circle of relatives [1%:<0.1%. 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 Skyla is inserted when the uterus is fixed retroverted or not completely involuted. Delay Skyla insertion a minimum of six weeks or until involution is complete following a delivery or a second trimester abortion. 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. Expulsion Partial or complete expulsion of Skyla may occur resulting in the loss of contraceptive protection. Expulsion may be associated with symptoms of bleeding or pain, or it may be asymptomatic and go unnoticed. Skyla typically decreases menstrual bleeding over time; therefore, an increase of menstrual bleeding may be indicative of an expulsion. The risk of expulsion may be increased when the uterus is not completely involuted. In clinical trials, a 3-year expulsion rate of 3.2% (54 out of 1665 subjects) was reported. Delay Skyla 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, Skyla may be replaced within 7 days after the onset of a menstrual period after pregnancy has been ruled out. Ovarian Cysts Because the contraceptive effect of Skyla is mainly due to its local effects within the uterus, ovulatory cycles with follicular rupture usually occur in women of fertile age using Skyla. During clinical trials, ovarian cysts (reported as adverse reactions if they were abnormal, non-functional cysts and/or had a diameter> 3 cm on ultrasound examination) were reported in 13.2% of women using Skyla. Most of these cysts are asymptomatic, although some may be accompanied by pelvic pain or dyspareunia. In most cases the ovarian cysts disappear spontaneously during two to three months observation. Evaluate persistent ovarian cysts. Surgical intervention is not usually required. Breast Cancer Women who currently have or have had breast cancer, or have a suspicion of breast cancer, should not use hormonal contraception because some breast cancers are hormone-sensitive [see Contraindications ( 4 )] . Spontaneous reports of breast cancer have been received during postmarketing experience with a LNG-releasing IUS. Observational studies of the risk of breast cancer with use of a LNG-releasing IUS do not provide conclusive evidence of increased risk. Clinical Considerations for Use and Removal Use Skyla with caution after careful assessment if any of the following conditions exist, and consider removal of the system if any of them arise during use: Coagulopathy or use of anticoagulants Migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia Exceptionally severe headache Marked increase of blood pressure Severe arterial disease such as stroke or myocardial infarction In addition, consider removing Skyla if any of the following conditions arise during use [see Contraindications ( 4 )] : Uterine or cervical malignancy Jaundice If the threads are not visible or are significantly shortened they may have broken or retracted into the cervical canal or uterus. Consider the possibility that the system may have been displaced, (for example, expelled or perforated the uterus) [see Warnings and Precautions ( 5.6 , 5.7 )]. Exclude pregnancy and verify the location of Skyla, for example, by sonography, X-ray, or by gentle exploration of the cervical canal with a suitable instrument. If Skyla is displaced, 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. Magnetic Resonance Imaging (MRI) Information Non-clinical testing has demonstrated that Skyla is MR Conditional. Skyla can be safely scanned only under specific conditions: Static magnetic field of 3 Tesla or less Spatial gradient field of 36,000 Gauss/cm (T/m) or less Maximum whole body averaged specific absorption rate (SAR) of 4W/kg in the First Level Controlled mode for 15 minutes of continuous scanning In non-clinical testing, the Skyla produced a temperature rise of less than 1.8 C at a maximum whole body averaged specific absorption rate (SAR) of 2.9 W/kg, for 15 minutes of MR scanning at 3T using a transit/receive body coil. MR Image quality may be compromised (that is, a small amount of artifact may occur) if the area of interest is in the exact same area or relatively close to the position of Skyla. Image artifact extended up to 5 mm from Skyla in a Gradient Echo pulse sequence. 