Parsabiv（etelcalcetide）静脉注射剂-12年来首个获FDA批准用于治疗肾透析患者甲亢新药 2017年2月9日，美国食品和药物管理局（FDA）已批准Parsabiv用于正接受血液透析治疗的慢性肾脏病（CKD）患者继发性甲状旁腺功能亢进（sHPT，简称继发性甲旁亢）的治疗。值得一提的是，安进原本期望着在2016年就拿到美国上市批文，但FDA在去年8月发布的一份完整回应函使安进这一期望成为了泡影。在欧盟，Parsabiv已于2016年11月获得欧盟委员会（EC）批准上市。 此次批准，使Parsabiv过去10多年来继发性甲旁亢（sHPT）领域的首个新药，该药也是首个在患者每次透析结束后每周三次静脉注射给药的静脉注射型拟钙剂。 Parsabiv的获批，是基于3个III期临床研究的数据，其中2个为安慰剂对照研究，另一个是头对头研究，这3个研究均达到了主要终点。去年2月公布头对头III期数据显示，Parsabiv疗效轻松击败安进自身已上市产品Sensipar（cinacalcet，西那卡塞），该药是FDA批准用于接受透析治疗的慢性肾病成人患者治疗继发性甲旁亢（sHPT）的首个口服拟钙剂，在2016年销售额实现突破16亿美元。业界对Parsabiv的商业前景十分看好，认为该药将成为安进的又一款重磅产品。 继发性甲状旁腺功能亢进（SHPT，简称继发性甲旁亢），是指在慢性肾功能不全、肠吸收不良综合征、Fanconi综合征和肾小管酸中毒、维生素D缺乏或抵抗以及妊娠、哺乳等情况下，甲状旁腺长期受到低血钙、低血镁或高血磷的刺激而分泌过量的甲状旁腺激素（PTH），以提高血钙、血镁和降低血磷的一种慢性代偿性临床表现，长期的甲状旁腺增生最终导致形成功能自主的腺瘤。 Parsabiv是一种新颖的拟钙剂（calcimimetic agent），能够抑制甲状旁腺激素（PTH）的分泌，目前正开发用于接受血液透析治疗的慢性肾脏病（CKD）患者继发性甲旁亢（sHPT）的治疗，在患者每次透析结束后每周三次静脉注射给药。继发性甲旁亢（SHPT）是接受透析治疗的CKD患者中一种常见且严重的代偿失调疾病。目前已知，持续升高的甲状旁腺激素（PTH）与CKD患者的关键临床结局相关。etelcalcetide可结合并激活甲状旁腺上的钙敏感受体，实现甲状旁腺激素（PTH）水平的降低。 原始出处：FDA Approves Amgen's Parsabiv? (Etelcalcetide), First New Treatment In More Than A Decade For Secondary Hyperparathyroidism In Adult Patients On Hemodialysis Parsabiv（etelcalcetide）First approved February 7th, 2017 Brand name: Parsabiv Generic name: etelcalcetide Dosage form: Injection Company: Amgen Inc. Treatment for: Secondary Hyperparathyroidism Parsabiv (etelcalcetide) is a calcium-sensing receptor agonist indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis Dosage Forms & Strengths solution for injection (single-dose vials) •2.5mg/0.5mL •5mg/mL •10mg/2mL Hyperparathyroidism Indicated for secondary hyperparathyroidism (SHPT) for patients with chronic kidney disease (CKD) on hemodialysis Recommended dose •Ensure corrected serum calcium is at or above the lower limit of normal prior to initiation, a dose increase, or reinitiation of therapy after a dosing interruption •Starting dose: 5 mg IV bolus injection 3 times/week at the end of hemodialysis treatment •Also see Administration •Maintenance dose ◦Individualize and determine by titration based on parathyroid hormone (PTH) and corrected serum calcium response ◦The maintenance dose is the dose that maintains PTH levels within the recommended target range and corrected serum calcium within the normal range ◦Lowest maintenance dose: 2.5 mg IV 3 times/week ◦Highest maintenance dose: 15 mg IV 3 times/week Monitoring •Monitor corrected serum calcium and PTH levels during dose initiation, dose adjustment, and dose maintenance •Corrected serum calcium levels ◦Obtain 1 week after dose initiation or dose adjustment ◦Obtain q4 weeks during maintenance •PTH levels ◦Obtain 4 weeks after dose initiation or dose adjustment ◦Obtain per clinical practice Dose adjustment •Increase dose ◦Increase by 2.5- or 5-mg increments in patients with corrected serum calcium within the normal range and PTH levels above the recommended target no more frequently than q4 weeks ◦Maximum dose of 15 mg 3 times/week •Decrease or temporarily discontinue dosing ◦Patients with PTH levels below the target range ◦In individuals with a corrected serum calcium below the lower limit of normal, but ≥7.5 mg/dL without symptoms of hypocalcemia, consider decreasing or temporarily discontinuing the drug or use concomitant therapies to increase corrected serum calcium ◦If the dose is stopped, then reinitiate at a lower dose when PTH is within the target range and hypocalcemia has been corrected •Stop and treat hypocalcemia ◦Stop drug if the corrected serum calcium is <7.5 mg/dL or patients report symptoms of hypocalcemia ◦May reinitiate at a dose 5 mg lower than the last dose administered when corrected serum calcium is within normal limits, symptoms of hypocalcemia have resolved, and predisposing factors for hypocalcemia have been addressed ◦If the last administered dose was 2.5 mg or 5 mg, reinitiate at a dose of 2.5 mg Switching from cinacalcet •Discontinue cinacalcet for at least 7 days before starting etelcalcetide •Initiate etelcalcetide at a starting dose of 5 mg IV bolus •Ensure corrected serum calcium is at or above the lower limit of normal prior to initiation Dosing Considerations Limitations of use •Has not been studied in adults with parathyroid carcinoma, primary hyperparathyroidism, or CKD who are not on hemodialysis •Not recommended for use in these populations Safety and efficacy not established No clinically significant differences in safety, efficacy, or etelcalcetide plasma concentrations were observed between patients ≥65 yr and younger patients This article Department of pharmacists/medical experts original translation finishing, welcome to reprint! At the same time the procurement of domestic scientific research institutions can contact us: 2363244352.3330889895