Pharmacokinetics and hematologic response to subcutaneous administration of recombinant human erythropoietin in children undergoing long-term peritoneal dialysis: A multicenter study

Montini, Giovanni; Zacchello, Graziella; Perfumo, Francesco; Edefonti, Alberto; Bassi, Sergio; Cantaluppi, A; Sarchi, C; Cazzin, Monica; Ferrari, V.; Boccazzi, A; Caringella, Angela; Cattarelli, Donatella; Coppo, Rosanna; Longo, Luigi; Sorino, Palma; Verrina, Enrico; Gusmano, Rosanna

doi:10.1016/s0022-3476(06)80137-x

Cited by 24 publications

(13 citation statements)

References 11 publications

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“…It is possible that the higher concentration of native EPO in the CAPD group (although not significant probably because of the small sample) might be one of the causes of the later occurrence of anemia after EPO withdrawal and the greater efficacy of lower EPO doses in children on CAPD. The initial EPO dose used in our study was lower than that used by Montini et al [9]. They showed that 50 U/kg EPO s.c. twice a week was effective in children on CAPD but in order to achieve a Hb 410 g/dl a longer treatment period than in our study was required.…”

Section: Discussionmentioning

confidence: 57%

Recombinant human erythropoietin dosage in children undergoing hemodialysis and continuous ambulatory peritoneal dialysis

Roszkowska‐Blaim

1997

Pediatric Nephrology

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The efficacy of erythropoietin (EPO) in 11 children on hemodialysis (HD) and 8 on continuous ambulatory peritoneal dialysis (CAPD) (mean age 11.8 years) was compared. The initial EPO dose was 50 U/kg s.c. once a week; the time of observation was 24 weeks. In the CAPD group, the mean hemoglobin (Hb) level increased from 7.7 +/- 0.2 to 11.2 +/- 0.6 g/dl (P < 0.001) and hematocrit (Hct) from 22.3 +/- 1.0 to 32.6 +/- 1.4% (P < 0.001), while in the HD group the mean Hb rose from 7.7 +/- 0.6 to 9.3 +/- 0.8 g/dl (P < 0.001) and mean Hct from 22.7 +/- 2.3 to 27.6 +/- 2.8% (P < 0.001) after 12 weeks of observation. An increase in Hb to over 10 g/dl was obtained in 87.5% of children on CAPD but in only 10% on HD after 8 weeks of EPO treatment. After 12 weeks of treatment, all children on CAPD had the target Hb level of more than 10 g/dl, while 7 children on HD required increased doses of EPO (100 U/kg per week). We conclude that the EPO dose of 50 u/kg given s.c. once a week is effective for children with anemia on CAPD but is insufficient for children on HD.

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Section: Discussionmentioning

confidence: 57%

Recombinant human erythropoietin dosage in children undergoing hemodialysis and continuous ambulatory peritoneal dialysis

Roszkowska‐Blaim

1997

Pediatric Nephrology

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“…Other investigators [15,21] have shown that the erythropoietic response to EPO is equivalent with either the lower but more sus tained levels following subcutaneous adminis tration or the brief and very high peaks ob tained after intravenous administration. In children aged 3 months to 18 years, it has been demonstrated [21 ] that low doses of sub cutaneously administered EPO result in a mean elimination half-life of 25.2 (6.2-58.7) h. Brown et al [16] in preterm infants found the half-life of subcutaneously administered EPO to be 7.1 ± (SD) 4.1 h and after intrave nous administration 8.1 ± (SD) 2.7 h. In adults, Macdougall et al [15] found that the plasma clearance of subcutaneously adminis tered EPO was less than when administered intravenously.…”

Section: Discussionmentioning

confidence: 98%

“…In children aged 3 months to 18 years, it has been demonstrated [21 ] that low doses of sub cutaneously administered EPO result in a mean elimination half-life of 25.2 (6.2-58.7) h. Brown et al [16] in preterm infants found the half-life of subcutaneously administered EPO to be 7.1 ± (SD) 4.1 h and after intrave nous administration 8.1 ± (SD) 2.7 h. In adults, Macdougall et al [15] found that the plasma clearance of subcutaneously adminis tered EPO was less than when administered intravenously. It appears that the difference in plasma clearance based on route of admin istration is due to the difference in absorption and not due to the difference in elimination.…”

