Frequently Asked Questions About Skyla®
If you have a question that is not covered here, please contact us directly.
What is Skyla and what is it indicated for?
Skyla is a levonorgestrel-releasing intrauterine system (IUS) consisting of a T-shaped polyethylene frame with a steroid reservoir that contains 13.5 mg of levonorgestrel. Skyla is indicated to prevent pregnancy for up to
3 years. Replace the system after 3 years if continued use is desired.
How long can Skyla be used?
Skyla is indicated to prevent pregnancy for up to 3 years. Skyla must be removed by the end of the third year and can be replaced at the time of removal with a new Skyla if continued contraceptive protection is desired.
Who is not appropriate for Skyla?
The use of Skyla is contraindicated when one or more of the following conditions exist:
- Pregnancy or suspicion of pregnancy
- For use as post-coital contraception (emergency contraception)
- Congenital or acquired uterine anomaly including fibroids, that distorts the uterine cavity
- Acute pelvic inflammatory disease (PID) or a history of PID unless there has been a subsequent intrauterine pregnancy
- Postpartum endometritis or infected abortion in the past 3 months
- Known or suspected uterine or cervical neoplasia
- Known or suspected breast cancer or other progestin-sensitive cancer, now or in the past
- Uterine bleeding of unknown etiology
- Untreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections until infection is controlled
- Acute liver disease or liver tumor (benign or malignant)
- Conditions associated with increased susceptibility to pelvic infections
- A previously inserted intrauterine device (IUD) that has not been removed
- Hypersensitivity to any component of this product
What are the risks of an intrauterine pregnancy with Skyla?
If pregnancy occurs while using Skyla, remove Skyla because leaving it in place may increase the risk of spontaneous abortion and preterm labor. Removal of Skyla or probing of the uterus may also result in spontaneous abortion. In the event of an intrauterine pregnancy with Skyla, consider the following:
In patients becoming pregnant with an IUS in place, septic abortion––with septicemia, septic shock, and death––may occur.
Continuation of pregnancy
If a woman becomes pregnant with Skyla in place and if Skyla cannot be removed or the woman chooses not to have it removed, warn her that failure to remove Skyla increases the risk of miscarriage, sepsis, premature labor and premature delivery. Follow her pregnancy closely and advise her to report immediately any symptom that suggests complications of the pregnancy.
What is the risk of ectopic pregnancy with Skyla?
Evaluate women for ectopic pregnancy if they become pregnant with Skyla in place because the likelihood of a pregnancy being ectopic is increased with Skyla. Approximately one-half of pregnancies that occur with Skyla in place are likely to be ectopic. 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.
The incidence of ectopic pregnancy in clinical trials with Skyla, which excluded women with a history of ectopic pregnancy, was approximately 0.1% per year. The risk of ectopic pregnancy in women who have a history of ectopic pregnancy and use Skyla is unknown. Women with a previous history of ectopic pregnancy, tubal surgery or pelvic infection carry a higher risk of ectopic pregnancy. Ectopic pregnancy may result in loss of fertility.
What was the study design for the Skyla clinical trial on contraception?
The contraceptive efficacy of Skyla was evaluated in a clinical trial that enrolled generally healthy women aged 18–35, 1,432 of whom received Skyla. Of these, 38.8 % (556) were nulliparous women, and 819 women completed 3 years of use. The trial was a multicenter, multi-national, randomized open-label study conducted in 11 countries in Europe, Latin America, the US and Canada. Women less than six weeks postpartum, with a history of ectopic pregnancy, with clinically significant ovarian cysts or with HIV or otherwise at high risk for sexually transmitted infections were excluded. A total of 540 (37.7%) were treated at US sites and 892 (62.3%) were at non-US sites. The racial demographics of enrolled women who received Skyla was: Caucasian (79.7%), Hispanic (11.5%), Black/African Americans (5.2%), Other (2.7%) and Asian (0.8%). The weight range was 38 to 155 kg (mean weight: 68.7 kg) and mean BMI was 25.3 kg/m2 (range 16–55 kg/m2). The clinical trial had no upper or lower weight or BMI limit. Of Skyla-treated women, 21.9% discontinued the study treatment due to an adverse event, 4.4% were lost to follow up, 1.8% withdrew for unspecified reasons, 1.1% discontinued due to protocol deviation, 0.6% discontinued due to pregnancy, and 13.0% discontinued due to other reasons.
