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英文药名:Epogen(Epoetin Alfa Injection)
中文药名:阿法依泊汀注射剂
生产厂家：安进制药
药品介绍
阿法依泊汀注射剂
别 名:EPO, Epoade, Epogen, Eprex, Erypo, Erythropoietin, Espo, Globuren, KRN-5702 E, Procrit
化学名称: 1-165-Erythropoietin (human clone Iambda HEPOFL 13 protein moiety), glycoform α
开发单位:Amgen
首次上市:1989年，美国
药效类别:抗贫血药
用 途
EPOGEN是一种重组促红细胞生成素，用于依赖透析的慢性肾衰相关的贫血。还用于癌症病人由于化疗引起的贫血。
本品是一种刺激红细胞生成的糖蛋白。它是应用dna重组技术及细胞培养技术而制成的人类红细胞生成素-α，与内源性红细胞生成素有相同的生物活性。
药理作用
红细胞生成素在红细胞系发育的其后各阶段的作用，包括对原始红细胞刺激增加合成血红蛋白，当激素处于高浓度时，加速网织红细胞由骨髓向循环释放。
内源性红细胞生成素主要由肾脏产生，慢性肾衰病人红细胞生成素的产生受到抑制因而不足，是这类病人贫血的原发因素。红细胞生成素对包括需要透析和不需要经常透析的慢性肾衰贫血病人可刺激红细胞生成。
药代动力学
慢性肾衰病人静脉给药循环半衰期大约为4～13h。肝脏是主要的清除途径，肾脏是清除的次要途径。
适应症
慢性肾衰伴有贫血的病人(包括透析和不透析的病人)，也用于多发性骨髓瘤相关的贫血和骨髓增生异常及癌症引起的贫血。
用法与用量
开始剂量：3000u，静注，每周3次，然后根据病情逐渐减少至维持量1500u，静注，每周2～3次：最高维持剂量不得超过3000u/次，每周3次。
不良反应
不良反应：偶可发生血压升高，心悸、高血压性脑病、头痛、头晕、发热、关节痛、肌肉痛、恶心、呕吐、腹泻、got及gpt升高、瘙痒、皮疹、过敏性休克。
注意事项
①用药期间应定期检查血红蛋白浓度与红细胞比容值(血红蛋白浓度不超过12g/dl或红细胞比容值36%以上)。密切观察血压变化情况，防止高血压性脑病发生，
②使用本品应注意补充铁质。
③本品应慎用于心肌梗塞、肺梗塞、脑梗塞、高血压、孕妇、儿童或有过敏倾向的病人。
完整资料附件：https://pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/epogen/epogen_pi_hcp_english.pdf
包装规格[以下产品不同规格和不同价格，采购者以咨询为准]
EPOGEN 10000U/ML 1ML SDV 10/PAC EPOETIN ALFA "AMGEN USA, INC."55513-0144-10
EPOGEN 10000U/ML 2ML MDV 10/PAC EPOETIN ALFA "AMGEN USA, INC." 55513-0283-10
EPOGEN 20000U/ML 1ML MDV 10/PAC EPOETIN ALFA "AMGEN USA, INC." 55513-0478-10
EPOGEN 2000U/ML 1ML SDV 10/PAC EPOETIN ALFA "AMGEN USA, INC." 55513-0126-10
EPOGEN 3000U/ML 1ML SDV 10/PAC EPOETIN ALFA "AMGEN USA, INC." 55513-0267-10
EPOGEN 4000U/ML 1ML SDV 10/PAC EPOETIN ALFA "AMGEN USA, INC." 55513-0148-10
"EPOGEN MDV 20,000U/ML 1ML 10" EPOETIN ALFA AMGEN USA INC 55513-0478-10
EPOGEN MDV 20MU 2ML 10 EPOETIN ALFA AMGEN USA INC 55513-0283-10
EPOGEN SDV 10MU 1ML 10 EPOETIN ALFA AMGEN USA INC 55513-0144-10
EPOGEN SDV 2MU 1ML 10 EPOETIN ALFA AMGEN USA INC 55513-0126-10
EPOGEN SDV 3MU 1ML 10 EPOETIN ALFA AMGEN USA INC 55513-0267-10
EPOGEN SDV 4MU 1ML 10 EPOETIN ALFA AMGEN USA INC 55513-0148-10
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EPOGEN(epoetin alfa Injection)
EPOGEN® decreases the need for transfusions.
