Erysaa Special Precautions

epoetin alfa


Duopharma (M)


Full Prescribing Info
Special Precautions
Cardiovascular and Thrombotic Events/ Increased Mortality: An increased incidence of thrombotic vascular events (TVEs) has been observed in patients receiving epoetin alfa. These include venous and arterial thromboses and embolism (including some with fatal outcomes), such as deep venous thrombosis, pulmonary emboli, retinal thrombosis and myocardial infarction. Additionally, cerebrovascular accidents (including cerebral infarction, cerebral haemorrhage and transient ischaemic attacks) have been reported.
The reported risk of TVEs should be carefully weighed against the benefits to be derived from treatment with epoetin alfa particularly in patients with pre-existing risk factors. In all patients, haemoglobin levels should be closely monitored due to a potential increased risk of thromboembolic events and fatal outcomes when patients are treated at haemoglobin levels above the target for the indication of use.
Use in Chronic Renal Failure Patients: Chronic renal failure patients being treated with epoetin alfa should have haemoglobin levels measured on a regular basis until a stable level is achieved, and periodically thereafter. In chronic renal failure patients the rate of increase in haemoglobin should be approximately 10 g/L per month and should not exceed 20 g/L per month to minimise risks of an increase in hypertension.
In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration range as recommended under Recommended Dosage. In controlled trials, haemoglobin levels targeted to 130 g/L were associated with a higher risk of cardiovascular events, including death.
Patients with chronic renal failure and insufficient haemoglobin response to ESA therapy may be at even greater risk for cardiovascular events and mortality than other patients. Shunt thromboses have occurred in haemodialysis patients, especially in those who have a tendency to hypotension or whose arteriovenous fistulae exhibit complications (e.g., stenoses, aneurysms, etc.) Early shunt revision and thrombosis prophylaxis by administration of acetylsalicylic acid, for example, is recommended in these patients.
Hyperkalaemia has been observed in isolated cases. Serum electrolytes should be monitored in chronic renal failure patients. If an elevated or rising serum potassium level is detected, then in addition to the appropriate treatment of the hyperkalaemia, consideration should be given to ceasing ESA administration until the serum potassium level has been corrected.
Hypertension: In all patients receiving epoetin alfa, blood pressure should be closely monitored and controlled as necessary. Epoetin alfa should be used with caution in the presence of untreated, inadequately treated or poorly controllable hypertension. It may be necessary to add or increase antihypertensive treatment. If blood pressure cannot be controlled, epoetin alfa treatment should be discontinued.
Hypertensive crisis with encephalopathy and seizures, requiring the immediate attention of a physician and intensive medical care, have also occurred during ESA treatment in patients with previously normal or low blood pressure. Particular attention should be paid to sudden stabbing migraine-like headaches as a possible warning signal.
Pure Red Cell Aplasia: Cases of pure red cell aplasia (PRCA) have been reported after months to years of treatment with erythropoietins. Most cases of PRCA associated with ESA occurred in patients receiving subcutaneous (SC) administration. Cases also have been reported in patients with hepatitis C treated with interferon and ribavirin, when ESAs are used concomitantly. ESAs are not approved in the management of anaemia associated with hepatitis C.
In patients developing sudden lack of efficacy typical causes of non-response should be investigated. If no cause is identified, a bone marrow examination should be considered. If antibodies to erythropoietin are detected, patients should not be switched to another ESA product as antierythropoietin antibodies cross-react with other ESAs.
Use in Surgery Patients in an Autologous Pre-Donation Programme (ABD): All special precautions associated with autologous pre-donation programmes, especially routine volume replacement, should be respected.
Seizures: Seizures have occurred in patients receiving ESA. Therefore, ESA should be used with caution in patients with epilepsy, history of seizures, or medical conditions associated with a predisposition to seizure activity such as CNS infections and brain metastases.
Sensitivity/ Resistance: The parenteral administration of any biologic product should be attended by appropriate precautions in case allergic or other untoward reactions occur. Hypersensitivity reactions, including cases of rash, urticaria, anaphylactic reaction, and angioneurotic edema have been reported.
Severe Cutaneous Adverse Reactions: Blistering and skin exfoliation reactions including erythema multiforme and Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), have been reported in association with ESA treatment. Discontinue ESA therapy immediately if a severe cutaneous adverse reaction, such as SJS/TEN, is suspected.
Iron Supplementation: Other causes of anaemia (iron, folate or Vitamin B12 deficiency, aluminium intoxication, infection or inflammation, blood loss, haemolysis and bone marrow fibrosis of any origin) should be evaluated and treated prior to initiating therapy with ESA, and when deciding to increase the dose. In most cases, the ferritin values in the serum fall simultaneously with the rise in packed cell volume. In order to ensure optimum response to ESA, adequate iron stores should be assured and iron supplementation should be administered if necessary: For chronic renal failure patients, iron supplementation (elemental iron 200-300 mg/day orally for adults and 100-200 mg/day orally for paediatrics) is recommended if serum ferritin levels are below 100 ng/mL.
For cancer patients, iron supplementation (elemental iron 200-300 mg/day orally) is recommended if transferring saturation is below 20%.
For patients in an autologous predonation programme, iron supplementation (elemental iron 200 mg/day orally) should be administered several weeks prior to initiating the autologous predeposit in order to achieve high iron stores prior to starting ESA therapy, and throughout the course of ESA therapy.
General: There may be a moderate dose-dependent rise in the platelet count within the normal range during treatment with ESA. This regresses during the course of continued therapy. In addition, thrombocythaemia above the normal range has been reported. It is recommended that the platelet count is regularly monitored during the first 8 weeks of therapy.
Very rarely, exacerbation of porphyria has been observed in ESA-treated patients. ESAs should be used with caution in patients with known porphyria.
ESA should also be used with caution in patients with chronic liver failure. The safety and dosage regime of ESA has not been established in the presence of hepatic dysfunction.
Patients should only be switched from one ESA to another under appropriate supervision.
Effect on Ability to Drive and Operate Machinery: No studies on the effects of epoetin alfa on the ability to drive and use machines have been performed.
Epoetin alfa has no or negligible influence on the ability to drive or use machines. But due to the increased risk of hypertension during the initial phase of Epoetin alfa treatment, patients with chronic renal failure should use caution when performing hazardous activities, such as driving or operating machinery, until the optimal maintenance dose of Epoetin alfa has been established.
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