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近日，美国食品药品监督管理局批准Veltassa（patiromer口服混悬液）用于治疗重度高钾血症。
“血液中钾浓度过高可引发各种危险，甚至是致命性的，改变心脏节律”，FDA药品评价研究中心心血管和肾脏产品负责人诺曼·斯托克布里奇医学博士说，“这对提供给高钾血症患者的选择性治疗方案十分重要”。
钾是通过食物递送至体内，维持细胞正常功能的矿物质。肾脏将钾离子从血液中清除出去以维持体内钾的平衡。但当肾脏不能将钾从血液中有效地清除时，血钾水平就会过高。高钾血症通常发生在急性或慢性肾脏疾病或心脏衰竭，特别是正在服用肾素-血管紧张素-醛固酮系统抑制剂来调节其血压和体液平衡的患者。
Veltassa是粉末状药物，与水混合后口服，其作用机制是结合胃肠道中的钾从而降低钾的吸收。临床试验中，Veltassa能效降低正在服用至少一种肾素-血管紧张素-醛固酮系统抑制剂的慢性肾脏疾病引发的高钾血症患者的血钾水平。
临床试验中，受试者报告的服用Veltassa后最常见的不良反应为便秘、血镁浓度降低（低镁血症）、腹泻，恶心，腹部不适和胀气。由于降低血清钾可能需要几个小时至几天的时间， 因此Veltassa不适用于快速纠正重症高钾血症。
Veltassa被批准时带有黑框警告，因为其可与众多其他口服药物相结合，从而降低这些药物的吸收和药效。警告中建议Veltassa和其他任何口服药物同服时，应间隔6小时以上。药物必须给出描述其使用和风险重要信息的患者用药指南。
批准日期：2015年10月21日；公司：Relypsa，Inc.
VELTASSA(patiromer)为口服悬液
美国初次批准：2015
作用机制
Veltassa是一种非-吸收的，阳离子交换聚合物含一种钙-山梨糖醇抗衡剂。
Veltassa通过在胃肠道官腔内钾的结合增加粪便家排泄。钾的结合减低胃肠道肠腔中游离钾浓度，导致血清钾水平的减低。
适应证和用途
Veltassa是一种钾结合剂适用为高钾血症的治疗。
使用的限制
Veltassa不应被用作对危及生命高钾血症紧急治疗因为其作用的延迟开始。
剂量和给药方法
Veltassa的推荐起始剂量是8.4克口服给药与食物每天1次。
需要时每天调整剂量8.4克间隔一周以得到想要血清钾目标范围。
剂型和规格
粉：8.4，16.8和25.2克patiromer包装。
禁忌证
对Veltassa或其任何组分已知超敏性。
警告和注意事项
胃肠道运动变差
低镁血症
不良反应
最常见不良反应(发生率≥2%)是便秘，低镁血症，腹泻，恶心，腹部不适和胃肠气胀。
药物相互作用
在Veltassa前至少6小时或后6小时服用其他口服给药药物。
供应/贮存和处置
供应
Veltassa以粉被供应为口服悬浮用黄原胶制剂。Veltassa被包装在一次用包装含8.4克，16.8 克或25.2克patiromer如下：
稳定性和贮存
Veltassa应被贮存在冰箱在2°C至8°C(36°F至46°F)。
如贮存在室温(25°C ± 2°C[77°F ± 4°F])，Veltassa从冰箱取出必须在3个月内使用。对任一贮存条件，不要使用在包装印有失效期后的Veltassa。
避免暴露与高于40°C(104°F)的热。
Veltassa, patiromer (RLY5016) (formerly Patiromer FOS)
Dosage Forms & Strengths
oral powder for suspension
8.4g/packet
16.8g/packet
25.2g/packet
Hyperkalemia
Indicated for hyperkalemia
First New Medicine for the Treatment of Hyperkalemia in More than 50 Years
VELTASSA (patiromer) for oral suspension is the first commercialized medicine resulting from Relypsa’s polymer technology platform.
VELTASSA™ Indication & Limitations of Use
VELTASSA is a potassium binder approved for the treatment of hyperkalemia.
VELTASSA should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.
Please see Important Safety Information, including Boxed WARNING for binding to other oral medications.
Click here for full Prescribing Information.
Available in powder form, VELTASSA is mixed with water and taken daily. Its smooth, spherical beads bind to potassium in exchange for calcium, primarily in the colon. The potassium is then excreted from the body through the normal excretion process.
VELTASSA™ Patient Access Program
Relypsa is committed to providing people living with hyperkalemia a comprehensive network of patient support services.
Visit VELTASSA.com for more information.
ADVERSE EVENT REPORTING
Important Safety Information
WARNING: BINDING TO OTHER ORAL MEDICATIONS
Veltassa binds to many orally administered medications, which could decrease their absorption and reduce their effectiveness. Administer other oral medications at least 6 hours before or 6 hours after Veltassa. Choose Veltassa or the other oral medication if adequate dosing separation is not possible.
Contraindications Veltassa is contraindicated in patients with a history of a hypersensitivity reaction to Veltassa or any of its components.
Worsening of Gastrointestinal Motility Avoid use of Veltassa in patients with severe constipation, bowel obstruction or impaction, including abnormal post-operative bowel motility disorders, because Veltassa may be ineffective and may worsen gastrointestinal conditions. Patients with a history of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders were not included in clinical studies.
Hypomagnesemia Veltassa binds to magnesium in the colon, which can lead to hypomagnesemia. In clinical studies, hypomagnesemia was reported as an adverse reaction in 5.3% of patients treated with Veltassa. Approximately 9% of patients in clinical trials developed hypomagnesemia with a serum magnesium value < 1.4 mg/dL. Monitor serum magnesium. Consider magnesium supplementation in patients who develop low serum magnesium levels.
Adverse Reactions The most common adverse reactions (incidence ≥ 2%) are constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort and flatulence. Mild to moderate hypersensitivity reactions were reported in 0.3% of patients treated with Veltassa and included edema of the lips.
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