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| Drug class description : | Erythropoietic agents |
| Generic Name : | Darbepoetin alfa |
| Drug description : | Solution for injection in a prefilled syringe |
| Presentation : | Injection, darbepoetin alfa 10 micrograms, 15 micrograms, 20 micrograms, 30 micrograms, 40 micrograms, 50 micrograms, 60 micrograms, 80 micrograms, 100 micrograms, 150 micrograms. |
| Indications : | Treatment of aneamia associated with chronic renal failure in adults and paediatric > 11 years of age. |
| Adult Dosage : | Aim of treatment is to increase haemoglobin concentration to above 11g/dl (6.8mmol/l). No difference has been noted between the average weekly dose administered by intravenous or subcutaneous injection. Correction phase: initially, 0.45 micrograms/kg as a single subcutaneous or intravenous injection once weekly. If haemoglobin increase is inadequate (less than 1g/dl [0.6mmol/l] in four weeks) increase dose by approximately 25%. Dose increases must not be made more frequently than once every four weeks. If haemoglobin increase is greater than 2.5g/dl (1.6mmol/l) in four weeks reduce the dose by 25-50% depending on the rate of increase. If the haemoglobin exceeds 14g/dl (8.7mmol/l), discontinue therapy until it falls below 13g/dl (8.1mmol/l) and then restart treatment at approximately 25% below the previous dose. Monitor haemoglobin level every one to two weeks until stable. Maintenance phase: establish exact target haemoglobin concentration above 11g/dl (6.8mmol/l) for individual patient. If necessary adjust dose by approximately 25% to maintain desired haemoglobin level. If haemoglobin exceeds 14g/dl (8.7mmol/l) act as above. Monitor heamoglobin every one or two weeks after any dose adjustment. Dose changes must not be made more frequently then every two weeks. Patients receiving r-HuEPO two or three times weelky may change to once weekly Aranesp, those receiving r-HuEPO once weekly may change to Aranesp once every other week. Determine initial dose of Aranesp (µg/week) by dividing the total weekly dose of r-HuEPO (IU/week) by 200. Titrate to optimal therapeutic dose. The same route of administration should be used. Monitor haemoglobin as above. |
| Child Dosage : | Children aged 11 years or older, as for adults; under 11 years, not recommended. |
| Contra Indications : | Hypersensitivity to darbepoetin alfa, r-HuEPO or any of the excipients. Poorly controlled hypertension. Lactation |
| Special Precautions : | Evaluate iron status prior to and during treatment; supplementary iron therapy is recommended for all patients with serum ferritin values below 100 micrograms/L or whose transferrin saturation is below 20%. No response to Aranesp therapy should promt a search for causative factors. Correct deficiencies of folic acid or vitamin B12 as these may reduce effectiveness of treatment. Severe aluminium toxicity, intercurrent infections, inflammatory or traumatic episodes, occult blood loss, haemolysis or bbone marrow fibrosis may alos cpmpromise the response to treatment. Monitor blood pressure, especially during initiation of therapy. Determine target haemoglobin individually in patients with chronic renal faliure and clinical evidence of ischaemic heart disease or congestive heart failure; aim for an upper limit of 12g/dL unless severe symptoms (eg, angina) dictate otherwise. Liver disease. Monitor serum potassium levels regularly during treatment. Sickle cell anaemia, epilepsy. Pregnancy. |
| Interactions : | If given with ciclosporin (cyclosporin), monitor blood levels of ciclosporin and adjust ciclosporin dose as haemoglobin rises. |
| Adverse Reactions : | Hypertension, thrombosis of the vascular access, injection site pain after subcutaneous administration, headache. |
| Manufacturer : | Amgen |
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