What primary endpoint was used to measure the contraceptive reliability of Skyla?
The pregnancy rate calculated as the Pearl Index (PI) in women aged 18-35 years was the primary efficacy endpoint used to assess contraceptive reliability. The PI was calculated based on 28-day equivalent exposure cycles; evaluable cycles excluded those in which back-up contraception was used unless a pregnancy occurred in that cycle. Skyla-treated women provided 15,763 evaluable 28-day cycle equivalents in the first year and 39,368 evaluable cycles over the 3-year treatment period. The PI estimate for the first year of use based on the 5 pregnancies that occurred after the onset of treatment and 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, based on 10 pregnancies, estimated by the Kaplan-Meier method was 0.9 per 100 women or 0.9%, with a 95% upper confidence limit of 1.7%.
What were the most common adverse reactions that were observed in greater than or equal to 5% of women during clinical trials?
Most common adverse reactions (occurring in ≥ 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%).
What were the most common adverse reactions leading to discontinuation of Skyla?
In the contraception studies 18% discontinued prematurely due to an adverse reaction. The most common adverse reactions leading to discontinuation (in >1% of users) were uterine bleeding complaints (4.6%), device expulsion (3.2%), acne/seborrhea (2.9%), abdominal pain (2.5%), dysmenorrhea/uterine spasms (2.0%) and pelvic pain (1.8%).
What is the risk of pelvic infection with Skyla?
Promptly examine users with complaints of lower abdominal or pelvic pain, odorous discharge, unexplained bleeding, fever, genital lesions or sores. Remove Skyla in cases of recurrent endometritis or pelvic inflammatory disease, or if an acute pelvic infection is severe or does not respond to treatment.
Pelvic Inflammatory Disease (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. In clinical trials, PID was observed in 0.4% of women overall and occurred more frequently within the first year and most often within the first month after insertion of Skyla.
Women at increased risk for PID
PID is often associated with a sexually transmitted infection (STI), and Skyla does not protect against STI. The risk of PID is greater for women who have multiple sexual partners, and also for women whose sexual partner(s) have multiple sexual partners. Women who have had PID are at increased risk for a recurrence or re-infection. In particular, ascertain whether the woman is at increased risk of infection (for example, leukemia, acquired immune deficiency syndrome [AIDS], intravenous drug abuse).
PID may be asymptomatic but still result in tubal damage and its sequelae.
Treatment of PID
Following a diagnosis of PID, or suspected PID, bacteriologic specimens should be obtained and antibiotic therapy should be initiated promptly. Removal of Skyla after initiation of antibiotic therapy is usually appropriate.1
Actinomycosis has been associated with IUDs. Remove Skyla from symptomatic women and treat with antibiotics. The significance of actinomyces-like organisms on Pap smear in an asymptomatic IUD user is unknown, and so this finding alone does not always require Skyla removal and treatment. When possible, confirm a Pap smear diagnosis with cultures.
What do I need to know about the silver ring on Skyla?
A ring composed of 99.95% pure silver is located at the top of the vertical stem close to the horizontal arms and is visible by ultrasound. Skyla is contraindicated in patients with hypersensitivity to any component of the product.
Please refer to the question below on how Skyla can be safely scanned with MRI under specific conditions. Inform the patient that Skyla can be safely scanned with MRI only under specific conditions. Instruct patients who will have an MRI to tell their doctor that they have Skyla. This information is included on the Follow-Up Reminder Card.
Can patients with Skyla safely receive an MRI?
Non-clinical testing has demonstrated that Skyla is MR conditional. A patient with Skyla can be safely scanned in an MR system meeting the following conditions:
• Static magnetic field of 3.0 T or less
• Maximum spatial field gradient of 36,000 gauss/cm (360 T/m)
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4W/kg (First Level Controlled Operating Mode).
Under the scan conditions defined above, the Skyla IUS is expected to produce a maximum temperature rise of less than 2°C after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the IUS extended up to 5 mm from the IUS when imaged with a gradient echo pulse sequence and a 3.0 T MRI system.
Inform the patient that Skyla can be safely scanned with MRI only under specific conditions. Instruct patients who will have an MRI to tell their doctor that they have Skyla. This information is included on the Follow-Up Reminder Card.