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 )] Bleeding Pattern Alterations [see Warnings and Precautions ( 5.5 )] Perforation [see Warnings and Precautions ( 5.6 )] Expulsion [see Warnings and Precautions ( 5.7 )] Ovarian Cysts [see Warnings and Precautions ( 5.8 )] 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 3: Adverse reactions that occurred in at least 1% of Skyla users in clinical trials by SOC * Ovarian cysts were reported as AEs if they were abnormal, non-functional cysts and/or had a diameter >3 cm on ultrasound examination Not all bleeding alterations were captured as adverse reactions [see Warnings and Precautions (5.5)]. System Organ Class Adverse Reaction Incidence (%) (N=1,672) Reproductive System and Breast Disorders Vulvovaginitis 20.2 Ovarian cyst * 13.2 Dysmenorrhoea 8.6 Increased bleeding 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/Seborrhoea 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 Postmarketing Experience The following adverse reactions have been identified during post approval use of a LNG-releasing IUS. 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 emboli, deep vein thrombosis and stroke Hypersensitivity including rash, urticaria, and angioedema Device breakage Drug Interactions No drug-drug interaction studies have been conducted with Skyla. Drugs or herbal products that induce enzymes, including CYP3A4, that metabolize progestins may decrease the serum concentrations of progestins. Some drugs or herbal products that may decrease the serum concentration of LNG include: Barbiturates Bosentan Carbamazepine Efavirenz Felbamate Griseofulvin Nevirapine Oxcarbazepine Phenytoin Rifabutin Rifampin St. John s wort Topiramate Significant changes (increase or decrease) in the serum concentrations of the progestin have been noted in some cases of co-administration with HIV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors. CYP3A4 inhibitors such as itraconazole or ketoconazole may increase plasma hormone levels. Consult the labeling of all concurrently used drugs to obtain further information about interactions with Skyla or the potential for enzyme alterations. USE IN SPECIFIC POPULATIONS Pregnancy The use of Skyla during an existing or suspected pregnancy is contraindicated. Many studies have found no harmful effects on fetal development associated with long-term use of contraceptive doses of oral progestins. The few studies of infant growth and development that have been conducted with progestin-only pills have not demonstrated significant adverse effects. [See Contraindications ( 4 ) and Warnings and Precautions ( 5.1 , 5.2 ).] Nursing Mothers In general, no adverse effects of progestin-only contraceptives have been found on breastfeeding performance or on the health, growth, or development of the infant. Isolated postmarketing cases of decreased milk production have been reported. Small amounts of progestins were observed to pass into the breast milk of nursing mothers who used a LNG-releasing IUS, resulting in detectable steroid levels in infant serum. [See Warnings and Precautions ( 5.6 ).] 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. Geriatric Use Skyla has not been studied in women over age 65 and is not approved for use in this population. Hepatic Impairment No studies were conducted to evaluate the effect of hepatic disease on the disposition of LNG released from Skyla [see Contraindications ( 4 )]. Renal Impairment No studies were conducted to evaluate the effect of renal disease on the disposition of LNG released from Skyla. Skyla IUD Description Skyla (levonorgestrel-releasing intrauterine system) contains 13.5 mg of LNG, a progestin, and is intended to provide an initial release rate of approximately14 mcg/day of LNG after 24 days. Levonorgestrel USP, (-)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one, the active ingredient in Skyla, has a molecular weight of 312.4, a molecular formula of C 21 H 28 O 2 , and the following structural formula: Skyla Skyla consists of a T-shaped polyethylene frame (T-body) with a steroid reservoir (hormone elastomer core) around the vertical stem. The white T-body has a loop at one end of the vertical stem and two horizontal arms at the other end. The reservoir consists of a whitish or pale yellow cylinder, made of a mixture of LNG and silicone (polydimethylsiloxane), containing a total of 13.5 mg LNG. The reservoir is covered by a semi-opaque silicone membrane, composed of polydimethylsiloxane and colloidal silica. 