Data from FDA - Curated by EPG Health - Last updated 17 March 2018

Indication(s)

1 INDICATIONS AND USAGE Skyla® is indicated to prevent pregnancy for up to 3 years. Replace the system after 3 years if continued use is desired. Skyla is a progestin-containing intrauterine system (IUS) indicated for prevention of pregnancy for up to 3 years. (1)

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Advisory information

contraindications
4 CONTRAINDICATIONS The use of Skyla is contraindicated when one or more of the following conditions exist: •Pregnancy or suspicion of pregnancy [see Warnings and Precautions (5.2), Use in Specific Populations (8.1)] •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 [see Warnings and Precautions (5.4)] •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 [see Warnings and Precautions (5.4)] •A previously inserted intrauterine device (IUD) that has not been removed •Hypersensitivity to any component of this product [see Adverse Reactions (6.2) and Description (11.1)] •Pregnancy or suspicion of pregnancy. Cannot be used for post-coital contraception (emergency contraception) (4) •Congenital or acquired uterine anomaly if it distorts the uterine cavity (4) •Acute pelvic inflammatory disease (PID) or a history of PID unless there has been a subsequent intrauterine pregnancy (4) •Postpartum endometritis or infected abortion in the past 3 months (4) •Known or suspected uterine or cervical neoplasia (4) •Known or suspected breast cancer or other progestin-sensitive cancer (4) •Uterine bleeding of unknown etiology (4) •Untreated acute cervicitis or vaginitis or other lower genital tract infections (4) •Acute liver disease or liver tumor (benign or malignant) (4) •Increased susceptibility to pelvic infection (4) •A previous intrauterine device (IUD) that has not been removed (4) •Hypersensitivity to any component of Skyla (4)
Adverse reactions
6 ADVERSE REACTIONS The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling: •Ectopic Pregnancy [see Warnings and Precautions (5.1)] •Intrauterine Pregnancy [see Warnings and Precautions (5.2)] •Group A Streptococcal Sepsis (GAS) [see Warnings and Precautions (5.3)] •Pelvic Inflammatory Disease [see Warnings and Precautions (5.4)] •Perforation [see Warnings and Precautions (5.5)] •Expulsion [see Warnings and Precautions (5.6)] •Ovarian Cysts [see Warnings and Precautions (5.7)] •Bleeding Pattern Alterations [see Warnings and Precautions (5.8)] The most common adverse reactions reported (>10% users) are bleeding pattern alterations, vulvovaginitis, abdominal/pelvic pain, acne/seborrhea, headache/migraine, ovarian cyst and dysmenorrhea/uterine spasm. (6) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The data described below reflect exposure to Skyla in 1,672 patients in two contraception studies, including 1,383 exposed for one year and 993 who completed the three year studies. The population was generally healthy, 18 to 40-year old females requesting contraception and predominately Caucasian (82.6%). The data cover more than 40,000 cycles of exposure. The frequencies of reported adverse drug reactions represent crude incidences. Most common adverse reactions (occurring in ≥ 5% users) were increased bleeding (7.8%), 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%) and nausea (5.5%). 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%). Other common adverse reactions (occurring in ≥ 1% users) by System Organ Class (SOC): The frequencies of adverse reactions observed in clinical trials are summarized in Table 3 by SOC (presented as crude incidences). Table 4: Adverse reactions that occurred in at least 1% of Skyla users in clinical trials by SOC System Organ Class Adverse Reaction Incidence (%) (N=1,672) Reproductive System and Breast Disorders Vulvovaginitis 20.2 Ovarian cyst Ovarian cysts were reported as adverse events if they were abnormal, non-functional cysts and/or had a diameter >3 cm on ultrasound examination 13.2 Dysmenorrhea 8.6 Increased bleeding Not all bleeding alterations were captured as adverse reactions [see Warnings and Precautions (5.8)]. 7.8 Breast pain/discomfort 5.3/3.3 Genital discharge 4.2 Device expulsion (complete and partial) 3.2 Upper genital tract infection 1.4 Gastrointestinal Disorders Abdominal pain/pelvic pain 12.7/6.2 Nausea 5.5 Skin and Subcutaneous Tissue Disorders Acne/Seborrhea 13.6/1.4 Alopecia 1.2 Nervous System Disorders Headache 12.4 Migraine 2.3 Psychiatric Disorders Depression/Depressed mood 3.8/0.5 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of LNG-releasing IUSs. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. •Arterial thrombotic and venous thromboembolic events, including cases of pulmonary embolism, deep vein thrombosis and stroke •Device breakage •Hypersensitivity (including rash, urticaria, and angioedema) •Increased blood pressure

