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 详细处方信息以本药内容附件PDF文件（2018112821192335.pdf）的“原文Priscribing Information”为准
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部分中文伊立替康脂质体注射液处方资料（仅供参考）

2015年10月23日，美国FDA批准Onivyde（伊立替康脂质体注射液）与氟尿嘧啶和亚叶酸联用用于治疗既往接受过吉西他滨化疗的晚期转移性胰腺癌患者。 据美国国立癌症研究所估计，2015年美国胰腺癌新确诊患者将达48,960例，胰腺癌死亡病例也达40,560例。胰腺癌早期诊断困难且治疗选择有限，特别是对于已经转移至身体其他部位（转移性）的胰腺癌患者，不能进行手术切除治疗。

FDA药品评价与研究中心血液与抗肿瘤产品办公室主任Richard Pazdur博士指出：“FDA许多新药审评专家也是临床医生，每当我们能够加速批准可用于尚未得到治疗满足需求患者的新药时，感觉特别有益。Onivyde通过优先审评获批，患者可早日得到这一药物治疗，有助于延长生存时间。”

FDA授予Onivyde优先审评和孤儿药资格认定。优先审评资格是授予那些一旦获批，可显著改善严重疾病治疗药物安全性和有效性的新药申请。孤儿药资格认定则通过税额抵免、消费者付费豁免、市场独占权等激励政策，扶持和鼓励罕见病治疗药物的开发。

Onivyde的有效性在一项三臂、随机、开放研究中得到证实。该研究纳入417例曾接受吉西他滨或以吉西他滨为基础化疗但未得到控制的转移性胰腺癌患者，旨在比较Onivyde+氟尿嘧啶/亚叶酸治疗或Onivyde单纯治疗患者生存期是否大于氟尿嘧啶/亚叶酸治疗患者。Onivyde+氟尿嘧啶/亚叶酸治疗患者平均生存期为6.1个月，而氟尿嘧啶/亚叶酸治疗患者为4.2个月。与氟尿嘧啶/亚叶酸治疗患者相比，单纯Onivyde治疗患者生存期未见改善。

此外，Onivyde+氟尿嘧啶/亚叶酸治疗患者肿瘤增长开始时间延迟，这些治疗患者肿瘤增长开始时间为3.1个月，而氟尿嘧啶/亚叶酸治疗患者为1.5个月。

通过398例Onivyde+氟尿嘧啶/亚叶酸治疗、Onivyde单纯治疗或氟尿嘧啶/亚叶酸治疗患者对Onivyde的安全性进行了评价。Onivyde治疗最常见副作用包括腹泻、乏力、呕吐、恶心、食欲下降、口腔感染（口腔炎）以及发热。Onivyde治疗还可导致抗感染细胞下降（淋巴细胞减少症和中性白细胞减少症），还有报告Onivyde治疗患者因中性白细胞减少症继发脓毒血症死亡病例。

Onivyde说明书中包含了一项有关严重嗜中性白细胞减少症和腹泻风险的黑框警告。Onivyde没有获准可单独用于转移性胰腺癌患者治疗。

【通用名】伊立替康脂质体注射液

【商品名】ONIVYDE

【英文名】Irinotecan

【汉语拼音】Yilitikang

【化学名】 4S-4，11-二乙基-4-羟基-9[（4-哌啶基哌啶）羰基]-1H 吡喃[3’,4’:6,7]吲哚嗪[1,2-b]喹啉-3,14(4H,12H)-二酮盐酸盐

【分子式】 C33H38N4O6•HCl•3H2O

【分子量】677.19

【成 份】本品主要成份为伊立替康

【适应症】 用于在基于吉西他滨的治疗后的转移性胰腺癌患者

【用法用量

】

（1）ONIVYDE的推荐剂量为每两周70mg/m2静脉输注90分钟。

（2）在UGT1A1 *28纯合子患者中推荐的ONIVYDE起始剂量为每两周50mg/m2。

（3）对于血清胆红素高于正常上限的患者，没有推荐剂量的ONIVYDE。

（4）服用ONIVYDE30分钟前服用皮质类固醇和止吐药。

On October 23, 2015, the US FDA approved Onivyde (Irinotecan liposome injection) in combination with fluorouracil and folinic acid for the treatment of patients with advanced metastatic pancreatic cancer who had previously received gemcitabine chemotherapy. According to estimates by the National Cancer Institute, the number of newly diagnosed pancreatic cancer patients in the United States will reach 48,960 in 2015, and 40,560 deaths from pancreatic cancer. Early diagnosis of pancreatic cancer is difficult and treatment options are limited, especially for patients with pancreatic cancer who have metastasized to other parts of the body (metastatic).

