新型避孕装置LILETTA(levonorgestrel-releasing intrauterine system)获美国FDA批准，避孕时间长达5年.
近日，美国食品和药物管理局（FDA）已批准Liletta（levonorgestrel-releasing 中文名：左炔诺孕酮宫内缓释系统，52mg）的一份补充新药申请（sNDA），将该产品用于预防妊娠的持续使用时间延长至5年。
批准日期：2018年10月18日 公司：艾尔建（Allergan）
LILETTA(左旋炔诺孕酮[levonorgestrel-releasing]）缓释系统，宫内节育器插入器
首次美国批准：2015
近期重大变化
适应症和使用：08／2017
剂量和给药：08／2017
警告与预防：08／2017
作用机理
连续释放LNG提供避孕的局部机制尚未得到证实。LNG释放IUSs的研究提示了几种预防妊娠的机制：由于宫颈粘液增厚，抑制精子通过宫颈，抑制精子的活动性和功能（获能），以及子宫内膜的改变。
适应症及用法
LILETTA是一种无菌的左炔诺孕酮宫内释放系统，用于预防妊娠长达4年。
剂量与给药
左炔诺孕酮(LNG)的释放率最初为19.5mcg/天，一年时逐渐下降到约17.0mcg/天，2年时下降到14.8mcg/天，3年时下降到12.9mcg/天，4年时下降到11.3mcg/天；LILETTA可以在任何时间被去除，但必须在f结束时被去除。我们的一年。
通过严格的无菌技术由受过培训的医疗提供者插入。严格按照所描述的插入指令进行操作。
患者应该在插入后4-6周内复查和评估，之后每年复查一次，或者如果临床指示更频繁。
剂型和强度
一种宫内系统，由T形聚乙烯框架和含有52mg LNG的药物贮存器组成，包装在无菌插入器内。
禁忌症
妊娠或疑似妊娠。
用于性交后避孕（紧急避孕）。
先天性或后天性子宫异常，扭曲子宫腔，与正确的IUS位置不一致。
急性盆腔炎（PID）或子宫内膜炎或PID病史，除非有后续宫内妊娠。
过去3个月的流产。
已知或怀疑子宫或宫颈肿瘤。
已知或怀疑乳腺癌或其他激素敏感的癌症。
原因不明的子宫出血。
未经治疗的急性宫颈炎或阴道炎或其他下生殖道感染。
急性肝病或肝肿瘤（良性或恶性）。
增加对盆腔感染的易感性。
未被移除的先前插入的IUS。
对Leleta的任何成分过敏。
警告和注意事项
如果怀孕发生在LILETTA，LILETTA在子宫中，则移除Leleta。如果发生妊娠，异位妊娠（包括失去生育能力）、妊娠丢失、败血症性流产（包括败血症、休克和死亡）以及早产和分娩的风险增加。
A组链球菌感染已被报道；严格无菌技术是必不可少的插入过程中。
在使用Lieleta之前，考虑PID的风险。
穿孔可能会发生，并减少避孕效果。风险增加，如果插入子宫固定子宫扭转，哺乳期和产后。
局部或完全排出可能发生。
评估持续扩大的卵巢滤泡或卵巢囊肿。
出血模式改变，可能保持不规则，闭经可能随之而来。
不良反应
临床试验中报告的最常见的不良反应（>10%）是阴道细菌感染、外阴阴道真菌感染和痤疮
包装供应/储存和搬运
LILETTA（左炔诺孕酮释放宫内系统）含有52mg左炔诺孕酮，在插入器内部分预载，并装入带盖的透明塑料托盘中。LILETA可在一个无菌单元的纸箱中使用。NDC×023-585-01。
LLIETA是无菌供应的。利莱塔用环氧乙烷灭菌。不要再消毒。仅供一次性使用。如果包装破损或包装打开，请勿使用。在包装上显示月底之前插入。在20-25℃（68-77°F）下储存，允许在15-30℃（59-86°F）之间移动。将密封的托盘用剥离的盖子放在外纸箱中，直到使用以保护光线。
完整资料附件：
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aaf0eb2a-f88a-4f26-a445-0fd30176c326

LILETTA(levonorgestrel-releasing intrauterine system) 52mg
LILETTA®(levonorgestrel-releasing intrauterine system) 52mg is a hormone-releasing system placed in your uterus to prevent pregnancy for as long as you want for up to 4 years.
IMPORTANT RISK INFORMATION ABOUT LILETTA
Do not use LILETTA if you:
Are or might be pregnant; LILETTA cannot be used as an emergency contraceptive
Have a serious pelvic infection called pelvic inflammatory disease (PID) or endometritis unless you have had a normal pregnancy after the infection went away (PID occurs in less than 1% of users)
Have an untreated lower genital infection now
Have had an infection from an abortion within the last 3 months
Can get infections easily; for example, if you:
Have problems with your immune system
Have multiple sexual partners or your partner has multiple sexual partners
Use or abuse intravenous drugs
Have or suspect you might have cancer of the uterus or cervix
Have bleeding from the vagina that has not been explained
Have short-term (acute) 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 system (IUS) 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, or barium sulfate
Call your healthcare provider right away if you think you are pregnant. If you get pregnant while using LILETTA, you may have an ectopic pregnancy, which means the pregnancy is not in the uterus. Unusual vaginal bleeding or abdominal pain especially with missed periods may be a sign of ectopic pregnancy. Ectopic pregnancy can cause internal bleeding. There are also risks if you get pregnant while using LILETTA and the pregnancy is in the uterus. Severe infection and premature delivery can occur with pregnancies that continue with an IUS
Although uncommon, pregnancy while using LILETTA can be life threatening and may result in loss of pregnancy or fertility
Bleeding and spotting may increase in the first 3 to 6 months and remain irregular. Periods over time usually become shorter, lighter or may stop
Life-threatening infection can occur within the first few days after LILETTA is placed. Call your healthcare provider immediately if you develop severe pain or fever shortly after LILETTA is placed
Some IUS users get a serious pelvic infection called pelvic inflammatory disease (PID) or endometritis. These are usually sexually transmitted. You have a higher chance of getting PID or endometritis if you or your partner has sex with other partners. PID or endometritis can cause serious problems such as infertility, ectopic pregnancy or pelvic pain that does not go away. More serious cases of PID or endometritis may require surgery. Removal of the uterus (hysterectomy) is sometimes needed. In rare cases, infections that start as PID or endometritis can even cause death. Tell your healthcare provider right away if you have any of these signs of PID or endometritis: long-lasting or heavy bleeding, unusual vaginal discharge, low abdominal pain, painful sex, chills, or fever
LILETTA may become attached to (embedded) or go through the uterus (perforation). If perforation occurs, LILETTA may move outside the uterus and can cause internal scarring, infection, or damage to other organs and you may need surgery to have LILETTA removed. Risk of perforation is increased in breastfeeding women
LILETTA may come out of your uterus (expulsion). Expulsion occurs in about 4 out of 100 women, most often in the first year of use. You may become pregnant if LILETTA comes out. If you think that LILETTA has come out, use another birth control method like condoms and spermicide or do not have sex (vaginal intercourse) until you are seen by a healthcare provider Ovarian cysts may occur but usually disappear