EPOGEN 2000U/ml/Vial 10Vials/box 阿法依泊汀

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 详细处方信息以本药内容附件PDF文件（201142823232612.pdf）的“原文Priscribing Information”为准
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部分中文阿法依泊汀处方资料（仅供参考）

Epogen - 简介
促红细胞生成素.

Epogen实际上是一种生物制剂而不是药物，因为它最初是人体中自然产生的一种物质——由肾制造的一种荷尔蒙，用于刺激红血球的再生。

Epogen - 介绍
Epogen是1976年芝加哥大学的尤金·哥得沃森（Eugene Goldwasser）发现的，他在若干个研究室中进行了基础研究，认为人体的肾必须能够制造出这样一种物质。哥得沃森和芝加哥大学都没有将这种荷尔蒙申请专利，也没有试图去合成它。而哥伦比亚大学的一项国家卫生研究所资助的研究发明了一种技术用于制造生物制剂，该大学很快将这项技术申请了专利。一家刚设立的小生物技术公司Amgen公司从哥伦比亚大学那里经过授权获得了这项技术，并开始大规模开发商业化合成促红细胞生成素分子的技术。Amgen公司现在已经成为制药业巨人，它每年通过医疗保险向肾衰竭病人销售Epogen能够赚得20亿美元的收入。因此，与紫杉醇（Taxol）的例子一样，公众需要为Epogen两次付费——第一次付费是支持了发现这种药物的研究工作，第二次通过医疗保险为购买药物付费。哥得沃森则没有因为他的基础性研究获得一分钱。

一种分子结构与Epogen亳无二致的药物Procrit由强生公司（Johnson& Johnson）推向了市场，就像它是一种不同的物质一样。这种毫无必要的复制品是Amgen和强生公司之间一笔交易的结果。因为我们知道，贫血症不仅仅出现在肾衰竭的情况下，它还可能出现在其他病状下。特别是，它很可能是癌症治疗中病人衰弱后出现的一种并发症。在Amgen公司从Epogen上获得巨额利润之前，Amgen出于公司资金流动的需求将它授权给了强生公司。强生公司在美国销售Epogen，只能针对除肾衰竭之外的其它病症（主要是癌症），在欧洲则没有限制用途。强生公司付给Amgen数百万美元，并保证在未来支付专利使用费。强生公司的分部Ortho将这种药物取名为Procrit进行推广。Procrit每年在全球的销售额大约是30亿美元，这其中的一小部分付给了Amgen。而Amgen需要将它所有关于Epogen销售收入的1％付给哥伦比亚大学。为了不被强生公司击败，Amgen现在获得了另一种疗效更长的相同药物的批准，名字为Aranesp，它希望能用这种药与Procrit展开竞争，同时又不会违背最初的交易合同。这些药物虽然名字不同，但实际上都是同一种药物。

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药物名称：阿法依泊汀  
药物别名：重组人红细胞生成素，生血素，利血宝，促红素 Recombinant Human Erythropoietin，Epogen，Recormon 
英文名称：Epoetin Alfa 
粉针剂：1500IU、3000IU；倍他依泊汀[基](Epoetin Beta)粉针剂：1000IU、2000IU、5000IU或10000IU。
功用作用：肾病终末期病人的贫血、接受叠氮胸苷治疗的艾滋病毒感染病人的贫血以及癌症化疗引起的贫血。
用法用量：静注或皮下注射，一般开始剂量为50IU～150IU/kg，3次/周。如4周内，网状红细胞计数、细胞压积或血红蛋白水平未见明显增加，可小辐度增加剂量；如在2周内红细胞压积增加超过4%，应减少剂量。以红细胞压积达30%～33%或血红蛋白达100g～120g/L为指标，调节维持量，一般25IU/kg，3次/周。接受长期血透患者，应在每次透析结束时给予本品。腹腔内给药，剂量大于或等于静注剂量。 
注意事项：妊娠C类。治疗期间应监测血压、血管栓塞情况及血清铁量，必要时应补铁。皮下注射倍他依泊汀整体平均反应比阿法依泊汀高出12%（P<0.05）。

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Indication
EPOGEN® (Epoetin alfa) is used to treat a lower than normal number of red blood cells (anemia) caused by chronic kidney failure in patients on dialysis. EPOGEN® stimulates the bone marrow to make more red blood cells and lessens the need for red blood cell transfusions. Having more red blood cells raises the hemoglobin level.