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. The polyethylene of the T-body is compounded with barium sulfate, which makes it radiopaque. A monofilament brown polyethylene removal thread is attached to a loop at the end of the vertical stem of the T-body. The polyethylene of the removal thread contains iron oxide as a colorant (see Figure 10). The components of Skyla, including its packaging, are not manufactured using natural rubber latex. Figure 10. Skyla Inserter Skyla is packaged sterile within an inserter. The inserter (Figure 11), which is used for insertion of Skyla into the uterine cavity, consists of a symmetric two-sided body and slider that are integrated with flange, lock, pre-bent insertion tube and plunger. The outer diameter of the insertion tube is 3.8 mm. The vertical stem of Skyla is loaded in the insertion tube at the tip of the inserter. The arms are pre-aligned in the horizontal position. The removal threads are contained within the insertion tube and handle. Once Skyla has been placed, the inserter is discarded. Figure 11: Diagram of Inserter Skyla IUD - Clinical Pharmacology Mechanism of Action The local mechanism by which continuously released LNG enhances contraceptive effectiveness of Skyla has not been conclusively demonstrated. Studies of Skyla and similar LNG IUS prototypes have suggested several mechanisms that prevent pregnancy: thickening of cervical mucus preventing passage of sperm into the uterus, inhibition of sperm capacitation or survival, and alteration of the endometrium . Pharmacodynamics Skyla has mainly local progestogenic effects in the uterine cavity. The high local levels of LNG2 lead to morphological changes including stromal pseudodecidualization, glandular atrophy, a leukocytic infiltration and a decrease in glandular and stromal mitoses. In clinical trials with Skyla, ovulation was observed in the majority of a subset of subjects studied. Evidence of ovulation was seen in 34 out of 35 women in the first year, in 26 out of 27 women in the second year, and in all 26 women in the third year . Pharmacokinetics Absorption Low doses of LNG are administered into the uterine cavity with the Skyla intrauterine delivery system. The in vivo release rate is approximately 14 mcg/day after 24 days and is reduced to approximately 10 mcg/day after 60 days and then decreases progressively to approximately 5 mcg/day after three years. The average LNG in vivo release rate is approximately 6 mcg/day over the period of three years. In a subset of 7 subjects, maximum observed serum LNG concentration was 192 105 pg/mL, reached after 2 days (median) of Skyla insertion. Thereafter, LNG serum concentration decreased after long-term use of 12, 24, and 36 months to concentrations of 77 21 pg/mL, 62 38 pg/mL, and 72 29 pg/mL, respectively. A population pharmacokinetic evaluation based on a broader data base (>1000 patients) showed similar concentration data of 168 46 pg/mL at 7 days after placement. Thereafter, LNG serum concentrations decline slowly to a value 61 19 pg/mL after 3 years. Distribution The apparent volume of distribution of LNG is reported to be approximately 1.8 L/kg. Levonorgestrel is bound non-specifically to serum albumin and specifically to sex hormone binding globulin (SHBG). Accordingly, changes in the concentration of SHBG in serum result in an increase (at higher SHBG concentration) or a decrease (at lower SHBG concentration) of the total LNG concentration in serum. In a subset of 7 subjects, the concentration of SHBG declined by a mean value of 18% within 2 weeks after insertion of Skyla and remains relatively stable over the 3 year period of use. Less than 2 % of the circulating LNG is present as free steroid. Metabolism Following absorption, LNG is conjugated at the 17β-OH position to form sulfate conjugates and, to a lesser extent, glucuronide conjugates in serum. Significant amounts of conjugated and unconjugated 3α, 5β-tetrahydrolevonorgestrel are also present in serum, along with much smaller amounts of 3α, 5α-tetrahydrolevonorgestrel and 16β-hydroxylevonorgestrel. LNG and its phase I metabolites are excreted primarily as glucuronide conjugates. Metabolic clearance rates may differ among individuals by several-fold, and this may account in part for wide individual variations in LNG concentrations seen in individuals using LNG containing contraceptive products. In vitro studies have demonstrated that oxidative metabolism of LNG is catalyzed by CYP enzymes, especially CYP3A4. Excretion About 45% of LNG and its metabolites are excreted in the urine and about 32% are excreted in feces, mostly as glucuronide conjugates. The elimination half-life of LNG after parenteral administration is approximately 20 hours. Specific Populations Pediatric: Safety and efficacy of Skyla have been established in women of reproductive