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION Skyla contains 13.5 mg of levonorgestrel (LNG) released in vivo at a rate of approximately 14 mcg/day after 24 days. This rate decreases 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 a period of 3 years. [See Clinical Pharmacology (12.3).] 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. Skyla can be physically distinguished from other intrauterine systems (IUSs) by the combination of the visibility of the silver ring on ultrasound and the brown color of the removal threads. Skyla is supplied in a sterile package within an inserter that enables single-handed loading (see Figure 1). Do not open the package until required for insertion [see Description (11)]. Do not use if the seal of the sterile package is broken or appears compromised. Use strict aseptic techniques throughout the insertion procedure [see Warnings and Precautions (5.3)]. •Release rate of levonorgestrel (LNG) is 14 mcg/day after 24 days and declines to 5 mcg/day after 3 years; Skyla must be removed or replaced after 3 years. (2) •To be inserted by a trained healthcare provider using strict aseptic technique. Follow insertion instructions exactly as described. (2) •Patient should be re-examined and evaluated 4 to 6 weeks after insertion; then, yearly or more often if clinically indicated. (2.2) 2.1. Insertion Instructions •Obtain a complete medical and social history to determine conditions that might influence the selection of a levonorgestrel-releasing intrauterine system (LNG IUS) for contraception. If indicated, perform a physical examination, and appropriate tests for any forms of genital or other sexually transmitted infections. [See Contraindications (4) and Warnings and Precautions (5.10).] •Follow the insertion instructions exactly as described to ensure proper placement and avoid premature release of Skyla from the inserter. Once released, Skyla cannot be re-loaded. •Skyla should be inserted by a trained healthcare provider. Healthcare providers should become thoroughly familiar with the insertion instructions before attempting insertion of Skyla. •Insertion may be associated with some pain and/or bleeding or vasovagal reactions (for example, syncope, bradycardia) or with seizure, especially in patients with a predisposition to these conditions. Consider administering analgesics prior to insertion. Timing of Insertion Table 1: When to Insert Skyla Starting Skyla in women not currently using hormonal or intrauterine contraception • Skyla can be inserted any time the provider can be reasonably certain the woman is not pregnant. Consider the possibility of ovulation and conception prior to initiation of this product [see Contraindications (4)]. • If Skyla is inserted during the first seven days of the menstrual cycle or immediately after a first trimester abortion, back up contraception is not needed. • If Skyla is not inserted during the first seven days of the menstrual cycle, a barrier method of contraception should be used or the patient should abstain from vaginal intercourse for seven days to prevent pregnancy. Switching to Skyla from an oral, transdermal or vaginal hormonal contraceptive • Skyla may be inserted at any time, including during the hormone-free interval of the previous method. • If inserted during active use of the previous method, continue that method for 7 days after Skyla insertion or until the end of the current treatment cycle. • If the woman was using continuous hormonal contraception, discontinue that method seven days after Skyla insertion. Switching to Skyla from an injectable progestin contraceptive • Skyla may be inserted at any time; a back-up method of contraception (such as condoms or spermicide) should also be used for 7 days if Skyla is inserted more than 3 months (13 weeks) after the last injection. Switching to Skyla from a contraceptive implant or another IUS • Insert Skyla on the same day the implant or IUS is removed. • Skyla may be inserted at any time during the menstrual cycle. Inserting Skyla after abortion or miscarriage First-trimester • Skyla may be inserted immediately after a first-trimester abortion or miscarriage. Second-trimester • 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 [see Warnings and Precautions (5.6, 5.7)]. • If the woman has not yet had a period, consider the possibility of ovulation and conception occurring prior to insertion of Skyla. [See Contraindications (4), Warnings and Precautions (5.2), and FDA-Approved Patient Labeling.] Skyla can be inserted any time the provider can be reasonably certain the woman is not pregnant. • If Skyla is not inserted during the first 7 days of the menstrual cycle, a back-up method of contraception should be used or the patient should abstain from vaginal intercourse for 7 days to prevent pregnancy. Inserting Skyla after Childbirth • Do not insert Skyla until a minimum