Adult Dosing
Anemia due to chronic renal failure
- Start 50-100 units/kg SC/IV three times weekly
- Increase dose by 25% if Hgb does not increase by 1 g/dL in 4 wks or if Hgb levels are < 10 g/dL; may increase q4 wks. Individualize dose to achieve Hgb in the range 10-12 g/dL, if this is not acheived despite dose titrations over 12 wks, do not increase further; use lowest effective dose to avoid need for recurrent RBC transfusions
- Decrease dose by 25% if Hgb increases > 1 g/dL/2wks or if Hgb approaches 12 g/dL. If Hgb continues to increase, temporarily withhold till Hgb decreases. Then restart at 25% decreased dose
Zidovudine-associated anemia in HIV-infected patients
- Start 100 units/kg IV/SC three times weekly x 8 wks. Max: 300 IU/kg three times a week
- Can be increased by 50-100 units/kg three times weekly if inadequate response after 8 wks; re-evaluate q4-8 wks
- If Hgb exceeds 12 g/dL, withhold until Hgb < 11 g/dL; then restart at 25% decreased dose
- Note: Only indicated for patients with endogenous erythropoietin levels
500 mUnits/mL receiving zidovudine at a dose of 4200 mg/wk
Chemotherapy-induced anemia
- Start 150 IU/kg SC three time weekly; increase to 300 units/kg three times weekly if Hgb increases <1 g/dL in 4 wks
- Alternatively: start 40,000 units SC qwk; increase to 60,000 units qwk if Hgb increases <1 g/dL in 4 wks
- Adjust dose to maintain the lowest Hgb levels to avoid RBC transfusion need; do not exceed Hgb levels of 12g/dL
- If Hgb exceeds level needed to avoid transfusion, hold until levels decrease and restart at 25% decreased dose
- Reduce dose by 25% if Hgb reaches a level needed to avoid transfusion or increases by >1 g/dL in 2 wks
- Discontinue after chemotherapy or if no response after 8wks
- Only initiate therapy in patients if hemoglobin is <10g/dL and if there is a minimum of 2 additional months of planned chemotherapy
Surgery patients (for Hgb levels 10-13 g/dL)
- Start: 300 units/kg/day SC for 10 days prior to surgery, on the day of surgery, and for 4 days after surgery
- Alternate schedule: 600 units/kg SC qwk starting 3 weeks prior to surgery and on the day of surgery
Pediatric Dosing
Anemia due to chronic renal failure
Child (1 month-16 yrs)
- Start 50 units/kg IV/SC three times weekly
- Increase dose by 25% if Hgb does not increase by 1 g/dL in 4 wks or if Hgb levels are < 10 g/dL; may increase q4 wks. Individualize dose to achieve Hgb in the range 10-12 g/dL, if this is not achieved despite dose titrations over 12 wks, do not increase further; use lowest effective dose to avoid need for recurrent RBC transfusions
- Decrease dose by 25% if Hgb increases >1 g/dL/2wks or if Hgb approaches 12 g/dL. If Hgb continues to increase, temporarily withheld till Hgb decreases. Then restart at 25% decreased dose
Chemotherapy-induced anemia
Child (6 months-18 yrs)
- Start 600 units/kg IV qwk; increase to 900 units/kg qwk if Hgb increases by < 1 g/dL in 4 wks
- Alternatively: start 40,000 units SC qwk; increase to 60,000 units qwk if Hgb increases by < 1 g/dL in 4 wks
- Adjust dose to maintain the lowest Hgb levels to avoid RBC transfusion need; do not exceed Hgb levels of 12g/dL
- If Hgb exceeds level needed to avoid transfusion, hold until levels decrease and restart at 25% decreased dose
- Reduce dose by 25% if Hgb reaches a level needed to avoid transfusion or increases by > 1 g/dL in 2 wks
- Discontinue after chemotherapy or if no response after 8wks
[Outline]
See Supplemental Patient Information
- The multidose preserved formulation contains benzyl alcohol; it is associated with an increased incidence of neurological and other complications in premature infants which can be potentially fatal
- Patients with chronic renal failure are susceptible to experience greater risks for death, serious CV events, and stroke on administering erythropoiesis-stimulating agents (ESAs) to target hemoglobin levels of
13 g/dL. Patients with chronic renal failure and an insufficient hemoglobin response to ESA therapy are more prone for greater risk for CV events and mortality than other patients - MI, stroke, CHF, and hemodialysis vascular access thrombosis, and even death may occur in patients with cancer. A rate of hemoglobin rise of >1 g/dL over 2 wks is an contributing factor to these risks
- Risk for higher mortality and a higher rate of fatal thrombotic events exists
- An increased incidence of deep vein thrombosis (DVT) in patients receiving this drug and undergoing surgical orthopedic procedures exists
- Strongly consider deep venous thrombosis prophylaxis when ESAs are used for the reduction of allogeneic RBC transfusions in surgical patients
- Increased mortality is associated in adult patients undergoing coronary artery bypass surgery. This drug is not approved for reduction of allogeneic red blood cell transfusions in patients scheduled for cardiac surgery
- This drug is associated with decreasing locoregional control/progression-free survival and/or overall survival
- Enroll and comply with ESA Apprise oncology program to prescribe and/or dispense this drug in patients with cancer. Provide written acknowledgement of a discussion of the risks associated with this drug
- Cases of pure red cell aplasia (PRCA) and of severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin may occur in patients treated with this drug. PRCA may also occur in patients receiving ESAs while undergoing therapy for hepatitis C with interferon and ribavirin
- Evaluate patients who developed a sudden loss of response to this drug and accompanied by severe anemia and low reticulocyte count for the etiology of loss of effect including the presence of neutralizing antibodies to erythropoietin
