英文药名:Procrit(epoetin alfa Injection)   中文药名:阿法依泊汀注射剂 生产厂家：JOM PHARMACEUTICAL 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。 (促红细胞生成素-α 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-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://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 GENERIC NAME: epoetin alfa BRAND NAME: Epogen, Procrit DRUG CLASS AND MECHANISM: Epoetin alfa is a man-made, injectable drug for treating anemia. Erythropoietin is a protein that normally is made in the body by the kidney. It causes the bone marrow to produce oxygen-carrying red blood cells. Under normal conditions, when the body senses a decrease in red blood cells or a deficiency in the supply of oxygen, more erythropoietin is produced, and this increases the number of red blood cells. When this natural mechanism is not working, it may become necessary to stimulate the bone marrow to produce red blood cells. The erythropoietin that is used for therapy, called epoetin alfa, is man-made. It is a product of the genetic engineering of ovarian cells of the Chinese hamster and is produced through recombinant DNA technology in bacteria. It does not cure the underlying cause of the anemia, and unless the underlying cause can be reversed, treatment with epoetin alfa must be continued indefinitely. Epoetin alfa belongs to a class of drugs called colony-stimulating factors because of their ability to stimulate cells in the bone marrow to multiply and form colonies of identical cells. Other colony-stimulating factors include filigrastim (Neupogen) and sargramostim (Leukine). Epogen and Procrit are both epoetin alfa, but they are marketed by two different pharmaceutical companies. GENERIC AVAILABLE: No PRESCRIPTION: Yes PREPARATIONS: Epoetin alfa is available as a liquid for injection in vials containing from 2,000 to 40,000 units of epoetin alfa. STORAGE: Epoetin alfa should be stored at 2-8°C (36-46°F). It should not be frozen. Multiple-use vials should be used within 21 days of the first use. PRESCRIBED FOR: Epoetin alfa is used to treat anemia that is associated with chronic kidney failure in patients who are or will be receiving renal dialysis. It also is used to treat anemia in patients with HIV infection who are receiving zidovudine and in patients with cancer who are receiving chemotherapyand develop anemia. Epoetin alfa may be used to replace transfusions of red blood cells in patients who are anemic and undergoing surgery. Epoetin alfa has not been shown to improve fatigue or quality of life in patients with cancer. DOSING: Epoetin alfa is administered intravenously or subcutaneously (under the skin) at 50-300 units per kilogram of weight, three times weekly. The dose is tailored to each patient based on targeted hemoglobin levels. Adult patients with cancer receiving chemotherapy may be treated with 40,000 to 60,000 units subcutaneously weekly. Epoetin alfa vials should not be shaken since the drug may be damaged, and bubbles may form that prevent some of the drug from being drawn up into the syringe during injection. Iron stores should be evaluated before therapy and supplemental iron should be administered if needed. DRUG INTERACTIONS: No clinical studies have been done to demonstrate epoetin alfa drug interactions. PREGNANCY: There are no studies of epoetin alfa use in pregnant women . NURSING MOTHERS: It is not known if epoetin alfa is excreted into breast milk. SIDE EFFECTS: Epoetin alfa is well-tolerated. The most common side effects in patients with kidney failure on dialysis are high blood pressure, headache, joint-pain and clotting at the injection site. Rare cases of stinging at the injection site, skin rash and flu-like symptoms (joint and muscle pain) have occurred within a few hours following administration. Allergic reactions, seizures and thrombotic events (e.g., heart attacks, strokes, and pulmonary embolism ) rarely occur. In HIV-infected patients receiving zidovudine, the most common side effects with epoetin alfa are fever, headache, rash, and nasal or chest congestion. Rare cases of seizures or severe rash have occurred in these patients. The most common side effects in patients undergoing surgery with anemia are fever, nausea, constipation, skin reactions, vomiting and headaches. Blood clots in veins, referred to as a deep venous thrombosis, also may occur. Among patients with cancer receiving chemotherapy, the most common side effects of epoetin alfa are fever, diarrhea, tissue swelling, shortness of breath, paresthesia (abnormal sensations like burning or prickling that may occur anywhere in the body), and upper respiratory infection. Treatment with epoetin alfa may increase the growth of several types of cancer and reduce survival, and, therefore, its use should be restricted to the conditions discussed previously.