NESP

Anaemia associated w/ chronic renal failure. Anaemia due to concomitantly administered chemotherapy in patients w/ non-myeloid malignancies. Anaemia w/ myelodysplastic syndrome.

Anaemia associated w/ chronic renal failure Correction of anaemia: Initially 0.45 mcg/kg once wkly as single SC or IV inj. May increase dose by approx 25% if Hb increase is inadequate (<1 g/dL in 4 wk) & Fe stores are adequate. May further increase at 4-wk intervals until desired response is attained. Maintenance of Hb conc: May be dosed wkly or once every 2 wk at titrated dose to maintain target Hb in patients on dialysis & not on dialysis. Do not make dose changes more frequently than every 2 wk. Dose adjustment: If Hb is increasing & approaching 12 g/dL, reduce dose by approx 25%. If Hb continues to increase after dose reduction, temporarily w/hold dose until Hb begins to decrease, at which point reinstate therapy at approx 25% below previous dose. If Hb increase is >1 g/dL in 2 wk, reduce dose by 25%. Anaemia due to concomitantly administered chemotherapy in non-myeloid malignancies Initially 2.25 mcg/kg once wkly as single SC inj. Do not commence treatment unless Hb falls <10-11 g/dL. Continue therapy for approx 4 wk after end of chemotherapy or until Hb conc approaches 12 g/dL. If Hb approaches 12 g/dL, reduce dose by approx 25-50%. If Hb exceeds 12 g/dL, temporarily w/hold dose until Hb decreases to approx 11 g/dL, at which point re-initiate therapy at 25-50% below previous dose. In patients receiving treatment on wkly basis, double dose to 4.5 mcg/kg once wkly if Hb increase is inadequate (<1 g/dL after approx 1 mth of therapy) or if response is not satisfactory in terms of reducing RBC transfusion requirements. Anaemia w/ myelodysplastic syndrome 240 mcg once wkly as single SC inj. If Hb conc exceeds approx 11 g/dL, reduce dose by approx 50%. If Hb conc falls below approx 9 g/dL after dose reduction, increase dose approx 2-fold. Do not exceed 240 mcg as single inj.

Hypersensitivity to darbepoetin α or products derived from mammalian cells. Uncontrolled HTN.

Immediately discontinue treatment if serious allergic or anaphylactic reaction occurs or if severe cutaneous reaction (eg, SJS/TEN) is suspected. Risk of CV & thrombotic events & increased mortality. Use lowest dose that will gradually increase Hb conc to reduce CV risks. Hb conc should not exceed target of 12 g/dL & Hb increase rate should not exceed 1 g/dL in any 2-wk period. Growth factor potential & risk of increased tumour progression. Not indicated for patients w/ active malignant disease receiving neither chemotherapy nor RT. When treatment is started for the 1st time or restarted after temporary discontinuation, inj a small amount intradermally & then administer the remaining portion only after confirming that any abnormal reactions do not develop. Carefully monitor Hb conc at regular intervals during treatment. Prevent excessive haemopoiesis (Hb conc >11 g/dL). Discontinue treatment when pure red cell aplasia (PRCA) is diagnosed. Do not administer in patients w/ PRCA secondary to neutralising Abs to any erythropoiesis-stimulating agents. Adequately control BP before initiation of therapy. BP may rise during treatment. Risk of hypertensive encephalopathy & seizures. Caution in patients w/ history of convulsions. Evaluate Fe status before & during treatment. Exclude or correct deficiencies of folic acid or vit B₁₂. Safety & efficacy have not been established in patients w/ underlying haematologic diseases (eg, haemolytic anaemia, sickle cell anaemia, thalassaemia & porphyria). Should be used during pregnancy only if potential benefit justifies potential risk to foetus. Caution when administered to breastfeeding woman. Safety & efficacy in paed patients have not been established.

Anaemia associated w/ chronic renal failure: Inj site pain; peripheral oedema, fatigue, fever, chest pain, access haemorrhage, flu-like symptoms, fluid overload, access infection; HTN, hypotension, vascular thrombosis; headache, dizziness; diarrhoea, vomiting, nausea, abdominal pain, constipation; myalgia, arthralgia, limb pain, back pain; upper resp infection, dyspnoea, cough, bronchitis; pruritus. Anaemia due to concomitantly administered chemotherapy in non-myeloid malignancies: Fatigue, fever, peripheral oedema, asthenia, chest pain (non-cardiac), pain, metastatic neoplasm, oedema; dizziness, headache, insomnia, paresthesia, hypoesthesia; nausea, vomiting, diarrhoea, constipation, anorexia, abdominal pain, dyspepsia; granulocytopenia; back pain, arthralgia, limb pain, myalgia, skeletal pain; depression, anxiety; dyspnoea, cough, upper infection, sore throat; alopecia, rash. Anaemia w/ myelodysplastic syndrome: Diarrhoea, increased blood alkaline phosphatase, hyperuricaemia, folate deficiency, headache, HTN.

Haematopoietic Agents

B03XA02 - darbepoetin alfa ; Belongs to the class of other antianemic preparations. Used in the treatment of anemia.

P₁S₁S₃