近日，美国批准肾病注射剂FERAHEME(FERUMOXYTOL)SOLUTION INTRAVENOUS作为一种铁替代疗法用于治疗成人慢性肾病患者的缺铁性贫血。ferumoxytol为一种半合成超顺磁性氧化铁纳米粒子，目前在开发用为核磁共振造影剂。 Feraheme的推荐用法为首次510mg静脉滴注，3-8天后再静脉滴注510mg。对持续与反复的缺铁性贫血患者可重复每次给予510mg的Feraheme。 批准日期：2009年12月31日 公司：AMAG制药 Feraheme（纳米氧化铁[ferumoxytol]）注射液 用于静脉（IV）使用 美国首次批准：2009年 警告： 严重的致敏性/反应性反应的风险 有关完整的盒装警告，请参阅完整的处方信息。在接受Feraheme的患者中发生了致命的和严重的超敏反应，包括过敏反应。初始症状可能包括低血压，晕厥，无反应，心脏/心肺呼吸停止。 只有当人员和治疗立即可用于治疗过敏反应和其他超敏反应时才施用Feraheme。 观察在Feraheme输注期间和在至少30分钟期间的超敏反应的体征或症状，包括在Feraheme施用期间和之后监测血压和脉搏。 在先前的Feraheme剂量被耐受的患者中发生超敏反应。 近期主要变化 盒装警告：03/2015 剂量和管理：03/2015 警告和注意事项， 严重的超敏反应：03/2015 作用机制 Feraheme由涂覆有碳水化合物壳的超顺磁性氧化铁组成，其帮助从血浆组分中分离生物活性铁，直到铁-碳水化合物络合物进入肝，脾和骨髓的网状内皮系统巨噬细胞。 铁从巨噬细胞囊泡内的铁 -碳水化合物复合物释放。 然后，铁进入细胞内存储铁池（例如铁蛋白）或转移至血浆转铁蛋白以转运至红细胞前体细胞以掺入血红蛋白。 适应症和用法 Feraheme是一种铁替代产品，用于治疗成人慢性肾脏病（CKD）患者的缺铁性贫血。 剂量和给药 Feraheme的推荐剂量是初始510mg剂量，随后是3至8天后的第二个510mg剂量。 在50-200mL 0.9％氯化钠注射液，USP或5％葡萄糖注射液USP中静脉输注Feraheme至少15分钟 剂量形式和强度 注射：在一次使用的小瓶中，每毫升中含有510mg铁（30mg/mL）。 禁忌症 对Feraheme或其任何组分的已知超敏反应。 任何静脉铁产品的过敏反应的历史 警告和注意事项 多药物过敏患者过敏反应的风险更大。 低血压：Feraheme可能引起低血压。监测每次施用Feraheme后低血压的体征和症状。 铁过载：定期监测Feraheme治疗期间的血液学反应。不要给铁过载的患者服用Feraheme。 磁共振成像：Feraheme可以改变磁共振成像（MRI）研究。 不良反应 在施用Feraheme后最常见的不良反应（≥2％）是腹泻，恶心，头晕，低血压，便秘和外周水肿。 ------------------------------------------------- 产地国家： 美国 原产地英文商品名: FERAHEME 30MG/ML 17ML SDV 10/PAC 原产地英文药品名: FERUMOXYTOL 中文参考商品译名: FERAHEME注射剂 30毫克/毫升 17毫升/瓶 10瓶/盒 中文参考药品译名: 纳米氧化铁 生产厂家英文名: AMAG PHARMACEUTICALS ------------------------------------------------- 产地国家： 美国 原产地英文商品名: FERAHEME 30MG/ML 17ML SDV 1/EA 原产地英文药品名: FERUMOXYTOL 中文参考商品译名: FERAHEME注射剂 30毫克/毫升 17毫升/瓶 中文参考药品译名: 纳米氧化铁 生产厂家英文名: AMAG PHARMACEUTICALS ------------------------------------------------- 产地国家：美国 原产地英文商品名: FERAHEME VIAL 510MG 17ML/Vial 1Vial/box 原产地英文药品名: Ferumoxytol 中文参考商品译名: FERAHEME注射剂 510毫克 17毫升/瓶 1瓶/盒 中文参考药品译名: 纳米氧化铁 生产厂家英文名: AMAG PHARMACEUTICALS INC ------------------------------------------------- 原产地英文商品名: FERAHEME 510MG 17ML/Vial 10Vial/box 原产地英文药品名: Ferumoxytol 中文参考商品译名: FERAHEME注射剂 510毫克 17毫升/瓶 10瓶/盒 中文参考药品译名: 纳米氧化铁 生产厂家英文名: AMAG PHARMACEUTICALS INC 完整使用资料附件： https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=32b0e320-a739-11dc-a704-0002a5d5c51b 静脉补铁剂Feraheme已获准用于治疗成人慢性肾病缺铁性贫血 2009年6月30日，美国AMAG制药公司宣布，美国食品药品管理局(FDA)已批准Feraheme(ferumoxytol)上市，用于治疗成人慢性肾病缺铁性贫血。据AMAG总裁兼首席执行官Brian J. G. Pereira博士称，“Feraheme为各类慢性肾病患者提供了一个治疗缺铁性贫血的新方案，且不受透析治疗的影响。” Feraheme可作为一种铁替代疗法，经静脉用药(IV)。推荐用法为，初始静脉滴注510 mg，3~8d后再次静脉滴注510 mg。该药静脉用药时无需稀释，给药速度达1 ml/s(即，30mg/s)。对于患有顽固性或复发性缺铁性贫血的患者，Feraheme给药时仍可采用其推荐剂量。 此次批准是基于4项对慢性肾病缺铁性贫血患者进行的III期试验的安全性和有效性资料。这些研究包括3项开放标签、多中心、随机、安全性和有效性临床试验和1项双盲、多中心、随机、安慰剂对照、交叉的安全性试验。主要终点为基线至首剂后35d血红蛋白水平的平均变化值，在此方面，各项核心的安全性和有效性研究均达到了统计学意义。这些研究显示，无论患有何类型的慢性肾病，与口服铁剂相比，应用Feraheme与血红蛋白水平显著增加均具有相关性。研发计划中，共有1,726例患者接受Feraheme治疗，其中包括1,562例处于不同期肾病的患者。 AMAG拟于儿童慢性肾病群体中进行2项上市后研究：一项针对接受透析的患者，另一项针对不接受透析的患者。各研究将募集大约75例患者。在这些试验中，研究人员将收集Feraheme相关的药代动力学、安全性和有效性资料，并与口服铁剂疗法作比较。公司期冀于2010年正式启动上述研究。 在临床试验中， Feraheme治疗组患者与口服铁剂治疗的患者相比，最常报告(≥2%)的不良反应如下：腹泻(4.0%对8.2%)，恶心(3.1%对7.5%)，头晕(2.6%对1.8%)，低血压(2.5%对0.4%)，便秘(2.1%对5.7%)，以及外周水肿(2.0%对3.2%)。 Feraheme (Ferumoxytol Injection) Medication name Generic name: Ferumoxytol - Injection Pronunciation: (FER-ue-MOX-i-tol) Brand name(s): Feraheme Uses This medicine is used to treat "iron-poor" blood (anemia) in people with long-term kidney disease. It is a form of iron that must be given by injection. You may need extra iron because of blood loss during kidney dialysis treatment.Iron is an important part of your red blood cells and is needed to carry oxygen throughout the body. Many patients with kidney disease cannot get enough iron from food and require injections. How to use This medication will be given by a health care professional. It is given slowly into a vein (IV), usually in a clinic or in a hospital. Treatment involves receiving two doses of ferumoxytol, given 3 to 8 days apart during dialysis.The dosage is based on your medical condition and response to treatment. Your doctor will take blood tests to monitor your treatment. Precautions Before taking ferumoxytol, tell your doctor or pharmacist if you are allergic to it; or if you have had a reaction to other types of injectable iron; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history.This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.During use and for 3 months after your last injection, tell X-ray staff that you use or used this medication. This medication can interfere with the results of an MRI scan.