Shock: Rarely shock may occur, so the observation should be taken. If the symptoms appear, the administration should be discontinued and an appropriate treatment should be taken.
Cardiovascular: Hypertension, thrombosis of blood vessel contact site such as fustula, sometimes palpitation may occur.
Hypertensive encephalopathy: As hypertensive encephalopathy (shows headache, conscious disorder, and seizures) and cerebral hemorrhage may occur, the drug should be administered cautiously with observation of the trends of blood pressure and hematocrit during the therapy.
Cerebral embolus: Cerebral embolus may occur, so full observation should be taken. If the symptoms appear, the administration should be discontinued and an appropriate treatment should be taken.
Skin: Sometimes, itching, skin rash, and decubitus may occur.
Liver: Elevation in AST, ALT, LDH, ALP, and total bilirubin may occur occasionally.
G.I: Occasionally, nausea vomiting, anorexia, diarrhea, and abdominal pain may occur.
Blood: Sometimes, leukocytosis, eosinophilia may occur. On occasion, granulocytopenia may occur in premature infant. Increased serum potassium, BUN, creatinine and uric acid have been reported occasionally. Rarely, thrombocytosis may occur. Rarely, pure red cell hypoplasia has been reported after treatment of epoetin products in chronic renal failure patients from several months to several years.
CNS: Sometimes headache, migraine, fatigue, chill, dizziness, fever, low fever, burning, general malaise may occur.
Others: Cerebral hemorrhage in the eyes, splenomegaly, nasal hemorrhage, edema, arthralgia, myalgia, bitter taste in mouth, tremor, and edema of eyelid may occur.
Eposis is generally well-tolerated. The adverse reactions reported are frequent sequela from patient's disease and are not necessarily attributable to Eposis therapy.
Chronic renal failure patients: In double-blind, placebo-controlled studies involving over 300 patients, the events reported in greater than 5% of patients treated with epoetin alfa were following. (See Table 1.)
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In the clinical studies in adult patients on dialysis (567 patients), the incidence of the most frequently reported adverse events were hypertension (0.75%), headache (0.40%), tachycardia (0.31%), nausea/vomiting (0.26%), clotted vascular access (0.25%), shortness of breath (0.14%), hyperkalemia (0.11%), and diarrhea (0.11%). Other reported events occurred at a rate of less than 0.10% events per patient per year. Events reported to have occurred within several hours of administration of epoetin alfa were rare, arthralgias and myalgias. In all studies analyzed to date, epoetin alfa administration was generally well-tolerated, irrespective of the route of administration.
Cancer patients: In double-blind, placebo-controlled studies of up to 3 months duration involving mild, and transient, and included injection site stinging in dialysis patients and flu-like symptoms such as 131 cancer patients, adverse events with an incidence>10% in either patients treated with epoetin alfa or placebo-treated patients were as indicated as follows. (See Table 2.)
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Although some statistically significant differences between patients being treated with epoetin alfa and placebo-treated patients were noted, the overall safety profile of epoetin alfa appeared to be consistent with the disease process of advanced cancer. During double-blind and subsequent open-label therapy in which patients (n=72) were treated for up to 32 weeks with doses as high as 927IU/kg, the adverse experience profile of epoetin alfa was consistent with the progression of advanced cancer. According to the basis for comparative data of survival rate, the rate of the patients with discontinuation of treatment by disease progress or adverse reactions (22% of test group, 13% of placebo group, p=0.25), the clinical result between test drug and placebo was similar. The useful data from animal tumor model, and the measurement result from clinical biopsy sample after administration showed that this drug does not promote the growth of the tumor. In spite of this, the possibility that this drug can promote the growth of the tumor such as myeloma cannot be excluded. To evaluate this fact, randomized, phase IV comparative clinical study is on-going. When compared with placebo group, the number of peripheral leukocyte was not changed by administration of the drug.