近日,美国FDA批准Venofer(iron sucrose)是第四sucrose-based铁产品,在欧美已经使用近50年,目前在40多个国家批准用于。蔗糖铁又称蔗糖铁，不含右旋糖酐多糖，和葡萄糖酸铁钠一样，蔗糖铁被用于治疗慢性血液透析患者的缺铁性贫血。对于其作为一线或二线治疗方案的使用没有任何限制。 批准日期：2000年11月4日 公司：IRON SUCROSE Venofer (蔗糖铁[iron sucrose]) 注射，供静脉使用 美国最初批准:2000年 作用机制 Venofer是蔗糖中多核铁(III)-氢氧化物的水成络合物。静脉给药后，静脉留置剂分解为铁和蔗糖，铁与转铁蛋白复合物运输到靶细胞，包括红细胞前体细胞。前体细胞中的铁在细胞成熟为红细胞时被并入血红蛋白。 适应症和用法 Venofer是一种用于治疗慢性肾脏病(CKD)患者缺铁性贫血的铁替代品。 剂量和管理 剂型及强度                  人口                                    剂量 成人患者中 血液透析依赖性慢性肾病(HDD-CKD)  100mg缓慢静脉注射或输注 非透析依赖性慢性肾病(NDD-CKD)     200mg缓静脉注射或输注 腹膜透析依赖性慢性肾病(PDD-CKD)   静脉输注300mg或400mg 儿科患者 HDD-CKD, PDD-CKD或NDD-CKD         0.5mg/kg缓慢静脉注射或输注 注射:50mg/2.5mL, 100mg/5mL，或200mg/10mL(20mg/mL)单剂量瓶。 禁忌症 已知对静脉留置管过敏 警告和预防措施 过敏反应:在静脉留置管期间和之后至少30分钟观察过敏的体征和症状，直到每次用药结束后临床稳定。只有当医护人员和治疗人员能够立即治疗严重的超敏反应时，才给予静脉留置管。 低血压:静脉留置管可引起低血压。在每次静脉留置期间和随后监测血压过低的体征和症状。 铁超载:在静脉输液治疗期间定期监测血液反应。不要给铁超载的病人使用静脉留置管。 不良反应 成人患者中:最常见的不良反应(≥2%)有腹泻、恶心、呕吐、头痛、头晕、低血压、瘙痒、肢体疼痛,关节痛、背痛、肌肉痉挛,注射部位反应,胸痛,周边水肿。 儿科患者:最常见的不良反应(≥2%)是头痛、呼吸道病毒感染、腹膜炎、呕吐、发热、头晕、咳嗽、恶心、动静脉瘘血栓形成,低血压、高血压。 要报告可疑的不良反应，请联系美国摄政公司1-800-734-9236或FDA 1-800-FDA-1088或www.fda.gov/medwatch。 药物的相互作用 最常见的不良反应(≥2%)以下Venofer管理腹泻、恶心、呕吐、头痛、头晕、低血压、瘙痒、肢体疼痛,关节痛、背痛、肌肉痉挛,注射部位反应,胸痛,周边水肿。 如何提供/存储和处理 提供 静脉留置剂在10ml、5ml和2.5mL的单剂量瓶中无菌供应。每10mL瓶含元素铁200 mg，每5ml瓶含元素铁100mg，每2.5mL瓶含元素铁50mg (20mg/mL)。 -------------------------------------------------------- 注：以下产品不同规格和不同价格，采购以咨询为准 -------------------------------------------------------- VENOFER 20MG/ML 10ML SDV PF NR 5/PAC  IRON SUCROSE     00517-2310-05 VENOFER 20MG/ML 2.5ML SDV PF 10/PAC  IRON SUCROSE      00517-2325-10 VENOFER 20MG/ML 5ML SDV PF NR 10/PAC  IRON SUCROSE     00517-2340-10 VENOFER SDV 20MG/ML 2.5ML 10  IRON SUCROSE COMPLEX     00517-2325-10 VENOFER SDV 20MG/ML 5ML A/R 10  IRON SUCROSE COMPLEX   00517-2340-10 VENOFER SDV 20MG/ML 5ML 25  IRON SUCROSE COMPLEX       00517-2340-25  VENOFER SDV 20MG/ML 10ML A/R 5  IRON SUCROSE COMPLEX   00517-2310-05 稳定和存储 不含防腐剂。商店在原来的纸箱20°C到25°C (68°F (77°F);远足允许15°30°C (59°- 86°F)(见USP室温控制)。不冻结。 注射器稳定:Venofer,当稀释0.9%氯化钠浓度从2毫克每毫升10毫克的铁元素,或稀释(每毫升20毫克铁元素)并存储在一个塑料注射器,被发现的物理及化学稳定在控制房间温度为7天(25°C±2°C)和制冷(4°C±2°C)。 静脉药物稳定性:Venofer,当添加到静脉输液袋(PVC或non-PVC)含0.9%氯化钠浓度从1毫克每毫升2毫克的铁元素,被发现为7天的物理及化学稳定控制室温(25°C±2°C)。 不要稀释到浓度低于1毫克/毫升。 不要将静脉留置管与其他药物混合或添加到静脉输液的肠外营养溶液中。 输液前应目视检查肠外药物的颗粒物质和变色情况。 完整资料附件： https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021135s032lbl.pdf Venofer(iron sucrose injection, USP) INDICATION Venofer® (iron sucrose injection, USP) is indicated for the treatment of iron deficiency anemia in patients with chronic kidney disease. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Venofer® is contraindicated in patients with known hypersensitivity to Venofer. WARNINGS AND PRECAUTIONS Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Venofer. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. If hypersensitivity reactions or signs of intolerance occur during administration, stop Venofer immediately. Monitor patients for signs and symptoms of hypersensitivity during and after Venofer administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Venofer when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Most reactions associated with intravenous iron preparations occur within 30 minutes of the completion of the infusion. Venofer may cause clinically significant hypotension. Monitor for signs and symptoms of hypotension following each administration of Venofer. Hypotension following administration of Venofer may be related to rate of administration and/or total dose delivered. Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. All adult and pediatric patients receiving Venofer require periodic monitoring of hematologic and iron parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). Do not administer Venofer to patients with evidence of iron overload. Transferrin saturation (TSAT) values increase rapidly after intravenous administration of iron sucrose; do not perform serum iron measurements for at least 48 hours after intravenous dosing. ADVERSE REACTIONS The most common adverse reactions (≥2%) following the administration of Venofer are diarrhea, nausea, vomiting, headache, dizziness, hypotension, pruritus, pain in extremity, arthralgia, back pain, muscle cramp, injection site reactions, chest pain and peripheral edema. Additional adverse reactions include infusion site pain or burning, graft complications, and nasopharyngitis, sinusitis, upper respiratory tract infections and pharyngitis. In pediatric patients, more than 50% of the patients experienced at least one treatment-emergent reaction. The most common adverse reactions (≥2%) were headache, respiratory tract viral infection, peritonitis, vomiting, pyrexia, dizziness, cough, renal transplant, nausea, arteriovenous fistula thrombosis, hypotension and hypertension. In post-marketing safety studies of Venofer in 1,051 patients with HDD-CKD, adverse reactions reported by > 1% were cardiac failure congestive, sepsis and dysgeusia. Because adverse reactions from post-marketing experience are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. In addition to potential serious hypersensitivity reactions, the following adverse reactions have been identified during post-approval use of Venofer® (iron sucrose injection, USP): bronchospasm, dyspnea, convulsions, light-headedness, confusion, angioedema, swelling of the joints, hyperhidrosis, bradycardia and chromaturia. Symptoms associated with Venofer total dosage or infusing too rapidly included hypotension, dyspnea, headache, vomiting, nausea, dizziness, joint aches, paresthesia, abdominal and muscle pain, edema and cardiovascular collapse. These adverse reactions have occurred up to 30 minutes after the administration of Venofer injection. Reactions have occurred following the first dose or subsequent doses of Venofer. Slowing the infusion rate may alleviate symptoms. 氢氧化铁蔗糖复合物（venofer）配合促红细胞生成素（Epo）治疗慢性肾功能不全（CRF）患者贫血的症状。 贫血是CRF的重要并发症，近年来，Epo广泛应用，改善了患者的贫血，但人们逐渐发现，许多透析贫血患者对Epo治疗无反应或疗效差，主要是铁缺乏，适当补充铁剂对取得Epo疗效至关重要，以往绝大多数患者选用口服补铁，但肠道对铁的吸收可能不足，加上口服铁剂对胃肠刺激，有的患者不愿意接受。 静脉注射100μg氢氧化铁蔗糖复合物，10min后即能达到最高浓度，半衰期约６h。 药物动力学显示;铁能很快从血清中清除，铁可结合于转运蛋白和贮存铁的血浆蛋白，迅速到达骨髓。静脉使用后数分钟即可检测出骨髓中铁，表明输入铁可很快用于造血 。 特别适合于需迅速补铁治疗，而口服铁剂疗效不满意或不能耐受口服补铁，对口服补铁无反应或吸收不良的患者及使用Epo治疗时引起功能性缺铁患者。用法：将氢氧化铁蔗糖复合物100～200mg溶于9g/L生理盐水 100～200ml于HD最后 30～60min，从透析器静脉端缓慢持续静滴30～60min，每周1～3次，根据Hb水平而定，直至完成补铁总预计量。 氢氧化铁蔗糖复合物严重副反应极少，偶有报道有过敏反应，首次给药宜先给20 mg，15min后如无副反应，继续将剩余药量注射完毕。本组资料显示出现面色潮红，头痛恶心、胃肠不适各占１例，停药后很快消失，未出现严重过敏反应。