سعر Aranesp 20 micrograms solution for injection in pre-filled syringe (1 pre-filled syringe) 2024

Aranesp (Amgen) 20 micrograms solution for injection in pre-filled syringe, pack of 1: darbepoetin alfa, a long-acting recombinant erythropoiesis-stimulating agent used to treat symptomatic anaemia of chronic renal failure and chemotherapy-induced anaemia in adult cancer patients with non-myeloid malignancies; given by subcutaneous or intravenous injection.

• Treatment of symptomatic anaemia associated with chronic renal failure in adults and paediatric patients.Population: Adults and paediatric patientsEuropean Medicines Agency (EPAR product information)
• Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.Population: AdultsEuropean Medicines Agency (EPAR product information)
• US label: anemia due to chronic kidney disease in patients on and not on dialysis; anemia due to the effect of concomitant myelosuppressive chemotherapy when at least two additional months of chemotherapy are planned. Not indicated when chemotherapy is given with curative intent, as a substitute for transfusion needing immediate correction, or for cancer patients not receiving myelosuppressive chemotherapy.Population: Adults and paediatric patients (CKD)DailyMed (U.S. National Library of Medicine)

• Chronic renal failure: very common - hypersensitivity, hypertension; common - stroke, rash/erythema, injection-site pain; uncommon - convulsions, thromboembolic events, vascular access thrombosis, injection-site bruising and haemorrhage; not known - pure red cell aplasia, SJS/TEN. Cancer patients: very common - hypersensitivity; common - hypertension, thromboembolic events including pulmonary embolism, rash/erythema, oedema, injection-site pain; uncommon - convulsions; not known - SJS/TEN.International label, same product · European Medicines Agency (EPAR product information)

• Hypersensitivity to darbepoetin alfa, r-HuEPO or any excipient; poorly controlled hypertension.International label, same product · European Medicines Agency (EPAR product information)
• Uncontrolled hypertension; pure red cell aplasia that begins after treatment with Aranesp or other erythropoietin products; serious allergic reactions to Aranesp.General active-ingredient information · DailyMed (U.S. National Library of Medicine)

• BOXED WARNING (US): ESAs increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access and tumour progression or recurrence. CKD: greater risks of death, serious cardiovascular reactions and stroke when targeting Hb above 11 g/dL; no trial identified a safe Hb target - use the lowest dose sufficient to reduce transfusions. Cancer: shortened overall survival and/or increased tumour progression in breast, non-small cell lung, head and neck, lymphoid and cervical cancers; use only for anaemia from myelosuppressive chemotherapy, not when the anticipated outcome is cure, and discontinue after completion of chemotherapy.General active-ingredient information · DailyMed (U.S. National Library of Medicine)
• Monitor blood pressure in all patients (hypertensive crisis, hypertensive encephalopathy and seizures reported); control hypertension before and during therapy. Assess iron status and give supplementary iron if serum ferritin is below 100 mcg/L or transferrin saturation below 20%. Investigate non-response (iron, folate or vitamin B12 deficiency, aluminium intoxication, infection/inflammation, blood loss, haemolysis, marrow fibrosis). Pure red cell aplasia caused by neutralising anti-erythropoietin antibodies has been reported - stop treatment and do not switch to another ESA. Severe cutaneous adverse reactions including SJS/TEN have been reported - stop permanently. Record the trade name and batch number (biological traceability).International label, same product · European Medicines Agency (EPAR product information)
• Chronic renal failure: maintenance Hb should not exceed 12 g/dL - targeting higher Hb increased the risk of death, serious cardiovascular events including thrombosis and stroke; thrombotic vascular events (including vascular access thrombosis) reported. Use with caution in epilepsy, sickle cell anaemia and liver disease; monitor serum potassium. Not for use in hepatitis C patients on interferon/ribavirin outside approved indications (PRCA reports). Misuse by healthy persons may cause life-threatening polycythaemia. The needle cover of the pre-filled syringe contains dry natural rubber (latex), which may cause allergic reactions.International label, same product · European Medicines Agency (EPAR product information)

• Ciclosporin, tacrolimusBlood levels of these red-cell-bound drugs may change as haemoglobin rises; monitor their blood levels and adjust doses.European Medicines Agency (EPAR product information)

• No adequate and well-controlled studies in pregnant women; animal studies do not indicate direct harmful effects on pregnancy, embryonal/fetal development, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women.International label, same product · European Medicines Agency (EPAR product information)
• Limited human data are insufficient to establish a drug-associated risk; in animal studies darbepoetin alfa caused increased early post-implantation loss at clinically relevant doses.General active-ingredient information · DailyMed (U.S. National Library of Medicine)
• It is unknown whether darbepoetin alfa is excreted in human milk; a risk to the suckling child cannot be excluded - decide whether to discontinue breast-feeding or Aranesp considering the benefit of each.International label, same product · European Medicines Agency (EPAR product information)

• Darbepoetin alfa: Stimulates erythropoiesis by the same mechanism as endogenous erythropoietin (binding the erythropoietin receptor on erythroid progenitor cells); two extra N-linked carbohydrate chains give it a roughly threefold longer terminal half-life than epoetin.