EPOGEN® increases hemoglobin (Hb) levels and decreases the need for blood transfusions. Your doctor will determine the appropriate Hb level for you to reduce the need for blood transfusions.
EPOGEN® should not be used in place of emergency red blood cell transfusions to treat anemia.
Transfusions are sometimes necessary because they can quickly increase red blood cells, which carry oxygen to the body.
Transfusions may also have risks, such as different types of reactions and infections.
Talk with your doctor about any questions you have about transfusions.
IMPORTANT SAFETY INFORMATION ABOUT EPOGEN®
Indication
EPOGEN® is a prescription medicine used to treat a lower than normal number of red blood cells (anemia) caused by chronic kidney disease in patients on dialysis to reduce or avoid the need for red blood cell transfusions.
EPOGEN® has not been proven to improve quality of life, fatigue, or well-being.
EPOGEN® should not be used in place of emergency treatment for anemia (red blood cell transfusions).
Important Safety Information
EPOGEN® may cause serious side effects that can lead to death, including:
For people with cancer:
In patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers: Your tumor may grow faster and you may die sooner if you choose to take EPOGEN®.
Your healthcare provider will talk with you about these risks.
For all people who take EPOGEN®, including people with cancer or chronic kidney disease:
Serious heart problems, such as heart attack or heart failure, and stroke. You may die sooner if you are treated with EPOGEN® to increase red blood cells (RBCs) to near the same level found in healthy people.
Blood clots. Blood clots may happen at any time while taking EPOGEN®. If you are receiving EPOGEN® for any reason and are going to have surgery, talk with your healthcare provider about whether you need to take 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 any of these symptoms:
Chest pain
Trouble breathing or shortness of breath
Pain or swelling in your legs
A cool or pale arm or leg
Sudden confusion, trouble speaking, or trouble understanding others’ speech
Sudden numbness or weakness in your face, arm, or leg, especially on one side of your body
Sudden trouble seeing
Sudden trouble walking, dizziness, loss of balance or coordination
Loss of consciousness (fainting)
Hemodialysis vascular access stops working
If you decide to take EPOGEN®, your healthcare provider should prescribe the smallest dose that is necessary to reduce your chance of needing RBC transfusions.
If your hemoglobin level stays too high or goes up too quickly, this may lead to serious health problems which may result in death. These serious health problems may happen if you take EPOGEN®, even if you do not have an increase in your hemoglobin level.
Do not take EPOGEN® if you:
Have cancer and have not been counseled by your healthcare provider about treatment with 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 had a serious allergic reaction to EPOGEN®.
Pregnant women, breastfeeding women, and babies should not receive EPOGEN® from multidose vials.
Before taking EPOGEN®, tell your healthcare provider if you: have heart disease; have high blood pressure; have had a seizure or stroke; receive dialysis; or if you are pregnant or breastfeeding, or plan to become pregnant or breastfeed.
EPOGEN® may cause other serious side effects:
High blood pressure. High blood pressure is a common side effect of EPOGEN® in people with chronic kidney disease. Your blood pressure may go up or be difficult to control with blood pressure medication 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. If you have seizures while taking EPOGEN®, get medical help right away and tell your healthcare provider.
Antibodies to EPOGEN®. Your body may make antibodies to EPOGEN® that can block or lessen your body’s ability to make RBCs and cause you to have severe anemia. Call your healthcare provider if you have unusual tiredness, lack of energy, dizziness, or fainting. You may need to stop taking EPOGEN®.
Serious allergic reactions. Serious allergic reactions can cause a skin rash, itching, shortness of breath, wheezing, dizziness and fainting due to a drop in blood pressure, swelling around your mouth or eyes, fast pulse, or sweating. If you have a serious allergic reaction, stop using EPOGEN® and call your healthcare provider or get medical help right away.
Severe skin reactions. Signs and symptoms of severe skin reactions with EPOGEN® may include: skin rash with itching, blisters, skin sores, peeling, or areas of skin coming off. If you have any signs or symptoms of a severe skin reaction, stop using EPOGEN® and call your healthcare provider or get medical help right away.
Dangers of using EPOGEN® from multiple-dose vials (which contain benzyl alcohol) in newborns, infants, and pregnant or breastfeeding women. Benzyl alcohol has been shown to cause brain damage, other serious side effects, and death in newborn and premature babies. If you use EPOGEN® from multiple-dose vials you should not breastfeed for at least 2 weeks after the last dose.
These are not all the possible side effects of EPOGEN®. Tell your healthcare provider about any side effects that bother you or do not go away.
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