Is Recormon | less painful than Eprex | after subcutaneous administration? M. W. G. Hendriks, F.P.J. Peters, P.M. Hooymans, T. W.M. Van de Wiel, D. Janknegt, R. Janknegt and J.J.H.M. L o h m a n
Introduction Recombinant h u m a n epoetin t r e a t m e n t has become a widely accepted therapy in the t r e a t m e n t of a n a e m i a due to chronic renal failure. Initially the suggested route of administration was the intravenous one. The subcutaneous route for administering recombinant h u m a n epoetin has rapidly gained popularity as the preferred route of administration in both haemodialysis and continuous ambulatory peritoneal dialysis (CAPD) patients. The pharmacokinetics of epoetin after subcutaneous administration are different from those after intravenous administration. The achieved maximal serum concentrations are higher after intravenous t h a n after subcutaneous injection. These high concentrations do not seem to be required for the therapeutic efficacy. The lower and more sustained serum concentrations after subcutaneous administration appear to be at least as effective as the intravenous therapy. The serum concentrations following intravenous administration r e t u r n to baseline after 2 to 3 days, in contrast to those obtained after subcutaneous injection, after which concentrations significantly larger t h a n endogenous levels are maintained for at least 4 days [1 2]. There is still little known, however, about the relationship between the pharmacokinetics and pharmacodynamics of epoetin, the 'ideal' plasma concentrations and the time profiles of the drug. The intravenous route is impractical for CAPD and nondialysing patients who have no ready vascular access. For these and for m a n y haemodialysis patients subcutaneous administration is preferable. After subcutaneous injection of Eprex | pain at the injection site has been re-
Keywords Epoetin Injections, subcutaneous Pain Rating scales M. W.G. Hendriks (correspondence), P.M. Hooymans, R. Janknegt and J.J.H.M. Lohman: Department of Clinical Pharmacy and Toxicology, Maasland Hospital, P.O. Box 5500, 6130 MB Sittard, the Netherlands. F.P.J. Peters and T. W.M. Van de Wiel: Department of Internal Medicine, Maasland Hospital, Sittard. D. Janknegt: statistician, Emmen, the Netherlands.
14(2) 1992
ported [3]. In this study we examined the differences in pain experienced after subcutaneous injections of two epoetin preparations (Eprex and Recormon|
Methods Patients In the haemodialysis centre all adult patients regularly receiving subcutaneous injections of epoetin (Eprex) were invited to participate in the study. The study had been approved by the Hospital's Committee on Medical Ethics. After giving informed consent 15 men and 15 women entered the study. The patients were between 30 and 77 years of age, their weight varied from 49.5 to 97.9 kg (mean • SD: 62.4___10.5 kg). They recieved Eprex in a dose r a n g i n g from 4,000 U 2 times a week to 8,000 U 3 times a week. The two brands of epoetin tested were Eprex (epoetin a 4,000 U/ml, batch hr. 90F20/579, Cilag, Brussels, Belgium) and Recormon (epoetin /3 5,000 U lyophilisate, batch hr. 82188880Q, Boehringer Mannheim, Almere, the Netherlands). The injections (1 ml = 4,000 U) were prepared in the Hospital P h a r m a c y Department. The epoetin lyophilisate in Recormon was dissolved in water for injection. Before injection the solutions were equilibrated at room temperature. A Sterican | needle of 0.55 • 25 m m was used. The patients received 5 injections Eprex and 5 injections Recormon in a randomized sequence blinded for both patient and nurse. Injections were given in the upper a r m by an experienced nurse at the end of the dialysis. For a dose of 8,000 U 2 injections of 4,000 U were given [4]. The patient received the first injection of 4,000 U
Hendriks MWG, Peters FPJ, Hooymans PM, Van de Wiel TWM, Janknegt D, Janknegt R, Lohman JJHM. Is Recormon| less painful than Eprex| after subcutaneous administration? Pharm Weekbl [Sci] 1992;14(2):55-8.
