英文药名: ELLENCE(epirubicin hydrochloride injection) 中文药名: 盐酸表柔比星注射剂 药品介绍 ELLENCE（epirubicin hydrochloride）注射用盐酸表柔比星获FDA批准，用于治疗在淋巴系统，肺，乳腺，胃和卵巢癌，并减缓它们的生长和扩散在体内 批准日期：1999    公司：辉瑞公司 注射用ELLENCE（盐酸表柔比星 epirubicin hydrochloride）注射液 供静注使用 美国首次批准：1999 警告： 严重或危及生命血液学和完整黑框警告等不良REACTIONSSee完整的处方信息。 执政期间与相关外渗严重的局部组织坏死 心肌毒性，由潜在的致命充血性心脏衰竭（CHF）的表现在其最严重的形式 继发性急性骨髓性白血病（AML） 减少剂量的患者肝功能受损 严重的骨髓抑制 辖只有在医生的谁是有经验，在使用的癌症化疗药物的监督 适应症和用法 ELLENCE注入是以下切除原发性乳腺癌的蒽环拓扑异构酶II抑制剂表示为辅助治疗的成分的患者的腋窝淋巴结受累肿瘤证据。 用法用量 在重复3〜4周的周期管理静脉内，无论是总剂量在每个周期的第1天或平分，并给予在第一天和第二天每个周期的8。 ELLENCE的推荐起始剂量为100至120mg /平方米。用法用量减少是可能的，当在某些组合给出。 应根据血液学和非血液学毒性制成的第一治疗周期之后调整剂量。 减少患者的肝功能损害的剂量。 考虑患者低剂量严重肾功能损害。 剂型和规格 每毫升含有2毫克盐酸表阿霉素为无菌，无防腐剂，准备使用的溶液单次使用的小瓶（50毫克/毫升25和200mg/100mL） 禁忌 病人不应该与ELLENCE注射治疗，如果他们有任何的条件如下：基线中性粒细胞计数<1500个/ mm3;心肌病和/或心脏衰竭，近期心肌梗死，严重心律失常;以前的治疗与蒽环类高达最大累积剂量;过敏表柔比星，其它蒽环类药物，或蒽;或重度肝功能障碍。 警告和注意事项 剂量依赖性的，可逆的白细胞减少和/或中性粒细胞减少是与ELLENCE关联血液学毒性的主要表现，表示最常见的急性剂量限制性毒性。 心脏毒性是蒽环类药物治疗的已知风险，并可能早期（或急性）或晚期（延迟）事件得到体现。 继发性急性髓细胞性白血病，有或没有相白血病前期的发生，据报道，在用蒽环类治疗的患者。 血清总胆红素和AST水平应之前，用ELLENCE治疗期间进行评估。患者的胆红素升高或AST可能会遇到的药物较慢的间隙的增加总体毒性。较低的剂量，建议这些患者。患者有严重肝损伤尚未评估。 血肌酐应该治疗前和治疗过程中进行评估。剂量调整是必要的患者的血清肌酸酐> 5毫克/分升。患者接受透析还没有研究。 ELLENCE可能诱发高尿酸血症的大量嘌呤分解代谢的结果，伴随着药物诱导的快速高度化疗敏感肿瘤细胞（肿瘤溶解综合征）溶解。 患者通过化疗药物包括ELLENCE免疫功能低下，活或减毒活疫苗的管理，可能会导致严重或致命的感染。 静脉硬化，可能会导致从注射到一个小容器中，或从重复注射到相同的静脉。 ELLENCE的输液过程中外渗可引起局部疼痛，严重的组织病变（vesication，严重蜂窝组织炎），和坏死。面部潮红，以及当地红斑沿静脉裸奔，可能预示过快管理。它可能先于局部静脉炎或血栓性静脉炎。患者服用ELLENCE的120毫克/ m2的方案是联合化疗的一个组成部分也应接受预防性的抗生素治疗，复方新诺明（例如，Septra®，Bactrim®）或氟喹诺酮。 ELLENCE是emetigenic。止吐药可减少恶心，呕吐;预防性使用止吐药应ELLENCE，特别是当与其它emetigenic药物一起给予的给药前加以考虑。 后先前放射疗法ELLENCE的给药可以诱发在照射部位的炎症反应召回 血栓性静脉炎和血栓栓塞现象，包括肺栓塞（在某些情况下是致命的）已被报道巧合与使用ELLENCE。 当给予孕妇ELLENCE可引起胎儿危害。提醒潜在风险的妇女胎儿。 不良反应 在早期乳腺癌，患者≥10％发生严重不良反应为白细胞减少，中性粒细胞减少，贫血，血小板减少，amenhorrhea，嗜睡，恶心/呕吐，黏膜炎，腹泻，感染，结膜炎/角膜炎，脱发，局部毒性和皮疹/瘙痒。 药物相互作用 不管理表柔比星与其它心脏毒性药物组合，除非患者的心脏功能密切监测。 与ELLENCE治疗期间停止西咪替丁。 特殊人群中使用 哺乳母亲：请停止之前服用ELLENCE哺乳。 儿童用药：安全性和ELLENCE儿童患者的有效性尚未确立。儿科病人可能在对蒽环类药物引起的急性心脏毒性的表现更大的风险和慢性CHF。 老年用药：应注意监测毒性时ELLENCE被给予女性患者≥70岁。 供应/贮存和处理 ELLENCE注入是在每毫升含有2毫克盐酸表阿霉素，聚丙烯单次使用CYTOSAFE™小瓶可用无菌的，不含防腐剂的，准备使用的溶液在下面的优势： 50毫克/毫升25单次使用的小瓶NDC0009-5091-01 200毫克/100mL单次使用的小瓶NDC0009-5093-01 存储2℃和8ºC（36ºF和46ºF）之间冷藏。不要冷冻。避光。 在冷藏条件下的溶液用于注射的存储可能导致凝胶化产物的形成。 2后这胶凝产品将返回到一个微粘性到移动溶液到最多4小时平衡在控制室温（15-25ºC）。解决方案注射应在24小时内去除冷却后即可使用。 INDICATIONS AND USAGE ELLENCE Injection is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer. DOSAGE AND ADMINISTRATION ELLENCE Injection is administered to patients by intravenous infusion. ELLENCE is given in repeated 3- to 4-week cycles. The total dose of ELLENCE may be given on Day 1 of each cycle or divided equally and given on Days 1 and 8 of each cycle. The recommended dosages of ELLENCE are as follows: Starting Doses The recommended starting dose of ELLENCE is 100 to 120 mg/m2. The following regimens were used in the trials supporting use of ELLENCE as a component of adjuvant therapy in patients with axillary-node positive breast cancer: Patients administered the 120-mg/m2 regimen of ELLENCE also received prophylactic antibiotic therapy with trimethoprim-sulfamethoxazole (e.g., Septra®, Bactrim®) or a fluoroquinolone. Bone Marrow Dysfunction Consideration should be given to administration of lower starting doses (75—90 mg/m2) for heavily pretreated patients, patients with pre-existing bone marrow depression, or in the presence of neoplastic bone marrow infiltration (see WARNINGS and PRECAUTIONS). Hepatic Dysfunction Definitive recommendations regarding