每月1次促红细胞生成刺激药物Omontys获准用于接受透析的贫血患者
2012年3月27日，Affymax和美国食品药物管理局(FDA)宣布Omontys(peginesatide)获准用于治疗与成人透析患者的慢性肾脏疾病(CKD)相关性贫血。Omontys是一种以肽类为基础的促红细胞生成刺激(ESA)注射剂，每月注射1次。
FDA的决定批准该药的依据是2项随机、对照、开放性3期研究。这2项研究比较了Omontys每月1次与依伯汀每周1~3次(根据产品说明书)的安全性和有效性，以尽可能使接受透析的CKD贫血患者的血红蛋白水平保持在可接受范围内。这2项研究共招募了2,606例患者，其中大约1,600例患者正在接受透析。研究者还前瞻性比较了不同ESA的心血管安全性，由一个设盲的独立委员会基于复合心血管安全性终点作出评估。
研究中最常见的不良反应是呼吸急促、腹泻、恶心、咳嗽和动静脉瘘部位并发症。
Omontys的标签中包含一则加框警告，指出使用ESA会增加死亡、心肌梗死、卒中、血栓栓塞、血栓形成，以及肿瘤进展或复发的风险。在对照试验中，当ESA治疗的目标血红蛋白水平11 g/dl时，患者的死亡、严重心血管不良反应和卒中风险升高。
未接受透析的CKD患者、正在接受抗癌治疗的患者，以及贫血与CKD无关的患者，均不属于Omontys的适用人群，也不建议对这些患者使用该药。对于需要立即纠正贫血的患者，该药也不可作为输注红细胞的替代治疗。Omontys禁忌用于高血压未得到控制的患者。Omontys并不能改善症状、身体功能或健康相关性生活质量。
接受Omontys治疗的患者可能需要加强肝素抗凝，以预防血液透析期间体外环路发生凝血。
OMONTYS® (peginesatide)注射液，为静脉或皮下使用
美国初始批准：2012年
 适应证和用途
OMONTYS是一种红细胞生成-刺激药物(ESA)适用于在成年由于慢性肾病(CKD)用透析患者中治疗贫血。
使用的限制
对于以下情况不适用OMONTYS和不推荐使用：
（1）有慢性肾病 不在透析患者.
（2）为癌症接受治疗患者和其贫血不是由于慢性肾病.
（3）需要立即纠正贫血患者作为对RBC输注替代物.
（4）OMONTYS未曾显示改善症状，身体功能或健康-相关生活质量。
剂量和给药方法
（1）初始治疗：0.04 mg/kg体重每月给药1次.
（2）从另一种红细胞生成-刺激药物转换：在转换时剂量每周1次根据每周重组人类促红细胞生成素[epoetin]或阿法达贝泊汀[darbepoetin alfa]总剂量。
剂型和规格
禁忌证
（1）未控制高血压.
警告和注意事项
（1）增加死亡率，心肌梗死，卒中，和血栓栓塞：使用各种红细胞生成-刺激药物至目标血红蛋白水平大于11 g/dL增加的风险严重不良心血管反应和未曾显示提供梁歪效益。在有共存心血管疾病和卒中患者中使用应谨慎.
（2）高血压：开始前和用OMONTYS治疗期间控制高血压.
不良反应
最常见不良事件(≥ 10%)是呼吸困难，腹泻，恶心，咳嗽，和动静脉瘘部位并发症。
特殊人群中使用
（1）哺乳母亲：当OMONTYS给予哺乳妇女应谨慎对待。
（2）儿童使用：尚未确定在儿童患者中OMONTYS 的 安全性和疗效。