of 6 weeks after delivery, or until the uterus is fully involuted. If involution is delayed, wait until involution is complete before insertion [see Warnings and Precautions (5.6, 5.7)]. • If the woman has not yet had a period, consider the possibility of ovulation and conception occurring prior to insertion of Skyla. [See Contraindications (4), Warnings and Precautions (5.2), and FDA-Approved Patient Labeling.] Skyla can be inserted any time the provider can be reasonably certain the woman is not pregnant. • If Skyla is not inserted during the first 7 days of the menstrual cycle, a back-up method of contraception should be used or the patient should abstain from vaginal intercourse for 7 days to prevent pregnancy. • There is an increased risk of perforation in lactating women. [See Warnings and Precautions (5.7).] Tools for Insertion Preparation •Gloves •Speculum •Sterile uterine sound •Sterile tenaculum •Antiseptic solution, applicator Procedure •Sterile gloves •Skyla with inserter in sealed package •Instruments and anesthesia for paracervical block, if anticipated •Consider having an unopened backup Skyla available •Sterile, sharp curved scissors Preparation for insertion •Exclude pregnancy and confirm that there are no other contraindications to the use of Skyla. •Ensure that the patient understands the contents of the Patient Information Booklet and obtain the signed patient informed consent located on the last page of the Patient Information Booklet. •Check expiration date of Skyla prior to initiating insertion. •With the patient comfortably in lithotomy position, do a bimanual exam to establish the size, shape and position of the uterus. •Gently insert a speculum to visualize the cervix. •Thoroughly cleanse the cervix and vagina with a suitable antiseptic solution. •Prepare to sound the uterine cavity. Grasp the upper lip of the cervix with a tenaculum forceps and gently apply traction to stabilize and align the cervical canal with the uterine cavity. Perform a paracervical block if needed. If the uterus is retroverted, it may be more appropriate to grasp the lower lip of the cervix. The tenaculum should remain in position and gentle traction on the cervix should be maintained throughout the insertion procedure. •Gently insert a uterine sound to check the patency of the cervix, measure the depth of the uterine cavity in centimeters, confirm cavity direction, and detect the presence of any uterine anomaly. If you encounter difficulty or cervical stenosis, use dilatation, and not force, to overcome resistance. If cervical dilatation is required, consider using a paracervical block. Insertion Procedure Proceed with insertion only after completing the above steps and ascertaining that the patient is appropriate for Skyla. Ensure use of aseptic technique throughout the entire procedure. Step 1–Opening of the package •Open the package (Figure 1). The contents of the package are sterile. Figure 1. Opening the Skyla Package •Using sterile gloves, lift the handle of the sterile inserter and remove from the sterile package. Opening the Package Step 2–Load Skyla into the insertion tube •Push the slider forward as far as possible in the direction of the arrow thereby moving the insertion tube over the Skyla T-body to load Skyla into the insertion tube (Figure 2). The tips of the arms will meet to form a rounded end that extends slightly beyond the insertion tube. Figure 2. Move slider all the way to the forward position to load Skyla •Maintain forward pressure with your thumb or forefinger on the slider. 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 re-loaded . Loading Skyla Step 3–Setting the Flange •Holding the slider in this forward position, set the upper edge of the flange to correspond to the uterine depth (in centimeters) measured during sounding (Figure 3). Figure 3. Setting the flange Setting Flange Step 4–Skyla is now ready to be inserted •Continue holding the slider in this forward position. Advance the inserter through the cervix until the flange is approximately 1.5–2 cm from the cervix and then pause (Figure 4). Figure 4. Advancing insertion tube until flange is 1.5 to 2 cm from the cervix Do not force the inserter. If necessary, dilate the cervical canal. Advancing Tube Step 5–Open the arms •While holding the inserter steady, move the slider down to the mark to release the arms of Skyla (Figure 5). Wait 10 seconds for the horizontal arms to open completely. Figure 5. Move the slider back to the mark to release and open the arms Releasing Arms Step 6–Advance to fundal position Advance the inserter gently towards the fundus of the uterus until the flange touches the cervix. If you encounter fundal resistance do not continue to advance. Skyla is now in the fundal position (Figure 6). Fundal positioning of Skyla is important to prevent expulsion. Figure 6. Move Skyla into the fundal position Fundal