mircera.txt

CLINICAL USE

Management of anaemia associated with renal impairment in pre-dialysis and dialysis patients

DOSE IN NORMAL RENAL FUNCTION

ESA-naive patients: 0.6 mcg/kg every 2 weeks, changing by 25% according to response; once stable change to monthly dosingTarget haemoglobin usually 10–12 g/dL If previously on an ESA: 120–360 mcg monthly depending on previous ESA dose, and adjust according to response

PHARMACOKINETICS

Molecular weight &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp :60 000

%Protein binding &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp :No data

%Excreted unchanged in urine &nbsp &nbsp : Unlikely

Volume of distribution (L/kg) &nbsp &nbsp &nbsp :3–5.4 litres

half-life – normal/ESRD (hrs)&nbsp &nbsp &nbsp :IV: 134/UnchangedSC: 139 (142 if not on dialysis)/Unchanged

DOSE IN RENAL IMPAIRMENT

GFR (mL/MIN)

20 to 50 &nbsp &nbsp : Dose as in normal renal function

10 to 20 &nbsp &nbsp : Dose as in normal renal function

<10 &nbsp &nbsp &nbsp &nbsp &nbsp : Dose as in normal renal function

DOSE IN PATIENTS UNDERGOING RENAL REPLACEMENT THERAPIES

CAPD &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp:Not dialysed. Dose as in normal renal function

HD &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp :Not dialysed. Dose as in normal renal function

HDF/high flux &nbsp :Not dialysed. Dose as in normal renal function

CAV/VVHD &nbsp &nbsp &nbsp:Not dialysed. Dose as in normal renal function

IMPORTANT DRUG INTERACTIONS

Potentially hazardous interactions with other drugsRisk of hyperkalaemia with ACE inhibitors and angiotensin-II antagonists

ADMINISTRATION

Reconstition

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Route

SC, IV

Rate of Administration

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Comments

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OTHER INFORMATION

Pre-treatment checks and appropriate correction/ treatment needed for iron, folate and B12 deficiencies, infection, inflammation or aluminium toxicity to produce optimum response to therapyConcomitant iron therapy (200–300 mg elemental oral iron) needed daily. IV iron may be needed for patients with very low serum ferritin (<100 nanograms/mL)May increase heparin requirement during

HD &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp :Reported association of pure red cell aplasia (PRCA) with epoetin therapy – very rare; due to failed production of red blood cell precursors in the bone marrow, resulting in profound anaemia. Possibly due to an immune response to the protein backbone of R-HuEPO. Resulting antibodies render the patient unresponsive to the therapeutic effects of all epoetins and darbepoetin.

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