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Chapter Eight
Published in Eugene Fukumoto, Advanced ICD-10 for Physicians Including Worker’s Compensation and Personal Injury, 2017
Some injections are subject to diagnosis code requirements. These are specified in published Local Coverage Determinations (LCDs). Darbepoetin Alfa and Epoetin Alfa have diagnosis requirements. In Southern California, LCD “L33525 Erythropoietin stimulating agents” specifies necessity and diagnosis requirements.
Development of palliative medicine in the United Kingdom and Ireland
Published in Eduardo Bruera, Irene Higginson, Charles F von Gunten, Tatsuya Morita, Textbook of Palliative Medicine and Supportive Care, 2015
26 Singh AK, Szczech L, Tang KL, Barnhart H, Sapp S, Wolfson M et al. Correction of anemia with epoetin alfa in chronic kidney disease. The New England Journal of Medicine. 2006;355(20):2085-2098. 27 Pfeffer MA, Burdmann EA, Chen CY, Cooper ME, de Zeeuw D, Eckardt KU et al. A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease. The New England Journal of Medicine. 2009;361(21):2019-2032.28 Henke M, Laszig R, Rube C, Schafer U, Haase KD, Schilcher B et al. Erythropoietin to treat head and neck cancer patients with anaemia undergoing radiotherapy: Randomised, double-blind, placebocontrolled trial. Lancet. 2003;362(9392):1255-1260. - 29 Leyland-Jones B, Semiglazov V, Pawlicki M, Pienkowski T, Tjulandin S, Manikhas G et al. Maintaining normal hemoglobin levels with epoetin alfa in mainly nonanemic patients with metastatic breast cancer receiving first-line chemotherapy: A survival study. Journal of Clinical Oncology. 2005;23(25):5960-5972.
The science of biotechnology
Published in Ronald P. Evens, Biotechnology, 2020
In the human body, proteins are all glycosylated, possessing carbohydate (CHO) molecules in their structure, which are comprised of a combination of several different CHO species, that is, mannose, or fucose, or galactose, or sialic acid, or n-acetylglycine. The CHOs are combined and configured as shown in the cartoon diagram (Figure 5.5) in a candelabra-like formation. However, many proteins can remain functional without the CHO content. Some proteins must have the glycosylation content the same as created naturally in mammals to be a fully physiologically active molecule, for example, epoetin alfa for red blood cell production in bone marrow. The impact of the CHO on a protein can be extensive, with changes in protein folding; ligand/receptor binding; biological activity, stability, or solubility of the molecule; protection from enzyme proteolysis; half-life of the molecule; and immunogenicity. The glycosylation entails changing or adding CHO species, for example, sialic acid residues, to the amino acid backbone of a protein. A CHO molecule is attached to an oxygen or nitrogen species in the protein structure and only at the amino acid sites in the protein where a series of three adjacent amino acids (asparagine-serine-threonine) exist. The CHO molecular engineering also requires site-directed mutagenesis (genetic engineering to alter the amino acid sequences), along with a specific transferase enzyme in the endoplasmic reticulum and chaperone proteins engaged as well. Figure 5.5 displays increased glycosylation of the epoetin alfa molecule to create darbepoetin alfa, both utilized to correct the anemia in chronic renal disease and some cancers. The molecular changes and the net outcomes are outlined in Figure 5.5.
Novel therapies in low- and high-risk myelodysplastic syndrome
Published in Expert Review of Hematology, 2019
Ulrich Germing, Thomas Schroeder, Jennifer Kaivers, Andrea Kündgen, Guido Kobbe, Norbert Gattermann
Platzbecker et al [17] published a very similar randomized, placebo-controlled phase III trial on darbepoetin alfa administered subcutaneously every three weeks in lower-risk MDS (IPSS low/intermediate-1). Patients included in the study had a Hb <10 g/dl, low RBC transfusion dependency, and a serum erythropoietin level <500 mU/ml. In patients with a Hb increase <1.5 g/dl, but without RBC transfusions during the last 28 days, dosage was escalated from 500 µg every three weeks to 500 µg every two weeks. Darbepoetin alfa was reported to significantly reduce the need of RBC transfusions and to induce hematologic improvement of the erythroid lineage (HI-E) (14.7% vs. 0%). Regarding transfusion need in the darbepoetin alfa group, patients with serum EPO levels <100 mU/ml needed fewer RBC transfusions than patients with serum EPO levels >100 mU/ml (23% vs. 57%). Drug safety results were similar for grade 3 adverse events in both the darbepoetin alfa and the placebo group, providing no evidence of a higher-risk for thrombovascular events in the darbepoetin alfa group. AML transformation rates were also similar in both groups. These results suggested that darbepoetin alfa is a useful treatment option for lower-risk MDS. However, the drug has not been submitted to EMA and FDA for approval.
Exercise and anemia in cancer patients: could it make the difference?
Published in Expert Review of Hematology, 2021
Alice Avancini, Lorenzo Belluomini, Daniela Tregnago, Ilaria Trestini, Michele Milella, Massimo Lanza, Sara Pilotto
As previously mentioned, one of the possible treatments for anemia consists of administering erythropoiesis-stimulating agents, such as epoetin alfa and darbepoetin alfa. Given the efficacy in terms of Hb response by the darbepoetin alfa and the possible benefits achieved through an exercise program, theoretically, the two interventions may have a synergic effect. The studies of Roth et al. [38] and Courneya et al. [39] tried to explore and clarify this point. In a nonrandomized trial, Roth and colleagues compared a sample of cancer patients receiving darbepoetin alfa and exercise with subjects participating in the same exercise program. After six weeks of training, including aerobic and resistance activities, an increase in Hb was detected only in patients treated with darbepoetin alfa, while a small decrease was noted in the group that attended only exercise [38]. Instead, in a randomized controlled trial, Courneya has evaluated the effects of darbepoetin alfa alone with those of darbepoetin alfa plus aerobic exercise training. A total of 55 anemic patients with solid tumors participated in the study; the exercise program was composed of three cycle-ergometer sessions per week (at 60–100% of the peak power output) for a total of 12 weeks. Although the overall Hb differences between the two groups were not significant, a trend toward a more rapid Hb response with less drug administration was observed in the exercising group, suggesting a possible synergistic effect between erythropoiesis-stimulating agents and exercise. Moreover, similar to Dolan and colleagues [36], the researchers found that an aerobic program was demonstrated to be effective in improving exercise capacity and cardiorespiratory fitness, typically impaired in anemic subjects [39].
Successful perinatal management of a dichorionic diamniotic twin pregnancy in an anaemic kidney transplant patient treated with Darbepoetin alfa: a case report
Published in Journal of Obstetrics and Gynaecology, 2020
Satoshi Tamaki, Kazunobu Shinoda, Tadashi Matsumoto, Shinya Morita, Hiroshi Asanuma, Tadashi Yoshida, Mototsugu Oya
Darbepoetin alfa was developed as a longer-acting erythropoiesis-stimulating agent with two additional N-linked carbohydrate chains, which allowed for the maintenance of haemoglobin levels in chronic kidney disease patients with a biweekly or monthly dosing regimen (Egrie and Browne 2001; Elliott et al. 2003; Ling et al. 2005). One of the adverse events associated with darbepoetin alfa treatment is hypertension, which may induce eclampsia and subsequent maternal and neonatal complications (Nissenson et al. 2002). The blood pressure in this patient was well controlled in the course of biweekly darbepoetin treatment (Figures 1(B,D)).