Darbepoetin alfa

Darbepoetin alfa
Names
Pronunciation/dɑːrbəˈpoʊɪtɪn/
Trade namesAranesp, Cresp, others
Clinical data
Drug classErythropoietin analogue
Main usesLow red blood cells due to chronic kidney failure or chemotherapy[1]
Side effectsHigh blood pressure, allergic reactions, swelling[2]
WHO AWaReUnlinkedWikibase error: ⧼unlinkedwikibase-error-statements-entity-not-set⧽
Pregnancy
category
  • AU: B3[3]
  • US: N (Not classified yet)[3]
    Routes of
    use    		Intravenous, subcutaneous injection
    External links
    AHFS/Drugs.comMonograph
    MedlinePlusa604022
    Legal
    License data
    Legal status
    • AU: S4 (Prescription only)
    • US: ℞-only
    • In general: ℞ (Prescription only)
    Chemical and physical data
    FormulaC815H1317N233O241S5
    Molar mass18396.19 g·mol−1

    Darbepoetin alfa, sold under the brand name Aranesp among others, is a medication used to treat low red blood cells due to chronic kidney failure or chemotherapy.[1] It is given by injection into a vein or under the skin.[1] Doses to achieve a hemoglobin greater than 110 g/L (11 g/dL) is not recommended.[4]

    Common side effects may include high blood pressure, allergic reactions, and swelling.[2] Other side effect may include blood clots and worsened cancer.[4] It works in the same way as erythropoietin, to increase red blood cell production by the bone marrow.[2] It is made by recombinant DNA technology.[4]

    Darbepoetin alfa was approved for medical use in the United States and Europe in 2001.[2][4] It is on the World Health Organization's List of Essential Medicines.[5] In the United Kingdom 4 weeks at a dose of 40 micrograms per week costs the NHS about £235.[1] This amount in the United States costs about 1,200 USD.[6]

    Medical uses

    Dosage

    For people with chronic kidney disease it is often started at 450 nanograms per kg once per week.[1] In chemotherapy 2,250 nanograms per kg per week may be used.[1] It may be possible to give every 3 weeks instead of every week.[7]

    Contraindications

    Use of darbepoetin alfa is contraindicated in patients with hypersensitivity to the drug, pre-existing uncontrolled hypertension, and pure red cell aplasia.[8]

    Side effects

    Darbepoetin alfa has black box warnings in the United States for increased risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence. To avoid side effects, it is recommended for patients with chronic kidney failure or cancer to use the lowest possible dose needed to avoid red blood cell (RBC) transfusions.[9]

    In addition to those listed in the black box warning, use of darbepoetin alfa also increases the risk of cardiovascular problems, including cardiac arrest, arrhythmia, hypertension and congestive heart failure, and edema.[8] A recent study has extended these findings to treatment of patients exhibiting cancer-related anemia (distinct from anemia resulting from chemotherapy).[10] Other reported adverse reactions include increased risk of seizure, hypotension, and chest pain.

    Cancer

    The FDA released a Public Health Advisory in March 2007, and a clinical alert in February 2007, about the use of erythropoeisis-stimulating agents (ESAs) such as epoetin alfa and darbepoetin alfa.[11][12] 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.

    According to the 2010 update to clinical practice guidelines from the American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH), use of ESAs such as darbepoetin alfa in cancer patients is appropriate when following stipulations outlined in FDA-approved labeling.[13]

    Pregnancy and breastfeeding

    Darbepoetin alfa is not assigned a pregnancy category in the United States.[3]

    It is not known if darbepoetin alfa is excreted in breast milk.[9][3]

    Mechanism of action

    Darbepoetin alfa binds to the erythropoietin receptor on erythroid progenitor cells, stimulating RBC production and differentiation.[8]

    Society and culture

    Like EPO, darbepoetin alfa 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.[14]

    Economics

    Epogen and Aranesp had more than $6 billion in combined sales in 2006. Archived 2020-09-18 at the Wayback Machine Procrit sales were about $3.2 billion in 2006.

    Dr. Reddy's Laboratories launched darbepoetin alfa in India under the brand name "Cresp" in August 2010.

    References

    1. 1 2 3 4 5 6 BNF 81: March-September 2021. BMJ Group and the Pharmaceutical Press. 2021. p. 1059. ISBN 978-0857114105.
    2. 1 2 3 4 "Aranesp". Archived from the original on 12 November 2020. Retrieved 21 December 2021.
    3. 1 2 3 4 "Darbepoetin alfa (Aranesp) Use During Pregnancy". Drugs.com. 31 December 2018. Archived from the original on 7 April 2020. Retrieved 7 April 2020.
    4. 1 2 3 4 "Darbepoetin Alfa Monograph for Professionals". Drugs.com. Archived from the original on 28 January 2021. Retrieved 21 December 2021.
    5. ↑ World Health Organization (2023). The selection and use of essential medicines 2023: web annex A: World Health Organization model list of essential medicines: 23rd list (2023). Geneva: World Health Organization. hdl:10665/371090. WHO/MHP/HPS/EML/2023.02.
    6. ↑ "Darbepoetin Alfa Prices, Coupons & Savings Tips - GoodRx". GoodRx. Retrieved 21 December 2021.
    7. ↑ "Erythropoiesis Stimulating Agents". LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. National Institute of Diabetes and Digestive and Kidney Diseases. 2012. Archived from the original on 12 January 2022. Retrieved 21 December 2021.
    8. 1 2 3 "Darbepoetin Alfa (Lexi-Drugs)". LexiComp. Retrieved 29 October 2014.
    9. 1 2 "Aranesp- darbepoetin alfa injection, solution Aranesp- darbepoetin alfa solution". DailyMed. Archived from the original on 19 October 2020. Retrieved 7 April 2020.
    10. ↑ Pollack A (2007-01-26). "Amgen Finds Anemia Drug Holds Risks in Cancer Use". The New York Times. Archived from the original on 2021-02-13. Retrieved 2007-01-27.
    11. ↑ "Information for Healthcare Professionals: Erythropoiesis Stimulating Agents (ESA)". Archived from the original on 2007-05-15. Retrieved 2007-06-05.
    12. ↑ "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.
    13. ↑ Rizzo JD, Brouwers M, Hurley P, Seidenfeld J, Arcasoy MO, Spivak JL, et al. (November 2010). "American Society of Clinical Oncology/American Society of Hematology clinical practice guideline update on the use of epoetin and darbepoetin in adult patients with cancer". Journal of Clinical Oncology. 28 (33): 4996–5010. doi:10.1200/jco.2010.29.2201. PMC 2988667. PMID 20975064. Archived from the original on 2014-11-03.
    14. ↑ McGrath M, Portal G (30 January 2002). "New drugs give cheats the edge". BBC News Online. Archived from the original on 6 March 2016. Retrieved 3 November 2014.
    Identifiers:
    • "Darbepoetin alfa". Drug Information Portal. U.S. National Library of Medicine. Archived from the original on 2020-04-07. Retrieved 2021-07-10.
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