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Efesa's Approved Indications
Important Safety Information
Special care should be taken with EFESA:
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If you have heart problems, as certain heart, blood vessel and blood clotting conditions such as a heart attack (myocardial infarction), where the heart does not receive enough oxygen (myocardial ischaemia), brain bleed and stroke (cerebrovascular haemorrhage and infarction), mini-strokes (transient ischaemic attacks), clotting in the deep veins, arteries, retina, lungs (deep venous, arterial and retinal thrombosis, pulmonary emboli), and blockage of dialysis tubes have been reported in people receiving medicines from the same class as EFESA (ESAs).
Efesa is approved by BPOM Indonesia for anemia in non-dialysis Chronic Kidney Disease
Efesa is approved by MOH Cambodia for anemia in non-dialysis Chronic Kidney Disease
Up to 80% Chronic Kidney Disease (CKD) Patients Grade 3-5 Suffer from Anemia¹
70% of ESA treatments are directed towards stage 5 CKD, while it is beneficial towards earlier stage in pre-dialysis¹˒²
A. Warnings
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A dose capable of maintaining the least blood Hb level not requiring RBC transfusion shall be administered.
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After the drug administration, if the blood Hb level exceeds 12 g/dL, risks of SAEs of the cardiovascular system and death will increase.
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The frequency of deep vein thrombosis was high in patients who used EPOs preoperatively to reduce the transfusion of homologous RBCs.
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Antibody-mediated PRCA has been rarely reported after months to years of subcutaneous epoetin treatment in Chronic Renal Failure patients. If anti-erythropoietin, antibody-mediated PRCA is suspected, therapy with EFESA should be discontinued immediately. No other ESA therapy should be commenced because of the risk of cross-reaction. Appropriate therapy, such as blood transfusions, may be given to patients when indicated.
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In all patients, hemoglobin concentrations should be closely monitored due to a potential increased risk of thromboembolic events and fatal outcomes when patients are treated at hemoglobin concentrations above the range for the indication of use.
B. Precautions
This product must be carefully administered to any patients with:
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Renal anemia who are receiving EPOs.
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Hypertension (increased blood pressure has been reported after administering Efepoetin alfa, therefore, hypertensive patients must follow antihypertensive treatment and dietary control during treatment with this drug).
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History of drug hypersensitivity.
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Predisposition to allergy.
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Myocardial infarction, pulmonary infarction, and cerebral infarction (since thromboembolism resulting from administration of this drug was reported, this drug has a risk of aggravating or causing thromboembolism).
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Liver disease (Efepoetin alfa is eliminated through the liver, so patients with active liver disease shall be excluded).
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The safety and efficacy of EFESA have not been established in patients with the underlying hematologic disease (e.g hemolytic anemia, sickle cell anemia, thalassemia).
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Epilepsy.
C. Special cautions for drug administration:
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Avoid co-administering this drug with any other drug.
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Visually inspect to confirm absence of foreign matter or discoloration, if any, before administration, and do not use any vials where foreign matter is found or if the contents are discolored.
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Do not use any drugs with insoluble matter seen, or if the solution is turbid.
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Never use any drugs that have been opened previously or whose primary package has been damaged.
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Do not attempt to use any fluids that have been frozen.
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To avoid injection site pains, gently inject this drug at different sites at every administration.
D. INTERACTIONS
Any interactions of other medications with this product have not been studied.
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