Continuous erythropoietin receptor activator (Mircera) for renal anemia.
(1) Continuous erythropoietin receptor activator (CERA) is a third-generation erythropoiesis stimulating agent (ESA). CERA is used to correct anemia and maintain hemoglobin levels in patients with renal (kidney) failure. CERA is administered either once every two weeks (to correct anemia) or once per month (to maintain hemoglobin levels). This offers a potential advantage over other ESAs that require more frequent administration. (2) Two phase 3 trials involving erythropoietin-naïve patients found no difference between correcting renal anemia with CERA once every two weeks compared to results with other ESAs that were administered up to three times weekly. Four phase 3 trials reported that maintenance of stable hemoglobin levels in dialysis patients with once-monthly CERA was comparable to other agents that were administered up to three times weekly. Further clinical trials are needed to examine other important outcomes, such as mortality and major adverse effects. (3) The most common adverse effects with CERA were hypertension, diarrhea, headache, and upper respiratory tract infection. There was a higher risk of procedural hypotension (low blood pressure during administration), gastrointestinal hemorrhage, and tachycardia with CERA compared to other ESAs. (4) Administration of CERA at extended intervals may simplify anemia management, reduce the burden on patients, and decrease health care staff time spent administering the treatment.
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D000740:Anemia / Q000188:drug therapy* / Q000209:etiology; D002170:Canada; D017326:Clinical Trials, Phase III as Topic; D017277:Drug Approval; D004921:Erythropoietin / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D006801:Humans; D007674:Kidney Diseases / Q000150:complications / Q000188:drug therapy*; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D017467:Receptors, Erythropoietin / Q000378:metabolism; D006435:Renal Dialysis; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration
D017467:Receptors, Erythropoietin; D004921:Erythropoietin; D011092:Polyethylene Glycols