studies suggest Skyla has several mechanisms that prevent pregnancy

The local mechanism by which continuously released LNG enhances 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

Pelvic inflammatory disease

  • Skyla is contraindicated in known or suspected pelvic inflammatory disease (PID) or a history of PID unless there has been a subsequent intrauterine pregnancy
  • PID may be asymptomatic but still result in tubal damage
  • IUDs have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion. In Skyla clinical trials, PID was observed in 0.4% of women and occurred more frequently within the first year and most often within the first month after insertion
  • Inform women about the possibility of PID, and that it can cause tubal damage leading to ectopic pregnancy or infertility, or infrequently can necessitate hysterectomy or cause death
  • Teach patients to recognize and promptly report any symptoms of PID, including prolonged or heavy bleeding, dyspareunia, unusual vaginal discharge, chills, abdominal or pelvic pain or tenderness, or fever
  • PID is often associated with sexually transmitted infections (STIs); Skyla does not protect against STIs, including HIV

Skyla provides low LNG serum levels

  • Skyla releases a low dose of LNG at a rate of ~14 mcg/day and decreases progressively to ~5 mcg/day after 3 years
  • In a subset of 7 patients, maximum observed serum LNG concentration was 192* ± 105 pg/mL after 2 days; over time, serum level concentration decreased to approximately 72 ± 29 pg/mL at 3 years
  • 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 is progestin-only contraception

Sepsis

  • Severe infection or sepsis, including group A streptococcal infection, has been reported; aseptic technique during insertion is essential to minimize serious infections

Help patients understand why their menstrual cycles may change

Local delivery of LNG in the uterus thins the uterine lining, which helps to reduce menstrual bleeding.

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
  • In Skyla clinical trials, 4.6% of subjects discontinued due to uterine bleeding complaints
  • Exclude endometrial pathology (polyps or cancer) prior to inserting Skyla in women with persistent or uncharacteristic bleeding. If a significant change in bleeding develops during prolonged use, rule out endometrial pathology
  • 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

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What Skyla® is indicated for

Skyla (levonorgestrel-releasing intrauterine system) 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

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

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. 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 does not protect against STIs, including HIV. 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.

Be aware of other serious complications and most common adverse reactions

Some serious complications with IUDs like 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.

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.

For important information about Skyla, please see the Full Prescribing Information.

*Median value.
Arithmetic mean.
LNG = levonorgestrel; IUD = intrauterine device.

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  • Coronal view of Skyla in the fundal position within the uterine cavity
  • Longitudinal view of Skyla in the uterus demonstrating the marked echogenicity of and posterior shadowing created by the silver ring

Images provided courtesy of Andrew Kaunitz, MD, Christine Bubier, RT(R), RDMS, Grace Horton, RDMS and Gwyn Grabner, RDMS. For the acknowledgment for Dr Gemzell: WHO Research Centre, Department of Obstetrics and Gynecology, Karolinska Institutet/Karolinska University Hospital Stockholm, Sweden.

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Site Last Modified: 08/2016

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