NEWS HIGHLIGHTSMedia Articles Related to Aranesp (Erythropoiesis Stimulating Protein)
Aranesp Misbranding - Amgen Agrees $762 Million Payment
Source: Litigation / Medical Malpractice News From Medical News Today [2012.12.19]
After being found guilty of promoting off-label use of Aranesp (darbepoetin alfa), an anemia drug, Amgen Inc. agreed to pay $150 million in criminal fines and penalties. Prosecutors added that the company will also pay $612 in civil settlements. The settlement would include a payment to a former Aranesp product manager, Kassie Westmoreland, to resolve a whistleblower lawsuit...
FDA: New Warning for Procrit, Epogen, Aranesp
Source: MedicineNet epoetin alfa Specialty [2011.06.27]
Title: FDA: New Warning for Procrit, Epogen, Aranesp
Category: Health News
Created: 6/25/2011 11:01:00 AM
Last Editorial Review: 6/27/2011 12:00:00 AM
FDA approves extended dosing of Aranesp
Source: The Doctors Lounge - Hematology
FDA has approved every-3-week dosing of Aranesp (darbepoetin alfa) for treatment of chemotherapy - induced anemia.
Published Studies Related to Aranesp (Erythropoiesis Stimulating Protein)
The Primavera study protocol design: evaluating the effect of continuous erythropoiesis receptor activator (C.E.R.A.) on renal function in non-anemic patients with chronic kidney disease. [2011.11]
Erythropoiesis stimulating agents (ESA) are widely used for hemoglobin correction in patients suffering from renal anemia. However, their beneficial non-hematopoietic effects on renal deterioration have not been adequately assessed...
Changes in erythropoiesis-stimulating agent (ESA) dosing and haemoglobin levels in US non-dialysis chronic kidney disease patients between 2005 and 2009. [2011.05]
BACKGROUND: Recent clinical trials in cancer patients treated with erythropoiesis-stimulating agents (ESAs) and in CKD patients treated to haemoglobin (Hb) targets above the labeled range of 10-12 g/dL with ESAs raised safety concerns regarding ESA therapy. Subsequently, product labeling was revised including addition of a black-box warning and removal of many quality of life claims not supported by current standards, and there were changes in reimbursement and anaemia guidelines. The extent to which these events influenced ESA dosing and Hb levels in patients with chronic kidney disease not on dialysis (CKD-NOD) is not known... CONCLUSION: The emergence of safety concerns and the subsequent changes in product labeling, reimbursement and clinical practice guidelines all appear to have influenced physician dosing practices resulting in less frequent use of ESAs, lower ESA doses and lower achieved Hb levels in CKD-NOD patients.
Are there implications from the Trial to Reduce Cardiovascular Events with Aranesp Therapy study for anemia management in dialysis patients? [2010.11]
PURPOSE OF REVIEW: Publication of the first large randomized placebo-controlled study of erythropoiesis-stimulating agent (ESA) treatment of anemia in patients with chronic kidney disease (CKD) not on dialysis, the Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) along with recent changes in the regulatory environment and reimbursement policies related to ESA treatment have prompted reexamination of clinical ESA use in patients with CKD, including those on dialysis.
Target haemoglobin to aim for with erythropoiesis-stimulating agents: a position statement by ERBP following publication of the Trial to reduce cardiovascular events with Aranesp therapy (TREAT) study. [2010.09]
The European Renal Best Practice (ERBP), which are issued by ERA-EDTA, are suggestions for clinical practice in areas in which evidence is lacking or weak, together with position statements on recently published randomized controlled trials, or on existing guidelines and recommendations... These recommendations are not intended to represent a new guideline as they are not the result of a systematic review of the evidence.
Are there implications from the Trial to Reduce Cardiovascular Events with Aranesp Therapy study for anemia management in dialysis patients? [2010.07.01]
PURPOSE OF REVIEW: Publication of the first large randomized placebo-controlled study of erythropoiesis-stimulating agent (ESA) treatment of anemia in patients with chronic kidney disease (CKD) not on dialysis, the Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) along with recent changes in the regulatory environment and reimbursement policies related to ESA treatment have prompted reexamination of clinical ESA use in patients with CKD, including those on dialysis.
Clinical Trials Related to Aranesp (Erythropoiesis Stimulating Protein)
An Evaluation of Aranesp® in Subjects With Anaemic Chronic Kidney Disease (CKD) [Completed]
The purpose of this study is to assess if Aranesp® administered once every 4 weeks to chronic
kidney disease subjects is safe and efficacious in maintaining haemoglobin levels greater
than or equal to 100 g/L.
A Dose Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid Tumor [Completed]
To assess the clinical effective dose of KRN321 administered with once triweekly schedule.
Darbepoetin Alfa (Aranesp) Following Allogeneic Stem Cell Transplantation [Completed]
The purpose of this study is to find out if Darbepoetin alfa is effective in treating low red
blood cell levels after allogeneic stem cell transplant. Darbepoetin alfa has been shown to
help raise red blood cell levels without blood transfusions.
Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Subjects With Chronic Kidney Disease [Recruiting]
The primary objectives of this study are the following:
1. To test if the proportion of subjects achieving a hemoglobin value greater than or
equal to 10. 0 g/dL at any time point after the first dose during the study is greater
than 0. 8 when administered de novo darbepoetin alfa QW for treatment of anemia in
pediatric subjects with chronic kidney disease receiving and not receiving dialysis,
and
2. To test if the proportion of subjects achieving a hemoglobin value greater than or
equal to 10. 0 g/dL at any time point after the first dose during the study is greater
than 0. 8 when administered de novo darbepoetin alfa Q2W for treatment of anemia in
pediatric subjects with chronic kidney disease receiving and not receiving dialysis
Study of Aranesp to Treat Anemia in Prostate Cancer Patients. [Completed]
The purpose of this study is to see if darbepoetin alfa is an effective treatment for anemia
in prostate cancer patients and, if so, what dose is most effective. Sometimes prostate
cancer patients have low red blood cell counts (low hemoglobin) from various treatments they
are receiving, such as chemotherapy. The red blood cells deliver oxygen to the tissue. This
then helps give the patient more energy.
Reports of Suspected Aranesp (Erythropoiesis Stimulating Protein) Side Effects
Aplasia Pure RED Cell (97),
Haemoglobin Decreased (88),
Anaemia (82),
Drug Ineffective (81),
Therapeutic Response Decreased (67),
Death (60),
Fatigue (36),
Dyspnoea (31),
Asthenia (28),
Hospitalisation (20), more >>
|