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding. Drug interactions Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: other iron products. Side effects Dizziness or fainting (hypotension) may occur. Pain, swelling, or redness at the injection site may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.To reduce the risk of dizziness or fainting, get up slowly when rising from a sitting or lying position.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if any of these unlikely but serious side effects occur: unusual bruising, skin darkens (bronze tone), swelling of hands/feet/lower legs, chest pain.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada-Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. Missed dose For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor immediately to establish a new dosing schedule. Overdose If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Notes Laboratory and/or medical tests (such as complete blood count, iron level) should be performed periodically to monitor your progress or check for side effects. Make sure you keep all your medical and laboratory appointments.It is important to eat a well-balanced diet to get enough iron, vitamins, and minerals. Good sources of iron include meats (especially liver), eggs, raisins, figs, broccoli, brussels sprouts, beans, lentils, and iron-fortified or enriched cereals. Follow diet recommendations for your condition. Storage Not applicable. This medication is given in a hospital or clinic and will not be stored at home. Photos by medication strength Common strengths  Feraheme 510 mg/17 mL (30 mg/mL) IV -------------------------------------------------------------- Feraheme (Ferumoxytol)Feraheme (ferumoxytol) is an iron consisting treatment. The iron is usually in normal limits in the organism due to your diet, especially if it is rich in meat. However, some people are more sensitive than others and if they are unable to control their diets or live a healthy lifestyle, they end up with various deficiencies. The iron deficiency is one of the most popular one. The most important substances in the organism that require iron are the myoglobin and the hemoglobin. The myoglobin is vital for the muscles. It maintains a high level of oxygen in there, resulting in firm and healthy muscles. On the other hand, the hemoglobin is probably one of the most important substances, as a main transporter of oxygen through your body, from the less important tissue to the most important organ. The iron deficiency is called anemia. It often shows up when the patient also suffers from a chronic hepatic insufficiency. This is when Feraheme (ferumoxytol) becomes vital for the patient. It is an iron supplement that maintains the level of iron in normal and healthy limits. It is based on ferumoxytol and can be taken with a medical prescription only. Administration Feraheme (ferumoxytol) is administered intravenously through an injection. Although other similar treatments may be taken at home if the patient is experienced enough, this one should be given by a specialist doctor or a nurse only. The initial dose is 510mg. A second shot is taken 3 to 8 days later. The dose remains the same. Unlike other injections, this one should not be diluted with any other substances, such as sodium or sterile water. The injection must be given slowly, at 1mL/sec. This is what the entire treatment consists of. In severe cases, it may be prolonged or replaced with a less powerful one. The Feraheme (ferumoxytol) treatment affects the blood, so make sure you don’t miss any upcoming consultations or appointments with your doctor. The blood must be checked in order to determine whether the iron therapy should go on or not. Contraindications Feraheme (ferumoxytol) is not indicated in the patients who are allergic to ferumoxytol or any other ingredients in the drug. Stay away from any supplements during this treatment, unless they are recommended by your doctor. Taking other iron supplements doesn’t mean your condition will improve faster.