Eprex

Eprex

epoetin alfa

Manufacturer:

Janssen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Epoetin α
Indications/Uses
Anemia associated w/ chronic renal failure in adults & paed on dialysis. Anemia & reduction of transfusions in adult cancer patients w/ nonmyeloid malignancies on chemotherapy. Anemia in zidovudine-treated HIV patients who have endogenous erythropoietin level ≤500 mIU/mL. Facilitate autologous blood collection w/in predeposit program in patients scheduled for major elective surgery. Adults w/ mild to moderate anemia scheduled for elective surgery. Anemia in adults w/ low- or intermediate-1-risk myelodysplastic syndromes (MDS) who have low serum erythropoietin (<200 mU/mL).
Dosage/Direction for Use
IV/SC Chronic renal failure Target Hb conc: Adult 10-12 g/dL. Childn 9.5-11 g/dL. Hemodialysis Preferably IV route. Correction phase: Adult & childn 50 IU/kg 3 times/wk IV, may be increased in increments of 25 IU/kg 3 times/wk at 4-wk intervals. Maintenance phase: Adult 75-300 IU/kg wkly. Childn >30 kg 30-100 IU/kg 3 times/wk, 10-30 kg 60-150 IU/kg 3 times/wk, <10 kg 75-100 IU/kg 3 times/wk. Peritoneal dialysis Adult Correction phase: 50 IU/kg twice/wk, may be increased in increments of 25 IU/kg twice/wk at 4-wk intervals. Maintenance phase: 25-50 IU/kg twice/wk. Predialysis Adult Correction phase: 50 IU/kg 3 times/wk, may be increased in increments of 25 IU/kg 3 times/wk at 4-wk intervals. Maintenance phase: 17-33 IU/kg 3 times/wk. Max: 200 IU/kg 3 times/wk. Cancer patient Target Hb conc: Not to exceed 10-12 g/dL. Initially 150 IU/kg SC 3 times/wk, may be increased to 300 IU/kg SC 3 times/wk after 4 wk of treatment. Zidovudine-treated, HIV-infected patient Correction phase: 100 IU/kg 3 times/wk for 8 wk, may be increased in increments of 50-100 IU/kg 3 times/wk at 4-wk intervals. Maintenance phase: Titrate dose to maintain hematocrit between 30-35%. Autologous pre-donation program in surgery 600 IU/kg IV twice/wk for 3 wk prior to surgery. Perisurgery patient w/o autologous blood donation 600 IU/kg SC wkly for 3 wk (days -21, -14 & -7) prior to & on day of surgery or 300 IU/kg SC daily for 10 days pre-op, on day of surgery & for 4 days post-op. Adult patient w/ low- or intermediate-1-risk MDS 450 IU/kg SC once wkly, may be increased to 1,050 IU/kg once wkly. Max: 80,000 IU wkly.
Contraindications
Hypersensitivity. Ab-mediated pure red cell aplasia (PRCA). Uncontrolled HTN. Patients scheduled for major elective orthopedic surgery & not participating in an autologous blood pre-donation program who have severe coronary, peripheral, arterial, carotid or cerebrovascular diseases including patients w/ recent MI or CVA. Surgical patients who cannot receive adequate antithrombotic prophylaxis.
Special Precautions
Discontinue use if anti-erythropoietin, Ab-mediated PRCA is suspected; severe cutaneous reaction eg, SJS/TEN is suspected. Not to be used in patients w/ baseline Hb >13 g/dL. Untreated, inadequately treated or poorly uncontrollable HTN; sudden stabbing migraine-like headache. Patients w/ hepatitis C; epilepsy; history of seizures; medical conditions associated w/ predisposition to seizure activity eg, CNS infections & brain metastases; underlying hematologic diseases eg, hemolytic & sickle cell anemia, thalassemia, thrombocythemia; porphyria. Increased incidence of thrombotic vascular events (TVEs); CVA. Closely monitor Hb, BP & platelet counts regularly. Ensure adequate Fe stores & supplementation. May cause allergic reactions in individuals sensitive to latex. May affect ability to drive & use machines. Renal & chronic liver failure. Pregnancy & lactation. Childn ≤17 yr. Elderly ≥65 yr.
Adverse Reactions
Increased BP, aggravation of existing HTN; diarrhea, nausea, vomiting, pyrexia, headache; flu-like illness; increased TVEs; hypersensitivity reactions eg, rash, urticaria, anaphylactic reaction, angioedema; hypertensive crisis w/ encephalopathy & seizures.
Drug Interactions
Decreased response w/ drugs decreasing erythropoiesis. Monitor cyclosporin blood levels. Potentiated effect w/ hematinic agent eg, ferrous sulphate.
MIMS Class
Haematopoietic Agents / Supportive Care Therapy
ATC Classification
B03XA01 - erythropoietin ; Belongs to the class of other antianemic preparations. Used in the treatment of anemia.
Presentation/Packing
Form
Eprex inj (pre-filled syringe) 10,000 IU/mL
Packing/Price
6 × 1's
Form
Eprex inj (pre-filled syringe) 2,000 IU/0.5 mL
Packing/Price
6 × 1's
Form
Eprex inj (pre-filled syringe) 4,000 IU/0.4 mL
Packing/Price
6 × 1's
Form
Eprex inj (pre-filled syringe) 40,000 IU/mL
Packing/Price
1's
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