近日，美国食品药品监督管理局（FDA）已批准Auryxia(Ferric Citrate）作其他适应症。该批准用于治疗患有慢性肾脏疾病（CKD）的成年人的铁缺乏性贫血，而不是用于透析。Auryxia最初于2014年9月获得批准，用于控制需要透析的慢性肾脏病患者的血清磷水平。
AURYXIA(Ferric Citrate Tablets）是一种磷酸盐结合剂，用于控制透析期慢性肾病患者的血清磷水平。AURYXIA®（铁柠檬酸铁）是第一个也是唯一可吸收的、基于铁的磷酸盐粘结剂，被临床证明可以控制高磷血症。Keryx对于AURYXIA的sNDA，主要是为了扩大AURYXIA的适应症范围，包括用于非透析依赖性慢性肾病患者的缺铁性贫血。
Auryxia药片的设计含量为210毫克三价铁，相当于1克柠檬酸铁，可方便地就餐。 透析患者治疗高磷酸盐血症的奥瑞克西的起始剂量为每天六片（每餐两次），而非透析患者的铁缺乏性贫血的起始剂量为每天三片（每餐一次）。
批准日期：2017年11月7日 公司：Keryx Biopharmaceuticals, Inc
AURYXIA（柠檬酸铁[ferric citrate]）片剂，口服
美国初次批准：2014年
最近的重大变化
适应症和用法，慢性肾病中的铁缺乏性贫血：11/2017
剂量和给药方法，慢性肾脏病铁缺乏性贫血的剂量：11/2017
作用机理
慢性肾脏病透析中的高磷酸盐血症
铁铁在胃肠道中结合膳食磷酸盐，并以磷酸盐铁的形式沉淀。 该化合物不溶并排泄在粪便中。 通过将磷酸盐结合在胃肠道中并降低吸收，柠檬酸铁降低了血清中的磷酸盐浓度。
慢性肾病中的缺铁性贫血未接受透析
胃肠道中的铁还原酶将铁从铁形式还原为亚铁形式。 通过肠上皮细胞转运到血液后，氧化的三价铁结合血浆蛋白转铁蛋白循环，并可以掺入血红蛋白中。
适应症和用途
Auryxia是一种磷酸盐粘合剂，可用于控制透析后患有慢性肾脏疾病的成年患者的血清磷水平。
Auryxia是一种铁替代产品，适用于治疗未经透析的慢性肾脏病成年患者的铁缺乏性贫血。
剂量和给药
慢性肾脏病透析中的高磷酸盐血症：
起始剂量为2片，每日3次，含餐。
根据需要将剂量调整为1至2片，以将血清磷维持在目标水平，每天最多12片。剂量可以1周或更长时间间隔滴定。
慢性肾病中的缺铁性贫血不接受透析：
起始剂量为一日三餐，每次口服1片。
根据需要调整剂量以达到和维持血红蛋白目标，每天最多12片。
剂量形式和强度
片剂：210毫克铁，相当于1克柠檬酸铁。
禁忌症
铁超负荷综合征（例如血色素沉着症）
警告和注意事项
铁过载：监测铁蛋白和TSAT。患者可能需要减少剂量或停用静脉铁剂。
意外过量服用含铁产品是导致6岁以下儿童致命中毒的主要原因。请将本产品放在儿童接触不到的地方。如果意外过量，请立即致电医生或毒物控制中心。
不良反应
最常见的不良反应（发生率≥5％）是粪便变色，腹泻，便秘，恶心，呕吐，咳嗽，腹痛和高钾血症。
要报告可疑的不良反应，请致电1-844-445-3799与Keryx Biopharmaceuticals联系，或致电1-800-FDA-1088与FDA联系或访问www.fda.gov/medwatch
药物相互作用
当预期有临床上显着的药物相互作用时，请考虑分开给药时间。考虑监测伴随药物的临床反应或血液水平。
包装供应/存储和处理方式
供应方式
片剂：Auryxia相当于1克柠檬酸铁的210毫克铁铁片剂以200片的形式装在400毫升高密度聚乙烯瓶中。 210毫克铁铁片是薄膜包衣的，桃红色的椭圆形药片，上面刻有“ KX52”。
1瓶200毫克210毫克铁铁片（NDC 59922-631-01）
储存和处理
存放：存放在20至25°C（68至77°F（华氏度））：允许偏移至15°至30°C（59°F至86°F）[请参阅USP室温控制]。 防潮。
完整说明资料附件：
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aadd18e0-3752-11e4-8510-0800200c9a66
U.S. FDA Approves Auryxia® (ferric citrate) Tablets as a Treatment for People with Iron Deficiency Anemia and Chronic Kidney Disease, Not on Dialysis
AURYXIA(FERRIC CITRATE) TABLETS
Auryxia®(ferric citrate) is an oral, absorbable, iron-based phosphate binder. It helps lower the amount of phosphate in your blood. In the United States, Auryxia was approved by the Food and Drug Administration (FDA) on September 5, 2014, for the control of serum phosphorous levels in patients with chronic kidney disease (CKD) on dialysis.
Auryxia is being marketed in the U.S. by Keryx Biopharmaceuticals, Inc.
IMPORTANT SAFETY INFORMATION
Contraindication
AURYXIA(ferric citrate)is contraindicated in patients with iron overload syndromes, e.g. hemochromatosis.
Warnings and Precautions
Iron Overload: Iron absorption from AURYXIA may lead to excessive elevations in iron stores. Increases in serum ferritin and transferrin saturation (TSAT levels) were observed in clinical trials. Assess iron parameters, e.g. serum ferritin and TSAT, prior to initiating AURYXIA and while on therapy.
