英文药名：KYBELLA（deoxycholic acid[ATX-101]） 中文药名：去氧胆酸注射液 生产厂家：Kythera Biopharmaceuticals，Inc 药品介绍 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。 FDA的药品评价和研究中心药物评价III室副主任“治疗Amy G. Egan，M.D.，M.P.H.说：“只能提供由许可的医疗保健专业人员用Kybella，和考虑治疗前患者应完全了解伴随使用药物的风险，”“重要是记住Kybella是只被允许批准为发生下巴下脂肪的治疗，和不知道对于这个区域外治疗它是否安全或有效。” 初次批准：2015年4月： 一般描述 KYBELLA(去氧胆酸[deoxycholic acid])注射液，10mg/mL是一种透明无色，无菌溶液为皮下使用。它含一种细胞溶解药，去氧胆酸，作为活性成分。去氧胆酸化学名为3α,12α-dihydroxy-5β-cholan-24-oic acid，和其分子式为C24H40O4，及其分子量为 392.57g/mol。去氧胆酸的化学结构为： 每个KYBELLA(去氧胆酸)注射液2 mL小瓶含20 mg合成去氧胆酸作为活性成分和以下无活性成分：苯甲醇(18 mg)，磷酸氢二钠(2.84 mg)，氯化钠(8.76 mg)，氢氧化钠(2.86 mg)注射用水，USP中。当需要时添加盐酸和添加氢氧化钠调整制剂至pH 8.3。每个小瓶是为单个患者使用。 作用机制 KYBELLA是一种细胞溶解药，当注入组织物理学地破坏细胞膜引起溶解。 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。 www.oneyao.net deoxycholic acid (Kybella) (ATX-101) About KYBELLA™ KYBELLA™ is the first and only approved injectable drug for contouring moderate to severe submental fullness, a condition that is commonly referred to as a double chin. KYBELLA™ is a non-human and non-animal formulation of deoxycholic acid, a naturally-occurring molecule in the body that aids in the breakdown and absorption of dietary fat.i When injected into subcutaneous fat, KYBELLA™ causes the destruction of fat cells. Once destroyed, those cells cannot store or accumulate fat.ii KYBELLA™ (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. The safe and effective use of KYBELLA for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended. Important Safety Information KYBELLA should only be administered by a trained healthcare professional. KYBELLA is contraindicated in the presence of infection at the injection sites. Avoid injecting in proximity to vulnerable anatomic structures due to the increased risk of tissue damage. Cases of marginal mandibular nerve injury, manifested as an asymmetric smile or facial muscle weakness, were reported during clinical trials. To avoid the potential for nerve injury, KYBELLA should not be injected into or in close proximity to the marginal mandibular branch of the facial nerve. All marginal mandibular nerve injuries reported from the trials resolved spontaneously (range 1-298 days, median 44 days). Difficulty swallowing (dysphagia) occurred in the clinical trials in the setting of administration site reactions, e.g., pain, swelling, and induration of the submental area. Cases of dysphagia spontaneously resolved (range 1-81 days, median 3 days). Subjects with current or prior history of dysphagia were excluded from clinical trials. Avoid use of KYBELLA in these patients as current or prior history of dysphagia may exacerbate the condition. In clinical trials, 72% of subjects treated with KYBELLA experienced injection