简介：

 Kybella注射液 10毫克/毫升/瓶 4瓶/盒 冷链产品（储存在2-8度） 

KYBELLA(去氧胆酸[deoxycholic acid])注射液为首款获准消除双下巴脂肪的药物
美国初次批准：2015
适应证和用途
KYBELLA™是一种细胞溶解药适用在成年中伴随颏下脂肪中度至严重凸起或丰满为改善外观。
使用限制：尚未确定KYBELLA为治疗颏下区皮下脂肪外使用的安全性和有效使用并建议不要使用。
剂量和给药方法
⑴0.2mL注射液间隔1-cm直至所有计划治疗区已被注射。
⑵在单次治疗可能注射至50次注射或10mL。
⑶在间隔不小于1个月可能给予至6次单次治疗。
⑷注射前见为给予和注射技术一般考虑。
剂型和规格
注射液：10mg/mL无菌溶液，在2mL小瓶中供应。每小瓶是为单个患者使用。
建议不稀释或与其他化合物混合。
禁忌证
在存在感染的注射部位是禁忌KYBELLA。
警告和注意事项
⑴下颌缘神经(MMN)损伤：遵循注射技术避免这个损伤。
⑵使用KYBELLA可能发生咽下困难。在有预先存在咽下困难患者中使用可能加重。
⑶ KYBELLA给药后频繁地发生颏下血肿/瘀伤。正在用抗血小板或抗凝剂治疗或有凝固异常患者中慎用。
⑷由于组织损伤风险的增加避免在靠近脆弱解剖结构注入。
不良反应
最常见不良反应(>20% of 受试者)包括注射部位水肿/肿胀，血肿，疼痛，麻木，红斑和硬结。

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.”