Manufacturer:
Affymax and Takeda

Pharmacological Class:
Erythropoiesis-stimulating agent (ESA).

Active Ingredient(s):
Peginesatide 2mg, 3mg, 4mg, 5mg, 6mg per 0.5mL single-use vial (preservative-free); 1mg, 2mg, 3mg, 4mg, 5mg, 6mg per 0.5mL single-use prefilled syringe (preservative-free); 10mg/mL, 20mg/2mL multiple-use vial (w. preservatives); solution for IV or SC injection.

Indication(s):
Anemia due to chronic kidney disease (CKD) in adult patients on dialysis.

Pharmacology:
Peginesatide binds to and activates the human erythropoietin receptor and stimulates erythropoiesis in red cell precursors in vitro.

Clinical Trials:
The efficacy and safety of Omontys in patients with CKD on dialysis were demonstrated in two randomized, active-controlled, open-label clinical studies that evaluated Omontys in the maintenance of hemoglobin (Hb) concentrations in patients who were being treated with another ESA (epoetin alfa or epoetin beta) at the time of study entry. The primary efficacy endpoint for each study was the change in Hb from baseline to the evaluation period (Weeks 29 to 36) using a non-inferiority comparison with epoetin. The median dose of Omontys was 0.07mg/kg administered once monthly and the median dose of epoetin was 113units/kg administered weekly (in 1 to 3 doses).

Patients were randomized (2 to 1) to receive Omontys once monthly, or to continue on their current ESA 1–3 times per week. The Omontys starting dose was based on the patient’s total weekly ESA dose during the last week of the screening period. Treatment with Omontys once monthly and with epoetin 1–3 times per week maintained Hb concentrations within the study pre-specified Hb range (10–12g/dL). In both studies, the proportion of patients receiving transfusions was similar in each treatment group.

Legal Classification:
Rx

Adults:
Use lowest effective dose. Initiate when Hb <10g/dL. Not currently on ESA: Initially 0.04mg/kg as a single IV or SC inj once monthly. Convert­ing from epoetin alfa: give first Omontys dose 1 week after last epoetin alfa dose. Convert­ing from darbepoetin alfa: give first Omontys dose at next scheduled dose in place of darbepoetin alfa. See literature for estimated Omontys starting doses for patients based on previous weekly ESA dose. Do not increase dose > once every 4 weeks. If Hb rises rapidly (eg, >1g/dL in 2 weeks prior to dose or >2g/dL in 4 weeks), reduce dose by 25% or more to reduce rapid responses. If Hb approaches or exceeds 11g/dL, reduce or interrupt dose; when Hb decreases, resume at a dose approx. 25% below previous dose. If response is inadequate and Hb does not increase by >1g/dL after 4 weeks, increase dose by 25%. If response inadequate over 12-week escalation period, use lowest dose that will maintain Hb sufficient to reduce need for RBC transfusions. Discontinue if response does not improve.

Children:
Not established.

Contraindication(s):
Uncontrolled hypertension.

Warnings/Precautions:
Risk of death, serious cardiovascular reactions, stroke when ESA given to target Hb >11g/dL. Not for patients with CKD not on dialysis or for anemia due to cancer chemotherapy. Not a substitute for RBC transfusions in patients who require immediate correction of anemia. Evaluate iron status before and during therapy; maintain iron repletion. Correct or exclude other causes of anemia. Monitor Hb at least every 2 weeks, then monthly. Control hypertension prior to initiating; reduce or withhold dose if BP difficult to control. Risk of tumor progression/recurrence in cancer patients receiving ESAs. Consider antibody formation in treatment failures. Adjust anticoagulant dose to prevent clotting of extracorporeal circuit during hemodialysis. Pregnancy (Cat. C). Nursing mothers.

Adverse Reaction(s):
Dyspnea, diarrhea, nausea, cough, arteriovenous fistula site complication.

