-----糖尿病性视网膜病变新药Lucentis（ranibizumab）治疗DR时每月1次注射给药 近日，美国FDA批准Lucentis0.3mg注射液的新适应症，用于治疗糖尿病性黄斑水肿（DME）患者的糖尿病性视网膜病变（DR）。Lucentis治疗DR时每月1次注射给药，需要与可控制血糖、血压和血脂的干预措施联用。 处方修改批准日期：2015年2月6日 公司：基因泰克 LUCENTIS（雷珠单抗ranibizumab）注射液 玻璃体腔注射 最初美国批准：2006年 目前的主要变化 适应证和用途-糖尿病视网膜病变患者的糖尿病性黄斑水肿 2/2015 用法与用量-患者糖尿病视网膜病变与糖尿病性黄斑水肿 2/2015 警告和注意事项 2/2015 警告和注意事项 2/2015 作用机理 兰尼单抗结合的VEGF-A的活性形式，包括该分子，VEGF110的生物活性，裂解形式的受体结合位点。VEGF-A已经显示出导致眼部血管生成和血管闭塞模型新生血管形成和泄漏和被认为有助于向新生血管性AMD，以下RVO，DR和DME黄斑水肿的病理生理学。兰尼单抗与VEGF-A的结合阻止与其内皮细胞，降低内皮细胞增殖，血管渗漏，和新血管形成的表面上的受体（VEGFR1和VEGFR2）的VEGF-A的相互作用。 适应症和用法 LUCENTIS，血管内皮生长因子（VEGF）抑制剂，表示为患者的治疗： 新生血管（湿）年龄相关性黄斑变性（AMD） 黄斑水肿视网膜静脉阻塞（RVO） 糖尿病性黄斑水肿（DME） 患者DME糖尿病视网膜病变 用法用量 对于眼玻璃体腔注射只 新生血管（湿）年龄相关性黄斑变性（AMD） 建议LUCENTIS 0.5毫克（为0.05mL）由玻璃体内注射了一个月（约28天）给药一次。 虽然不是那么有效，患者可能有3每月剂量，随后用定期评估较不频繁的给药来治疗。 虽然不是那么有效，病人也可以用一个剂量每3个月后4每月剂量治疗。患者应定期评估。 黄斑水肿视网膜静脉阻塞（RVO） 建议LUCENTIS 0.5毫克（0.05mL）添加到通过玻璃体内注射一个月（约28天）一次施用。 糖尿病性黄斑水肿（DME）和糖尿病视网膜病变（DR）患者的糖尿病性黄斑水肿。 建议LUCENTIS 0.3毫克（0.05mL）添加到通过玻璃体内注射一个月（约28天）一次施用。 剂型和规格 单次使用的玻璃小瓶旨在提供0.05毫升为玻璃体内注射： 10毫克/毫升溶液（LUCENTIS 0.5mg的） 6毫克/毫升溶液（LUCENTIS为0.3mg） 禁忌症 眼或眼周感染 过敏症 警告和注意事项 眼内炎和视网膜脱离，可能会出现以下的玻璃体内注射。患者应注射（5.1）以下进行监测。 在眼内压（IOP）升高已经注意到前和后的玻璃体内注射。 有下列玻璃体内使用的VEGF抑制剂的动脉血栓性事件的潜在风险。 致命事件患者的DME和DR在基线，谁是使用Lucentis治疗每月与对照组相比更频繁地发生。 不良反应 最常见的不良反应（LUCENTIS治疗的受试者比对照受试者更频繁报道的）的结膜出血，眼痛，玻璃体漂浮物，并增加眼压。 ---------------------------------------------  注：本品是美国包装规格上市 VA LUCENTIS 6MG/ML DS 1  RANIBIZUMAB     50242-0082-01 LUCENTIS 10MG/ML 0.05ML SDV PHY 1/EA  RANIBIZUMAB     50242-0080-01 LUCENTIS 6MG/ML 0.05ML SDV PHY 1/EA  RANIBIZUMAB     50242-0082-01    Lucentis®(ranibizumab)About Lucentis Lucentis is an antibody fragment approved for the treatment of neovascular (wet) age-related macular degeneration (AMD). Lucentis is the only approved treatment for wet AMD proven to improve or maintain vision. Wet AMD is characterized by a loss of function in the portion of the eye responsible for central vision and is highly correlated with aging. Lucentis has become the “gold standard” for treating wet AMD and can be used at various intervention points in first-line and second-line therapy. Lucentis is marketed in the United States by Genentech and in the rest of the world by Novartis. How Lucentis Works Lucentis binds and inhibits vascular endothelial growth factor-A (VEGF-A), a protein critical to the formation of new, leaky blood vessels in the back of the eye that cause damage to the macula, which contains a high density of photoreceptors responsible for visual acuity. Current Indications Lucentis was approved for wet AMD in the US in 2006 and in the EU in 2007. Wet AMD is the leading cause of blindness in persons over 60 years of age in the developed world. What important safety information should I know about LUCENTIS? You