Methoxy polyethylene glycol-epoetin beta

Treatment must be initiated under the supervision of a physician experienced in the management of patients with renal impairment. Titration (ESA-naive adults): increase the dose by approximately 25% of the previous dose if the rate of rise in haemoglobin is less than 1.0 g/dl over a month, with further approximately 25% increases at monthly intervals until the individual target haemoglobin is obtained. If the rate of rise exceeds 2 g/dl in one month, or haemoglobin is increasing and approaching 12 g/dl, reduce the dose by approximately 25%. If haemoglobin continues to increase, interrupt therapy until it begins to decrease, then restart at approximately 25% below the previous dose (expect a fall of about 0.35 g/dl per week after interruption). Dose adjustments should not be made more frequently than once a month. Patients treated once every two weeks whose haemoglobin is above 10 g/dl may be switched to once-monthly dosing using twice the previous once-every-two-week dose. Adults currently treated with an ESA: can be switched to once-monthly IV or SC injection, with the starting dose based on the calculated previous weekly dose of darbepoetin alfa or epoetin (SPC Table 1: previous darbepoetin alfa under 40 microgram/week or epoetin under 8,000 IU/week gives 120 microgram monthly; 40-80 microgram/week or 8,000-16,000 IU/week gives 200 microgram monthly; over 80 microgram/week or over 16,000 IU/week gives 360 microgram monthly). The first injection should start at the next scheduled dose of the previously administered ESA. Monitor haemoglobin every two weeks until stabilised and periodically thereafter. Avoid a rise in haemoglobin of more than 2 g/dl over four weeks in adults (more than 1 g/dl in paediatric patients). Caution with dose escalation in chronic renal failure - high cumulative epoetin doses may be associated with increased mortality and serious cardiovascular and cerebrovascular events. Limited experience in peritoneal dialysis: regular haemoglobin monitoring and strict adherence to dose adjustment guidance recommended. Supplementary iron therapy is recommended for all patients with serum ferritin below 100 microgram/l or transferrin saturation below 20%. Paediatric (3 months to under 18 years) - conversion only: paediatric patients whose haemoglobin has been stabilised on another ESA can be converted to methoxy polyethylene glycol-epoetin beta once every 4 weeks by IV or SC injection, keeping the same route, with the starting dose calculated from the total weekly ESA dose at the time of conversion (SPC Table 2 - the conversion table itself is truncated in the fetched source and must be read from the full SPC). Paediatric dosing is conversion-table based, not per-kg. Children under 1 year should be carefully evaluated before switching and haemoglobin stabilised beforehand; monitor haemoglobin every 4 weeks after conversion. Patients on less than 9 microgram/week darbepoetin alfa or less than 2,000 IU/week epoetin should not be switched, as the lowest available pre-filled syringe strength is 30 micrograms; administration of partial doses with pre-filled syringes is not recommended. Verify paediatric use against a children's formulary and the full SPC.