Epoetin beta

UNITS ARE INTERNATIONAL UNITS (IU) PER KG — NOT mg. Therapy should be initiated by physicians experienced in the indications; the first dose should be given under medical supervision (isolated anaphylactoid reactions). RENAL ANAEMIA — dose escalation: subcutaneous dose may be increased every 4 weeks by 3 x 20 IU/kg and week if the increase in Hb is not adequate (< 0.25 g/dl per week); intravenous dose may be raised after 4 weeks to 80 IU/kg three times per week, and by further increments of 20 IU/kg three times per week at monthly intervals. Maintenance phase: to maintain Hb between 10 and 12 g/dl the dose is initially reduced to half of the previously administered amount, then adjusted at intervals of one or two weeks individually; subcutaneously the weekly dose may be given as one injection per week or divided three to seven times per week; patients stable on once-weekly dosing may be switched to once every two weeks (dose increases may be necessary). Hb target range 10 g/dl to 12 g/dl; avoid a sustained Hb greater than 12 g/dl and a rise greater than 2 g/dl over four weeks — if the rise exceeds 2 g/dl in one month or Hb is increasing and approaching 12 g/dl, reduce the dose by approximately 25%; if Hb continues to increase, interrupt therapy until Hb begins to decrease then restart approximately 25% below the previous dose. Treatment is normally long-term but can be interrupted at any time; once-weekly data are based on 24-week studies. CHEMOTHERAPY-INDUCED ANAEMIA IN CANCER PATIENTS: subcutaneous route, in patients with anaemia (e.g. Hb <= 10 g/dl); recommended initial dose 30,000 IU per week (corresponding to approximately 450 IU/kg body weight per week for an average weighted patient), given as one injection per week or divided 3 to 7 times per week. If after 4 weeks Hb has increased by at least 1 g/dl continue the current dose; if not, consider doubling the weekly dose; if after 8 weeks Hb has not increased by at least 1 g/dl, response is unlikely and treatment should be discontinued. Continue for up to 4 weeks after the end of chemotherapy. Once the therapeutic objective is achieved reduce the dose by 25 to 50%; if Hb exceeds 12 g/dl reduce by approximately 25 to 50%; temporarily discontinue if Hb exceeds 13 g/dl and reinitiate at approximately 25% lower than the previous dose once Hb falls to 12 g/dl or below; if the rise exceeds 2 g/dl in 4 weeks reduce by 25 to 50%. INCREASING THE AMOUNT OF AUTOLOGOUS BLOOD: given intravenously over approx. 2 minutes or subcutaneously, twice weekly over 4 weeks; administered at the end of blood donation when PCV >= 33%; PCV of 48% must not be exceeded during the treatment period. The single dose must be determined by the surgical team individually from the required amount of pre-donated blood and the endogenous red cell reserve using the SPC nomogram (endogenous red cell reserve = blood volume [ml] x (PCV - 33) / 100; women: blood volume [ml] = 41 [ml/kg] x body weight [kg] + 1200 [ml]; men: blood volume [ml] = 44 [ml/kg] x body weight [kg] + 1600 [ml], body weight >= 45 kg) — the nomogram itself is not reproducible from the fetched text. PREVENTION OF ANAEMIA OF PREMATURITY: subcutaneous 3 x 250 IU/kg body weight per week for a recommended 6 weeks (see paedDose). Caution with dose escalation in chronic renal failure; consider alternative explanations for a poor Hb response. In hypertension or existing cardiovascular, cerebrovascular or peripheral vascular disease, determine the weekly Hb increase and target Hb individually. Pre-filled syringe is single use only. Section 4.8 was truncated at the source-fetch limit.

UNIT IS INTERNATIONAL UNITS (IU) PER KG, NOT mg. This structured entry is the PREVENTION OF ANAEMIA OF PREMATURITY regimen only: 'The solution is administered subcutaneously at a dose of 3 x 250 IU/kg b.w. per week' with a recommended treatment duration of 6 weeks; premature infants already transfused by the start of treatment are not likely to benefit as much as untransfused infants. For paediatric chronic renal failure anaemia the SPC gives the same IU/kg regimens as adults (correction phase: subcutaneous 3 x 20 IU/kg per week, intravenous 3 x 40 IU/kg per week; maximum 720 IU/kg per week) and notes that, on average, the younger the patient the higher the dose required, but the recommended dosing schedule should still be followed as individual response cannot be predicted.