奥普瑞粉末注射剂Oprelvekin(Neumega Injection 5mg)

产地国家美国

处方药

所属类别 5毫克/瓶

包装规格 5毫克/瓶

计价单位

生产厂家英文名WYETH PHARMACEUTICALS

原产地英文商品名NEUMEGA Injection 5mg/Vial

原产地英文药品名OPRELVEKIN

中文参考商品译名纽密伽粉末注射剂 5毫克/瓶

中文参考药品译名奥普瑞白介素

简介

NEUMEGA(oprelvekin)Neumega(Oprelvekin)已被批准用于促进正在接受化疗的实体瘤或淋巴瘤患者体内血小板供应的产生。通过显著降低严重低血小板水平(血小板减少症)的发生率,Neumega可能会给一些癌症患者提供更好的机会接受治疗,他们需要与疾病作斗争。

临床结果:在涉及170例患者的临床试验中,Neumega降低了严重化疗所致血小板耗竭的发生率,减少了对血小板的输血需求,减少了所需的血小板输血数量。

适应症:Neumega用于预防严重血小板减少症,减少成人非髓系恶性肿瘤患者在接受骨髓抑制化疗后输血的需要。对于在前一个化疗周期后出现严重血小板减少的患者,疗效得到证实。骨髓消融化疗后不提示使用Neumega(见警告,骨髓消融治疗后毒性增加)。Neumega的安全性和有效性尚未在儿科患者中得到证实。

用法用量:没有严重肾功能损害的成人推荐的Neumega剂量为50微克/公斤,每日一次。Neumega应在腹部、大腿或臀部(或上臂,如果不是自体注射)皮下注射一次。在儿童中还没有确定安全有效的剂量(见预防措施,儿童使用)。成人严重肾功能损害患者(肌酐清除率< 30mL/min)推荐的Neumega剂量为25 mcg/kg。需要估计患者的肌酐清除率(CLcr)(mL/min)。根据血肌酐(mg/dL)的测定,可以使用以下公式估计mL/min的CLcr:男:(体重(公斤)x(140岁)(72)血清肌酐(mg/100mL)女性(0.85)x(高于数值)化疗结束后6-24小时开始给药。应定期监测血小板计数,以评估最佳治疗时间。剂量应持续到≥50000/μL post-nadir血小板计数。在对照临床试验中,给药时间为10至21天。不建议每次疗程服用超过21天。在开始下一个化疗周期前至少两天,应停止使用Neumega的治疗。

副作用:与Neumega治疗相关的最常见副作用包括周围水肿、呼吸困难、心动过速和结膜发红。

警告:过敏反应包括过敏反应Neumega引起过敏或超敏反应,包括过敏反应。任何出现过敏或超敏反应的患者应永久停用Neumega(见警告、禁忌、不良反应及不良反应、免疫原性)。

英文版说明书

NDICATIONSNeumega is indicated for the prevention of severe thrombocytopenia and the reduction of the need for platelet transfusions following myelosuppressive chemotherapy in adult patients with nonmyeloid malignancies who are at high risk of severe thrombocytopenia.Efficacy was demonstrated in patients who had experienced severe thrombocytopenia following the previous chemotherapy cycle.Neumega is not indicated following myeloablative chemotherapy (see WARNINGS, Increased Toxicity Following Myeloablative Therapy). The safety and effectiveness of Neumega have not been established in pediatric patients.DOSAGE AND ADMINISTRATIONThe recommended dose of Neumega in adults without severe renal impairment is 50 mg/kg given once daily.Neumega should be administered subcutaneously as a single injection in either the abdomen, thigh, or hip (or upper arm if not self-injecting).A safe and effective dose has not been established in children (see PRECAUTIONS, Pediatric Use).The recommended dose of Neumega in adults with severe renal impairment (creatinine clearance <30 mL/min) is 25 mg/kg.An estimate of the patient’s creatinine clearance (CLcr) in mL/min is required. CLcr in mL/min may be estimated from a spot serum creatinine (mg/dL) determination using the following formula:CLcr »[140 – age (years)] x weight (kg)72 x serum creatinine (mg/dL) {x 0.85 for female patients}Dosing should be initiated six to 24 hours after the completion of chemotherapy. Platelet counts should be monitored periodically to assess the optimal duration of therapy. Dosing should be continued until the post-nadir platelet count is ≥50,000/mL.In controlled clinical trials, doses were administered in courses of 10 to 21 days. Dosing beyond 21 days per treatment course is not recommended.Treatment with Neumega should be discontinued at least two days before starting the next planned cycle of chemotherapy.Preparation of Neumega1. Neumega is a sterile, white, preservative-free, lyophilized powder for subcutaneous injection upon reconstitution.Reconstitute the Neumega 5 mg vial using the 1.0 mL of Sterile Water for Injection, USP (without preservative) contained in the pre-filled syringe included in the kit The reconstituted Neumega solution is clear, colorless, isotonic, with a pH of 7.0, and contains 5 mg/mL of Neumega. Any unused portion of the reconstituted Neumega solution should be discarded.2. During reconstitution, the Sterile Water for Injection, USP should be directed at the side of the vial and the contents gently swirled. Excessive or vigorous agitation should be avoided.3. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If particulate matter is present or the solution is discolored, the vial should not beused.4. Administer Neumega within 3 hours following reconstitution.Reconstituted Neumega may be refrigerated [2°C to 8°C (36°F to 46°F)] or maintained at room temperature [up to 25°C (77°F)]. Do not freeze or shake the reconstituted solution.HOW SUPPLIEDNeumega is supplied as a sterile, white, preservative-free, lyophilized powder  in vials containing 5 mg oprelvekin.Neumega is available in boxes containing one single-dose Neumega vial and one pre-filled syringe containing 1 mL Sterile Water for Injection, USP.- NDC 58394-004-08StorageThe kit containing the vial of lyophilized Neumega and pre-filled diluent syringe should be stored in a refrigerator at 2°C to 8°C (36°F to 46°F). Protect Neumega powder from light. Do not freeze.United States Patent Numbers: 5,215,895; 5,270,181; 5,371,193; 6,066,317; 6,143,524; 6,270,757.This product’s label may have been updated. For current package insert and further product information, please visit www.wyeth.com or call our medical communications department toll-free at 1-800-934-5556.WyethÃ?Wyeth Pharmaceuticals Inc.Philadelphia, PA 19101US Govt. License No. 3FDA rev date: 08/10/06.

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