Patients receiving IV iron may require a reduction in dose or discontinuation of IV iron therapy.
Accidental Overdose of Iron: Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6 years of age. Counsel your patients to keep this product out of the reach of children and to call a doctor or poison control center immediately in the case of accidental overdose.
Patients with Gastrointestinal Bleeding or Inflammation: Safety has not been established in these populations.
Adverse Events
The most common adverse events with AURYXIA were diarrhea (21%), nausea (11%), constipation(8%), vomiting(7%)and cough (6%). Gastrointestinal adverse reactions were the most common reason for discontinuing AURYXIA (14%).
Special Populations
Pregnancy Category B and Nursing Mothers: It is not known whether AURYXIA can cause fetal harm. However, overdosing of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. Data from rat studies have shown the transfer of iron into milk, hence there is a possibility of infant exposure when AURYXIA is administered to a nursing woman.
Pediatric and Geriatric Use:The safety and efficacy of AURYXIA have not been established in pediatric patients. Overall, the clinical study experience has not identified any obvious differences in responses between the elderly and younger patients in the tolerability or efficacy of AURYXIA.
Overdose
AURYXIA contains iron.Iron absorption from AURYXIA may lead to excessive elevations in iron stores, especially when concomitant IV iron is used. AURYXIA must be kept out of the reach of children. In case of accidental overdose contact a doctor or poison control center immediately.
Drug Interactions
Doxycycline should be taken at least 1 hour before AURYXIA. Ciprofloxacin should be taken at least 2 hours before or after AURYXIA. Consider separation of the timing of the administration of AURYXIA with drugs where a reduction in their bioavailability would have a clinically significant effect on safety or efficacy. Monitor blood levels of concomitant medications that have a narrow therapeutic range.
Patient Counseling
Dosing and Administration: Inform patients to take AURYXIA as directed with meals and adhere to their prescribed diets. Instruct patients on concomitant medications that should be dosed apart from AURYXIA.
Adverse Reactions: Advise patients that AURYXIA may cause discolored(dark)stools, which is considered normal with oral medications containing iron. Advise patients to report severe or persistent gastrointestinal symptoms to their physician.