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June 28, 2016


Company: Hospira Ireland Ltd.
Legal category: Prescription. Sport prohibited.
Active ingredient: Epoetin zeta (recombinant human erythropoietin) 3333 IU/ml, 10000 IU/ml, 40000 IU/ml.
Description: Clear, colourless solution for injection in pre-filled syringe.
Presentation: 1000 IU/0.3ml-6, €54.59; 2000 IU/0.6ml-6, €104.82; 3000 IU/0.9ml-6, €155.05; 4000 IU/0.4ml-6, €203.83; 5000 IU/0.5ml-6, €272.98; 6000 IU/0.6ml-6, €314.47; 8000 IU/0.8ml-6, €436.76; 10000 IU/1ml-6, €509.56; 40000 IU/1ml-1, €363.97.
Indications: Treatment of anaemia associated with chronic renal failure in adult and paediatric patients on haemodialysis and adult patients on peritoneal dialysis. Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient’s general status. To increase the yield of autologous blood from adult surgery patients in a predonation programme (see SPC).

Pharmacology: Antianaemic preparation. Erythropoietin is a glycoprotein that stimulates, as a mitosis-stimulating factor and differentiating hormone, the formation of erythrocytes from precursors of the stem cell compartment.
Dosage: Adult: Chronic renal failure (haemodialysis): Correction phase, 50 IU/kg intravenously (IV) thrice weekly; adjust dose if necessary by 25 IU/kg thrice weekly in steps of at least 4 weeks. Maintenance total weekly dose 75-300 IU/kg. Chronic renal failure (peritoneal dialysis): Correction phase, 50 IU/kg (IV) twice weekly; maintenance, 25-50 IU/Kg (IV) twice weekly. Renal insufficiency without dialysis: Correction phase, 50 IU/kg (IV) thrice weekly; adjust dose if necessary by 25 IU/kg thrice weekly in steps of at least 4 weeks. Maintenance, 17-33 IU/kg thrice weekly. Cancer patients receiving chemotherapy: Initially 150 IU/kg subcutaneously thrice weekly, alternatively 450 IU/kg once weekly. Continue until 1 month after the end of chemotherapy (see SPC for dose adjustment). Autologous predonation programme: Mildly anaemic patients (Hct 33-39%) requiring predeposit of >4 blood units, 600 IU/kg (IV) twice weekly after blood donation procedure for 3 weeks prior to surgery, with adequate iron supplement. Elderly: As per adults. Children: Chronic renal failure (haemodialysis): Correction phase as per adults. Maintenance, see SPC.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Patients who develop Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin, uncontrolled hypertension. Patients unable to receive adequate antithrombotic prophylaxis. Autologous predonation programme: Myocardial infarction or stroke in the month preceding treatment, unstable angina pectoris, increased risk of deep venous thrombosis (history of venous thromboembolic disease).
Special precautions: Consider and treat all other causes of anaemia prior to treatment; ensure adequate iron stores. Monitor blood pressure, platelet count, reticulocyte count, haemoglobin (patients with chronic renal failure and heart disease, cancer patients, see SPC). Chronic renal failure: Monitor serum electrolytes; hyperkalaemia may occur (discontinue until corrected). Caution: Epilepsy, chronic liver failure. PRCA may occur (discontinue immediately, see SPC). Increased risk of thrombotic vascular events in cancer patients. Tumour growth potential cannot be excluded. Pregnancy, lactation (only if benefit outweighs risk). Contains phenylalanine.
Drug interactions: Ciclosporin, monitor blood levels and adjust dose as haematocrit (Hct) rises.
Adverse drug reactions: Headache, dose-dependent increase in blood pressure, hypertensive crisis with encephalopathy-like symptoms, skin rashes, flu-like symptoms, PRCA, antibodies to erythropoietins, hypersensitivity reactions, thrombotic/vascular events, shunt thromboses.
Full prescribing information and references available from Hospira Ireland Ltd. Telephone: (01) 2962102. Fax: (01) 2962571. Email: sheena.dowling@hospira.com