Hemax Special Precautions

Chronic renal failure patients: Increased risk of mortality and of occurrence of serious cardiovascular events was observed in two clinical studies when erythropoiesis stimulating agents were administered to patients targeted to attain higher haemoglobin levels compared to lower values (13.5 vs 11.3 g/dl; 14 vs 10 g/dl). It is recommend to individualize the dose with the aim of attaining and maintaining the haemoglobin level in the range 10 to 12 g/dl.
Cancer diagnosed patients: Erythropoiesis-stimulating agents (ESAs) shortened overall survival and/or increased the risk of tumour progression or recurrence in some clinical studies in patients with breast, head and neck, lymphoid, non-small cell lung, and cervical cancers. To decrease these risks, as well as the risk of serious cardiovascular events, it is recommended to use the lowest dose needed to avoid red blood cell transfusion. To minimize the risks previously mentioned, the haemoglobin level should not be over 12 g/dl. Use of epoetin is not recommended in patients on chemotherapy when the anticipated outcome is cure.
Patients who receive erythropoiesis stimulating agents peri-surgically to reduce the need of allogeneic red blood cell transfusions: An increased rate of deep venous thrombosis has been reported for patients on erythropoiesis stimulating agents not receiving prophylactic anticoagulation. Prophylactic anticoagulation should be considered when an erythropoiesis stimulating agent (including epoetin) is indicated to reduce the number of allogeneic transfusions.
Immunogenicity: The parenteral administration of any biologic product, including Hemax, should be attended by appropriate precautions in case allergic cases occur after administration.
Haematology: Exacerbation of porphyria has been observed in epoetin-treated patients on dialysis. Although this event is not frequently observed, it should be regarded in patients with history of porphyria.
Lack or loss of response: If patients fail to respond or to maintain the response to epoetin maintenance doses, the following causes should be considered and evaluated: Iron deficiency; Underlying infections or inflammatory processes or neoplasia; Occult blood loss; Underlying haematologic diseases (thalassaemia, myelodysplasia, etc.); Haemolysis; Aluminum overload; Vitamin deficiencies: vitamin B₁₂ or folic acid; Cystic fibrosis; Pure red cell aplasia; Bone marrow fibrosis; Bone marrow suppression from uremia; Hyperparathyroidism/osteitis fibrosa cystica; Erythrocyte enzyme abnormalities.
Iron supplement: Iron requirements may increase if already existent iron stores had been used for erythropoiesis. Some physicians recommend iron supplement for those patients whose iron stores are not enough due to frequent transfusions. In some patients, oral administration of such supplement may be insufficient and require parenteral iron (such as iron sucrose) by intravenous route.
Diet: When hematocrit increases, there is an improved sense of appetite. It is for this reason that food ingestion in Hemax-treated patients tends to increase. Under these circumstances, caution should be taken regarding potassium level, since it may increase as a consequence of larger food intake.
Albumin (human): Hemax contains albumin, a derivative of human blood. The risk for transmission of viral diseases is considered extremely remote based on the albumin obtention and manufacturing process of the product. The theoretical risk for the transmission of the Creutzfeldt-Jakob disease is also considered extremely remote. No cases of transmission of viral disease have been identified for the albumin used in Hemax.
Effects on Ability to Drive and Use Machines: No data are available.