DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Aranesp (Erythropoiesis Stimulating Protein) - Summary

 
 



WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE

 
Chronic Kidney Disease:

  • In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL.
  • No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks.
  • Use the lowest Aranesp dose sufficient to reduce the need for red blood cell (RBC) transfusions [see Warnings and Precautions ].

Cancer:

  • ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers [see Table 3, Warnings and Precautions].
  • Because of these risks, prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense Aranesp to patients with cancer. To enroll in the ESA APPRISE Oncology Program, visit www.esa-apprise.com or call 1-866-284-8089 for further assistance [see Warnings and Precautions ].
  • To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions [see Dosage and Administration].
  • Use ESAs only for anemia from myelosuppressive chemotherapy [see Indications and Usage ].
  • ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure [see Indications and Usage].
  • Discontinue following the completion of a chemotherapy course [see Dosage and Administration].
 

ARANESP SUMMARY

Aranesp (darbepoetin alfa) is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Aranesp is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons.

Anemia Due to Chronic Kidney Disease

Aranesp is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.

Anemia Due to Chemotherapy in Patients With Cancer

Aranesp is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.

Limitations of Use

Aranesp has not been shown to improve quality of life, fatigue, or patient well-being.

Aranesp is not indicated for use:

  • In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.
  • In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
  • As a substitute for RBC transfusions in patients who require immediate correction of anemia [see Clinical Pharmacology].

See all Aranesp indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Aranesp (Erythropoiesis Stimulating Protein)

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.

Amgen to pay $71 million over allegations of unlawfully marketing biologic medications
Source: Pharma Industry / Biotech Industry News From Medical News Today [2015.08.20]
Resolving allegations that it unlawfully promoted biologic medications Aranesp and Enbrel for uses not approved by the U.S. Food and Drug Administration (FDA), Amgen, Inc.

more news >>

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.

more studies >>

Clinical Trials Related to Aranesp (Erythropoiesis Stimulating Protein)

A Study Comparing Two Different PROCRIT Doses to a Dose of ARANESP in Anemic Cancer Patients Receiving Chemotherapy [Terminated]
The purpose of this study is to compare hemoglobin response rates between two PROCRIT (epoetin alfa) doses and ARANESP (darbepoetin alfa) in anemic cancer patients receiving chemotherapy

Safety and Efficacy Study of BCD-066 Compared to Aranesp� for Anemia Treatment in Chronic Kidney Disease Patients [Not yet recruiting]

Pharmacokinetics and Pharmacodynamics Study of BCD-066 Compared to Aranesp in Healthy Volunteers [Completed]
This is a randomized double-blind crossover study of pharmacokinetics, pharmacodynamics and safety of BCD-066 (darbepoetin alfa manufactured by CJSC BIOCAD, Russia) and Aranesp (Amgen Europe B. V., Netherlands) in healthy volunteers. The purpose of the study is to demonstrate the equivalence of pharmacokinetics, pharmacodynamics and safety parameters after single subcutaneous or intravenous injection. Each drug will be administered to each volunteer at a dose of 1 g per kilogram as a single subcutaneous or intravenous injection with an interval of at least 25 days.

A Web-based Study of Quality of Life Benefits Associated Aranesp in Anemic Patients With Cancer [Active, not recruiting]
This is a web-based pilot study to evaluate the association between the treatment of anemia with darbepoetin alfa (aranesp) and the clinical benefits in symptom palliation, improved functional status and quality of life in patients with cancer. The feasibility of web-based assessments and data capture will be evaluated.

Darbepoetin Alfa in Anemic Low or Intermediate-1 Risk MDS Subjects [Active, not recruiting]
This is a Phase 3, multicenter, randomised, double-blind, placebo-controlled trial of darbepoetin alfa 500 μg administered once every 3 weeks (Q3W) to approximately 141 low or intermediate-1 risk anaemic MDS subjects who have not previously received erythropoiesis-stimulating agents (ESAs) or biologic response modifiers to treat MDS. This study consists of a 3-week screening period, a 24-week double-blind treatment period, and a 48-week active treatment period and the long-term follow-up period. An end of treatment period (EOTP) visit occurs at week 25, or 3 weeks after last dose of investigational product (IP) for subjects who withdraw from the study. After entering the active treatment period, an end of active treatment period (EOATP) visit occurs at week 72 / 73, or 3 weeks after the last dose of darbepoetin alfa Q3W (2 weeks after the last dose of darbepoetin alfa administered every 2 weeks [Q2W]) for subjects who withdraw from the study. Long-term follow-up (LTFU) will occur every 26 weeks (± 4 weeks) from the EOATP visit (or EOTP visit if the subject does not enter the active treatment period) and will continue for a minimum of 3 years from the first dose of IP. Follow-up may occur through clinic visit or telephone contacts. Information on the subject's survival and progression to AML status will be collected during LTFU. Approximately 141 subjects who meet all eligibility requirements will be randomised in a 2: 1 ratio to 1 of 2 groups: 1. darbepoetin alfa 500 μg Q3W (n=94) 2. placebo Q3W (n=47) Randomisation will be stratified by the International Prognostic Scoring System (IPSS) category (low versus intermediate-1) established at screening.

more trials >>

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 >>


Page last updated: 2015-08-20

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2015