Is Skyla latex-free?
Yes. The components of Skyla, including its packaging, are not manufactured using natural rubber latex.
What are the dimensions of Skyla and its inserter?
The T-body of Skyla is 28 mm across and 30 mm tall. The diameter of the insertion tube is 3.8 mm.
Do I need to provide backup contraception for the first 2 to 3 weeks after Skyla is inserted?
If inserted within the first 7 days of the menstrual cycle or immediately after a first trimester abortion, no backup contraception is needed with Skyla. For additional information, please refer to timing of insertion in the Prescribing Information.
Can Skyla be reloaded?
Skyla is packaged in an inserter that contains the removal threads inside the handle. It is designed to allow you to load Skyla into the insertion tube without handling the threads manually. This design also means that Skyla can only be loaded once. By pushing the slider on the inserter forward, Skyla loads into its proper position inside in the insertion tube. Do not move the slider downward at this time, as this may prematurely release the threads of Skyla. Once the slider is moved below the mark, Skyla cannot be reloaded. For more information on the Skyla inserter, including full insertion instructions and an instructional video, please visit Insertion & Removal.
What bleeding changes are to be expected?
Skyla can alter the bleeding pattern and result in spotting, irregular bleeding, heavy bleeding, oligomenorrhea and amenorrhea. During the first 3–6 months of Skyla use, the number of bleeding and spotting days may be higher and bleeding patterns may be irregular. Thereafter, the number of bleeding and spotting days usually decreases but bleeding may remain irregular.
In Skyla clinical trials, amenorrhea developed by the end of the first year of use in approximately 6% of Skyla users. A total of 77 subjects out of 1,672 (4.6%) discontinued due to uterine bleeding complaints. Table 2 shows the bleeding patterns as documented in the Skyla clinical trials based on 90-day reference periods. Table 3 shows the number of bleeding and spotting days based on 28-day cycle equivalents.
1Defined as subjects with no bleeding/spotting throughout the 90-day reference period.
2Defined as subjects with 1 or 2 bleeding/spotting episodes in the 90-day reference period.
3Defined as subjects with more than 5 bleeding/spotting episodes in the 90-day reference period.
4Defined as subjects with bleeding/spotting episodes lasting more than 14 days in the 90-day reference period. Subjects with prolonged bleeding may also be included in one of the other categories (excluding amenorrhea).
5Defined as subjects with 3 to 5 bleeding/spotting episodes and less than 3 bleeding/spotting-free intervals of 14 or more days.
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. Consider the possibility of pregnancy if menstruation does not occur within six weeks of the onset of a previous menstruation. Once pregnancy has been excluded, repeated pregnancy tests are generally not necessary in amenorrheic women unless indicated, for example, by other signs of pregnancy or by pelvic pain.
Does Skyla have an indication for heavy menstrual bleeding?
No. The clinical development program for Skyla did not include trials designed to obtain that indication.
Can women breastfeed during use of Skyla?
Women may use Skyla when they are breastfeeding if more than six weeks have passed since they had their baby.
Published studies report the presence of LNG in human milk. Small amounts of progestins (approximately 0.1% of the total maternal doses) were detected in the breast milk of nursing mothers who used other LNG-releasing IUSs, resulting in exposure of LNG to the breastfed infants. There are no reports of adverse effects in breastfed infants with maternal use of progestin-only contraceptives. Isolated cases of decreased milk production have been reported with a LNG-releasing IUS. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Skyla and any potential adverse effects on the breastfed child from Skyla or from the underlying maternal condition.
Clinical trials with Skyla excluded breast-feeding women. A large postmarketing safety study conducted in Europe over a 1-year observational period reported that lactation at the time of insertion of an IUD/IUS was associated with an increased risk of perforation. 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.
What uterine size is appropriate for Skyla use?
In the clinical trials for Skyla, the inclusion and exclusion criteria did not include parameters on the size of the uterus. Do not insert Skyla until a minimum of 6 weeks after second trimester abortion or miscarriage, or until the uterus is fully involuted. If involution is delayed, wait until involution is complete before insertion. 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 or not completely involuted.
How do I bill for Skyla?
Visit Ordering & Reimbursement to learn all about billing for Skyla.