英文药名: Lucentis(Ranibizumab Injections)

中文药名: 兰尼单抗注射剂

生产厂家: Novartis

药品介绍

英文药名: Lucentis (Ranibizumab Injections)

中文药名: 兰尼单抗注射剂

Generic Name for LUCENTIS
Ranibizumab 10mg/mL; soln for oph intravitreal inj; preservative-free.

Legal Classification:
Rx

Pharmacological Class for LUCENTIS
Recombinant humanized IgG1 kappa isotype monoclonal antibody fragment.

Manufacturer of LUCENTIS
Genentech, Inc.
 

Indications for LUCENTIS
Neovascular (wet) age-related macular degeneration (AMD). Macular edema following retinal vein occlusion (RVO).

Adult dose for LUCENTIS
Give by intravitreal inj. AMD: 0.5mg once a month (approx. 28 days); or 0.5mg every 3 months after the first 4 injections if monthly is not feasible (less effective). RVO: 0.5mg once a month.

Children's dosing for LUCENTIS
Not recommended.

Contraindications for LUCENTIS
Ocular or periocular infections.

Warnings/Precautions for LUCENTIS
Monitor intraocular pressure, perfusion of optic nerve after inj. Monitor for infection during the week following inj (endophthalmitis and retinal detachments possible). Pregnancy (Cat.C). Nursing mothers.

Adverse Reactions for LUCENTIS
Conjunctival hemorrhage, eye pain, vitreous floaters, increased intraocular pressure, intraocular inflammation; rare: arterial thromboembolic events.

How is LUCENTIS supplied?
Single-use vial (0.2mL)—1 (w. supplies)

Related Disease:
Macular degeneration

Lucentis Spritze(n) à 0.23 ml    Injektionslösung: Ranibizumabum 10 mg/ml Novartis PharmaSchweiz AG

FDA推荐雷珠单抗治疗糖尿病黄斑水肿

2012年7月26日，美国食品药品与药物管理局（FDA）咨询委员会推荐批准雷珠单抗注射液（Lucentis）每月注射1次用于治疗糖尿病黄斑水肿，委员会成员以8：2的投票支持推荐药物剂量为0.5mg。

雷珠单抗的给药方式是玻璃体内注射，目前被推荐用于治疗由于视网膜静脉闭塞引起的湿性年龄相关性黄斑变性以及黄斑水肿。它能够通过阻断血管内皮生长因子-A(VEGF-A)的作用和降低视网膜毛细血管的通透性而降低视网膜水肿。

糖尿病黄斑水肿美导致国人群视力下降和失明的主要原因，目前的标准治疗方案激光治疗能够延缓视力下降的进程，但无法使视力恢复。

FDA委员会讨论了一项多中心、随机化双盲3期研究，在759例患者中比较了安慰剂、雷珠单抗0.3mg和0.5mg的治疗作用，随访36个月。试验结束时以标准视力表测量患者视力，结果发现接受雷珠单抗治疗的2组患者视力均比治疗前至少升高15个字母。

随访结束时，3组患者各250人，安慰剂组、雷珠单抗0.3mg组和0.5mg组死亡情况如下：3 (1.2%)，7人(2.8%)，11 (4.4%)；心肌梗死分别为：9 (3.6%)，9 (3.6%)和7 (2.8%)；卒中分别为：4 (1.6%)，3 (1.2%)，8 (3.2%)；死亡风险与晚期糖尿病患者并发症相吻合，而雷珠单抗是否与致死性事件相关目前并不明确。

据中国医学论坛报之前的报道消息，雷珠单抗注射液已获得中国国家食品药品监督管理局（SFDA）批准，用于湿性年龄相关性黄斑变性的治疗。这是在中国首个且唯一用于眼科的抗血管内皮生长因子类生物制剂药物。
Lucentis (ranibizumab) for the Treatment of Diabetic Macular Edema (DME), United States of America

Lucentis (ranibizumab) is a monoclonal antibody indicated for the treatment of diabetic macular edema (DME). The drug is developed by Genentech, a subsidiary of Roche Group.

The US Food and Drug Administration (FDA) approved Lucentis for the treatment of diabetic macular edema in August 2012.
Earlier in June 2006, Lucentis 0.5mg was approved by the FDA for the treatment of neovascular wet age-related macular edema (AMD). The drug was also approved for macular edema following retinal vein occlusion (RVO), in June 2010.