Medication name
Generic name: Peginesatide - Injection
Brand name(s): Omontys
Warning
See also Side Effects section.Discuss the risks and benefits of using peginesatide with your doctor, as this medication may rarely cause very serious (possibly fatal) side effects, including blood clots. It will be very important to keep all laboratory test appointments, as your doctor will need to carefully check your red blood cell tests (hemoglobin). The lowest effective dose of this medication should be used.
Uses
This medication is used to treat anemia (low red blood cell count) in people with long-term serious kidney disease (chronic renal failure) on dialysis. Peginesatide helps to reverse anemia. It also helps to reduce the need for blood transfusions. It works by causing the bone marrow to make more red blood cells. This medication is very similar to the natural substance in your body (erythropoietin) that prevents anemia.
How to use
Read the Medication Guide provided by your pharmacist before you start using peginesatide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.This medication is given by injection under the skin or into a vein as directed by your doctor, usually once every month. Hemodialysis patients should receive this medication by injection into a vein. Peritoneal dialysis patients should receive this medication by injection under the skin.If you are injecting this medication under the skin, do not inject into skin that is tender, red, bruised, hard, or with scars or stretch marks.The dosage is based on your medical condition, response to treatment, weight, and laboratory tests. Blood tests should be performed frequently to check how well this medication is working and to determine the correct dose for you. Consult your doctor for more details.If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. This medication is normally clear and colorless to slightly yellow. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely. Do not reuse the syringes or needles.Do not increase your dose or use this drug more often or for longer than prescribed. Use this medication regularly to get the most benefit from it. To help you remember, use it on the same day each month. It may help to mark your calendar with a reminder.Tell your doctor if your condition does not improve or if it worsens.
Precautions
Before using peginesatide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: uncontrolled high blood pressure, bleeding/clotting problems, blood vessel problems (such as stroke), heart problems (such as angina, heart failure), seizure disorder, certain vitamin deficiencies (such as folic acid, vitamin B12).Infrequently, patients with long-term kidney failure on dialysis may be at increased risk of seizures during the first 3 months of treatment with this medication, possibly caused by the number of red blood cells increasing too quickly. Therefore, these patients should use caution and avoid activities such as driving or using machinery during this period. Limit alcoholic beverages because alcohol may also increase the risk of seizures.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. In some women of child-bearing age, menstrual periods have resumed during treatment with a similar drug (epoetin alfa). If this occurs with peginesatide treatment, it may be possible to get pregnant while using this medication. Discuss the need for birth control with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Drug interactions
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Side effects
Headache, nausea, vomiting, diarrhea, and body aches may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Peginesatide may sometimes cause or worsen high blood pressure, especially in patients with long-term kidney failure. This effect may be caused by the number of red blood cells increasing too quickly, usually within the first 3 months of starting treatment. If you have high blood pressure, it should be adequately controlled before beginning treatment with this medication. Your blood pressure should be checked frequently. Ask your doctor if you should learn how to monitor your own blood pressure. If high blood pressure develops or worsens, follow your doctor's instructions about diet changes and starting or adjusting your high blood pressure medication. Lowering high blood pressure helps prevent strokes, heart attacks, and further kidney problems. Keep all laboratory appointments to have your blood count (hemoglobin) tested regularly to reduce the chance of this side effect.Tell your doctor right away if you have any serious side effects, including: muscle spasm/weakness, seizures, confusion, loss of consciousness.This medication may rarely cause blood clots. Get medical help right away if you have any very serious side effects, including: pain/redness/swelling/weakness of the arms or legs, calf pain/swelling that is warm to the touch, new/worsening shortness of breath, sudden vision changes, slurred speech, weakness on one side of the body, sudden severe headache, chest/jaw/left arm pain, fainting, blood clots in your hemodialysis vascular access site.Rarely, this medication may suddenly stop working well after a period of time because your body may make antibodies that reduce the effectiveness of peginesatide, and a very serious anemia can result. Tell your doctor right away if symptoms of anemia return (such as increased tiredness, low energy, pale skin, shortness of breath).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Missed dose
For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Overdose
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.
Notes
Do not share this medication with others.Laboratory and/or medical tests (such as complete blood count that includes hemoglobin, reticulocyte count) must be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.Blood tests for your iron levels will be performed and you may be prescribed iron supplements. Your doctor may recommend that you eat a well-balanced diet rich in iron (including foods such as raisins, figs, meat, eggs, vegetables, iron-fortified cereals). Follow your doctor's instructions and dietary recommendations.
Storage
Store in the refrigerator between 36-46 degrees F (2-8 degrees C) away from light. Do not freeze. Brief storage up to 77 degrees F (25 degrees C) is permitted for up to 30 days. Store in the original carton until ready for use. Do not store in the bathroom. Keep all medications away from children and pets.For the single-use vials, discard any unused portion immediately. For the multi-use vials, store opened vials in the refrigerator and discard any unused medication after 28 days.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Photos by medication strength
Click the "Photos" link to see sample photographs for a specific medication strength.
Common strengths
Omontys 10 mg/mL Injection
The photos shown are samples only. Not all photos of the drug may be displayed. Your medication may look different. If you have questions, ask your pharmacist.
Important note
HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised April 2012. Copyright(c) 2012 First Databank, Inc.

Injection
Solution

peginesatide|
Decrease in Red Blood Cells due to Kidney Failure|
Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First DataBank, Inc., 2012. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.