- On suspection of anti-erythropoietin antibody withheld therapy with this drug and other ESAs
- Permanently discontinue therapy with this drug in patients with antibody-mediated anemia. Switch to other ESAs as antibodies may cross-react
- Avoid treatment of patients with uncontrolled hypertension. Adequately control blood pressure before initiation of therapy. Patients on dialysis may require initiation of or increase in antihypertensive therapy during the early phase of therapy. Hypertensive encephalopathy and seizures may occur in patients with CRF treated with this drug
- Take special care to closely monitor and aggressively control blood pressure in patients treated with this drug. Advise patients for the importance of compliance with antihypertensive therapy and dietary restrictions
- Decrease the dose of this drug if the hemoglobin increases exceeds >1 g/dL in any 2-week period
- Carefully adjust dose of this drug in CRF patients on hemodialysis having clinical evidence of ischemic heart disease or CHF for achieving and maintaining hemoglobin levels between 10-12 g/dL
- Seizures may occur in patients with CRF. Potential for an increased risk of seizures exists during the first 90 days of therapy; closely monitor blood pressure and the presence of premonitory neurologic symptoms. Caution patients to avoid potentially hazardous activities such as driving or operating heavy machinery during this period
- Patients undergoing hemodialysis having treatment with this drug may require increased anticoagulation with heparin for prevention of clotting of the artificial kidney
- Risk of thrombotic events, including vascular access thrombosis may significantly increase in adult patients having ischemic heart disease or CHF. Closely monitor patients with pre-existing cardiovascular disease
- Increased risk for serious cardiovascular events exists in Zidovudine-treated HIV-infected patients
- Appropriate precautions are essential on occurrence of allergic or other untoward reactions
- The safety and efficacy of this drug have not been established in patients with a known history of a seizure disorder or underlying hematologic disease (e.g., sickle cell anemia, myelodysplastic syndromes, or hypercoagulable disorders
- Menses may resume in some female patients following therapy with this drug; discuss the possibility of pregnancy and evaluate the need for contraception
- Measure hemoglobin in CRF patients twice a week; measure hemoglobin once a week until hemoglobin is stabilized and periodically thereafter in Zidovudine-treated HIV-infected and cancer patients
- Consider and evaluate iron deficiency, underlying infectious, inflammatory, or malignant processes, occult blood loss, underlying hematologic diseases, folic acid or vitamin B12 vitamin deficiencies, hemolysis. aluminum intoxication, osteitis fibrosa cystica, pure red cell aplasia (PRCA) or anti-erythropoietin antibody-associated anemia if the patient fails to respond or to maintain a response to doses within the recommended dosing range
- Absolute or functional iron deficiency may occur during therapy. Evaluate the patient’s iron status, including transferrin saturation (serum iron divided by iron binding capacity) and serum ferritin prior to and during therapy
- Patients may require supplemental iron for increasing or maintaining transferrin saturation to levels which will adequately support erythropoiesis stimulated by this drug
- Provide adequate iron supplementation throughout the course of therapy in order to support erythropoiesis and avoid depletion of iron stores in all surgery patients being treated with this drug
Cautions: Use cautiously in
- History of hypertension
- History of CAD
- History of CHF
- Seizure disorder
- Hematologic disorder
- Sickle cell disease
- Hemolytic disease
- Pure red cell aplasia
- Iron deficiency
- Folic acid or vitamin B12 deficiency
- Porphyria
Supplemental Patient Information
- Inform patients about the increased risks of mortality, serious cardiovascular events, thromboembolic events, and increased risk of tumor progression or recurrence
- Inform patients abut the possible side effects of this drug and for the signs and symptoms of allergic drug reaction and advise them for appropriate actions
Pregnancy Category:C
Breastfeeding: Safety unknown. Erythropoietin in milk might help maintain the integrity of the lining of the mammary epithelium and the infant GI tract. It might also have a beneficial effect on the infant's red cell production. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 31 March 2011). Manufacturer advises caution when this drug is administer to a nursing woman.
Pricing data from www.DrugStore.com in U.S.A.
- Epogen 10000 UNIT/ML SOLN [Box] (AMGEN)
10 ml = $1356.86
30 ml = $3989.79 - Epogen 20000 UNIT/ML SOLN [Box] (AMGEN)
10 ml = $2731.05
30 ml = $7970.13 - Procrit 3000 UNIT/ML SOLN [Vial] (JANSSEN PRODUCTS)
6 ml = $322.98
18 ml = $942.96 - Procrit 20000 UNIT/ML SOLN [Vial] (JANSSEN PRODUCTS)
1 ml = $383.99
3 ml = $1144.99 - Procrit 4000 UNIT/ML SOLN [Vial] (JANSSEN PRODUCTS)
6 ml = $476.15
18 ml = $1401.14 - Epogen 2000 UNIT/ML SOLN [Vial] (AMGEN)
1 ml = $40.28
3 ml = $112.79 - Procrit 10000 UNIT/ML SOLN [Vial] (JANSSEN PRODUCTS)
6 ml = $1086.03
18 ml = $3234.96 - Epogen 10000 UNIT/ML SOLN [Vial] (AMGEN)
2 ml = $292.51
6 ml = $854.19 - Procrit 40000 UNIT/ML SOLN [Vial] (JANSSEN PRODUCTS)
4 ml = $3002.09
8 ml = $5899.15 - Procrit 2000 UNIT/ML SOLN [Vial] (JANSSEN PRODUCTS)
6 ml = $243.31
18 ml = $697.43 - Epogen 3000 UNIT/ML SOLN [Vial] (AMGEN)
1 ml = $51.36
3 ml = $137.97 - Epogen 4000 UNIT/ML SOLN [Vial] (AMGEN)
1 ml = $63.45
10 ml = $568.07
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
