Company: Novartis Ireland Ltd.
Legal category: Prescription. High Tech. Sport prohibited.
Active ingredient: Epoetin alpha 20,000 IU/0.5ml, 30,000 IU/0.75ml.
Description: Solution for injection in a pre-filled syringe.
Presentation: 20,000 IU/0.5ml-6, €839.00; 30,000 IU/0.75ml-6, €1, 275.00.
Indication: Treatment of anaemia and reduction of transfusion requirements in adults receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient’s general status.
Pharmacology: 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: Aim Hb concentration 10-12g/dl (6.2-7.5mmol/l). Avoid sustained Hb level > 12g/dl (7.5mmol/l). If Hb rising by more than 2g/dl (1.25mmol/l) per month, or if sustained Hb > 12g/dl (7.5mmol/l), reduce epoetin alfa dose by 25%-50%. If Hb > 13g/dl (8.1mmol/l), discontinue until it falls below 12g/dl (7.5mmol/l) and then reinstitute at a dose 25% below the previous level. Dose: 150 IU/kg SC three times per week. Alternatively, epoetin alfa can be administered at initial dose of 450 IU/kg SC once weekly. If after 4 weeks Hb increase < 1g/dl (< 0.62mmol/l) and reticulocyte count increase < 40,000 cells/µl above baseline, increase dose to 300 IU/kg three times per week. If after an additional 4 weeks, Hb and reticulocyte count increases still below the levels stated above, discontinue.
Contraindications: Hypersensitivity to active substance or to any of the excipients. Patients developing Pure Red Cell Aplasia (PRCA) following erythropoietin treatment. Uncontrolled hypertension. Patients who cannot receive antithrombotic prophylaxis. Pregnancy (unless benefit outweighs risk), lactation.
Special precautions: Monitor BP. Caution: Epilepsy, chronic liver failure. Monitor Hb closely (potential increased risk of thromboembolic events if above target). Monitor platelet count regularly during first 8 weeks of therapy. Evaluate Iron status prior to and during treatment and administer iron supplementation if necessary. Oral iron substitution of 200-300mg Fe2+/day recommended in all cancer patients with transferrin saturation < 20%. Antibody-mediated PRCA very rarely reported (discontinue if suspected). Hyperkalaemia (interrupt until corrected). Carefully weigh thrombotic vascular events against benefits.
Drug interactions: Caution with ciclosporin.
Adverse drug reactions: Hypertension, nausea, vomiting, rash, headache, arthralgia, flu- like illness. Deep vein thrombosis, pulmonary embolism, diarrhoea, pyrexia.
Full prescribing information and references available from Novartis Ireland Ltd. Telephone (01) 2601255. Fax (01) 2601263.