部份中文阿法依泊汀处方资料(仅供参考) 英文药名:Procrit(epoetin alfa Injection) 中文药名:阿法依泊汀 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 PROCRIT Rx Generic Name and Formulations: Epoetin alfa 2000 Units, 3000 Units, 4000 Units, 10000 Units, 40000 Units; per mL; soln for IV or SC inj; contains albumin (human); preservative-free. Company: Janssen Biotech, Inc. Indications for PROCRIT: Anemia in chronic kidney disease (CKD). Anemia related to zidovudine in HIV-infected patients. Chemotherapy-induced anemia in patients with non-myeloid malignancies with a minimum of two additional months of planned chemotherapy upon initiation. To reduce need for allogeneic blood transfusions in anemic (hemoglobin >10 to ≤13g/dL) patients scheduled for elective, noncardiac, nonvascular surgery. Adult: Individualize (see full labeling for titration). CKD: initially 50–100 Units/kg 3 times per week IV (dialysis or non dialysis) or SC (non dialysis); usual max (non dialysis) 150 Units/kg 3 times per week; (dialysis) 200 Units/kg 3 times per week; target hemoglobin: 10–12g/dL. Zidovudine-treated HIV patients: if serum erythropoietin ≤500 mUnits/mL and zidovudine dose ≤4.2g/wk: initially 100 Units/kg IV or SC 3 times per week for 8 weeks; usual max 300 Units/kg 3 times per week. Chemotherapy-induced: initially 150 Units/kg SC 3 times per week; may increase to 300 Units/kg 3 times per week after 8 weeks. Or, initially 40000 Units SC once weekly; may increase to 60000 Units once weekly after 4 weeks. Discontinue after completion of chemotherapy course. Surgery: If ≥21 days until surgery: 600 Units/kg once weekly SC at 21, 14 and 7 days before surgery, and a 4th dose on day of surgery. If <21 days until surgery: 300 Units/kg per day SC for 10 days before, on day of, and for 4 days after surgery. All: adjust dose to maintain the lowest hemoglobin level (target max 12g/dL) sufficient to avoid red blood cell transfusion; see full labeling. Children: Individualize (see full labeling for monitoring). CKD (dialysis): <1 month: not recommended. ≥1 month: initially 50 Units/kg three times per week IV or SC. Target hemoglobin: 10–12g/dL. Chemotherapy-induced: ≥5yrs: 600 Units/kg IV weekly (max 40,000 Units); may increase to 900 Units/kg IV weekly (max 60,000 Units) after 4 weeks. Discontinue after completion of chemotherapy course. Other uses: see full labeling. Contraindications: Uncontrolled hypertension. Pure red cell aplasia that begins after Procrit or other erythropoietin drug therapy. Also with Multidose: neonates and infants. Pregnancy. Nursing mothers. Warnings/Precautions: See full labeling. Increased mortality, MI, stroke, and thromboembolism. Coexistent cardiovascular disease and stroke. Increased risk of tumor progression or recurrence in those with cancer. Evaluate serum iron, ferritin, transferrin saturation before therapy; all patients will need iron supplementation. Monitor hemoglobin (measure twice weekly for 2–6 weeks after any dosage adjustment; reduce dose if hemoglobin increases >1g/dL in any 2-week period; withhold dose if hemoglobin exceeds 12g/dL), blood pressure, renal function, iron levels, clotting times, serum chemistry, CBC, and for premonitory neurological symptoms. Seizure disorders. Hematologic disorders. Hypertension (esp. in renal failure). Porphyria. Concurrent infection, inflammation, increased zidovudine dose, or other factors may reduce effectiveness. Possible risk for viral disease and Creutzfeldt-Jakob disease transmission. Discontinue if severe skin reaction (eg, SJS, TEN) is suspected. Perisurgery: consider DVT prophylaxis. Consider other etiologies in treatment failures. Adjust anticoagulant dose in dialysis patients. Menses may resume. Neonates and infants (use single-dose vials). Pregnancy. Nursing mothers. Pharmacological Class: Erythropoietin (human, recombinant). Interactions: ESAs increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence. Adverse Reactions: Iron deficiency, hypertension, headache, arthralgia, GI disturbances, edema, local reaction, rash (may be severe), paresthesia, dizziness, clotted vascular access (A-V shunt), pyrexia, respiratory congestion, seizures. Increased risk of death, cardiovascular or thrombotic events if hemoglobin >12g/dL. May stimulate tumor growth, shorten time to tumor progression or overall survival if hemoglobin ≥12g/dL. Children: also abdominal pain, upper respiratory infection, cough, pharyngitis, constipation. How Supplied: Single-use 1mL vials (2000 Units/mL, 3000 Units/mL, 4000 Units/mL)—6; Single-use 1mL vials (10000 Units/mL)—6, 25; Single-use 1mL vials (40000 Units/mL)—4; Multidose 2mL vials (10000 Units/mL)—4; Multidose 1mL vials (20000 Units/mL)—4
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