Erykine Special Precautions

Please consult with the doctor if you experience the things as follows: Erythropoietin alfa should be used with caution in patients with chronic-liver failure. The safety of Erythropoietin alfa has not been established in patients with hepatic dysfunction. Due to decrease metabolism, patients with hepatic dysfuction may have been increased erythropoiesis with Erythropoietin alfa.
In all patients, hemoglobin concentration should be closely monitored due to a potential increased risk of thromboembolic events and fatal outcomes when patients are treated at haemoglobin concentration above the range for the indication of use.
The safety and efficacy of Erythropoietin alfa therapy have not been established in patients with underlying haematologic diseases (e.g haemolytic anaemia, sickle cell anaemia, thalasemia).
It recommended that platelet count should be regularly monitored during the fisrt 8 weeks of therapy.
Antibody mediated pure red cell aplasia (PRCA) has been rarely reported after months to years of SC Erythropoietin alfa treatment. In patients developing sudden lack of efficacy, defined by a decrease in haemoglobin (1 to 2g/dL per month) with increased need for transfusions, a reticulocyte count should be obtained and typical cause of non response (e.g. Iron folate or vitamin B12 deficiency, aluminium intoxication, infection or inflammation, blood loss, haemolysis, and bone marrow fibrosis of any origin) should be investigated. If the reticulocyte count corrected for anemia (i.e the reticulocyte index) is low (<20,000/mm³ or <20,000/ul or <0,5%) platelet and white blood cell counts are normal, and if no other cause of loss of effect has been found, anti erythropoietin antibodies should be determined and a bone marrow examination should be considered for diagnosis of PRCA. If anti-erythropoietin, antibody mediated PRCA is suspected, therapy with Erythropoietin alfa, should be discontinued immediately. No other erythropoietic therapy should be commenced because of the risk of cross reaction. Appropriate therapy, such as blood transfusions, may be given to patients when indicated.
Cancer patients on Erythropoietin alfa should have haemoglobin levels measured on a regular basis until a stable level is achieved and periodically thereafter.
The safety and efficacy of Erythropoietin therapy have not been established in patients with a known history of a seizure disorder or underlying hematologic disease (e.g. sickle cell anemia, myelodysplastic syndromes, or hypercoagulable disorders).
Hematology: Exacerbation of porphyria has been observed rarely in patients with CRF treated with Erythropoietin. Erythropoietin should be used with caution in patients with known porphyria.
Iron evaluation: Transferrin saturation should be at least 20% and ferritin should be at least 100 ng/mL, transferrin saturation (serum iron divided by iron binding capacity) and serum ferritin, should be evaluated. Virtually all patients will eventually require supplemental iron to increase or maintain transferrin saturation to levels which will adequately support erythropoiesis stimulated by Erythropoietin.
CRF Patients: Hypertension: patients with uncontrolled hypertension should not be treated with Erythropoietin, blood pressure should be controlled adequately before initiation of therapy. During the early phase of treatment when the hematocrit is increasing, approximately 25% of patients on dialysis may require initiation of, or increases in, antihypertensive therapy. Hypertensive encephalopathy and seizures have been observed in patients with CRF treated with Erythropoietin.
Seizures : seizures have occurred in patients with CRF participating in Erythropoietin clinical trials. It is recommended that the dose of Erythropoietin be decreased if the hematocrit increase exceeds 4 points in any 2-week period.
Thrombotic events: during hemodialysis, patients treated with Erythropoietin may require increased anticoagulation with heparin to prevent clotting of the artificial kidney.
Effect on ability and use machines: No studies on the effects of Erythropoietin alfa on the ability to drive and use machines have been performed.
Use in Pregnancy: In animal studies, Erythropoietin alfa has been shown to decrease foetal body weight, delay assification and increase foetal mortality when given in weekly doses of approximately 20 times the recommended human weekly dose. These changes are interpreted as being secondary to decreased maternal body weight gain.
There are no adequate and well controlled studies in pregnant women.
Use in Lactation: Erythropoietin is present in human milk. However, it is not known whether Erythropoietin alfa is distributed into human milk, Erythropoietin alfa should be used with caution in nursing woman.
In pregnant or lactating surgical patients participating in an autologous blood predonation programme, the use of erythropoietin alfa is not recommended.
Use in Children: The safety and efficacy of Erykine in paediatric patients have not yet been established.