Epoetin alfa

CLINICAL USE

Anaemia associated with renal impairment in pre-dialysis and dialysis patients, and in patients receiving cancer chemotherapyIncreased yield of autologous blood

DOSE IN NORMAL RENAL FUNCTION

Renal: CORRECTION PHASE: (To raise —haemoglobin to target level) 50 u/kg 2–3 times weekly; increase, according to response, by 25 u/kg 3 times weekly at intervals of 4 weeks. Rise in haemoglobin should not exceed 2 g/100 mL/month (optimum rise in haemoglobin up to 1 g/100 mL/month to avoid hypertension)Target haemoglobin usually 10– —12 g/100 mLMAINTENANCE PHASE: Adjust dose —to maintain required haemoglobin level; usual dose needed is 75–300 u/kg weekly in 1–3 divided dosesCancer: Initially 150 u/kg 3 times a week and adjust according to responseAutologous blood harvest: 600 u/kg IV once or twice a week for 3 weeks prior to surgery

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: 4/5SC: ≅24/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 drugsHyperkalaemia with ACE inhibitors and angiotensin-II antagonists

    ADMINISTRATION

    Reconstition

    Route

    IV/SC (maximum 1 mL per injection site)

    Rate of Administration

    1–5 minutes

    Comments

    When given IV, higher doses normally needed to produce required response

    OTHER INFORMATION

    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 darbepoetinPre-treatment checks and appropriate correction/ treatment needed for iron, folate and B12 deficiency, 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

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