Dr. Richard Pazdur, Director of the Office of Blood and Anti-Tumor Products at the FDA Center for Drug Evaluation and Research, said: "Many new drug review experts at the FDA are also clinicians. Whenever we can speed up the approval of new drugs that can be used for patients who have not yet received treatment to meet their needs, It feels particularly beneficial. Onivyde is approved by a priority review and patients can get this medication as soon as possible, which helps to prolong survival.”

The FDA grants Onivyde a priority review and orphan drug qualification. Priority review is the granting of new drug applications that, once approved, can significantly improve the safety and efficacy of treatments for serious illnesses. The orphan drug qualification certification supports and encourages the development of rare disease treatment drugs through incentives such as tax credits, consumer fee exemptions, and market exclusivity.

The effectiveness of Onivyde was confirmed in a three-arm, randomized, open-label study. The study included 417 patients with metastatic pancreatic cancer who had received gemcitabine or gemcitabine-based chemotherapy but were not controlled to compare whether patients with Onivyde+fluorouracil/leucovorin or Onivyde treatment had greater survival than patients treated with fluorouracil/leucovorin. The mean survival of patients treated with Onivyde + fluorouracil/leucovorin was 6.1 months, compared with 4.2 months for patients treated with fluorouracil/leucovorin. Compared with patients treated with fluorouracil/leucovorin, the survival of patients treated with Onivyde alone did not improve.

In addition, onivyde + fluorouracil / leucovorin treatment patients with delayed tumor growth time, the tumor growth start time of these patients was 3.1 months, and fluorouracil / leucovorin treatment patients for 1.5 months.

The safety of Onivyde was evaluated in 398 patients treated with Onivyde+fluorouracil/leucovorin, Onivyde monotherapy or fluorouracil/leucovorin. The most common side effects of Onivyde treatment include diarrhea, fatigue, vomiting, nausea, loss of appetite, oral infections (stomatitis), and fever. Onivyde treatment can also lead to a decline in anti-infective cells (lymphopenia and neutropenia), as well as deaths from sepsis caused by neutropenia in patients treated with Onivyde.

The Onivyde instructions contain a black box warning about the risk of severe neutropenia and diarrhoea. Onivyde is not approved for the treatment of patients with metastatic pancreatic cancer alone.

[Common name] Irinotecan liposome injection

[product name] ONIVYDE

[English name] Irinotecan

[Chinese Pinyin]Yilitikang

[Chemical name] 4S-4,11-Diethyl-4-hydroxy-9[(4-piperidylpiperidine)carbonyl]-1H pyran[3',4':6,7]吲Pyridazine [1,2-b]quinoline-3,14(4H,12H)-dione hydrochloride

[Molecular formula] C33H38N4O6•HCl•3H2O

[Molecular weight] 677.19

【Component】The main ingredient of this product is irinotecan

[Indications] for patients with metastatic pancreatic cancer after gemcitabine-based therapy

[Usage and Usage

]

(1) The recommended dose for ONIVYDE is an intravenous infusion of 70 mg/m2 every two weeks for 90 minutes.

(2) The recommended starting dose of ONIVYDE in UGT1A1*28 homozygous patients is 50 mg/m2 every two weeks.

(3) There is no recommended dose of ONIVYDE for patients with serum bilirubin above the upper limit of normal.

(4) Take corticosteroids and antiemetics 30 minutes before taking ONIVYDE.

[Approved information at home and abroad] Merrimack Pharmaceuticals (formerly HERMES Biosciences) authorized Shire to develop and launch irinotecan lipid (MM-398) with PharmaEngine. Approved in Europe in May 2015 and approved for listing in the US in October 2015. Currently, irinotecan liposome injection is not listed in China. Features 1. The spontaneous formation of phospholipids in water, the preparation process is relatively simple; 2. It is non-toxic, non-immunogenic, degradable and slow-release in the human body; 3. It can enhance the stability and pharmacological action of the contained drug in the human body, release the drug after it reaches the target tissue stably, reduce the required dose and reduce the side effects; 4. Small single-chamber liposomes have passive targeting properties in the treatment of tumors, and can also be made into immunoliposomes to achieve active targeting; 5. Due to the hydrophilic and lipophilic properties of liposomes, they can carry lipids. The soluble drug reaches the target tissue through the blood circulation, making up for the defects that some important fat-soluble drugs are insoluble in water; 6. The FDA granted a priority review of irinotecan liposomal injections and orphan drug qualifications during the review.

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 详细处方信息以本药内容附件PDF文件（2018112821192335.pdf）的“原文Priscribing Information”为准
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