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Aranesp 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 (see section 4.2). 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.
Aranesp treatment should be initiated by physicians experienced in the above mentioned indications. Posology 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. 5 mmol/L). Caution should be exercised with escalation of Aranesp doses in patients with chronic renal failure.
1). 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 Aranesp is divided into two stages, correction and maintenance phase. Guidance is given separately for adult and paediatric patients. 45 mcg/kg body weight, as a single injection once weekly.
5 mcg/kg once monthly. 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 dialysis patients, Aranesp 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 Aranesp should initially receive a dose equivalent to twice the previous once weekly dose.
4. Injection site pain was reported as attributable to treatment in studies where Aranesp was administered via subcutaneous injection. The injection site discomfort was generally mild and transient in nature and occurred predominantly after the first injection.
Tabulated list of adverse reactions Incidence of adverse reactions are listed below by system organ class and frequency.
Frequencies are defined as:
Very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data). Data are presented separately for CRF and cancer patients reflecting the different adverse reaction profile in these populations.
12 Chronic renal failure patients Data presented from controlled studies included 1,357 patients, 766 who received Aranesp and 591 patients who received r-HuEPO. In the Aranesp group, 83% were receiving dialysis and 17% were not receiving dialysis.
1). Incidence of adverse reactions from controlled clinical studies and post-marketing experience are: MedDRA system organ class Subject incidence Adverse reaction Blood and lymphatic system disorders Not known2 Pure red cell aplasia Immune system disorders Very common Hypersensitivitya Nervous system disorders Common Strokeb Uncommon1 Convulsions Cardiac disorders Very common Hypertension Vascular disorders Uncommon Thromboembolic eventsc Uncommon1 Dialysis vascular access thrombosisd Skin and subcutaneous tissue disorders Common Rash/erythemae Not known2 SJS/TEN, erythema multiforme, blistering, skin exfoliation General disorders and administration site conditions Common Injection site pain Uncommon1 Injection site bruising Injection site haemorrhage Source: Includes 5 randomised, double-blind, active-controlled studies (970200, 970235, 980117, 980202, and 980211) except for the adverse reaction of stroke which was identified as an adverse reaction in the TREAT study (study 20010184).
General In order to improve the traceability of erythropoiesis-stimulating agents (ESAs), the trade name of the administered ESA should be clearly recorded (or stated) in the patient file. Blood pressure should be monitored in all patients, particularly during initiation of Aranesp therapy.
2). Cases of severe hypertension, including hypertensive crisis, hypertensive encephalopathy, and seizures, have been observed in CRF patients treated with Aranesp. 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 Aranesp should prompt a search for causative factors. Deficiencies of iron, folic acid or vitamin B12 reduce the effectiveness of ESAs 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.
9 Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association with epoetin treatment. More severe cases have been observed with long-acting epoetins.
At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, Aranesp should be withdrawn immediately and an alternative treatment considered.
1. Poorly controlled hypertension.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In patients not on dialysis, Aranesp may continue to be administered as a single injection once weekly or once every two weeks or once monthly. For patients treated with Aranesp once every two weeks, after the target haemoglobin has been achieved, Aranesp may then be administered subcutaneously once monthly using an initial dose equal to twice the previous once every two week dose.
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.
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 Aranesp. The initial weekly dose of Aranesp (mcg/week) can be determined by dividing the total weekly dose of r-HuEPO (IU/week) by 200.
The initial every other week dose of Aranesp (mcg/every other week) can be determined by 6 dividing the total cumulative dose of r-HuEPO administered over a two-week period by 200. Because of individual variability, titration to optimal therapeutic doses is expected for individual patients.
When substituting Aranesp for r-HuEPO the haemoglobin should be monitored every one or two weeks and the same route of administration should be used. Paediatric population with chronic renal failure Treatment of […]
1 Adverse reactions identified in the post-marketing environment. Per the Guideline on Summary of Product Characteristics (Revision 2, September 2009), frequency of adverse reactions identified in the post-marketing setting was determined using the “Rule of three”.
2 Frequency cannot be estimated from the available data. a Hypersensitivity events includes all events under the hypersensitivity SMQ. b Stroke events includes PT haemorrhagic stroke, ischaemic stroke, cerebrovascular accident, and stroke in evolution.
c Thromboembolic events adverse reaction includes PT embolism arterial, thrombophlebitis, thrombosis, venous thrombosis limb. d Dialysis vascular access thrombosis includes all adverse reactions under the dialysis vascular access thrombosis AMQ e Rash/erythema adverse reaction includes PT rash, rash pruritic, rash macular, rash generalised, erythema.
