Kybella（deoxycholic acid）的上市，将为“双下巴”人群提供一个高质量的非手术治疗选择，大部分患者注射2-4次后，即可取得满意的效果，少部分患者可能需要注射6次。
近日，美国FDA提前2周批准了全球首个“双下巴”溶脂针Kybella（ATX-101），用于中度至重度“双下巴”成人，
该针剂是用于消除多余颏下脂肪（双下巴）的首个也是唯一一个非手术治疗产品。
ATX-101是一种人造的脱氧胆酸（deoxycholic acid），这是人体内天然存在的一种物质，帮助分解脂肪。在临床试验中，相比安慰剂，ATX-101能够有效消除颏下脂肪并改善整体外观。此次批准，使ATX-101成为同类产品中首个获批用于美容目的的注射针剂。
批准日期：2015年4月29日 公司：艾尔建
KYBELLA（脱氧胆酸[deoxycholic acid]）注射液，皮下使用
美国首次批准：2015
最近的主要变化
用法用量：05/2020
警告和注意事项：05/2020
作用机制
KYBELLA注射液是一种细胞溶解药物，当注射到组织中时会物理破坏细胞膜，导致细胞溶解。
适应症和用法
KYBELLA是一种溶细胞药物，用于改善与成人颏下脂肪相关的中度至重度凸度或丰满度的外观。
使用限制
KYBELLA用于治疗颏下区域以外的皮下脂肪的安全有效使用尚未确立，不推荐使用。
剂量和给药
0.2mL注射间隔1cm，直到已注射计划治疗区域中的所有部位。一次治疗最多可注射50次或10mL。最多可进行6次单次治疗，间隔不少于 1个月。
参见注射前给药和注射技术的一般注意事项。
剂型和规格
注射剂：10mg/mL
禁忌症
KYBELLA禁忌：
在注射部位存在感染的情况下。
警告和注意事项
下颌缘神经(MMN)损伤：遵循注射技术以避免这种损伤。
使用KYBELLA可能会出现吞咽困难。用于先前存在吞咽困难的患者可能会加重病情。
KYBELLA给药后经常发生颏下血肿/瘀伤。正在接受抗血小板或抗凝治疗或有凝血异常的患者慎用。
由于组织损伤和血管损伤的风险增加，避免在脆弱的解剖结构附近注射。
注射部位脱发：停止后续治疗直至解决。
注射部位溃疡和坏死：在完全消退之前不要对受影响的区域进行给药。
不良反应
最常见的不良反应（>20% 的受试者）包括注射部位水肿/肿胀、血肿、疼痛、麻木、红斑和硬结。
要报告疑似不良反应，请致电1-800-678-1605 联系艾尔建，或致电1-800-FDA-1088或
www.fda.gov/medwatch联系FDA。
包装提供/储存和处理
KYBELLA（脱氧胆酸）注射液，10mg/mL是一种透明、无色、无菌溶液，以2mL提供，单个患者使用的小瓶装在以下分配包中：
4瓶，NDC 61168-101-04
储存于20°C至25°C（68°F至77°F）；允许在 15°C至30°C（59°F至86°F）之间偏移 [参见USP控制的室温]。KYBELLA在小瓶标签上有一个独特的全息图。 如果您没有看到全息图，请不要使用该产品并致电1-800-678-1605。
每个小瓶供单个患者使用。不要稀释。丢弃未使用的部分。
请参阅随附的KYBELLA完整处方信息：
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fe431ed4-ea6f-4e99-b4bc-ec25ae7b8553
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Generic Name: deoxycholic acid
Date of Approval: April 29, 2015
Company: Kythera Biopharmaceuticals, Inc.
Treatment for: Submental Fullness
Kythera’s investigational submental contouring injectable ATX-101 may be a useful adjunct to plastic surgeons’ armamentarium for treating the dreaded double chin, according to a pooled analysis of two positive ATX-101 Phase III trials (REFINE-1 and REFINE-2) presented at the Annual Meeting of the American Society for Aesthetic Plastic Surgery (ASAPS) in San Francisco.
ATX-101 is a purified synthetic version of Deoxycholic acid that aids in the breakdown of dietary fat. When injected into subcutaneous fat, ATX-101 contours the area under the chin by destroying fat cells while leaving surrounding tissue largely unaffected. The fat is naturally excreted from the body.
According to the pooled analyses, 68.2% of study participants treated with ATX-101 (2 mg/cm2) demonstrated a simultaneous improvement of at least one grade from baseline on clinician and patient reported rating scales vs. 20.5% in the placebo arm.
After two treatments, 52.2% achieved at least a one grade change from baseline in the clinician submental fat ratings, and 71.5% after four treatments.
Approximately 80% of subjects treated with ATX-101 demonstrated at least a one-grade improvement in the clinician submental fat ratings regardless of age, gender, race, BMI, Fitzpatrick Skin Type, and baseline severity, the study showed.
Those treated with ATX-101 reported significant improvement in the visual and emotional impact of chin fat, including appearing thinner and more youthful, compared with those treated with placebo.
Close to 81% of ATX-101 treatment-emergent adverse events were mild, and 1.4% of ATX-101 subjects discontinued the studies due to adverse events. The most common adverse events included temporary injection site events of pain, swelling, bruising, and numbness. The incidence and severity of pain and swelling declined after the first treatment session.
Plastic Surgery Practice editorial advisor W. Grant Stevens, MD, a plastic surgeon in Marina del Rey, Calif, has been following ATX-101 as it moves through the pipeline. “I’m very excited about nonsurgical fat reduction,” he tells PSP. “This technology won’t replace liposuction, but it will expand the market.” Many individuals want to lose fat, but don’t want or can’t tolerate surgery and its associated downtime. If approved, ATX-101 will expand the audience of people who will opt to recountour their neck fat.”
