Epoetin zeta

SOURCE: UK SPC (eMC) for Retacrit 1,000 IU/0.3 ml solution for injection in pre-filled syringe, section 4.2 (https://www.medicines.org.uk/emc/product/6413/smpc). Treatment must be initiated under the supervision of physicians experienced in the management of these patients. Evaluate and treat all other causes of anaemia (iron, folate or vitamin B12 deficiency, aluminium intoxication, infection or inflammation, blood loss, haemolysis, bone marrow fibrosis) before starting and when deciding to increase the dose; ensure adequate iron stores and supplement iron if necessary. ADULT RENAL TARGETS: recommended haemoglobin range 10 to 12 g/dL; do not exceed 12 g/dL and avoid a rise of more than 2 g/dL over four weeks. If Hb rises by more than 2 g/dL per month or sustained Hb exceeds 12 g/dL, reduce the dose by 25%; if Hb exceeds 13 g/dL, discontinue until it falls below 12 g/dL then restart at a dose 25% below the previous dose. ADULT HAEMODIALYSIS: correction 50 IU/kg three times per week, increasing or decreasing by 25 IU/kg (three times per week) in steps of at least four weeks until the target range is reached; maintenance total weekly dose 75 to 300 IU/kg. ADULT RENAL INSUFFICIENCY NOT YET ON DIALYSIS: correction 50 IU/kg three times per week with 25 IU/kg increments; maintenance three times per week, or (subcutaneously) once weekly or once every 2 weeks, within the maxima above - extending dose intervals may require an increase in dose. ADULT PERITONEAL DIALYSIS: correction 50 IU/kg two times per week; maintenance 25 to 50 IU/kg two times per week in 2 equal injections. CHEMOTHERAPY-INDUCED ANAEMIA (adults, Hb 10 g/dL or less): initial 150 IU/kg subcutaneously three times per week, or alternatively 450 IU/kg subcutaneously once weekly. After 4 weeks - if Hb has risen at least 1 g/dL or reticulocytes have risen 40,000 cells/microlitre or more above baseline, keep the dose; if the Hb rise is less than 1 g/dL and reticulocyte rise less than 40,000 cells/microlitre, increase to 300 IU/kg three times per week; if after a further 4 weeks at 300 IU/kg three times per week Hb has still risen less than 1 g/dL and reticulocytes less than 40,000 cells/microlitre, response is unlikely and treatment should be discontinued. Reduce the dose by about 25 to 50% if Hb rises more than 2 g/dL per month or exceeds 12 g/dL; discontinue if Hb exceeds 13 g/dL until below 12 g/dL then restart 25% below the previous dose. Continue until one month after the end of chemotherapy. ADULT AUTOLOGOUS PREDONATION PROGRAMME: mildly anaemic patients (haematocrit 33 to 39%) requiring predeposit of 4 or more units of blood - 600 IU/kg intravenously two times per week for 3 weeks prior to surgery, given after completion of the blood donation procedure. ADULT MAJOR ELECTIVE ORTHOPAEDIC SURGERY: 600 IU/kg subcutaneously weekly for three weeks (days -21, -14 and -7) prior to surgery and on the day of surgery; if the lead time must be shortened to less than three weeks, 300 IU/kg subcutaneously daily for 10 consecutive days prior to surgery, on the day of surgery and for four days immediately thereafter. Stop if the haemoglobin reaches 15 g/dL or higher during the preoperative period. LOW- OR INTERMEDIATE-1-RISK MDS (symptomatic anaemia, Hb 10 g/dL or less): starting dose 450 IU/kg (maximum total dose 40,000 IU) subcutaneously once every week with not less than 5 days between doses; assess initial erythroid response at 8 to 12 weeks; change dose one dosing step at a time with a minimum of 4 weeks between increases; withhold when Hb exceeds 12 g/dL and restart when Hb is below 11 g/dL at the same or one step lower dose; consider a one-step decrease if Hb rises more than 2 g/dL over 4 weeks. Leave the syringe to reach room temperature (usually 15 to 30 minutes) before use.

Indication: symptomatic anaemia in paediatric chronic renal failure patients on haemodialysis. Correction phase starting dose 50 IU/kg intravenously three times per week; increase or decrease by 25 IU/kg (three times per week) in steps of at least four weeks until the target haemoglobin of 9.5 to 11 g/dL is achieved. Recommended paediatric haemoglobin range is 9.5 to 11 g/dL - do not increase Hb above 11 g/dL, and avoid a rise of more than 2 g/dL over four weeks. Maintenance doses observed in clinical trials after 6 months (IU/kg given three times per week): under 10 kg - median 100, usual 75 to 150; 10 to 30 kg - median 75, usual 60 to 150; over 30 kg - median 33, usual 30 to 100. Children under 30 kg generally require higher maintenance doses than children over 30 kg and adults; paediatric patients with very low initial haemoglobin (below 6.8 g/dL) may require higher maintenance doses. Safety and efficacy have NOT been established in paediatric chronic renal failure patients before initiation of dialysis or on peritoneal dialysis (no posology recommendation can be made), nor in paediatric patients receiving chemotherapy, in autologous predonation programmes, or scheduled for major elective orthopaedic surgery. Verify against a children's formulary before use.