【英 文 名】Caelyx 

【通 用 名】盐酸多柔比星脂质体注射液

【药物分类】抗肿瘤抗生素类

【成    分】盐酸多柔比星脂质体 liposomal doxorubicin HCl 

【性    状】盐酸多柔比星的化学名称为 ：(1S,3S)-3-乙醇酰-1,2,3,4,6,11-六氧-3,5,12-三羟基-10-甲氧基-6,13-二氧并四苯-1-基-3-氨基-2,3,6-三去氧-α-L-来苏吡喃糖苷。分子式：C27H29NO11 · HCl，分子量 ：579.99。 　
    本品这种工艺被称作为空间稳定或隐匿，可以保护脂质体免受单核巨噬细胞系统（MPS）识别，从而延长其在血液循环中的时间。楷莱本品为无菌、半透明的红色混悬液，每瓶10 mL，含盐酸多柔比星2 mg/mL，是用于单剂量静脉滴注给药的浓缩液。本品的活性成分为盐酸多柔比星，是从一种波塞链霉菌表灰变种（strep tomyces peucetius var. caesius）培养液中提取得到的蒽环类细胞毒性抗生素。

【适 应 症】本品可用于低CD4（<200 CD4淋巴细胞/mm3）及有广泛皮肤粘膜内脏疾病的与艾滋病相关的卡波氏肉瘤（AIDS-KS）病人。

【用法用量】本品应为每2-3周静脉内给药20 mg/m2，给药间隔不宜少于10天，因为不能排除药物蓄积和毒性增强的可能。病人应持续治疗2-3个月以产生疗效。为保持一定的疗效，在需要时继续给药。本品用250毫升5%葡萄糖注射液稀释，静脉滴注30分钟以上。禁止大剂量注射或给用未经稀释的药液。建议本品滴注管与5%葡萄糖滴注管相连接以进一步稀释并最大限度地减少血栓形成和外渗危险。

【剂型/包装】注射液 20 mg x 10 mL/支

【贮藏/有效期】未开封的药瓶应保存在2-8°C环境下，避免冷冻。本品用5%葡萄糖注射液稀释后供静脉滴注的药液应立即使用。稀释液不立即使用时应保存在2-8°C环境下，不超过24小时。

【原产地英文商品名】NUDOXA(Caelyx generic)20mg/bottle
【原产地英文药品名】LIPOSOMAL DOXORUBICIN HCL
【中文参考商品译名】NUDOXA(楷莱仿制药)20毫克/瓶
【中文参考药品译名】盐酸多柔比星脂质体
【生产厂家中文参考译名】Zydus Cadila
【生产厂家英文名】Zydus Cadila

Zydus Cadila has introduced an NDDS product 'Nudoxa' for the treatment of various cancers. One of the critical drugs used in chemotherapy, Nudoxa heralds a new approach in cancer therapy.

With chemotherapy being a common mode of treatment in cancers, there has been a long standing need for a drug that is stable and long lasting with reduced toxicity and side effects. Nudoxa addresses this need. A patented product in India and South Africa, patents for Nudoxa have also been filed in EU, US, Japan and several countries globally.

Doxorubicin, the first generation drug, was launched in 1960s and gave a new lease of life to cancer patients with its ability to combat aggressive and malignant tumours. This DNA-interacting drug, however, was discovered to cause life-threatening side effects in the form of cardiac abnormalities.

An advancement on this therapy resulted in liposomal doxorubicin in which the molecules of the drug are encapsulated in a fatty coating known as liposomes. The liposomes allow the doxorubicin to be delivered specifically in greater amounts to the cancer cells, while having fewer side effects on the healthy tissues. A further advancement in this line of treatment was the Pegylated-liposomal doxorubicin, a unique form of liposomal doxorubicin in which the liposomes are coated with polyethylene glycol, leading to a much longer half-life in the blood. However Pegylated-liposomal doxorubicin are likely to cause ‘Hand-Foot Syndrome,' characterized by skin eruptions on the palms of the hand or soles of the feet, leading to interruption in therapy.

A new variant of liposomal doxorubicin, Nudoxa with its unique drug delivery system is a breakthrough in cancer therapy as it offers the benefits of Pegylated-liposomal doxorubicin without its major side effects like the Hand Foot syndrome. Marketed by Zydus Biogen, Nudoxa is manufactured by Zydus-BSV Pharma Pvt. Ltd., the joint venture company of Zydus Cadila and Bharat Serums and Vaccines Pvt. Ltd. Founded in 2005, Zydus-BSV Pharma focuses on targeted therapies in the area of Oncology.

Nudoxa is being used as a chemotherapy drug to treat various cancers, particularly, breast cancer - the second most common type of cancer, ovarian cancer - the fifthleading cause of cancer death in women, and AIDS-related Kaposi sarcoma which develops in people who are infected with the human immunodeficiency virus (HIV).