Eposis-3000iu Inj. Pfs

Class: Recombinant human erythropoietin Action Stimulates red blood cell production. Indications Treatment of anemia related to chronic renal failure, zidovudine therapy in HIV-infected patients and nonmyeloid malignancies. Reduction of allogenic blood transfusions in surgery patients. Unlabeled use(s): Increased procurement of autologous blood in patients about to undergo elective surgery. Pruritis associated with renal failure. Contraindications Hypersensitivity to mammalian cell–derived products or human albumin, uncontrolled hypertension. Route/Dosage Chronic Renal Failure ADULTS: IV/SC Initial dose: 50–100 U/kg 3 times weekly. Maintenance: Individually titrate. Zidovudine-treated HIV-infected Patients ADULTS: IV/SC Initial dose: 100 U/kg for 8 wk; increase by 50–100 U/kg 3 times weekly until appropriate maintenance dose is reached. Nonmyeloid Malignancies ADULTS: SC Initial dose: 150 U/kg 3 times weekly for 8 wk; if response not satisfactory, may increase up to 300 U/kg 3 times weekly. Surgery ADULTS: SC 300 U/kg/day for 10 days before surgery, on the day of surgery and for 4 days after surgery. Alternate dose schedule: SC 600 U/kg once weekly doses (21, 14, 7 days before surgery) plus a fourth dose on the day of surgery. Interactions None well documented. INCOMPATIBILITIES: Do not give with other drug solutions. Lab Test Interferences None well documented. Adverse Reactions CV: Hypertension; tachycardia; clotted vascular access. CNS: Headache; seizures. GI: Nausea; vomiting; diarrhea. RESP: Shortness of breath. OTHER: Allergy, including anaphylaxis, skin rashes and urticaria; fever; paresthesia; arthralgia. Precautions Pregnancy: Category C. Lactation: Undetermined. Children: Safety and efficacy not established. Hypersensitivity: Anaphylactoid reactions, mild and transient skin rashes and urticaria may occur. Seizures: May occur; relationship to drug uncertain. Thrombotic events: During hemodialysis, patients may need increased anticoagulation to prevent clotting of vascular access. PATIENT CARE CONSIDERATIONS Administration/Storage When administering through IV tubing, flush the line with saline before and after administration of epoetin alfa. Do not shake vial. Use only one dose per vial; do not reenter vial. Discard unused portions. Refrigerate. Do not freeze or shake. Assessment/Interventions Obtain patient history, including drug history and any known allergies. Note any hypersensitivity to human albumin or mammalian cell–derived products. Obtain baseline CBC, bleeding time, urinalysis, BUN, creatinine, electrolytes, serum iron, iron-binding capacity and serum ferritin. Obtain baseline vital signs. Note any history of hypertension, cardiovascular disease, seizures or porphyria. Monitor vital signs routinely. In chronic renal failure patients, determine hematocrit twice/wk until stabilized then for 2–6 wk with each dosage change; perform CBC with differential and platelet counts regularly; monitor electrolytes, uric acid and phosphorus regularly; monitor serum iron and iron-binding capacity; monitor potassium, BUN and creatinine. In zidovudine-treated HIV-infected patients, determine hematocrit once/wk until stabilized then periodically; monitor serum iron and iron-binding capacity; monitor potassium, BUN and creatinine. If rashes, urticaria or anaphylactic reactions occur, withhold medication immediately and notify physician. Surgery patients: Prior to initiating treatment with epoetin alfa, obtain a hemoglobin to establish that it is > 10 to £ 13 g/dl. Iron indices, particularly serum ferritin and transferrin saturation, must be monitored. Almost all patients will eventually require supplemental iron to increase or maintain transferrin saturation to levels that will adequately support epoetin-stimulated erythropoiesis. Notify physician if hct increases > 4 points in 2-wk period or if hct does not increase 5–6 points after 8 wk of therapy. Notify physician if hct exceeds “target hct”. Closely monitor patients with preexisting vascular disease. OVERDOSAGE: SIGNS & SYMPTOMS Polycythemia Patient/Family Education Advise patient that the use of iron supplements and monitoring will probably be needed. Advise patient to have BP checked regularly. Instruct patient to notify physician if seizures, severe headache, shortness of breath, dyspnea, cough, nausea, vomiting or diarrhea occur. Inform patient that drug may be associated with risk of seizures during first 90 days of treatment and advise patient to avoid potentially hazardous activities during this period.