should not use LUCENTIS if you have an infection in or around the eye or are allergic to LUCENTIS or any of its ingredients. LUCENTIS is a prescription medication given by injection into the eye, and it has side effects. LUCENTIS is not for everyone. Some LUCENTIS patients have serious side effects related to the injection. These include serious infections of the eye, detached retinas, and cataracts. Other uncommon serious side effects include inflammation inside the eye and increased eye pressure. These side effects can make your vision worse. Some patients have had increased eye pressure before and within 1 hour of an injection. Your eye doctor should check your eye pressure and eye health after your LUCENTIS injection. Uncommonly, LUCENTIS patients have had serious, sometimes fatal, problems related to blood clots, such as heart attacks or strokes. Some patients have had increased eye pressure before and within 1 hour of an injection. Your eye doctor should check your eye pressure and eye health after your LUCENTIS injection. Serious side effects include inflammation inside the eye and, rarely, problems related to the injection procedure, such as cataracts. These side effects can make your vision worse. The most common eye-related side effects are increased redness in the white of the eye, eye pain, small specks in vision, and increased eye pressure. The most common non-eye-related side effects are nose and throat infections, headache, lung/airway infections, and nausea. If your eye becomes red, sensitive to light, or painful, or if you have a change in vision, call or visit your eye doctor right away. You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555. For additional safety information, please talk to your doctor and see the LUCENTIS full prescribing information. Who is LUCENTIS for? LUCENTIS® (ranibizumab injection) is a prescription medicine for the treatment of patients with wet age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), and diabetic macular edema (DME). BOXED WARNINGS & ADDITIONAL IMPORTANT SAFETY INFORMATION 近日，美国FDA批准Lucentis（雷珠单抗ranibizumab）注射液的新适应症，用于治疗糖尿病性黄斑水肿（DME）患者的糖尿病性视网膜病变（DR）。 糖尿病性视网膜病变是美国成年人最常见的糖尿病性眼部疾病和最主要的致盲原因。根据CDC的数据，美国越过2900万糖尿病患者（包括1型和2型糖尿病），糖尿病也是美国0~74岁成人失明的主要原因。2008年，美国40岁以上糖尿病患者中大约有33%的人患有某种形式的DR，在一些DME和DR患者中，视网膜表面可见异常的新生血管，如果新生血管呈爆发式增生，就会导致重度视力丧失或失明。 Lucentis治疗DR时每月1次注射给药，需要与可控制血糖、血压和血脂的干预措施联用。 FDA药物评价与研究中心抗菌产品办公室主任Edward Cox表示：“糖尿病是严重的公众健康问题，每年都会越来越多的人。Lucentis的获批为治疗DR这种会严重损伤视力的糖尿病并发症提供了新的治疗选择”。 Lucentis治疗DME患者糖尿病性视网膜病变的安全性和疗效在2项涉及759例患者的临床研究中为期3年的临床研究中得到了证实。结果显示，第2年时，Lucentis相比未接受注射治疗的患者，可以显著改善DR的严重程度。最常见不良反应包括结膜出血、眼睛疼痛、飞蚊症、眼压升高。严重不良反应包括眼球感染和视网膜脱落。 完整处方资料附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de4e66cc-ca05-4dc9-8262-e00e9b41c36d 2/2015