age. Use of this product before menarche is not indicated . In a one-year phase 3 study in post-menarcheal female adolescents (mean age 16.2, range 12 to 18 years) using Skyla, the population pharmacokinetic analysis of 278 adolescents showed mean estimated LNG serum concentrations slightly higher (approximately 10%) in adolescents compared to prior data in adults. This correlates to the generally lower body weight in adolescents. The ranges estimated for adolescents lie within the ranges estimated for adults. Geriatric: Skyla has not been studied in women over age 65 and is not currently approved for use in this population . Race: A three-year phase 3 study in the Asian-Pacific region (93% Asian women, the majority of whom were Chinese, 7% other ethnicities) using Skyla was performed. The population pharmacokinetic analysis of the Asian (Chinese) population in this study showed that mean estimated LNG serum concentrations in Asian women were slightly higher (approximately 5 to 16% for total LNG and 4 to 12% for unbound LNG) than those in another phase 3 study which was performed in mainly Caucasian women (79.7%). This slightly higher exposure might be explained by the lower body weight of Asian women. Hepatic Impairment: No studies were conducted to evaluate the effect of hepatic disease on the disposition of Skyla . Renal Impairment: No formal studies were conducted to evaluate the effect of renal disease on the disposition of Skyla. Drug-Drug Interactions No drug-drug interaction studies were conducted with Skyla [see Drug Interactions ( 7 )] . Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility [See Warnings and Precautions ( 5.9 ).] Clinical Studies Clinical Trials on Contraception The contraceptive efficacy of Skyla was demonstrated in a clinical trial that enrolled generally healthy women aged 18 35, 1,432 of whom received Skyla. The Skyla arm included 38.8 % (556) nulliparous women. 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. For Skyla-treated women, 540 (37.7%) were treated at US sites and 892 (62.3%) were at non-US sites. The racial demographic of enrolled women who received Skyla was: Caucasian (79.7%), Hispanic (11.5%), Black (5.2%), Asian (0.8%), and Other (2.7%). The weight range for treated women was 38 to 155 kg (mean weight: 68.7 kg) and mean BMI was 25.3 kg/m 2 (range 16 55 kg/m 2 ). 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 their consent, 13.0% discontinued due to other reason, 1.1% discontinued due to protocol deviation, and 0.6% discontinued due to pregnancy. 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 three 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%. About 77% of women wishing to become pregnant conceived within 12 months after removal of Skyla. REFERENCES 1 Farley T M M, Rosenberg M J, Rowe P J, Chen J, Meirik O. Intrauterine devices and pelvic inflammatory disease: an international perspective. Lancet 1992; 339:785-788. 2 Nilsson CG, Haukkamaa M, Vierola H, Luukkainen T. Tissue concentrations of LNG in women using a LNG-releasing IUD. Clinical Endocrinol 1982; 17:529-536. How Supplied/Storage and Handling Skyla (levonorgestrel-releasing intrauterine system), containing a total of 13.5 mg LNG, is available in a carton of one sterile unit. NDC# 50419-422-01 Skyla is supplied sterile. Skyla is sterilized with ethylene oxide. Do not resterilize. For single use only. Do not use if the inner package is damaged or open. Insert before the end of the month shown on the label. Store at 25 C (77 F); with excursions permitted between 15 30 C (59 86 F) [see USP Controlled Room Temperature]. Patient Counseling Information Advise the patient to read the FDA-approved patient labeling (Patient Information) Sexually Transmitted Infections: Counsel the patient that this product does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs). Risk of Ectopic Pregnancy: Inform the patient about the risks of ectopic pregnancy, including the loss of fertility. Teach her to recognize and report to her healthcare provider promptly any symptoms of ectopic pregnancy. [See Warnings and Precautions (5.1).] Pregnancy or Suspected Pregnancy: Counsel the patient to inform her healthcare provider if she determines or suspects she is pregnant with Skyla in place. Pelvic Infection: Inform the patient about the possibility of pelvic inflammatory disease (PID) and that PID can cause tubal damage leading to ectopic pregnancy or infertility, or infrequently can necessitate hysterectomy, or cause death. Teach the patient to