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Nespo is a brand name for Darbepoetin Alfa. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients. Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.
Verbatim from this product's EMA label. Tap a section to expand.
Nespo treatment should be initiated by physicians experienced in the above mentioned indications. Nespo is supplied ready for use in a pre-filled syringe. 6. Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician’s evaluation of the individual patient’s clinical course and condition is necessary.
5 mmol/l). Subcutaneous use is preferable in patients who are not receiving haemodialysis to avoid the puncture of peripheral veins. Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
5 mmol/l). 5 mmol/l) are observed are described below. 25 mmol/l) over a four week period should be avoided. If it occurs, appropriate dose adjustment should be made as provided. Treatment with Nespo is divided into two stages – correction and maintenance phase.
Guidance is given separately for adult and paediatric patients. 45 μg/kg body weight, as a single injection once weekly. 75 μg/kg may be administered subcutaneously as a single injection once every two weeks. 6 mmol/l) in four weeks) increase the dose by approximately 25%.
Dose increases must not be made more frequently than once every four weeks. 25 mmol/l) in four weeks reduce the dose by approximately 25%. 5 mmol/l), a dose reduction should be considered. If the haemoglobin continues to increase, the dose should be reduced by approximately 25%.
If after a dose reduction, haemoglobin continues to increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at approximately 25% lower than the previous dose.
The haemoglobin should be measured every one or two weeks until it is stable. Thereafter the haemoglobin can be measured at longer intervals. Maintenance Phase In the maintenance phase, Nespo may continue to be administered as a single injection once weekly or once every two weeks.
Dialysis patients converting from once weekly to once every other week dosing with Nespo should initially receive a dose equivalent to twice the previous once weekly dose. In patients not on dialysis, once the target haemoglobin has been achieved with once every two week dosing, Nespo may be administered subcutaneously once monthly using an initial dose equal to twice the previous once every two week dose.
General There have been reports of serious allergic reactions including anaphylactic reaction, angioedema, dyspnoea, skin rash and urticaria associated with darbepoetin alfa. Clinical Trial Experience Chronic renal failure patients Data presented from controlled studies included 1357 patients, 766 who received Nespo and 591 patients who received r-HuEPO.
In the Nespo group, 83% were receiving dialysis and 17% were not receiving dialysis. Injection site pain was reported as attributable to treatment in studies where Nespo was administered via subcutaneous injection. This was seen more frequently than with r-HuEPO.
The injection site discomfort was generally mild and transient in nature and occurred predominantly after the first injection. Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical studies are: MedDRA system organ class Subject Incidence Adverse Drug Reaction Cardiac Disorders Very Common (≥ 1/10) Hypertension Skin and Subcutaneous Tissue Disorders Common (≥ 1/100 to < 1/10) Rash/Erythema Vascular disorders Uncommon (≥ 1/1,000 to < 1/100) Thromboembolic Events General Disorders and Administration Site Conditions Common (≥ 1/100 to < 1/10) Injection site pain Adverse reactions were determined based on pooled data from seven randomised, double-blind, placebo-controlled studies of Nespo with a total of 2112 patients (Nespo 1200, placebo 912).
, lymphoma, multiple myeloma) were enrolled in the clinical studies. Medicinal product no longer authorised9 Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical studies are: MedDRA system organ class Subject Incidence Adverse Drug Reaction Skin and Subcutaneous Tissue Disorders Common (≥ 1/100 to < 1/10) Rash/Erythema Vascular disorders Common (≥ 1/100 to < 1/10) Thromboembolic events, including pulmonary embolism General Disorders and Administration Site Conditions Very Common (≥ 1/10) Oedema Common (≥ 1/100 to < 1/10) Injection site pain Postmarketing Experience The following adverse reactions have been identified during postmarketing use of Nespo: • Pure Red Cell Aplasia.
General Blood pressure should be monitored in all patients, particularly during initiation of Nespo therapy. 2). In order to ensure effective erythropoiesis, iron status should be evaluated for all patients prior to and during treatment and supplementary iron therapy may be necessary.
Non-response to therapy with Nespo should prompt a search for causative factors. Deficiencies of iron, folic acid or vitamin B12 reduce the effectiveness of erythropoiesis stimulating agents and should therefore be corrected. Intercurrent infections, inflammatory or traumatic episodes, occult blood loss, haemolysis, severe aluminium toxicity, underlying haematologic diseases, or bone marrow fibrosis may also compromise the erythropoietic response.