About diabetic macular edema
Diabetic macular edema occurs when the damaged blood vessels from diabetic retinopathy leak fluid and lipids onto the macula. Macula is a vital part of the retina, which is responsible for central vision. DME may cause blurring of central vision or complete loss of eyesight. The onset of the disease is painless, so it may go unidentified by the patient until it manifests with complete or partial loss of vision.

It is estimated that the disease affects about 560,000 people in the US. A study by Wisconsin Epidemiologic observed that over a 10-year period, more than 19% of people with diabetes were diagnosed with diabetic macular oedema.

The World Health Organisation (WHO) estimates that there are more than 150 million diabetics worldwide. All diabetics are prone to the development of diabetic retinopathy.

Lucentis' mechanism of action
Lucentis is made from a human antibody fragment, which binds and inhibits vascular endothelial growth factor (VEGF)-A, a protein that is believed to play a critical role in the formation of new blood vessels. The drug controls the formation of new blood vessels under the retina.

The drug is administered intravenously.

Genentech clinical trials
Genentech conducted phase I and II clinical trials on Lucentis between January 2008 and October 2010. It was an open label, randomised, parallel assessment which was initiated on 10 DME patients to establish the safety and efficacy of Lucentis. The primary outcome measure of the study was finding the percentage of change in macular edema measured by retinal thickness by optical coherence tomography (OCT). The secondary outcome measures included finding the change in Best Corrected Visual Acuity (BCVA) and percentage of patients gaining three or more lines of vision.

The approval for Lucentis was based on two phase III clinical trials named RIDE and RISE. Genentech conducted the two sham-treatment controlled trials for 24 months. They were identically designed, double-blind, double-masked and parallel trials. The clinical studies enrolled 759 patients, who were randomised into three groups to receive monthly treatment with 0.3mg Lucentis, 0.5mg Lucentis or a sham injection.

The primary outcomes of the studies were evaluated after 24 months. The results of the study revealed that Lucentis improved clinical outcomes including substantial visual gain for many DME patients. The patients who were administered with Lucentis 0.3mg experienced significant early vision on the seventh day and sustained improvements in vision after 24 months. Most of the patients who were administered with Lucentis were able to read 15 letters on the eye chart at 24 months.

The pooled safety analysis of Lucentis in the RIDE and RISE studies at 24 months showed that the ocular safety of patients who used the drug for DME treatment was generally consistent. The same treatment was continued for 36 months after encouraging improvements were observed in patients treated with Lucentis for 24 months.

Lucentis marketing commentary
Lucentis is the first FDA-approved DME drug. Genentech holds the marketing rights of the drug in the United States. Novartis was licensed to sell the drug elsewhere under the brand name Lucentis. The other drug approved for the same indication is Iluvien, which was developed by Alimera Sciences.

眼病黄斑变性治疗药物Lucentis（雷珠单抗，ranibizumab）已获SFDA批准

据悉，瑞士制药集团诺华公司近日表示，其眼病黄斑变性治疗药物Lucentis（雷珠单抗，ranibizumab）已获批在中国上市。

该公司在一份声明中说，其已收到中国国家食品药品监督管理局（SFDA）对该药物的批准，用于治疗年龄相关性黄斑变性（AMD），这是一种新生血管性眼病，可导致年龄在50岁以上人群的视力减退。

 “在中国的新生血管性 AMD患者中有一个巨大的未满足的需求，自从2006年Lucentis最先在美国上市后，我们一直等待着该药在中国获批，” 该声明中引用中国眼底协会主席李晓新的话说。

Lucentis是一种由诺华公司和其竞争对手罗氏合作开发的药物。罗氏在美国子公司基因泰克公司已获Lucentis美国销售权，而诺华拥有世界其他地方的销售权。

诺华公司还宣布在中国推出一种治疗2型糖尿病的口服药物Galvus（维格列汀，vildagliptin），该药物已可在市场上购得。

近年来，我国糖尿病患者的人数几乎翻了两番，这使中国成为了患这种慢性疾病的成年人口最多的国家，据统计我国约有7500万人患有2型糖尿病。