Who Might Be The Right Candidate to Use Skyla®?
Do you see women
like these in your practice?
Skyla can offer women like these:
- One of the most effective methods of contraception, with over 99% efficacy for up to 3 years
- 99.6% at year 1 (Pearl Index of 0.41; 95% upper CI: 0.96); 99.1% cumulative over 3 years (0.9% cumulative 3-year pregnancy rate; 95% upper CI: 1.7%)
- Birth control they don’t need to think about taking daily
- 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 1 time per month
- A low dose of levonorgestrel (LNG) released 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.
- No monthly prescription refills or trips to the pharmacy
- Reexamine patients 4 to 6 weeks after insertion and once a year thereafter, or more frequently if clinically indicated
- Reversibility, so they can try to become pregnant immediately upon removal if their plans change
- About 77% of women who desired pregnancy after study discontinuation and provided follow-up information, conceived within 12 months after removal of Skyla
Use in specific populations
- The use of Skyla is contraindicated in pregnancy or with a suspected pregnancy because there is no need for pregnancy prevention in a woman who is already pregnant and Skyla may cause adverse pregnancy outcomes. If a woman becomes pregnant with Skyla in place, the likelihood of ectopic pregnancy is increased and there is an increased risk of miscarriage, sepsis, premature labor, and premature delivery.
- Remove Skyla, if possible, if pregnancy occurs in a woman using Skyla. If Skyla cannot be removed, follow the pregnancy closely.
- Studies report no adverse effects on fetal and infant development associated with long-term use of contraceptive doses of oral progestins in a pregnant woman. However, there have been reported cases of masculinization of the external genitalia of the female fetus following exposure to progestins at doses greater than those currently used for oral contraception. Animal reproduction studies have not been conducted with Skyla.
New moms and nursing mothers
- 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.
- Do not insert Skyla until a minimum of 6 weeks has passed or until involution of the uterus is complete following a delivery or second trimester abortion due to the increased risk of perforation and expulsion. If involution is delayed, wait until involution is complete before insertion
- Clinical trials with Skyla excluded breastfeeding 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 1000 insertions for lactating women, compared to 1.0 per 1000 insertions for non-lactating women
- Perforation may reduce contraceptive efficacy and result in pregnancy. The risk of perforation may be increased if Skyla is inserted when the uterus is fixed retroverted or not completely involuted.
- The use of Skyla is contraindicated in women with postpartum endometritis or infected abortion in the past 3 months
- Safety and efficacy of Skyla have been established in women of reproductive age
- Efficacy is expected to be the same for postpubertal females under the age of 18 as for users 18 years and older
- Use of this product before menarche is not indicated
- Skyla has not been studied in women over age 65 and is not approved for use in this population
- No studies were conducted to evaluate the effect of hepatic disease on the disposition of LNG released from Skyla
- No studies were conducted to evaluate the effect of renal disease on the disposition of LNG released from 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 Skyla is displaced (e.g., expelled or perforated the uterus), remove it. A new Skyla may be inserted at that time or during the next menses if it is certain that conception has not occurred. If Skyla is in place with no evidence of perforation, no intervention is indicated.
Skyla can be safely scanned with MRI only under specific conditions
INDICATION FOR SKYLA
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.
For important information about Skyla, please see the Full Prescribing Information.