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出典(authority):フリー百科事典『ウィキペディア（Wikipedia）』「2013/11/21 15:14:32」(JST)

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Darbepoetin alfa (rINN) /dɑrbəˈpɔɪtɨn/ is a synthetic form of erythropoietin. It stimulates erythropoiesis (increases red blood cell levels) and is used to treat anemia, commonly associated with chronic renal failure and cancer chemotherapy. Darbepoetin is marketed by Amgen under the trade name Aranesp.

The drug was approved in September 2001 by the Food and Drug Administration for treatment of anemia in patients with chronic renal failure by intravenous or subcutaneous injection.^[1] In June 2001, it had been approved by the European Medicines Agency for this indication as well as the treatment of anemia in cancer patients undergoing chemotherapy.^[2]

Dr. Reddy's Laboratories launched darbepoetin alfa in India under the brand name ‘Cresp’ in August 2010. This is the world’s first generic darbepoetin alfa. Cresp has been approved in India.

Darbepoetin is produced by recombinant DNA technology in modified Chinese hamster ovary cells.^{[citation needed]} It differs from endogenous erythropoietin (EPO) by containing two more N-linked oligosaccharide chains. It is an erythropoiesis-stimulating 165-amino acid protein.

Like EPO, its use increases the risk of cardiovascular problems, including cardiac arrest, arrhythmia, hypertension and hypertensive encephalopathy, congestive heart failure, vascular thrombosis or ischemia, myocardial infarction, edema, and stroke. It can also increase risk of seizures. A recent study has extended these findings to treatment of patients exhibiting cancer-related anemia (distinct from anemia resulting from chemotherapy).^[3] Pre-existing untreated hypertension is a contra-indication for darbepoetin, as well as some hematologic diseases. Other reported adverse reactions include hypotension, fever, chest pains, nausea and myalgia.

Like EPO, it has the potential to be abused by athletes seeking a competitive advantage. Its use during the 2002 Winter Olympic Games to improve performance led to the disqualification of cross-country skiers Larisa Lazutina and Olga Danilova of Russia and Johann Mühlegg of Spain from their final races.

Safety advisories in anemic cancer patients[edit]

Amgen sent a "dear doctor" letter in January, 2007, that highlighted results from a recent anemia of cancer trial, and warned doctors to consider use in that off-label indication with caution.

Amgen advised the U.S. Food and Drug Administration (FDA) as to the results of the DAHANCA 10 clinical trial. The DAHANCA 10 data monitoring committee found that 3-year loco-regional control in subjects treated with Aranesp was significantly worse than for those not receiving Aranesp (p=0.01).

In response to these advisories, the FDA released a Public Health Advisory^[4] on March 9, 2007, and a clinical alert^[5] for doctors on February 16, 2007, about the use of erythropoeisis-stimulating agents such as epogen and darbepoetin. The advisory recommended caution in using these agents in cancer patients receiving chemotherapy or off chemotherapy, and indicated a lack of clinical evidence to support improvements in quality of life or transfusion requirements in these settings.

In addition, on March 9, 2007, drug manufacturers agreed to new "black box" warnings about the safety of these drugs. On November 8, 2007, additional "black box" warnings were included on the aranesp label, at the request of the FDA.

On March 22, 2007, a congressional inquiry into the safety of erythropoeitic growth factors was reported in the news media. Manufacturers were asked to suspend drug rebate programs for physicians and to also suspend marketing the drugs to patients.

Business considerations for drug manufacturers[edit]

Epogen and Darbepoetin alfa had more than $6 billion in combined sales in 2006. Procrit sales were about $3.2 billion in 2006.

References[edit]

^ Jay P. Siegel (2001-09-17). "Product Approval Information - Licensing Action". United States Food and Drug Administration. Archived from the original on 2006-10-22. Retrieved 2007-01-27.
^ "European Public Assessment Report (Abstract)" (PDF). European Medicines Agency. 2001-06-08. Retrieved 2007-01-27.
^ Pollack, Andrew (2007-01-26). "Amgen Finds Anemia Drug Holds Risks in Cancer Use". The New York Times. Retrieved 2007-01-27.
^ "FDA Public Health Advisory: Erythropoiesis-Stimulating Agents (ESAs): Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp)". Archived from the original on 2007-05-28. Retrieved 2007-06-05.
^ "Information for Healthcare Professionals: Erythropoiesis Stimulating Agents (ESA)". Archived from the original on 2007-05-15. Retrieved 2007-06-05.

UpToDate Contents

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1. 慢性腎疾患における貧血のマネージメントのためのダルベポエチンアルファ darbepoetin alfa for the management of anemia in chronic kidney disease
2. 癌患者での貧血における赤血球生成刺激剤の役割 role of erythropoiesis stimulating agents in the treatment of anemia in patients with cancer
3. 慢性腎疾患における貧血：エリスロポエチン製剤を投与した患者でのヘモグロビン／ヘマトクリットの目標値 anemia of chronic kidney disease target hemoglobin hematocrit for patients treated with erythropoietic agents
4. エリスロポエチン：皮下投与 erythropoietin subcutaneous administration
5. 骨髄異形成症候群の合併症のマネージメント management of the complications of the myelodysplastic syndromes

English Journal

Association of higher erythropoiesis stimulating agent dose and mortality in children on dialysis.

