The volume of distribution following IV administration is the same for epoetin alfa and darbepoetin alfa and is approximately equal to the plasma volume, suggesting limited extravascular distribution of ESAs [ 6 , 12 ]. Per the Guideline on Summary of Product Characteristics (Revision 2, September 2009), frequency of ADRs identified in the post marketing setting was determined using the “Rule of three”. Aranesp 30 micrograms solution for injection in pre-filled syringe. Caution should be exercised when prescribing Aranesp to pregnant women. 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). Together, the pharmacokinetic and pharmacodynamic properties of ESAs influence the clinical use (e.g. 1 mL solution for injection (500 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe and stainless steel 27 gauge needle. In the study by Disney and colleagues, 83% of patients who received at least one QM dose of darbepoetin alfa (the modified intent-to-treat population; mITT) and 95% of the patients who completed the study achieved a target haemoglobin level of ≥10 g/dl [ 43 ]. The most recent pharmacokinetic studies using sampling times of 27 or 28 days established that the mean terminal half-life of darbepoetin alfa is 70–105 h when administered SC. Haemoglobin levels were successfully maintained within the target range (for the majority of studies, 10–13 g/dl) and without the need for darbepoetin alfa dose increases [ 34–38 ]. Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients.
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This study supports 500 mcg once every three weeks being comparable to once weekly administration with respect to the incidence of subjects receiving at least one red blood cell transfusion from week 5 to the end of treatment phase. Aranesp 40 micrograms solution for injection in pre-filled pen. The patients had CRI, were not receiving renal replacement therapy and were currently receiving or about to initiate QM darbepoetin alfa therapy. Using data from nine individual studies, Jang and colleagues examined the pharmacokinetics of SC darbepoetin alfa in adults with normal renal function, with CRI, or requiring dialysis and in paediatric CKD patients requiring dialysis (HD or PD not specified) [ 17 ].
Pharmacokinetic investigations of darbepoetin alfa using prolonged blood sampling times established that the mean terminal half-life after subcutaneous (SC) administration is 70 to 105 hours. Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 mcg/L or whose transferrin saturation is below 20%. Where the same sampling duration was used, observed pharmacokinetic data and population pharmacokinetic modelling demonstrated that the pharmacokinetics of darbepoetin alfa was similar for paediatric and adult patients with CRF. Patients < 6 years of age may need higher doses for maintenance of haemoglobin than patients above that age. Do not administer more than one dose. • non-inferiority of darbepoetin alfa to placebo for overall survival and progression free survival in patients with advanced stage non-small cell lung cancer receiving chemotherapy when administered to a target haemoglobin of 12 g/dL (7.5 mmol/L) (see section 5.1). Pharmacodynamic studies were conducted to assess the suitability of darbepoetin alfa for use in weekly or less frequent (once every other week or once a month) dosing regimens to maintain haemoglobin levels in patients with anaemia of renal disease. The main site and mechanism for removal of endogenous erythropoietin and the ESAs from the circulation have yet to be fully elucidated [ 21 ]. Each pre-filled syringe contains 40 micrograms of darbepoetin alfa in 0.4 mL (100 mcg/mL). Epoetin alfa is not altered by differing degrees of renal function [ 5 ] or haemodialysis [ 5 , 20 ] and it is not found in the dialysate following IV administration [ 20 ]. Patients should be monitored closely, if the haemoglobin exceeds 12 g/dL (7.5 mmol/L), the dose should be reduced by approximately 25 to 50%.
The frequency is estimated from clinical trial data as uncommon.
Erythropoiesis-stimulating agents are active at several points in the erythropoiesis sequence, including the proliferation and maturation of progenitor cells and prevention of apoptosis in mature RBCs. Erythropoietin is a growth factor that primarily stimulates red blood cell production.
Darbepoetin is produced by recombinant DNA technology in modified Chinese hamster ovary cells.
The initial every other week dose of Aranesp (mcg/every other week) can be determined by dividing the total cumulative dose of r-HuEPO administered over a two-week period by 240.
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