Cancer patients Adverse reactions were determined based on pooled data from eight randomised, double-blind, placebo-controlled studies of Aranesp with a total of 4,630 patients (Aranesp 2,888, placebo 1,742). , lymphoma, multiple myeloma) were enrolled in the clinical studies.
Incidence of adverse reactions from controlled clinical studies and post-marketing experience are: MedDRA system organ class Subject incidence Adverse reaction Immune system disorders Very common Hypersensitivitya Nervous system disorders Uncommon1 Convulsions Cardiac disorders Common Hypertension Vascular disorders Common Thromboembolic eventsb, including pulmonary embolism 13 MedDRA system organ class Subject incidence Adverse reaction Skin and subcutaneous tissue disorders Common Rash/erythemac Not known2 SJS/TEN, erythema multiforme, blistering, skin exfoliation General disorders and administration site conditions Common Oedemad Common Injection site paine Uncommon1 Injection site bruising Injection site haemorrhage 1 ADRs identified in the post marketing environment.
Per the Guideline on Summary of Product Characteristics (Revision 2, September 2009), frequency of ADRs identified in the post marketing setting was determined using the “Rule of three”. 2 Frequency cannot be estimated from the available data.
Source: includes 8 randomised, double-blind, placebo-controlled studies (980291-schedule 1 and 2, 980297, 990114, 20000161, 20010145, 20030232, and 20070782) a Hypersensitivity events includes all events under the hypersensitivity SMQ.
b Thromboembolic events adverse reactions includes PT embolism, thrombosis, deep vein thrombosis, jugular vein thrombosis, venous thrombosis, arterial thrombosis, pelvic venous thrombosis, peripheral embolism, pulmonary embolism, as well as thrombosis in device from SOC product issues.
c Rash adverse reactions includes PT rash, rash pruritic, rash generalised, rash papular, erythema, exfoliative rash, rash maculo-papular, rash vesicular as well as rash pustular from SOC Infections and Infestations. d Oedema: includes PT Oedema Peripheral, Oedema, Generalised Oedema, Oedema due to Cardiac Disease, Face oedema e Injection site pain adverse reaction includes PT injection site pain, administration site pain, catheter site pain, infusion site pain and vessel puncture site pain.
1). In isolated cases, neutralising anti-erythropoietin antibody mediated pure red cell aplasia (PRCA) associated with Aranesp therapy have been reported predominantly in patients with CRF treated subcutaneously. In case PRCA is diagnosed, therapy […]
If the patient has developed a severe cutaneous skin reaction such as SJS or TEN due to the use of Aranesp, treatment with Aranesp must not be restarted in this patient at any time. Pure red cell aplasia caused by neutralising anti-erythropoietin antibodies has been reported in association with ESAs, including Aranesp.
This has been predominantly reported in patients with CRF treated subcutaneously. 8). A paradoxical decrease in haemoglobin and development of severe anaemia associated with low reticulocyte counts should prompt to discontinue treatment with epoetin and perform anti-erythropoietin antibody testing.
Cases have been reported in patients with hepatitis C treated with interferon and ribavirin, when epoetins are used concomitantly. Epoetins are not approved in the management of anaemia associated with hepatitis C. Active liver disease was an exclusion criteria in all studies of Aranesp, therefore no data are available from patients with impaired liver function.
Since the liver is thought to be the principal route of elimination of darbepoetin alfa and r-HuEPO, Aranesp should be used with caution in patients with liver disease. Aranesp should also be used with caution in those patients with sickle cell anaemia.
Misuse of Aranesp 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. The needle cap of the pre-filled syringe or pre-filled pen contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
Aranesp should be used with caution in patients with epilepsy. Convulsions have been reported in patients receiving Aranesp. , deep venous thrombosis, pulmonary embolism, and cerebral vascular accident). This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
2. 5 mmol/L). Caution should be exercised with escalation of Aranesp doses in patients with chronic renal failure, since high cumulative epoetin doses may be associated with an increased risk of mortality, serious cardiovascular and cerebrovascular events.
1). 10 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.
Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 mcg/L or whose transferrin saturation is below 20%. Serum potassium levels should be monitored regularly during Aranesp therapy. Potassium elevation has been reported in a few patients receiving Aranesp, though causality has not been established.
If an elevated or rising potassium level is observed then consideration […]