英文药名:Procrit(epoetin alfa Injection)   中文药名:阿法依泊汀注射剂 生产厂家：JANSSEN PRODUCTS, LP 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 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 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://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5 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] PROCRIT 10000U/ML 1ML SDV 25/PAC  EPOETIN ALFA  "JANSSEN PRODUCTS, LP"  59676-0310-02             PROCRIT 10000U/ML 1ML SDV 6/PAC  EPOETIN ALFA  "JANSSEN PRODUCTS, LP"  59676-0310-01             PROCRIT 10000U/ML 2ML MDV 4/PAC  EPOETIN ALFA  "JANSSEN PRODUCTS, LP"  59676-0312-04          PROCRIT 20000U/ML 1ML MDV 4/PAC  EPOETIN ALFA  "JANSSEN PRODUCTS, LP"  59676-0320-04   PROCRIT 2000U/ML 1ML SDV 6/PAC  EPOETIN ALFA    59676-0302-01            PROCRIT 3000U/ML 1ML SDV 6/PAC  EPOETIN ALFA  "JANSSEN PRODUCTS, LP"  59676-0303-01     PROCRIT 40000U/ML 1ML SDV 4/PAC EPOETIN ALFA  "JANSSEN PRODUCTS, LP"  59676-0340-01  PROCRIT 4000U/ML 1ML SDV 6/PAC  EPOETIN ALFA    59676-0304-01             PROCRIT VL 40000U 1ML 4 NR EPOETIN ALFA  JOM PHARMACEUTICAL  59676-0340-01 PROCRIT MDV 10000U/ML 2ML 4 NR  EPOETIN ALFA  JOM PHARMACEUTICAL  59676-0312-04 PROCRIT MDV 20000U/ML 1ML 4 NR  EPOETIN ALFA  JOM PHARMACEUTICAL  59676-0320-04 PROCRIT VL 2000U 1ML 6NR  EPOETIN ALFA  JOM PHARMACEUTICAL  59676-0302-01 PROCRIT VL 3000U 1ML 6NR  EPOETIN ALFA  JOM PHARMACEUTICAL  59676-0303-01 PROCRIT VL 4000U 1ML 6NR  EPOETIN ALFA  JOM PHARMACEUTICAL  59676-0304-01 PROCRIT VL 10000U 1ML 6NR EPOETIN ALFA  JOM PHARMACEUTICAL  59676-0310-01 PROCRIT VL 10000U 1ML 25NR EPOETIN ALFA  JOM PHARMACEUTICAL  59676-0310-02  --------------------------------------------- Procrit(epoetin alfa)Injection Important Safety Information For PROCRIT® What is the most important information I should know about PROCRIT® (epoetin alfa)? PROCRIT® may cause serious side effects that can lead to death, including: For people with cancer: Your tumor may grow faster and you may die sooner if you choose to take PROCRIT®. Your healthcare provider will talk with you about these risks. For all people who take PROCRIT®, including patients 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 PROCRIT® 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 PROCRIT®. If you are receiving PROCRIT ® for any reason and you are going to have surgery, talk to your healthcare provider about whether or not you need to take a blood thinner to lessen the chance of blood clots during or following surgery. Blood clots can form in blood vessels (veins), especially in your leg (deep venous thrombosis or DVT). Pieces of a blood clot may travel to the lungs and block the blood circulation in the lungs (pulmonary embolus). 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 in your legs, with or without swelling 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 PROCRIT®, your healthcare provider should prescribe the smallest dose of PROCRIT® that is necessary to reduce your chance of needing red blood cell transfusions. Who should not take PROCRIT®? Do not take PROCRIT® if you: Have cancer and have not been counseled by your healthcare provider about treatment with PROCRIT®. 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 PROCRIT® or other erythropoietin protein medicines. Have had a serious allergic reaction to PROCRIT®. Do not give PROCRIT® from multiple-dose vials to: Pregnant or breastfeeding women Babies What should I tell my healthcare provider before taking PROCRIT®? PROCRIT® may not be right for you. Tell your healthcare provider about all your health conditions, including if you: Have heart disease. Have high blood pressure. Have had a seizure (convulsion) or stroke. Receive dialysis treatment. Have any other medical conditions. Are pregnant or planning to become pregnant. It is not known if PROCRIT® may harm your unborn baby. Talk with your healthcare provider about possible pregnancy and birth control choices that are right for you. Are breastfeeding or planning to breastfeed. It is not known if PROCRIT® passes into breast milk. Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. What are the possible side effects of PROCRIT®? PROCRIT® may cause serious side effects. See "What is the most important information I should know about PROCRIT®?" High blood pressure. High blood pressure is a common side effect of PROCRIT® in patients with chronic kidney disease. Your blood pressure may go up or be difficult to control with blood pressure medicine while taking PROCRIT®. This can happen even if you have never had high blood pressure before. Your healthcare provider should check your blood pressure often. If your blood pressure does go up, your healthcare provider may prescribe new or more blood pressure medicine. Seizures. If you have any seizures while taking PROCRIT®, get medical help right away and tell your healthcare provider. Antibodies to PROCRIT®. Your body may make antibodies to PROCRIT®. These antibodies 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 unusual tiredness, lack of energy, dizziness, or fainting. You may need to stop taking PROCRIT®. Serious allergic reactions. Serious allergic reactions can cause a skin rash, itching, shortness of breath, wheezing, dizziness and fainting because of a drop in blood pressure, swelling around your mouth or eyes, fast pulse, or sweating. If you have a serious allergic reaction, stop using PROCRIT® and call your healthcare provider or get medical help right away. Sever skin reactions. Signs and symptoms of severe skin reactions with PROCRIT® 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 PROCRIT® and call your healthcare provider or get medical help right away. Dangers of using PROCRIT® from multiple-dose vials in newborns, infants, and pregnant or breastfeeding women. Do not use PROCRIT® from multiple-dose vials in newborns, infants, pregnant or breastfeeding women because the PROCRIT® in these vials contains benzyl alcohol. Benzyl alcohol has been shown to cause brain damage, other serious side effects, and death in newborn and premature babies. If you use PROCRIT® from multiple-dose vials, you should not breastfeed for at least 2 weeks after the last dose. PROCRIT® that comes in single-dose vials does not contain benzyl alcohol. See "Who should not take PROCRIT®?". Common side effects of PROCRIT® include: Joint, muscle, or bone pain Fever Cough Dizziness High blood sugar Low potassium levels in the blood Chills Redness and pain at the PROCRIT® injection site Rash Nausea Vomiting Blood vessel blockage Low white blood cells Trouble sleeping Difficulty swallowing Soreness of mouth Itching Headache Respiratory infection Weight decrease Depression Muscle spasm These are not all of the possible side effects of PROCRIT®. Your healthcare provider can give you a more complete list. Tell your healthcare provider about any side effects that bother you or that do not go away.