Abstract In this study, we examined the differences in pain score after subcutaneous injection of the epoetin preparations Eprex | and Recormon| Patients (n = 30) received 5 injections Eprex | and 5 injections Recormon| in a randomized double-blind sequence. 10 Min after receiving the injection the patient was asked to complete a visual and a verbal analogue scale and two descriptive scales. The results of 25 patients were used for statistical evaluation. The overall results indicate that there are significantly more patients reporting pain after subcutaneous injection of Eprex| than after Recormon| (11 versus 2 patients, p
Introduction Recombinant h u m a n epoetin t r e a t m e n t has become a widely accepted therapy in the t r e a t m e n t of a n a e m i a due to chronic renal failure. Initially the suggested route of administration was the intravenous one. The subcutaneous route for administering recombinant h u m a n epoetin has rapidly gained popularity as the preferred route of administration in both haemodialysis and continuous ambulatory peritoneal dialysis (CAPD) patients. The pharmacokinetics of epoetin after subcutaneous administration are different from those after intravenous administration. The achieved maximal serum concentrations are higher after intravenous t h a n after subcutaneous injection. These high concentrations do not seem to be required for the therapeutic efficacy. The lower and more sustained serum concentrations after subcutaneous administration appear to be at least as effective as the intravenous therapy. The serum concentrations following intravenous administration r e t u r n to baseline after 2 to 3 days, in contrast to those obtained after subcutaneous injection, after which concentrations significantly larger t h a n endogenous levels are maintained for at least 4 days [1 2]. There is still little known, however, about the relationship between the pharmacokinetics and pharmacodynamics of epoetin, the 'ideal' plasma concentrations and the time profiles of the drug. The intravenous route is impractical for CAPD and nondialysing patients who have no ready vascular access. For these and for m a n y haemodialysis patients subcutaneous administration is preferable. After subcutaneous injection of Eprex | pain at the injection site has been re-
Keywords Epoetin Injections, subcutaneous Pain Rating scales M. W.G. Hendriks (correspondence), P.M. Hooymans, R. Janknegt and J.J.H.M. Lohman: Department of Clinical Pharmacy and Toxicology, Maasland Hospital, P.O. Box 5500, 6130 MB Sittard, the Netherlands. F.P.J. Peters and T. W.M. Van de Wiel: Department of Internal Medicine, Maasland Hospital, Sittard. D. Janknegt: statistician, Emmen, the Netherlands.
14(2) 1992
ported [3]. In this study we examined the differences in pain experienced after subcutaneous injections of two epoetin preparations (Eprex and Recormon|
Methods Patients In the haemodialysis centre all adult patients regularly receiving subcutaneous injections of epoetin (Eprex) were invited to participate in the study. The study had been approved by the Hospital's Committee on Medical Ethics. After giving informed consent 15 men and 15 women entered the study. The patients were between 30 and 77 years of age, their weight varied from 49.5 to 97.9 kg (mean • SD: 62.4___10.5 kg). They recieved Eprex in a dose r a n g i n g from 4,000 U 2 times a week to 8,000 U 3 times a week. The two brands of epoetin tested were Eprex (epoetin a 4,000 U/ml, batch hr. 90F20/579, Cilag, Brussels, Belgium) and Recormon (epoetin /3 5,000 U lyophilisate, batch hr. 82188880Q, Boehringer Mannheim, Almere, the Netherlands). The injections (1 ml = 4,000 U) were prepared in the Hospital P h a r m a c y Department. The epoetin lyophilisate in Recormon was dissolved in water for injection. Before injection the solutions were equilibrated at room temperature. A Sterican | needle of 0.55 • 25 m m was used. The patients received 5 injections Eprex and 5 injections Recormon in a randomized sequence blinded for both patient and nurse. Injections were given in the upper a r m by an experienced nurse at the end of the dialysis. For a dose of 8,000 U 2 injections of 4,000 U were given [4]. The patient received the first injection of 4,000 U
Hendriks MWG, Peters FPJ, Hooymans PM, Van de Wiel TWM, Janknegt D, Janknegt R, Lohman JJHM. Is Recormon| less painful than Eprex| after subcutaneous administration? Pharm Weekbl [Sci] 1992;14(2):55-8.
Abstract In this study, we examined the differences in pain score after subcutaneous injection of the epoetin preparations Eprex | and Recormon| Patients (n = 30) received 5 injections Eprex | and 5 injections Recormon| in a randomized double-blind sequence. 10 Min after receiving the injection the patient was asked to complete a visual and a verbal analogue scale and two descriptive scales. The results of 25 patients were used for statistical evaluation. The overall results indicate that there are significantly more patients reporting pain after subcutaneous injection of Eprex| than after Recormon| (11 versus 2 patients, p
