Epoetin beta

CLINICAL USE

Anaemia associated with renal impairment in pre-dialysis and dialysis patients, and in patients receiving cancer chemotherapy

DOSE IN NORMAL RENAL FUNCTION

Renal: CORRECTION PHASE: (To raise —haemoglobin to target level) 60 u/kg SC or 40 u/kg IV 3 times weekly for 4 weeks; increase, according to response, in steps of 20 u/kg 3 times weekly at monthly intervals. Maximum dose 720 u/kg weekly. Target haemoglobin usually 10–12 g/100mLMAINTENANCE DOSE: (To maintain —haemoglobin at target level) Half correction phase dose, then adjust according to response at intervals of 1–2 weeksCancer: Initially 450 u/kg weekly in 3–7 divided doses and adjust according to response

PHARMACOKINETICS

Molecular weight                           :30 400

%Protein binding                           :No data

%Excreted unchanged in urine     : No data

Volume of distribution (L/kg)       :0.03–0.05

half-life – normal/ESRD (hrs)      :IV: 4–12/UnchangedSC: 13–28/Unchanged

DOSE IN RENAL IMPAIRMENT

GFR (mL/MIN)

20 to 50     : Dose as in normal renal function

10 to 20     : Dose as in normal renal function

<10           : Dose as in normal renal function

DOSE IN PATIENTS UNDERGOING RENAL REPLACEMENT THERAPIES

CAPD                :Not dialysed. Dose as in normal renal function

HD                     :Not dialysed. Dose as in normal renal function

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

CAV/VVHD      :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

Reconstitute using diluent provided only for multidose vial and penfill cartridges

Route

SC, IV

Rate of Administration

2 minutes

Comments

May also be given IV, but higher doses are needed to produce required response

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                     :Reported association of pure red cell aplasia (PRCA) with epoetin therapy.This is a very rare condition; 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

See how to identify renal failure stages according to GFR calculation

See how to diagnose irreversible renal disease

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