How Supplied:
Single-use vial, single-use prefilled syringe, multi-use vial—1

制造商：
Affymax与武田

类药物：
红血球生成刺激剂（ESA）。

活性成分（S）：
peginesatide 2毫克，3毫克，4毫克，5毫克，6毫克每0.5mL时单用小瓶（不含防腐剂）; 1毫克，2毫克，3毫克，4毫克，5毫克，6毫克每0.5mL时一次性使用的预充式注射器（不含防腐剂）10毫克/;毫升，静脉或皮下注射20mg/2mL多用小瓶（W.防腐剂）;解决方案。

指示（S）：
由于慢性肾脏病在成人患者透析（散件组装）的贫血。

药理作用：
peginesatide结合并激活人类促红细胞生成素受体，刺激红细胞前体在体外的红细胞。

临床试验：
在两项随机，主动控制，开放标签临床研究透析CKD患者Omontys的疗效和安全性进行了论证，在维护患者的血红蛋白（Hb）人与其他欧空局正在接受治疗的浓度的评估Omontys（促红细胞生成素alfa或促红细胞生成素β）在进入研究的时间。每个研究的主要疗效终点是从基线评估期（29至36周），使用促红细胞生成素与非劣效性比较中血红蛋白的变化。中位数Omontys剂量0.07mg/kg管理的每月一次的促红细胞生成素的剂量中位数113units/kg管理每周（1至3次服用）。

患者被随机（1）接收Omontys每月一次，或继续其目前的欧空局，每周1-3次。上周在电影节放映期间，根据病人的每周总ESA剂量起始剂量Omontys。治疗Omontys每月一次，每周1-3倍血红蛋白浓度维持在预先指定的血红蛋白研究范围（10-12g/dL）与促红细胞生成素。在两项研究中，接受输血的病人的比例在各治疗组相似。

法律分类：
RX

成人：
使用最低有效剂量。开始时，血红蛋白<10g/dL。目前欧空局：最初是作为一个单一的IV或SC注射每月一次0.04mg/kg。转换：从使用epoetin alfa剂量第一Omontys最后的促红细胞生成素干扰素剂量后1周。从darbepoetin的阿尔法转换：第一Omontys剂量在下次预定剂量的darbepoetin alfa的地方。看到以前每周ESA剂量根据患者开始剂量估计Omontys文学。不增加剂量>一次，每4周。如果血红蛋白迅速上升（例如，在2个星期1g/dL前4周的剂量或> 2g/dL），减少25％以上的剂量，以减少快速反应。如果血红蛋白接近或超过11g/dL，减少或中断的剂量时，血红蛋白下降，恢复剂量约。 25％，低于先前的剂量。如果反应是不够的，血红蛋白并不会增加> 1g/dL 4周后，增加了25％的剂量。如果超过12周的升级期间响应不足，使用最低剂量，将保持，血红蛋白足以减少红细胞输血的需要。停止响应，如果没有改善。

儿童：
不成立的。

禁忌症（S）：
未控制的高血压。

警告/注意事项：
死亡的风险，严重的心血管反应，中风时，欧空局的目标血红蛋白> 11g/dL。不适用于未接受透析治疗或因癌症化疗贫血的慢性肾病患者。不是需要立即纠正贫血患者的红细胞输血的替代品。评估前和治疗期间的铁营养状况;维持铁饱食。纠正或排除其他原因引起的贫血。监视器血红蛋白至少每2周，然后每月。控制高血压启动之前，减少或隐瞒剂量如果血压难以控制。在接受欧空局的癌症患者的肿瘤进展/复发的风险。考虑在治疗失败的抗体形成。调整抗凝血剂的剂量，以防止在体外循环的血液透析凝血。怀孕（部件）。哺乳的母亲。

不良反应（S）：
呼吸困难，腹泻，恶心，咳嗽，动静脉瘘网站并发症。

如何提供：
单次使用的小瓶，一次性使用的预充式注射器，多用小瓶-1

最后更新：
2012年5月25日

FDA批准OMONTYS注射剂用于治疗肾病透析引起贫血

美国食品药监局（FDA）批准OMONTYS（聚乙二醇肽）注射剂用于治疗由慢性肾病（CKD）透析引起的贫血，这种药是由Affymax和Takeda医药公司共同研发的。
 
OMONTYS是一种用于贫血的促红细胞生成刺激剂，一个月只需要注射一次。

批准基于2个Ⅲ期临床研究，EMERALD 1 和EMERALD 2两项Ⅲ期临床研究涉及1608名透析的CKD贫血患者。研究结果表明，与促红细胞生成素相比，OMONTYS能够有效的维持患者的血红蛋白水平,而且显示了很好的安全性。

Affymax公司首席执行官John Orwin说：“OMONTYS为CKD患者由于透析引起的贫血提供了一种新治疗选择，而且OMONTYS服用方便，Omontys的优势在于只需每月注射一次，而市场上已有的同类药物至少需每周注射一次。”