use of ELLENCE in patients with hepatic dysfunction are not available because patients with hepatic abnormalities were excluded from participation in adjuvant trials of FEC-100/CEF-120 therapy. In patients with elevated serum AST or serum total bilirubin concentrations, the following dose reductions were recommended in clinical trials, although few patients experienced hepatic impairment: Bilirubin 1.2 to 3 mg/dL or AST 2 to 4 times upper limit of normal 1/2 of recommended starting dose Bilirubin > 3 mg/dL or AST > 4 times upper limit of normal 1/4 of recommended starting dose Information regarding experience in patients with hepatic dysfunction is provided in CLINICAL PHARMACOLOGY, Pharmacokinetics In Special Populations. Renal Dysfunction While no specific dose recommendation can be made based on the limited available data in patients with renal impairment, lower doses should be considered in patients with severe renal impairment (serum creatinine > 5 mg/dL). Dose Modifications Dosage adjustments after the first treatment cycle should be made based on hematologic and nonhematologic toxicities. Patients experiencing during treatment cycle nadir platelet counts <50,000/mm3, absolute neutrophil counts (ANC) <250/mm3, neutropenic fever, or Grades 3/4 nonhematologic toxicity should have the Day 1 dose in subsequent cycles reduced to 75% of the Day 1 dose given in the current cycle. Day 1 chemotherapy in subsequent courses of treatment should be delayed until platelet counts are ≥100,000/mm3, ANC ≥1500/mm3, and nonhematologic toxicities have recovered to ≤ Grade 1. For patients receiving a divided dose of ELLENCE (Day 1 and Day 8), the Day 8 dose should be 75% of Day 1 if platelet counts are 75,000—100,000/mm3 and ANC is 1000 to 1499/mm3. If Day 8 platelet counts are <75,000/mm3, ANC <1000/mm3, or Grade 3/4 nonhematologic toxicity has occurred, the Day 8 dose should be omitted. Preparation & Administration Precautions Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Procedures normally used for proper handling and disposal of anticancer drugs should be considered for use with ELLENCE. Several guidelines on this subject have been published.1—8 Protective measures The following protective measures should be taken when handling ELLENCE: Personnel should be trained in appropriate techniques for reconstitution and handling. Pregnant staff should be excluded from working with this drug. Personnel handling ELLENCE should wear protective clothing: goggles, gowns and disposable gloves and masks. A designated area should be defined for syringe preparation (preferably under a laminar flow system), with the work surface protected by disposable, plastic-backed, absorbent paper. All items used for reconstitution, administration or cleaning (including gloves) should be placed in high-risk, waste-disposal bags for high temperature incineration. Spillage or leakage should be treated with dilute sodium hypochlorite (1% available chlorine) solution, preferably by soaking, and then water. All contaminated and cleaning materials should be placed in high-risk, waste-disposal bags for incineration. Accidental contact with the skin or eyes should be treated immediately by copious lavage with water, or soap and water, or sodium bicarbonate solution. However, do not abrade the skin by using a scrub brush. Medical attention should be sought. Always wash hands after removing