recognize and report to her healthcare provider promptly any symptoms of PID. These symptoms include development of menstrual disorders (prolonged or heavy bleeding), unusual vaginal discharge, abdominal or pelvic pain or tenderness, dyspareunia, chills, and fever. [See Warnings and Precautions ( 5.4 ).] Bleeding Pattern Alterations: Counsel the patient that irregular or prolonged bleeding and spotting, and/or cramps may occur during the first few weeks after insertion. If her symptoms continue or are severe she should report them to her healthcare provider. [See Warnings and Precautions (5.5).] Perforation and Expulsion: Counsel the patient that the IUS may be expelled from or perforate the uterus and instruct her on how she can check that the threads still protrude from the cervix. Caution her not to pull on the threads and displace Skyla. Inform her that there is no contraceptive protection if Skyla is displaced or expelled. [See Warnings and Precautions (5.6, 5.7).] Clinical Considerations for Use and Removal: Instruct the patient to contact her healthcare provider if she experiences any of the following: A stroke or heart attack Very severe or migraine headaches Unexplained fever Yellowing of the skin or whites of the eyes, as these may be signs of serious liver problems Pregnancy or suspected pregnancy Pelvic pain or pain during sex HIV positive seroconversion in herself or her partner Possible exposure to sexually transmitted infections (STIs) Unusual vaginal discharge or genital sores Severe vaginal bleeding or bleeding that lasts a long time, or if she misses a menstrual period Inability to feel Skyla's threads Magnetic Resonance Imaging (MRI) Information: Inform the patient that Skyla can be safely scanned with MRI only under specific conditions [see Warnings and Precautions (5.11)] . 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. Complete the Follow-up Reminder Card and give to the patient. FDA-Approved Patient Labeling Patient Information Skyla (sky-lah) (levonorgestrel-releasing intrauterine system) Skyla does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs). Read this Patient Information carefully before you decide if Skyla is right for you. This information does not take the place of talking with your gynecologist or other healthcare provider who specializes in women s health. If you have any questions about Skyla, ask your healthcare provider. You should also learn about other birth control methods to choose the one that is best for you. What is Skyla? Skyla is a hormone-releasing system placed in your uterus by your healthcare provider to prevent pregnancy for up to 3 years. Skyla can be removed by your healthcare provider at any time. Skyla can be used whether or not you have had a child. Skyla is a small, flexible plastic T-shaped system that slowly releases a progestin hormone called levonorgestrel that is often used in birth control pills. Because Skyla releases levonorgestrel into your uterus, only small amounts of the hormone enter your blood. Skyla does not contain estrogen. Two thin threads are attached to the stem of Skyla. The threads are the only part of Skyla you can feel when Skyla is in your uterus; however, unlike a tampon string, the threads do not extend outside your body. Skyla is small and flexible What if I need birth control for more than 3 years? Skyla must be removed after 3 years. Your healthcare provider can place a new Skyla during the same office visit if you choose to continue using Skyla. What if I want to stop using Skyla? Skyla is intended for long-term use but you can stop using Skyla at any time by asking your healthcare provider to remove it. You could become pregnant as soon as Skyla is removed, so you should use another method of birth control if you do not want to become pregnant. What if I change my mind about birth control and want to become pregnant in less than 3 years? Your healthcare provider can remove Skyla at any time. You may become pregnant as soon as Skyla is removed. About 3 out of 4 women who want to become pregnant will become pregnant sometime in the first year after Skyla is removed. How does Skyla work? Skyla may work in several ways including thickening cervical mucus, inhibiting sperm movement, reducing sperm survival, and thinning the lining of your uterus. It is not known exactly how these actions work together to prevent pregnancy. How well does Skyla work for contraception? The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant. Skyla, an intrauterine device (IUD), is