Eposis Special Precautions

epoetin alfa


Daewoong Pharmaceutical




Daewoong Pharmaceutical
Full Prescribing Info
Special Precautions
Eposis should be administered with caution to the following patients: Patients with hypertension.
(Blood pressure may rise or hypertensive encephalopathy may occur during Eposis therapy.)
Patients with known history of a hypersensitivity to drugs.
Patients with known history of allergic reactions to drugs.
Patients with myocardial infarction, pulmonary infarction or cerebral embolus.
(It is reported that the density of the blood increased. Thromboembolism may be aggravated or occur. And hemocoagulation capacity can be increased when used autologous blood or after surgery, the enough observation is required.)
Patients with cerebral bleeding or premature infant with cerebral bleeding.
(Cerebral hemorrhage may be aggravated.)
Patients with ischemic vascular disease.
Patients with history of seizure.
Patients with epilepsy.
Patients with thrombocytosis.
Patients with chronic hepatic failure.
General Precautions: Eposis treatment should be limited in anemic patients with CRF less than 10g/dl of hemoglobin (30% as hematocrit) or cancer patients with serum epoetin less than 200mU/mL.
Eposis should not be used in patients with anemia from blood loss, hematocytopenia and aluminum intoxication. The deficiency of folic acid and vitamin B12 can decrease the effect of the Eposis.
Special monitoring of patient's history should be done to forecast shock or other responses. Low dosage should be allowed by intravenous route to determine a patient's responsiveness to the administration of Eposis before initiation the therapy or resumption after withholding.
During the Eposis therapy, hemoglobin concentration or hematocrit should be observed periodically (once a week at initial therapy, biweekly at maintenance therapy). Special caution should be taken not to result in excessive erythropoiesis (more than 12g/ dl of hemoglobin or 36% of hematocrit). In case of excessive erythropoiesis, withholding of the drug or appropriate treatment should be taken.
Hypertension and hypertensive encephalopathy have been reported in patients treated with Eposis, associated with a significant increase in hematocrit. Hematocrit increase may be occurred in case of discontinuation of the therapy. Blood pressure in patients treated with Eposis should be monitored carefully, particularly in patients with an underlying history of hypertension or cardiovascular disease. The dosage should be adjusted in patients with a fast rate of rise of hematocrit (greater than 4% in any two-week period) owing to the potential for an increased risk.
Seizures have occurred in patients with CRF participating in Eposis clinical trials. In patients on dialysis, there was a higher incidence of seizures during the first 90 days of therapy (occurring in approximately 2.5% of patients) as compared with later timepoints. Seizures also have occurred in cancer patients on chemotherapy. In double blind, placebo-controlled trials, 3.2% (N=2/63) of patients treated with Eposis and 2.9% (N=2/68) of placebo-treated patients had seizures. Seizures in 1.6% (N=1/63) of patients treated with Eposis occurred in the context of a significant increase in blood pressure and hematocrit from baseline values. However, both patients treated with Eposis also had underlying CNS pathology which may have been related to seizure activity. Given the potential for an increased risk of seizures during the therapy, blood pressure and the presence of premonitory eurologic symptoms should be monitored closely.
Since hyperkalemia may be occurred, the importance of compliance with dietary prescriptions should be reinforced.
It may be occurred shunt infarct or residual blood in dialysis kit, so, carefully monitored the blood circulation in shunt or dialysis kit.
In case of iron deficiency, adequate iron supplementation in order to support erythropoiesis should be done.
Eposis is a growth factor that primarily stimulates red blood cell production. However, the possibility that Eposis can act as a growth factor for any tumor type, particularly myeloid malignancies, cannot be excluded.
Rarely pure red cell aplasia (erythroblastopenic) was reported after treatment of this drug or epoetin drug for several months or years to the patients with chronic renal failure. These cases were normally related to the S.C, and Eposis may be administered to the patients with chronic renal failure by IV, if necessary. Most of the patients with pure red cell aplasia were observed the anti-body of epoetin. In case of the patients occurred the decrease of efficacy by sudden, the typical reasons (e.g. deficiency of Fe, Folic acid, or Vitamin B12, aluminum-poisoning, infection, or inflammation, hematozemia, and hemolyis) should be tested. If the cause didn't come out, marrow examination is considered. If pure red cell aplasia is diagnosed, then discontinue the drug immediately, and anti-epoetin test is considered. Anti-epoetin antibody is crossed with other epoetin agents, do not change to other drugs. Remove the cause of pure red cell aplasia, and perform the appropriate therapy.
Use in Children: The safety of the children is not established.
Use in the Elderly: Normally, the physiologic ability is decreased, and the cardiovascular diseases were combined in the elderly patients, so measure the blood pressure, concentration of the hemoglobin, or hetocridose for several times, and administration number should be controlled appropriately.
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