阿法依泊汀注射液说明书

1、阿法依泊汀注射液|PROCRIT(Epoetin alfa） 【中文品名】阿法依泊汀【药效类别】抗贫血药【通用药名】EPOETIN ALFA【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 【CA登记号】113427-24-0【结 构 式】【分 子 式】CHNOPS·【分 子 量】【收录药

2、典】【开发单位】Amgen【首次上市】1989年，美国【性状】【用途】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。(促红细胞生成素- epoetin epo，利血宝，怡泼津)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-，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

3、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413h。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23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

4、高、瘙痒、皮疹、过敏性休克。【注意事项】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，使用本品应注意补充铁质。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。【制剂、规格及参考单价】注射液：1500u/瓶， 3000u/瓶，EPOGEN® (Epoetin alfa) is used to treat a lower than normal number of red blood cells (anemia) caused by chronic kidne

5、y 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 treatmen

6、t (red blood cell transfusions).Important Safety InformationUsing 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

7、 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

8、®. 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;

9、 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 conscio

10、usness (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 Onc

11、ology 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

12、 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

13、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 f

14、inished 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 Profes

15、sional (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) t

16、hat 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 pat

17、ients 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.

18、 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 bodys ability to make red blood cells and cause you to have severe anemia. Call

19、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.