Position Step 7–Release Skyla and withdraw the inserter •Holding the entire inserter firmly in place, release Skyla by moving the slider all the way down (Figure 7). Figure 7. Move the slider all the way down to release Skyla from the insertion tube •Continue to hold the slider all the way down while you slowly and gently withdraw the inserter from the uterus. • Using a sharp, curved scissor, cut the threads perpendicular, leaving about 3 cm visible outside of the cervix [cutting threads at an angle may leave sharp ends (Figure 8)]. Do not apply tension or pull on the threads when cutting to prevent displacing Skyla. . Figure 8. Cutting the threads Skyla insertion is now complete. Prescribe analgesics, if indicated. Keep a copy of the Consent Form with lot number for your records. Moving Slider to Release Cutting Threads Important information to consider during or after insertion •If you suspect that Skyla is not in the correct position, check placement (for example, using transvaginal ultrasound). Remove Skyla if it is not positioned completely within the uterus. Do not reinsert a removed Skyla. •If there is clinical concern, exceptional pain or bleeding during or after insertion, take appropriate steps (such as physical examination and ultrasound) immediately to exclude perforation. 2.2 Patient Follow-up •Reexamine and evaluate patients 4 to 6 weeks after insertion and once a year thereafter, or more frequently if clinically indicated. 2.3 Removal of Skyla Timing of Removal •Skyla should not remain in the uterus after 3 years. •If pregnancy is not desired, the removal should be carried out during the first 7 days of the menstrual cycle, provided the woman is experiencing regular menses. If removal will occur at other times during the cycle or the woman does not experience regular menses, she is at risk of pregnancy: start a new contraceptive method a week prior to removal for these women. [See Dosage and Administration (2.4).] Tools for Removal Preparation •Gloves •Speculum Procedure •Sterile forceps Removal Procedure •Remove Skyla by applying gentle traction on the threads with forceps (Figure 9). Figure 9. Removal of Skyla •If the threads are not visible, determine location of Skyla by ultrasound [see Warnings and Precautions (5.10)]. •If Skyla is found to be in the uterine cavity on ultrasound exam, it may be removed using a narrow forceps, such as an alligator forceps. This may require dilation of the cervical canal. After removal of Skyla, examine the system to ensure that it is intact. •Removal may be associated with some pain and/or bleeding or vasovagal reactions (for example, syncope, bradycardia) or seizure, especially in patients with a predisposition to these conditions. Remove Skyla 2.4 Continuation of Contraception after Removal •If pregnancy is not desired and if a woman wishes to continue using Skyla, a new system can be inserted immediately after removal any time during the cycle. •If a patient with regular cycles wants to start a different contraceptive method, time removal and initiation of the new method to ensure continuous contraception. Either remove Skyla during the first 7 days of the menstrual cycle and start the new method immediately thereafter or start the new method at least 7 days prior to removing Skyla if removal is to occur at other times during the cycle. •If a patient with irregular cycles or amenorrhea wants to start a different contraceptive method, start the new method at least 7 days before removal. Inserter
Use in special populations
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary 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 [see Contraindications (4), Warnings and Precautions (5.1, 5.2)]. 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 [see Warnings and Precautions (5.1, 5.2)]. 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. 8.2 Lactation Risk Summary 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. 8.4 Pediatric Use 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. 8.5 Geriatric Use Skyla has not been studied in women over age 65 and is not approved for use in this population.

Interactions

7 DRUG INTERACTIONS No drug-drug interaction studies have been conducted with Skyla. Drugs or herbal products that induce or inhibit LNG metabolizing enzymes, including CYP3A4, may decrease or increase, respectively, the serum concentrations of LNG during the use of Skyla. However, the contraceptive effect of Skyla is mediated via the direct release of LNG into the uterine cavity and is unlikely to be affected by drug interactions via enzyme induction or inhibition.

More information

Category Value
Authorisation number NDA203159
Agency product number 5W7SIA7YZW
Orphan designation No
Product NDC 50419-422
Date Last Revised 01-03-2018
Type HUMAN PRESCRIPTION DRUG
RXCUI 1366334
Marketing authorisation holder Bayer HealthCare Pharmaceuticals Inc.