造商 Roche 成份 Methoxy polyethylene glycol- epoetin β 適應症 Treatment of symptomatic anemia associated with chronic kidney disease (CKD). Not indicated for the treatment of anemia due to cancer chemotherapy. 用量 The dose should be reduced as the Hb approaches 12 g/dL or increases by > 1 g/dL in any 2-week period. Adult not currently treated with an ESA Initially 0.6 mcg/kg as a single IV/SC once every 2 weeks. Once Hb has been maintained within 10-12 g/dL, it may be administered once monthly using a dose that is twice that of the every-2-week dose & subsequently titrated as necessary. Adult currently treated with an ESA Initially administered as single IV/SC once every 2 weeks or once monthly to patients whose Hb has been stabilized: Previous weekly Epoetin α or β < 4000 u/week or Darbepoetin α < 20 mcg/week 80 mcg/mth or 40 mcg every 2 weeks. Previous weekly Epoetin α or β 4000-< 8000 u/week or Darbepoetin α 20-< 40 mcg/week 120 mcg/mth or 60 mcg every 2 weeks. Previous weekly Epoetin α or β 8000-16000 u/week or Darbepoetin α 40-80 mcg/week 200 mcg/mth or 100 mcg every 2 weeks. Previous weekly Epoetin α or β > 16000 u/week or Darbepoetin α > 80 mcg/week 360 mcg/mth or 180 mcg every 2 weeks. Dose adjustments should not be made more often than once a month. 過量 View Mircera[美血樂] overdosage for action to be taken in the event of an overdose. 禁忌 Uncontrolled hypertension. 警告 For additional cautionary notes to warn of the potential risk of using the medicine... click to view Mircera[美血樂] detailed prescribing infomation 注意事項 When therapy is initiated or adjusted, Hb should be monitored every 2 weeks until stabilized, & every 2-4 weeks thereafter. Patients with chronic renal failure & an insufficient Hb response to ESA therapy may be at even greater risk for CV events & mortality. Safety & efficacy have not been established for use among patients with anemia due to cancer chemotherapy or for reduction in the need for allogeneic RBC transfusion in the peri-surgical setting. BP should be controlled adequately before initiation of therapy. Special care should be taken to closely monitor & control BP during therapy, especially in patients with a history of CV disease or hypertension. Monitor for presence of premonitory neurologic symptoms, renal function & fluid electrolyte balance. Any patient who develops a sudden loss of response to the therapy, accompanied by severe anemia & low reticulocyte count, should be evaluated for the etiology of the altered Hb response, including evaluation for the development of neutralizing antibodies to erythropoietin. Deficiencies of Fe, folic acid & vit B12 should be excluded or corrected if lack of a Hb response or failure to maintain a Hb response within recommended dose. Patients who are marginally dialyzed may require adjustments in their dialysis prescription. Pregnancy, lactation. 不良反應 Hypertension, diarrhea, nasopharyngitis, headache & upper respiratory tract infections. Increased mortality, serious cardiovascular & thromboembolic events; Increased mortality and/or tumor progression; seizures; pure red cell aplasia. View ADR Monitoring Website[參閱藥物不良反應監測表格] 交互作用 No formal drug/drug interaction studies have been performed. View more drug interactions with Mircera[美血樂] 儲存 View Mircera[美血樂] storage conditions for details to ensure optimal shelf-life. 描述 View Mircera[美血樂] description for details of the chemical structure and excipients (inactive components). 作用 View Mircera[美血樂] mechanism of action for pharmacodynamics and pharmacokinetics details. MIMS 藥理分類 造血、補血藥 (Haematopoietic Agents) ATC 分類 B03XA01 - Erythropoietin ; Belongs to the class of other antianemic preparations. 欧盟批准抗贫血药甲氧基聚乙二醇促红细胞生成素-β注射剂上市 欧盟批准罗氏公司的甲氧基聚乙二醇促红细胞生成素-β注射剂（methoxy polyethylene glycol-epoetin beta，Mircera）上市，一月1次治疗慢性肾病（CKD）引起的贫血。本品注射液剂量规格：甲氧基聚乙二醇促红细胞生成素-β 50 μg /mL〕、 100 μg /mL、200 μg /mL、300 μg /mL、400 μg /mL、 600 μg /mL及1000 μg /mL/瓶；预填充注射剂每支：甲氧基聚乙二醇促红细胞生成素-β 50 μg/0.3 mL、75 μg/0.3 mL、 100 μg/0.3 mL、150 μg/0.3 mL、 200 μg/0.3 mL、250 μg/0.3 mL、400 μg/0.6 mL、600 μg/0.6 mL和 800 μg/0.6 mL。