in the box at the top of the chart. Who might use Skyla? You might choose Skyla if you: Want long-term birth control that provides a low chance of getting pregnant (less than 1 in 100) Want birth control that works continuously for up to 3 years Want birth control that is reversible Want a birth control method that you do not need to take daily Are willing to use a birth control method that is placed in the uterus Want birth control that does not contain estrogen Who should not use Skyla? Do not use Skyla if you: Are or might be pregnant; Skyla cannot be used as an emergency contraceptive Have had a serious pelvic infection called pelvic inflammatory disease (PID) unless you have had a normal pregnancy after the infection went away Have an untreated pelvic infection now Have had a serious pelvic infection in the past 3 months after a pregnancy Can get infections easily. For example, if you have: o Multiple sexual partners or your partner has multiple sexual partners Problems with your immune system Intravenous drug abuse Have or suspect you might have cancer of the uterus or cervix Have bleeding from the vagina that has not been explained Have liver disease or liver tumor Have breast cancer or any other cancer that is sensitive to progestin (a female hormone), now or in the past Have an intrauterine device in your uterus already Have a condition of the uterus that changes the shape of the uterine cavity, such as large fibroid tumors Are allergic to levonorgestrel, silicone, polyethylene, silver, silica, barium sulfate or iron oxide Before having Skyla placed, tell your healthcare provider if you: Have had a heart attack Have had a stroke Were born with heart disease or have problems with your heart valves Have problems with blood clotting or take medicine to reduce clotting Have high blood pressure Recently had a baby or if you are breastfeeding Have severe migraine headaches How is Skyla placed? Skyla is placed by your healthcare provider during an in-office visit. First, your healthcare provider will examine your pelvis to find the exact position of your uterus. Your healthcare provider will then clean your vagina and cervix with an antiseptic solution and slide a slim plastic tube containing Skyla into your uterus. Your healthcare provider will then remove the plastic tube, and leave Skyla in your uterus. Your healthcare provider will cut the threads to the right length. Placement takes only a few minutes. You may experience pain, bleeding or dizziness during and after placement. If your symptoms do not pass within 30 minutes after placement, Skyla may not have been placed correctly. Your healthcare provider will examine you to see if Skyla needs to be removed or replaced. Should I check that Skyla is in place? Yes, you should check that Skyla is in proper position by feeling the removal threads. It is a good habit to do this once a month. Your healthcare provider should tell you how to check that Skyla is in place. First, wash your hands with soap and water. You can check by reaching up to the top of your vagina with clean fingers to feel the removal threads. Do not pull on the threads. If you feel more than just the threads or if you cannot feel the threads, Skyla may not be in the right position and may not prevent pregnancy. Use non-hormonal back-up birth control (such as condoms and spermicide) and ask your healthcare provider to check that Skyla is still in the right place. How soon after placement of Skyla should I return to my healthcare provider? Call your healthcare provider if you have any questions or concerns (see When should I call my healthcare provider ). Otherwise, you should return to your healthcare provider for a follow-up visit 4 to 6 weeks after Skyla is placed to make sure that Skyla is in the right position. Can I use tampons with Skyla? Tampons may be used with Skyla. What if I become pregnant while using Skyla? Call your healthcare provider right away if you think you are pregnant. If you get pregnant while using Skyla, you may have an ectopic pregnancy. This means that the pregnancy is not in the uterus. Unusual vaginal bleeding or abdominal pain may be a sign of ectopic pregnancy. Ectopic pregnancy is a medical emergency that often requires surgery. Ectopic pregnancy can cause internal bleeding, infertility, and even death. There are also risks if you get pregnant while using Skyla and the pregnancy is in the uterus. Severe infecti moms and dads
the workers Skyla IUD in good shape
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