EPOGEN® should not be used for treatment of anemia in place of emergency treatment (red blood cell transfusions).

Important Safety Information
Using EPOGEN® can lead to death or other serious side effects.

All patients, including patients with cancer or chronic kidney failure:
You may get serious heart problems such as heart attack, stroke, heart failure, and may die sooner if you are treated with EPOGEN® to a hemoglobin level above 12 g/dL. Serious health problems may happen even if you take EPOGEN® and do not have an increase in your hemoglobin level. Your doctor should monitor your hemoglobin regularly.

You may get blood clots at any time while taking EPOGEN®. If you are going to have surgery, talk to your healthcare provider about whether you will need a blood thinner to lessen the chance of blood clots during or following surgery. Call your healthcare provider or get medical help right away if you have symptoms of blood clots such as chest pain; trouble breathing or shortness of breath; pain or swelling in your legs; arm or leg feels cool or appears pale; sudden confusion or trouble with speech; sudden numbness or weakness in your face, arm, or leg; sudden trouble seeing; sudden dizziness or trouble with walking or balance; loss of consciousness (fainting); your hemodialysis vascular access stops working.

Patients with cancer:
Your healthcare provider has received special training through the ESA APPRISE Oncology Program in order to prescribe EPOGEN®. Before you can begin to receive EPOGEN®, you must sign the ESA APPRISE Oncology Patient and Healthcare Professional (HCP) Acknowledgement Form to document that your healthcare provider discussed the risks of EPOGEN® with you. When you sign this form, you are stating that you are aware of the risks associated with use of EPOGEN®.

If you have breast, non-small cell lung, head and neck, lymphoid, or cervical cancer, your tumor may grow faster and you may die sooner when EPOGEN® is used experimentally to try to raise your hemoglobin beyond the amount needed to avoid red blood cell transfusion, or if you are taking EPOGEN® and not getting strong doses of chemotherapy. It is not known whether these risks exist when EPOGEN® is given according to the FDA-approved directions for use.

Your healthcare provider should prescribe the smallest dose of EPOGEN® to lower the chance of getting red blood cell transfusions
After you have finished your chemotherapy course, EPOGEN® treatment should be stopped

You should not take EPOGEN® if you:
Have cancer and have not been counseled by your healthcare provider regarding the risks of EPOGEN® and signed the ESA APPRISE Oncology Program Patient and Healthcare Professional (HCP) Acknowledgement Form before you begin to receive EPOGEN®.
Have high blood pressure that is not controlled (uncontrolled hypertension).
Have been told by your healthcare provider that you have or have ever had a type of anemia called Pure Red Cell Aplasia (PRCA) that starts after treatment with EPOGEN® or other erythropoietin medicines.
Have allergies to any of the ingredients in EPOGEN®.

Do not give EPOGEN® from multidose vials to premature babies.

Other side effects, which may also be serious, include:
High blood pressure in patients with chronic kidney failure. Your blood pressure may go up or be difficult to control with blood pressure medicine while taking EPOGEN®. This can happen even if you have never had high blood pressure before. Your healthcare provider should check your blood pressure often.
Seizures. Seizures have occurred in patients taking EPOGEN®. If you have a seizure, get medical help right away.
Antibodies to EPOGEN®. Your body may make antibodies to EPOGEN® that can block or lessen your body’s ability to make red blood cells and cause you to have severe anemia. Call your healthcare provider if you have signs of anemia such as unusual tiredness, lack of energy, dizziness, or fainting.
Serious allergic reactions. Serious allergic reactions can cause a rash over your whole body, shortness of breath, dizziness, and fainting because of a drop in blood pressure, swelling around your mouth or eyes, fast pulse, or sweating. If you have such a reaction, stop using EPOGEN® and get medical help right away.
Dangers of giving EPOGEN® to premature babies. EPOGEN® from multi-dose vials contains benzyl alcohol and should not be given to premature babies because it can cause death and brain damage.

While you are on EPOGEN®, tell your healthcare provider if you are, or are planning to, become pregnant or breast-feed.

Common side effectsof EPOGEN® in patients with chronic kidney failure include: high blood pressure, headache, joint pain, nausea, rash, swelling in legs and arms, and injection site reaction, including irritation and pain.

These are not all of the possible side effects of EPOGEN®. Tell your healthcare provider about any side effects that bother you or that do not go away.

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 详细处方信息以本药内容附件PDF文件（201142823232612.pdf）的“原文Priscribing Information”为准
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