Darbepoetin Alfa History
Darbeopetin alfa was developed as a prescription drug by Amgen. The U.S.Food & Drug Administration first approved it for sale in 2001. Amgen is the world’s largest biotechnologies company, and the same firm that first brought recombinant erythropoietin (epoetin alfa) to the U.S. market in 1984. The main focus with darbepoetin alfa appears to have been the development of a much longer acting erythropoietic protein in comparison to their earlier recombinant erythropoietin, which is commonly injected on a schedule of three times per week. The prescribing guidelines for darbepoetin alfa recommend a once per week schedule, which seems to offer strong comfort advantages to epoetin alfa for patients that do not like receiving frequent injections. Darbepoetin alfa has not yet reached the level of market success that has been noted with epoetin alfa preparations, but has been a strong selling drug for Amgen ever since its release.
How is Darbepoetin Alfa Supplied
Darbepoetin alfa is most commonly found in single-dose vials and prefilled syringes containing 25, 40, 60, 100, 150, 200, 300, or 500 mcg of drug.
Structural Characteristics of Darbepoetin Alfa
Darbepoetin alfa is a 165-amino acid protein that differs from human erythropoietin by the substitution of amino acids on the erythropoietin peptide backbone, which allows the addition of two additional N-linked oligosaccharide chains.
Darbepoetin Alfa Warnings (Death, Viral Disease)
The misuse of darbepoetin alfa for physique- or performance-enhancing purposes is characterized as a high-risk practice. Like traditional blood doping methods, darbepoetin alfa can produce an abnormally high concentration of hemoglobin in the blood (polycythemia), which may result in heart attack, stroke, seizure, or death.
Some forms of darbepoetin alfa contain albumin, a purified human blood product. Although effective donor screening and product manufacturing procedures are in place, it still carries a risk, though extremely remote, for transmission of viral disease.
Darbepoetin Alfa Side Effects
Side effects associated with the use of darbepoetin alfa may include flu-like symptoms such as fever, chills, headache, muscle pain, weakness, or dizziness. Such effects tend to be more pronounced at the initiation of therapy. Other adverse reactions may include infection, rash, swelling of the skin, nausea, vomiting, diarrhea, high blood pressure, low blood pressure, cough, bronchitis, or edema. In some instances darbepoetin alfa has been associated with thromboembolism, deep-vein thrombosis, pulmonary embolism, heart attack, and cerebrovascular accidents.
Darbepoetin Alfa Administration
Darbepoetin alfa is indicated for the treatment of anemia associated with chronic renal failure (CRF) and chemotherapy. The recommended starting dose for the treatment of anemia in adult CRF patients is .45 mcg/kg body weight, administered once per week as a single IV or SC injection. The dosage is subsequently adjusted based on changes in hematocrit.
Healthy athletes using darbepoetin alfa for performance-enhancing purposes generally start on the very low end of the therapeutic spectrum, and adjust according to changes in hematocrit. very low end of the therapeutic spectrum, and adjust according to changes in hematocrit. This may entail initiating therapy with as little as .05 mcg/kg of body weight once per week. Note that it is considered very important to monitor blood cell counts closely during the entire intake of darbepoetin alfa to help ensure hematocrit is not allowed to increase to an unhealthy level.
Darbepoetin Alfa Availability
Darbepoetin alfa is not widely sold on the black market. Yet because of the high cost for erythropoiesis stimulating agents like darbepoetin alfa, it is a high profile target for counterfeit drug manufacturing operations. Counterfeit drugs of this class have even infiltrated legitimate pharmaceutical distribution channels, suggesting that care should be taken when purchasing this and similar drug products.
Wlliam Llewellyn (2011) - Anabolics