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Important Safety Information Full Prescribing Information Close KYLEENA ® (levonorgestrel-releasing intrauterine system) 19.5 mg Kyleena Important Safety Information MIRENA ® (levonorgestrel-releasing intrauterine system) 52 mg Mirena Important Safety Information SKYLA ® (levonorgestrel-releasing intrauterine system) 13.5 mg Skyla Important Safety InformationThis site is intended for US healthcare providers.Important Safety Information Full Prescribing InformationConsumer Site Stay Up-to-Date on Kyleena IMPORTANT SAFETY INFORMATION ABOUT KYLEENA Who is not appropriate for Kyleena Use of Kyleena 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… Continue belowAbout Kyleena Did You Know? Efficacy Mechanism of Action Bleeding Data Insertion & Removal Insertion & Removal Video Insertion Instructions Ordering & Reimbursement Resource Center Safety Request A Rep Consumer site Stay Up-to-Date on Kyleena Terms of Use Privacy Policy Site Map Full Prescribing Information Contact Us Kyleena ® : the smallest, lowest-dose 5-year IUD About Kyleena Learn more about her low-maintenance option for contraception. Counsel patients to check their threads once a month Reexamine and evaluate patients 4 to 6 weeks after insertion and once a year thereafter, or more frequently if clinically indicated Explore Efficacy & Reversibility Low-dose Kyleena prevents pregnancy for up to 5 years 1 98.6% cumulative efficacy over 5 years The efficacy of Kyleena over 5 years was studied in parous and nulliparous women across a broad range of ages and body mass index (BMI) Fertility is rapidly restored once hormone-releasing IUDs like Kyleena are removed 1,2 In a study of 1,452 parous and nulliparous women aged 18-35 years: About 71% of 163 women wishing to become pregnant conceived within 12 months after removal of Kyleena Read More Instructional Video See step-by-step instructions on how to properly insert and remove Kyleena. Watch Video Ordering and Reimbursement Learn how to order and get support for reimbursement and coverage questions. Go to WHC Support Center Safety Please see Important Safety Information for Kyleena. Learn More Patients using OCs may miss more pills than you realize 3 57% of young women (aged 18-31) missed an average of 3 or more pills per cycle 3* Learn more about Kyleena, a non-daily option* A randomized controlled trial (N=82) tracked OC dosing for 3 months by electronic and wireless data collection. During the study period, half the participants (n=41) received a daily reminder text message. IUD=intrauterine device; OCs=oral contraceptives Resource Center Downloadable Materials FAQs Stay Up-to-Date on Kyleena Access educational and support materials for you, your staff, and your patients. Kyleena Patient Brochure View All Materials Browse frequently asked questions about Kyleena. Do I need to provide backup contraception when Kyleena is first inserted? Answer See More Questions Register to meet with a Bayer Sales Consultant to learn more about Kyleena and Bayer Pharmaceuticals. Complete Request Form second headingINDICATION FOR KYLEENA Kyleena ® (levonorgestrel-releasing intrauterine system) 19.5 mg is indicated for the prevention of pregnancy for up to 5 years. Replace the system after 5 years if continued use is desired. second headingIMPORTANT SAFETY INFORMATION ABOUT KYLEENA second headingWho is not appropriate for Kyleena Use of Kyleena 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 Kyleena. second headingClinical considerations for use and removal of Kyleena Use Kyleena 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 the intrauterine system 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 Kyleena is displaced (e.g., expelled or perforated the uterus), remove it. Kyleena can be safely scanned with MRI only under specific conditions. second headingPregnancy related risks with Kyleena If pregnancy should occur with Kyleena in place, remove the intrauterine system 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 Kyleena. 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. second headingEducate her about PID Kyleena 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). Kyleena does not protect against STIs, including HIV. PID may be asymptomatic but still result in tubal damage and its sequelae. In clinical trials with Kyleena PID occurred more frequently within the first year and most often within the first month after insertion. second headingExpect changes in bleeding patterns with Kyleena 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 Kyleena use, exclude endometrial pathology (polyps or cancer) prior to the insertion of Kyleena 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. second...