药品信息:
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安进公司贫血症治疗新药Aranesp临床试验呈现正面结果 在进行了475例心力衰竭及贫血症患者的临床试验后,Amgen公司负责贫血症治疗新药Aranesp开发的Scott Wasserman博士近日在欧洲心脏病学会会议上说:“所有的数据都表明,我们正沿着正确的方向前进。”
Wasserman博士表示,尽管目前进行的临床试验只是为了验证药物的安全性而非有效性,但就目前的试验结果来看,Aranesp不仅可以安全的用于心力衰竭患者的治疗,而且可以显著改善临床症状。荷兰Groningen大学医学中心的Dirk J. van Veldhuisen教授表示,目前的结果非常喜人,因为现在还没有一种手段可以有效治疗贫血症引起的心力衰竭,而Aranesp可望为我们提供一种新的治疗手段。
目前Aranesp已经被美国FDA批准用于化疗引起的贫血,Amgen公司希望将其适应症进一步扩大,目前扩大适应症的临床试验正在筹备当中,预计将有3400名患者参与试验。
部分中文阿法达贝泊汀处方资料(仅供参考)
1. Aranesp的劑量調整是依照適應症而有所不同。由於有較長的血中半衰期,Aranesp的給藥頻率少於Epoetin alfa (例如:當Epoetin alfa 每週給藥3次,Aranesp則應每週給藥一次)。 2. 起始劑量︰a.治療貧血︰治療慢性腎衰竭患者的貧血症狀,Aranesp的建議起始劑量為每公斤體重0.45毫微克,靜脈注射或皮下注射每週一次。因為患者的個體差異,Aranesp給藥應逐漸校正到維持患者的血紅素濃度不超過目標值12g/dL。b.從Epoetin alfa治療轉換成Aranesp︰因為AranespR具有較長的血漿半衰期,給藥的頻率相對比Epoetin alfa少。若患者先前Epoetin alfa每週給藥2到3次,則Aranesp應每週給藥一次。若患者先前Epoetin alfa每週給藥一次,則Aranesp應每兩週給藥一次。原先的給藥途徑維持不變(靜脈注射或皮下注射)。 3. 劑量調整:增加Aranesp的藥量時,頻率每個月不應多於一次。如果患者的血紅素濃度上升並接近12g/dL,就需要降低大約25%的Aranesp給藥劑量。如果患者的血紅素濃度持續上升,Aranesp就需要暫時停藥直到血紅素濃度下降,血紅素濃度回復後再度給藥,Aranesp的起始劑量就需要降低大約25%的原來給藥劑量。如果患者的血紅素濃度在兩週內上升超過1g/dL,就需要降低大約25%的Aranesp給藥劑量。 4. 維持劑量:如果患者的血紅素濃度超過12g/dL以上,則應依照上述調整劑量。則應依照上述調整劑量。Aranesp的劑量調整必須個別化,以確保每位患者能夠維持適當的血紅素濃度。 5. 接受化學治療之癌症患者︰建議之起始劑量為2.25mcg/kg皮下注射每週1次。每患者之劑量應調整以維持目標血紅素值。治療6週後,假如血紅素值增加少於1.0g/dL,則Aranesp之劑量應增至4.5mcg/kg。假如於兩週內血紅素值增加超過1.0g/dL,或血紅素值超過12g/dL,則劑量應減少約25%。假如血紅素值超過13g/dL,則劑量應暫時保留直到血紅素值降至12g/dL。基於此點,再重新治療之劑量應比先前劑量減少大約25%。 6. 調配及給藥時注意事項:a.請勿振搖Aranesp,劇烈振搖可能造成Aranesp蛋白變性,導致Aranesp喪失生物活性。b.在調配Aranesp之前,應先檢視藥品溶液是否有顆粒或變色的情形。請勿使用有顆粒或變色Aranesp藥品溶液。c.請勿稀釋Aranesp。d.請勿將Aranesp與其他藥品溶液混合調配。e.Aranesp為單劑量玻璃瓶裝而且不含防腐劑,開封後未使用的藥品請丟棄。請勿儲存未使用的藥品。
Aranesp® is contraindicated in patients with uncontrolled hypertension. Patients with chronic renal failure (CRF) experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels in two clinical studies. Patients with CRF and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular events and mortality than other patients. These events included myocardial infarction, stroke, congestive heart failure, and hemodialysis vascular access thrombosis. A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these risks. Seizures have occurred in patients with CRF participating in Aranesp® clinical trials.
Cases of pure red cell aplasia (PRCA) and of severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin have been reported in patients treated with Aranesp®. This has been reported predominantly in patients with CRF receiving ESAs by subcutaneous administration. PRCA has also been reported in patients receiving ESAs while undergoing treatment for hepatitis C with interferon and ribavirin. A sudden loss of response to Aranesp®, accompanied by severe anemia and low reticulocyte count, should be evaluated. If anti-erythropoietin antibody-associated anemia is suspected, withhold Aranesp® and other ESAs. Aranesp® should be permanently discontinued in patients with antibody-mediated anemia. Patients should not be switched to other ESAs as antibodies may cross-react.
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(20097720562121.pdf)的“原文Priscribing Information”为准 ---------------------------------------------------------------
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