Lestz RM1, Fivush BA, Atkinson MA.
Pediatric nephrology (Berlin, Germany).Pediatr Nephrol.2014 Oct;29(10):2021-8. doi: 10.1007/s00467-014-2820-9. Epub 2014 May 3.
BACKGROUND: Higher doses of erythropoiesis-stimulating agents (ESA) have been associated with an increased risk of adverse outcomes in adults with chronic kidney disease (CKD) and end-stage kidney disease (ESRD), but to our knowledge no trials have been performed in children. We examined the associa
PMID 24794833

Incidence of erythropoietin antibody-mediated pure red cell aplasia: the Prospective Immunogenicity Surveillance Registry (PRIMS).

Macdougall IC1, Casadevall N2, Locatelli F3, Combe C4, London GM5, Di Paolo S6, Kribben A7, Fliser D8, Messner H9, McNeil J10, Stevens P11, Santoro A12, De Francisco AL13, Percheson P14, Potamianou A14, Foucher A14, Fife D14, Mérit V14, Vercammen E14; on Behalf of the PRIMS Study Group.
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association.Nephrol Dial Transplant.2014 Sep 19. pii: gfu297. [Epub ahead of print]
BACKGROUND: Subcutaneous administration of Eprex® (epoetin alfa) in patients with chronic kidney disease (CKD) was contraindicated in the European Union between 2002 and 2006 after increased reports of anti-erythropoietin antibody-mediated pure red cell aplasia (PRCA). The Prospective Immunogenicit
PMID 25239637

Periodontal Status, Inflammation, and Malnutrition in Hemodialysis Patients - Is There a Link?

Garneata L1, Slusanschi O2, Preoteasa E3, Corbu-Stancu A4, Mircescu G5.
Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation.J Ren Nutr.2014 Sep 10. pii: S1051-2276(14)00124-1. doi: 10.1053/j.jrn.2014.07.004. [Epub ahead of print]
BACKGROUND: Periodontal disease (PDD) was associated with inflammation, malnutrition, and higher mortality in hemodialysis (HD) patients.STUDY DESIGN AND OBJECTIVE: Cross-sectional observational study, aiming to assess the prevalence of PDD and the possible relationship among PDD, inflammation, and
PMID 25218877

Japanese Journal

L-カルニチン補充療法によりESA低反応性貧血の改善を認めた維持血液透析症例

セレスタギャヌラジャ,松本昭英
日本透析医学会雑誌 47(10), 647-651, 2014
… 腎性貧血は, 高用量のerythropoiesis stimulating agent (ESA) darbepoetin-alfa (DA) 60μg/週に十分な鉄剤を投与したにもかかわらず, 改善しなかった (Hb 8.5±0.73g/dL). …
NAID 130004701794

Hepatic Cyst Infection in an Autosomal Dominant Polycystic Kidney Disease Patient Diagnosed by Right Pleural Effusion

Ihara Katsuhito,Naito Shotaro,Yamaguchi Wakaba,Mori Yutaro,Toda Takayuki,Rai Tatemitsu,Uchida Shinichi,Sasaki Sei,Matsui Noriaki
Internal Medicine 53(12), 1355-1359, 2014
… Renal function and anemia, which had been resistant to darbepoetin treatment, also improved after the procedure. …
NAID 130004466363

血液透析患者の腎性貧血に対するレボカルニチンの有効性

樋口輝美,石川由美子,山崎俊男,水野真理,大川恵里奈,瀬戸口晴美,柳沢順子,中島詩織,安藤英之,及川治,井下篤司,阿部雅紀,上野高浩,相馬正義
日本透析医学会雑誌 47(2), 119-127, 2014
… 服希望患者による介入試験であり，非ランダム化比較試験である．内服群はレボカルニチンを20mg/kg/日（最大用量1,200mg/日）を投与した．Erythropoiesis stimulating agents（ESAs）はrecombinant human erythropoietin（rHuEPO）とDarbepoetinα（DA）を使用しているため，rHuEPOとDAの比を200：1としrHuEPOの換算量とし，週あたりのESAs使用量，ESAs治療反応性の指標としてerythropoiesis resistance index（ERI）をESA doses/kg/g/dL/週として算出した．【結果】対象 …
NAID 130003395188

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「darbepoetin alfa」

Darbepoetin alfa
Clinical data
AHFS/Drugs.com	monograph
MedlinePlus	a604022
Licence data	EMA:Link, US FDA:link
Pregnancy cat.	B3 (AU)
Legal status	Prescription Only (S4) (AU)
Identifiers
CAS number	11096-26-7
ATC code	B03XA02
DrugBank	DB00012
UNII	15UQ94PT4P
Chemical data
Formula	C815H1317N233O241S5
Mol. mass	18396.1 g/mol
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ダルベポエチンアルファ

[1] Jay P. Siegel (2001-09-17). "Product Approval Information - Licensing Action". United States Food and Drug Administration. Archived from the original on 2006-10-22. Retrieved 2007-01-27.

[2] "European Public Assessment Report (Abstract)" (PDF). European Medicines Agency. 2001-06-08. Retrieved 2007-01-27.

[3] Pollack, Andrew (2007-01-26). "Amgen Finds Anemia Drug Holds Risks in Cancer Use". The New York Times. Retrieved 2007-01-27.

[4] "FDA Public Health Advisory: Erythropoiesis-Stimulating Agents (ESAs): Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp)". Archived from the original on 2007-05-28. Retrieved 2007-06-05.

[5] "Information for Healthcare Professionals: Erythropoiesis Stimulating Agents (ESA)". Archived from the original on 2007-05-15. Retrieved 2007-06-05.

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