Eposis

Eposis

epoetin alfa

Manufacturer:

Daewoong Pharmaceutical

Distributor:

Leaderplus

Marketer:

Daewoong Pharmaceutical
Concise Prescribing Info
Contents
Recombinant human epoetin α
Indications/Uses
Symptomatic or transfusion requiring anemia associated w/ chronic renal failure.
Dosage/Direction for Use
Initially 50 U/kg for 1-2 min IV or SC 3 times/wk. May be increased by 25 U/kg in 4-wk period. Maintenance: 25-50 U/kg 2 or 3 times/wk. Max: 200 U/kg & not >3 times/wk.
Contraindications
Hypersensitivity to epoetin, or mammalian cell-derived products or human albumin. History of pure red cell hypoplasia after treatment w/ epoetin. Uncontrolled HTN.
Special Precautions
Known history of hypersensitivity, allergic reactions, seizure. HTN, MI, pulmonary infarction or cerebral embolus, cerebral bleeding (including premature infant), ischemic vascular disease, epilepsy, thrombocytosis, chronic hepatic failure. Hypertensive encephalopathy, thromboembolism, & cerebral hemorrhage. Should be limited to anemic patients w/ CRF w/ Hb count <10 g/dL or cancer patients w/ serum epoetin <200 mU/mL. Not to be used in patients w/ anemia from blood loss, hematocytopenia & Al intoxication. Administer low dose by IV route prior to or after withholding therapy. Observe Hb conc or hematocrit periodically during therapy (once a wk at initial therapy, biweekly at maintenance therapy). Withhold in case of excessive erythropoiesis (>12 g/dL Hb or 36% hematocrit). Monitor BP carefully particularly in patients w/ underlying HTN or CV disease history, & blood circulation in shunt or dialysis kit. Seizures; hyperkalemia. Adequate Fe supplementation in case of Fe deficiency. Drug may act as growth factor for any tumor type particularly myeloid malignancies. Pure red cell aplasia w/ SC administration. Test for Fe, folic acid or vit B12 deficiency, Al poisoning, infection or inflammation, hematozemia, & hemolysis. Consider marrow exam. Discontinue treatment if pure red cell aplasia is diagnosed & consider anti-epoetin test. Pregnancy & lactation. Childn.
Adverse Reactions
HTN, thrombosis of blood vessel contact (eg, fistula), palpitation; hypertensive encephalopathy, cerebral hemorrhage; cerebral embolus; itching, skin rash, decubitus; AST, ALT, lactate dehydrogenase, alkaline phosphatase & bilirubin elevation; nausea, vomiting, anorexia, diarrhea, abdominal pain; leukocytosis, eosinophilia; increased serum K, BUN, creatinine & uric acid; headache, migraine, fatigue, chill, dizziness, fever, burning, general malaise; cerebral hemorrhage in the eyes, splenomegaly, nasal hemorrhage, edema, arthralgia, myalgia, bitter taste in mouth, tremor, eyelid edema.
Drug Interactions
Increased hematocrit w/ cyclosporine. Increased efficacy w/ hematinic drug.
ATC Classification
B03XA01 - erythropoietin ; Belongs to the class of other antianemic preparations. Used in the treatment of anemia.
Presentation/Packing
Form
Eposis inj 5,000 IU/0.5 mL
Packing/Price
6 × 1's
Form
Eposis inj 4,000 IU/0.4 mL
Packing/Price
6 × 1's
Form
Eposis inj 10,000 IU/mL
Packing/Price
6 × 1's
Form
Eposis inj 3,000 IU/0.3 mL
Packing/Price
6 × 1's
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