gloves. Incompatibilities Prolonged contact with any solution of an alkaline pH should be avoided as it will result in hydrolysis of the drug. ELLENCE should not be mixed with heparin or fluorouracil due to chemical incompatibility that may lead to precipitation. ELLENCE can be used in combination with other antitumor agents, but it is not recommended that it be mixed with other drugs in the same syringe. Preparation of Infusion Solution ELLENCE is provided as a preservative-free, ready-to-use solution. ELLENCE should be administered into the tubing of a freely flowing intravenous infusion (0.9% sodium chloride or 5% glucose solution). Patients receiving initial therapy at the recommended starting doses of 100—120 mg/m2 should generally have epirubicin infused over 15—20 minutes. For patients who require lower epirubicin starting doses due to organ dysfunction or who require modification of epirubicin doses during therapy, the epirubicin infusion time may be proportionally decreased, but should not be less than 3 minutes. This technique is intended to minimize the risk of thrombosis or perivenous extravasation, which could lead to severe cellulitis, vesication, or tissue necrosis. A direct push injection is not recommended due to the risk of extravasation, which may occur even in the presence of adequate blood return upon needle aspiration. Venous sclerosis may result from injection into small vessels or repeated injections into the same vein (see PRECAUTIONS). ELLENCE should be used within 24 hours of first penetration of the rubber stopper. Discard any unused solution. HOW SUPPLIED ELLENCE Injection is available in polypropylene single-use CYTOSAFE™ vials containing 2 mg epirubicin hydrochloride per mL as a sterile, preservative-free, ready-to-use solution in the following strengths: 50 mg/25 mL single-use vial         NDC 0009-5091-01 200 mg/100 mL single-use vial     NDC 0009-5093-01 Store refrigerated between 2°C and 8°C (36°F and 46°F). Do not freeze. Protect from light. Discard unused portion. Storage of the solution for injection at refrigerated conditions can result in the formation of a gelled product. This gelled product will return to a slightly viscous to mobile solution after 2 to a maximum of 4 hours equilibration at controlled room temperature (15—25°C). http://www.info.pmda.go.jp/go/pack/4235404A1040_1_04/ http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0A03C798-A652-4895-B29C-3B521A89BA42 ------------------------------------ 产地国家： 美国 原产地英文商品名: ELLENCE Injection 25mL（50mg/25mL）/Vial 原产地英文药品名: epirubicin hydrochloride 中文参考商品译名: ELLENCE射剂 25毫升（50毫克/25毫升）/瓶 中文参考药品译名: 盐酸表柔比星 生产厂家中文参考译名: 辉瑞 生产厂家英文名: pfizer ------------------------------------ 产地国家： 美国 原产地英文商品名: ELLENCE Injection 25mL（200mg/100mL）/Vial 原产地英文药品名: epirubicin hydrochloride 中文参考商品译名: ELLENCE射剂 25毫升（200毫克/100毫升）/瓶 中文参考药品译名: 盐酸表柔比星 生产厂家中文参考译名: 辉瑞 生产厂家英文名: pfizer ------------------------------------ 产地国家： 日本 原产地英文商品名: Epirubicin（エピルビシン塩酸塩注射液「NK」）10mg/5mL/Vial  5Vial/box 原产地英文药品名: Epirubicin Hydrochloride 中文参考商品译名: Epirubicin (エピルビシン塩酸塩注射液「NK」)10毫克/5毫升/瓶  5瓶/盒 中文参考药品译名: 盐酸表柔比星 生产厂家中文参考译名: 日本化药有限公司 生产厂家英文名: Nippon Kayaku Co., Ltd. ------------------------------------ 产地国家： 日本 原产地英文商品名: Epirubicin（エピルビシン塩酸塩注射液「NK」）50mg/25mL/Vial  5Vial/box 原产地英文药品名: Epirubicin Hydrochloride 中文参考商品译名: Epirubicin (エピルビシン塩酸塩注射液「NK」)50毫克/25毫升/瓶  5瓶/盒 中文参考药品译名: 盐酸表柔比星 生产厂家中文参考译名: 日本化药有限公司 生产厂家英文名: Nippon Kayaku Co., Ltd.