site hematoma/bruising. KYBELLA should be used with caution in patients with bleeding abnormalities or who are currently being treated with antiplatelet or anticoagulant therapy as excessive bleeding or bruising in the treatment area may occur. To avoid the potential of tissue damage, KYBELLA should not be injected into or in close proximity (1-1.5 cm) to salivary glands, lymph nodes and muscles. The most commonly reported adverse reactions in the pivotal clinical trials were: injection site edema/swelling, hematoma/bruising, pain, numbness, erythema, and induration. About KYTHERA® KYTHERA Biopharmaceuticals, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic medicine market. In addition to its lead product KYBELLA™, KYTHERA also licensed the worldwide rights to setipiprant (KYTH-105), an early-stage potential treatment for hair loss. KYTHERA's longer-term strategy is to leverage its biotechnology and aesthetics experience to expand its product portfolio and pipeline. KYTHERA has submitted regulatory filings for ATX-101 in Canada, Switzerland and Australia. Find more information at www.kythera.com. vi American Society for Dermatologic Surgery 2014 Consumer Survey on Cosmetic Dermatologic Procedures (N=8,315); Exact survey language was, "How bothered are you by excess fat under the chin/neck?" vii Stryer L, ed. Biochemistry. 4th Edition. New York, NY: WH Freeman and Co.; 1995: 691-707 viii Package Insert 03/06, section 12.1 (ATX-101 is a cytolytic drug, which when injected into tissue physically disrupts the cell membrane causing lysis) Kybella（deoxycholic acid）去氧胆酸注射液-FDA首批注射溶质药物治疗颏下脂肪 2015年4月29日，美国FDA批准Kybella(ATX-101, 脱氧胆酸)(KYTHERA Biopharmaceuticals, Inc.)用于改善成年人颏下脂肪导致的中至重度轮廓突出或面部过度丰满。这是FDA 首次也是目前唯一批准用于治疗颏下脂肪的非手术疗法。但该药物未批准也不推荐用于治疗人体其他部位。 颏下过于丰满是一种常见的问题，各年龄层男性和女性均可见，影响面部外观，使人显老或显胖，至今未能完全解决。它跟年龄以及基因遗传有关，难以通过运动和饮食改善。据美国皮肤外科协会(ASDS)2014年的一项针对消费者的调查显示，68%的人抱怨下巴过于丰满。 关于Kybella Kybella同人体产生的脱氧胆酸成分一致，是一种非人体源和非动物源成分脱氧胆酸。人体脱氧胆酸有助于身体吸收脂肪，Kybella是一种溶解脂肪的药物，当注射至组织时对细胞壁产生破坏。适量注射至颏下脂肪组织时，该药物将破坏脂肪细胞。与此同时，它也能破坏其他类型的细胞，如果不慎注射至皮肤，皮肤细胞将受损。 作为一种用于颏下脂肪组织的注射药物，每位患者单次治疗最多注射50次，需要15-20分钟，最多6次治疗，多数患者在2-4次治疗后即可见效，每次治疗间隔不低于1个月。Kybella以注射小瓶的方式提纲给患者，不得稀释或与其他化合物混合。 Kybella治疗颏下脂肪安全性及有效性基于两次临床试验，包括对1022 位中至重度颏下脂肪堆积成年志愿者的研究观察。志愿者经随机分组，分别接受Kybella和安慰剂治疗，治疗不超过6次。结果显示接受Kybella治疗组较之安慰剂治疗组，观察到更多人脂肪减少。 安全使用信息 Kybella目前仅允许用于颏下脂肪治疗，对其他部位治疗的安全性及疗效尚不清楚。 Kybella只能经有资质的专家使用，患者在接受该治疗前必须充分了解其风险。 Kybella可能引发严重副反应，包括下颌神经损伤从而导致笑容不均或面部肌肉无力以及吞咽困难。最常见副反应包括注射部位肿胀、淤青、疼痛、肌肉麻痹、红肿和治疗部位僵硬。据研究显示，轻度副反应患者占比81%，中度副反应患者占比17.4%，重度副反应患者占比1.6%。 Kybella不得注射至颏部外部位，同时，颏部如接受过填充注射、外科手术或美容治疗的患者不宜注射治疗。避免对解剖结构脆弱处进行注射，否则将增加组织损伤风险。面神经下颌缘支处避免注射。避免在靠近唾液腺、淋巴结和肌肉处(1-1.5cm)处注射。 Kybella 采用分量包装的模式销售，注射小瓶标签上有特殊全息图作为防伪标识，如无该标识，不得使用。