Section: Discussionmentioning

confidence: 98%

Pharmacokinetics of Erythropoietin following Single-Dose Subcutaneous Administration in Preterm Infants

Krishnan

Shankaran²,

Krishnan

et al. 1996

Neonatology

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The pharmacokinetics of recombinant human erythropoietin was studied in 12 very low birth weight preterm infants < 32 weeks of gestation after subcutaneous administration of 300 IU/kg at a postconceptional age of 34 (32-37) weeks and a weight of 1,505 (1330–1,740)g (median and range). The administration of recombinant human erythropoietin produced a rapid increase n serum erythropoietin levels with a peak level of 362.8 mlU/ml at 8.9 h. The area under the curve was 8,177.5 (4,597.1–15,453.0) mlU/ml/h, the absorption half-life was 5.5 (1.6–6.6) h, the elimination half-life was 7.9 (5.6–19.4) h, and the residence time was 19.6 (5.1–32.6) h (all values reflect median and range). There was no significant correlation between absorption and elimination half-life of erythropoietin and birth weight, gestational age, sex, and age and weight of the infants at the time of administration of erythropoietin. Based on absorption and elimination kinetics, the dosing interval for subcutaneous administration must not be < 48h.

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“…Previous reports indicated that the mean terminal half-life of epoetin after IV administration to pediatric patients ranged from 5.6 to 10.9 h, with mean clearance values ranging from 6 to 10.1 ml/h per kg [10,11,12,13]. After SC dosing, absorption was rate limiting, such that the mean terminal half-life ranged from 13.3 to 25.2 h, with bioavailability estimates ranging from 33% to 40% [10,13,14,15]. Due to the wide range in values, comparison with literature estimates for adults is difficult.…”

Section: Discussionmentioning

confidence: 99%

Pharmacokinetics of darbepoetin alfa in pediatric patients with chronic kidney disease

Lerner

Kale

Warady

et al. 2002

Pediatric Nephrology

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Darbepoetin alfa is a novel erythropoiesis-stimulating protein with a two- to threefold longer half-life than recombinant human erythropoietin (epoetin) in adult patients with chronic kidney disease (CKD). This randomized, open-label, crossover study was conducted to determine the pharmacokinetic profile of darbepoetin alfa in pediatric patients with CKD. Twelve patients 3-16 years of age with CKD were randomized and received a single 0.5 micro g/kg dose of darbepoetin alfa administered intravenously (IV) or subcutaneously (SC). After a 14- to 16-day washout period, patients received an identical dose of darbepoetin alfa by the alternate route. After IV administration, the mean clearance of darbepoetin alfa was 2.3 ml/h per kg, with a mean terminal half-life of 22.1 h. After SC administration, absorption was rate limiting, with a mean terminal half-life of 42.8 h and a mean bioavailability of 54%. Comparison of these results with those from a previous study of darbepoetin alfa in adult patients indicated that the disposition of darbepoetin alfa administered IV or SC is similar in adult and pediatric patients, although absorption may be slightly more rapid in pediatric patients after SC dosing. The mean terminal half-life of darbepoetin alfa in this study was approximately two- to fourfold longer than that previously reported for epoetin in pediatric patients.

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Pharmacokinetics and hematologic response to subcutaneous administration of recombinant human erythropoietin in children undergoing long-term peritoneal dialysis: A multicenter study

Cited by 24 publications

References 11 publications

Recombinant human erythropoietin dosage in children undergoing hemodialysis and continuous ambulatory peritoneal dialysis

Recombinant human erythropoietin dosage in children undergoing hemodialysis and continuous ambulatory peritoneal dialysis

Pharmacokinetics of Erythropoietin following Single-Dose Subcutaneous Administration in Preterm Infants

Pharmacokinetics of darbepoetin alfa in pediatric patients with chronic kidney disease

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