Peginesatide是由Affymax和武田药品工业公司(Takeda Pharmaceutical Company)合作研发的，是一种合成的聚乙二醇肽，可以结合和激活促红细胞生成素受体,因此同红细胞生成刺激药物一样起治疗作用，可用于治疗接受透析的慢性肾脏病(chronic kidney disease，简称CKD)患者贫血。临床研究报告中最常见的不良反应为腹泻、咳嗽、呼吸困难、恶心和肌肉痉挛。

FDA批OMONTYS注射剂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

IMPORTANT SAFETY INFORMATION
WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE.
Chronic Kidney Disease:
•In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL.
•No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks.
•Use the lowest OMONTYS dose sufficient to reduce the need for red blood cell (RBC) transfusions.
Contraindications
OMONTYS is contraindicated in patients with uncontrolled hypertension.

Warnings and Precautions
Increased mortality, myocardial infarction, stroke, and thromboembolism:
•Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit. Use caution in patients with coexistent cardiovascular disease and stroke. Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. A rate of hemoglobin rise of >1 g/dL over 2 weeks may contribute to these risks
•In controlled clinical trials of ESAs in patients with cancer, increased risk for death and serious adverse cardiovascular reactions was observed. These adverse reactions included myocardial infarction and stroke
•In controlled clinical trials of ESAs, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and deep venous thrombosis (DVT) in patients undergoing orthopedic procedures
•In 2 trials of OMONTYS, patients with CKD not on dialysis experienced increased specific cardiovascular events
Increased mortality and/or increased risk of tumor progression or recurrence in patients with cancer: The safety and efficacy of OMONTYS have not been established for use in patients with anemia due to cancer chemotherapy. OMONTYS is not indicated in patients with cancer receiving chemotherapy.
Hypertension: OMONTYS is contraindicated in patients with uncontrolled hypertension. Appropriately control hypertension prior to initiation of and during treatment with OMONTYS. Reduce or withhold OMONTYS if blood pressure becomes difficult to control. Advise patients of the importance of compliance with antihypertensive therapy and dietary restrictions.
Lack or loss of response to OMONTYS: For lack or loss of hemoglobin response to OMONTYS, initiate a search for causative factors. If typical causes of lack or loss of hemoglobin response are excluded, evaluate for antibodies to peginesatide.
Dialysis management: Patients receiving OMONTYS may require increased anticoagulation with heparin to prevent clotting of the extracorporeal circuit during hemodialysis.
Laboratory monitoring: Evaluate transferrin saturation and serum ferritin prior to and during OMONTYS treatment. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%.
Adverse reactions
The most common adverse reactions in clinical studies in patients with CKD on dialysis treated with OMONTYS were dyspnea, diarrhea, nausea, cough, and arteriovenous fistula site complication.

INDICATION AND LIMITATIONS OF USE
OMONTYS® (peginesatide) Injection is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis.

OMONTYS is not indicated and is not recommended for use in patients with CKD not on dialysis, in patients receiving treatment for cancer and whose anemia is not due to CKD, or as a substitute for red blood cell (RBC) transfusions in patients who require immediate correction of anemia. OMONTYS has not been shown to improve symptoms, physical functioning, or health-related quality of life.