NESP

Darbepoetin α

Anaemia associated w/ chronic renal failure (CRF). Anaemia & reduction of transfusion requirements in patients w/ non-myeloid malignancies where anaemia develops as a result of concomitantly administered chemotherapy. Anaemia w/ myelodysplastic syndrome.

CRF patient & those w/ non-myeloid malignancies receiving chemotherapy Lowest dose that will gradually increase Hb conc to approach a target of not more than 12 g/dL; rate of Hb increase should not exceed 1 g/dL in any 2-wk period. Correction of anaemia Initially 0.45 mcg/kg SC/IV as a single inj once wkly. May be increased by approx 25%. Further increases may be made at 4-wk intervals until the desired response is attained. Maintenance of Hb conc Patient on dialysis & not on dialysis May be dosed wkly or once every 2 wk at the titrated dose to maintain target Hb. For dose adjustment to maintain target Hb, individual dose may be adjusted at 4-wk intervals until the appropriate Hb level is achieved. Conversion from recombinant human erythropoietin (r-HuEPO) to NESP Initial SC dose: Divide the total wkly r-HuEPO SC dose (u/wk) by 200. Initial IV dose: Divide the total wkly r-HuEPO IV dose (u/wk) by 240. Patient w/ non-myeloid malignancies receiving chemotherapy Initially 2.25 mcg/kg once wkly as single SC inj. Dose adjustment in cancer patients: If Hb approaches 12 g/dL, reduce dose by approx 25-50%. If Hb is >12 g/dL, temporarily w/hold dose & re-initiate when Hb decreases to 11 g/dL at 25-50% below the previous dose. Anaemia w/ myelodysplastic syndrome Adult 240 mcg as a single SC inj once wkly. Dose should be decreased in view of the degree of anaemic symptoms & patient's age.

Hypersensitivity. Known sensitivity to products derived from mammalian cells. Uncontrolled HTN.

Immediately discontinue therapy if serious allergic or anaphylactic reaction; severe cutaneous reactions (eg, SJS, TEN) occur. Patients who are in intermediate-2 or high risk categories under International Prognostic Scoring System. Risk of CV & thrombotic events. Increased risk of death & serious CV events or strokes. Growth factor potential for any tumour type particularly myeloid malignancies. Increased risk of death when administered to a Hb target of 12-14 g/dL in patients w/ active malignant disease receiving neither chemotherapy nor RT. Carefully assess risk of reactions (eg, shock); prepare instruments & medicines beforehand in case of shock; keep patient calm & monitor sufficiently from start through end of administration. Carefully monitor Hb conc at regular intervals. May increase BP & possibly cause hypertensive encephalopathy; closely monitor parameters (eg, BP & haemoglobin conc) during treatment. Administer Fe to patients w/ Fe deficiency. Do not use in patients w/ uncontrolled HTN. Adequately control BP before initiation of therapy; closely monitor & control BP during therapy. Advise patient on the importance of compliance w/ anti-HTN therapy & dietary/fluid restriction during therapy. Discontinue use when pure red cell aplasia is diagnosed & evaluate patient for presence of binding & neutralising Ab to NESP, native erythropoietin & any other recombinant erythropoietin administered to the patient. History of convulsions. Evaluate Fe status before & during treatment. Exclude or correct folic acid or vit B₁₂ deficiencies. Patients w/ underlying haematologic diseases (eg, haemolytic & sickle cell anaemia, thalassaemia & porphyria). Pregnancy & lactation. Childn.

Inj site pain; peripheral oedema, fatigue, fever, chest pain, access haemorrhage & infection, flu-like symptoms, fluid overload; HTN, hypotension, access vascular thrombosis; headache, dizziness; diarrhoea, vomiting, nausea, abdominal pain, constipation; myalgia, arthralgia, limb & back pain; upper resp infection, dyspnoea, cough, bronchitis; pruritus. CVA/transient ischaemic attack, convulsions, MI. CRF, UTI, hypoglycaemia, nasopharyngitis, fall, cellulitis, sinusitis, contusion, rash, skin ulcer. Asthenia, granulocytopenia. Pain, chest pain (non-cardiac), metastatic neoplasm, oedema; insomnia, paresthesia, hypoesthesia; anorexia, dyspepsia; skeletal pain; depression, anxiety; sore throat; alopecia. Rarely, serious allergic reactions; severe cutaneous reactions including blistering, skin exfoliation, erythema multiforme & SJS/TEN.

Haematopoietic Agents / Supportive Care Therapy

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

POM