A reticulocyte count should be considered as part of the evaluation. If typical causes of non-response are excluded, and the patient has reticulocytopenia, an examination of the bone marrow should be considered. If the bone marrow is consistent with PRCA, testing for anti-erythropoietin antibodies should be performed.
Pure red cell aplasia caused by neutralising anti-erythropoietin antibodies has been reported in association with recombinant erythropoietic proteins, including darbepoetin alfa. This has been predominantly reported in patients with CRF treated subcutaneously.
8). Active liver disease was an exclusion criteria in all studies of Nespo, therefore no data are available from patients with impaired liver function. Since the liver is thought to be the principal route of elimination of Nespo and r-HuEPO, Nespo should be used with caution in patients with liver disease.
Nespo should also be used with caution in those patients with sickle cell anaemia or epilepsy. Misuse of Nespo by healthy persons may lead to an excessive increase in packed cell volume. This may be associated with life-threatening complications of the cardiovascular system.
Hypersensitivity to darbepoetin alfa, r-HuEPO or any of the excipients. Poorly controlled hypertension. Medicinal product no longer authorised6
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Dosing should be titrated as necessary to maintain the haemoglobin target. If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%. 25 mmol/l) in four weeks reduce the dose by approximately 25%, depending on the rate of increase.
5 mmol/l), a dose reduction should be considered. If the haemoglobin continues to increase, the dose should be reduced by approximately 25%. If after a dose reduction, haemoglobin continues to increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at approximately 25% lower than the previous dose.
Patients should be monitored closely to ensure that the lowest approved dose of Nespo is used to provide adequate control of the symptoms of anaemia. After any dose or schedule adjustment the haemoglobin should be monitored every one or two weeks.
Dose changes in the maintenance phase of treatment should not be made more frequently than every two weeks. When changing the route of administration the same dose must be used and the haemoglobin monitored every one or two weeks so that the appropriate dose adjustments can be made to keep the haemoglobin at the desired level.
Clinical studies have demonstrated that adult patients receiving r-HuEPO one, two or three times weekly may be converted to once weekly or once every other week Nespo. The initial weekly dose of Nespo (μg/week) can be determined by dividing the total weekly dose of r-HuEPO (IU/week) by 200.
The initial every other week dose of Nespo (μg/every other week) can be determined by dividing the total cumulative dose of r-HuEPO administered over a two-week period by 200. Because of Medicinal product no longer authorised4 individual variability, titration to optimal therapeutic doses is expected for individual patients.
When substituting Nespo for r-HuEPO the haemoglobin should be monitored every one or two weeks and the same route of administration should be used. 45 μg/kg body weight, as a single injection once weekly. 75 μg/kg may be administered subcutaneously as a single […]
In isolated cases, neutralising anti-erythropoietin antibody mediated pure red cell aplasia (PRCA) associated with Nespo therapy have been reported predominantly in patients with CRF treated subcutaneously. 4). • Allergic reactions, including anaphylactic reaction, angioedema, skin rash and urticaria.
• Convulsions.
The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions. 2. 5 mmol/l). Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
Nespo should be used with caution in patients with epilepsy. Convulsions have been reported in patients receiving Nespo. Chronic renal failure patients Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 μg/l or whose transferrin saturation is below 20%.
Medicinal product no longer authorised7 In patients with chronic renal failure and clinical evidence of ischaemic heart disease or congestive heart failure, the target haemoglobin should be determined individually. g. angina) dictate otherwise.
Serum potassium levels should be monitored regularly during Nespo therapy. Potassium elevation has been reported in a few patients receiving Nespo, though causality has not been established. If an elevated or rising potassium level is observed then consideration should be given to ceasing Nespo administration until the level has been corrected.
Cancer patients Effect on tumour growth Epoetins are growth factors that primarily stimulate red blood cell production. Erythropoietin receptors may be expressed on the surface of a variety of tumour cells. As with all growth factors, there is a concern that epoetins could stimulate the growth of tumours.
In several controlled studies, epoetins have not been shown to improve overall survival or decrease the risk of tumour progression in patients with anaemia associated with cancer. 7 mmol/l), ESAs are not indicated for use in this patient population.
ESAs are not indicated for use in this patient population. In view of the above, in some clinical situations blood transfusion should be the preferred treatment for the management of anaemia in patients with cancer. The decision to administer recombinant erythropoietins should be based on a benefit-risk assessment with the participation of the individual patient, which should take into account the specific clinical context.
Factors that should be considered in this assessment should include the type of tumour and its stage; the degree of anaemia; life- expectancy; the environment in which the patient is being treated; […]