Epoetin Alfa Dosage

This dosage information may not include all the information needed to use Epoetin Alfa safely and effectively. See additional information for Epoetin Alfa.

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for Anemia Associated with Zidovudine

Initial: 100 units/kg subcutaneously or IV 3 times a week.

Usual Adult Dose for Anemia Associated with Chemotherapy

Initial: 150 units/kg subcutaneously 3 times weekly or 40,000 units subcutaneously once weekly until completion of chemotherapy course.

Initiate epoetin alpha in patients on cancer chemotherapy only if the hemoglobin is less than 10 g/dL, and if there is a minimum of two additional months of planned chemotherapy.
Use the lowest dose of epoetin alpha necessary to avoid RBC transfusions

Usual Adult Dose for Anemia Associated with Chronic Renal Failure

50 to 100 units/kg subcutaneously or IV 3 times weekly.

The intravenous route is recommended for patients on hemodialysis.

Usual Adult Dose for Anemia Prior to Surgery

In patients with hemoglobin greater than 10 to less than or equal to 13 g/dL scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogenic blood transfusions: 300 units/kg/day subcutaneously for 10 days before and on the day of surgery, and 4 days after surgery for a total of 14 days of epoetin therapy.

Alternate dosage schedule: 600 units/kg subcutaneously in once weekly doses (21, 14, and 7 days before surgery) plus a fourth dose on the day of surgery.

Usual Pediatric Dose for Anemia Associated with Zidovudine

Infants and Children 8 months to 17 years: Limited data available; doses ranging from 50 to 400 units/kg 2 to 3 times/week have been reported. If patients have not responded satisfactorily to a dose of 300 units/kg 3 times weekly, it is unlikely that they will respond to higher doses.

Usual Pediatric Dose for Anemia Associated with Chemotherapy

Infants and Children 6 months to 18 years: Doses ranging from 25 to 300 units/kg 3 to 7 times a week have been reported.

Manufacturer's recommendation: Starting dose: Using intravenous administration only: 600 units/kg weekly (not to exceed 40,000 units/week); may increase to 900 units/kg weekly (not to exceed 60,000 units/week). Use caution in considering this dosage for administration by the subcutaneous route as subcutaneous administration has been shown to produce effect at doses 30% to 50% lower than intravenous administration.

Reduce dose by 25% when hemoglobin reaches a level needed to avoid transfusion or increases by greater than 1 g/dL in any two weeks. Increase dose by 25% if response is not satisfactory to achieve and maintain the lowest hemoglobin level sufficient to avoid the need for RBC transfusion.

Usual Pediatric Dose for Anemia Associated with Chronic Renal Failure

Starting dose for infants, children and adolescents: 50 units/kg, intravenously or subcutaneously, 3 times weekly. Increase dose by 25% if hemoglobin is less than 10 g/dL and has not increased by 1 g/dL after 4 weeks of therapy or if hemoglobin decreases below 10 g/dL. In patients on hemodialysis, the intravenous route is recommended.

Usual Pediatric Dose for Anemia

The safety and efficacy of epoetin alfa in children have not been established. However, the use of epoetin alfa may be appropriate in some situations.

Anemia of prematurity: Dosing range: 500 to 1250 units/kg/week divided into 2 to 5 doses for 10 doses; commonly used dose: 250 units/kg/dose 3 times weekly; supplement with oral iron therapy 3 to 8 mg/kg/day.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Zidovudine treated patients:

The dose can be adjusted after 8 weeks and every 4 to 8 weeks thereafter, in 50 to 100 units/kg increments 3 times weekly until hemoglobin reaches a level needed to avoid RBC transfusion or up to a maximum dose of 300 units/kg three times weekly. Withhold epoetin alpha if hemoglobin exceeds 12 g/dL. Resume therapy at a dose 25% below the previous dose when hemoglobin declines to less than 11 g/dL.

All CKD patients:

When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly.

When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.

Do not increase the dose more frequently than once every 4 weeks. Decreases in dose can occur more frequently. Avoid frequent dose adjustments.

If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2 week period), reduce the dose of epoetin alfa by 25% or more as needed to reduce rapid responses.

For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%.

For patients who do not respond adequately over a 12 week escalation period, increasing the epoetin alfa dose further is unlikely to improve response and may increase risks. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Evaluate other causes of anemia. Discontinue epoetin alfa if responsiveness does not improve.

CKD, on Dialysis:

If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of epoetin alfa.

CKD, not on Dialysis:

If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of epoetin alfa, and use the lowest dose of epoetin alfa sufficient to reduce the need for RBC transfusions.

Cancer chemotherapy patients:

Reduce dose by 25% if hemoglobin increases greater than 1 g/dL in any 2 week period or hemoglobin reaches a level needed to avoid RBC transfusion.

Withhold dose if hemoglobin exceeds a level needed to avoid RBC transfusion. Reinitiate at a dose 25% below the previous dose when hemoglobin approaches a level where RBC transfusions may be required.

After the initial 4 weeks of epoetin alfa therapy, if hemoglobin increases by less than 1 g/dL and remains below 10 g/dL, increase dose to either 300 Units/kg 3 times per week or 60,000 Units weekly in adults.

After 8 weeks of therapy, if there is no response as measured by hemoglobin levels or if RBC transfusions are still required, discontinue epoetin alfa.

Precautions

Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of death, serious adverse cardiovascular reactions and stroke and has not been shown to provide additional benefit No trial has identified a hemoglobin target level, or dosing strategy that does not increase these risks. Use the lowest epoetin alfa dose sufficient to reduce the need for red blood cell (RBC) transfusions. Use extra caution in patients with coexistent cardiovascular disease and stroke.

Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may also contribute to these risks.

ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies in patients with breast, head and neck, non-small cell lung malignancies, lymphoid, and cervical cancers. To minimize these risks, as well as the risk of serious cardio- and thrombovascular events, the lowest dose needed to avoid red blood cell transfusions should be used. Discontinue use following the completion of a chemotherapy course. ESAs should not be used in patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure.

In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures. Deep venous thrombosis prophylaxis is recommended during epoetin alfa therapy.

Epoetin alfa is contraindicated in patients with uncontrolled hypertension. Appropriately control hypertension prior to initiation of and during treatment with epoetin alfa.

Epoetin alfa increases the risk of seizures in patients with CKD. During the first several months following initiation of epoetin alfa, monitor patients closely for premonitory neurologic symptoms.

For lack or loss of hemoglobin response to epoetin alfa, initiate a search for causative factors (e.g., iron deficiency, infection, inflammation, bleeding). If typical causes of lack or loss of hemoglobin response are excluded, evaluate for pure red cell aplasia (PRCA). In the absence of PRCA, follow dosing recommendations for management of patients with an insufficient hemoglobin response to epoetin alfa therapy.

Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin have been reported in patients treated with epoetin alfa. This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which epoetin alfa is not approved). If severe anemia and low reticulocyte count develop during treatment with epoetin alfa, withhold epoetin alfa and evaluate patients for neutralizing antibodies to erythropoietin. Contact Amgen (1-800-77-AMGEN) to perform assays for binding and neutralizing antibodies. Permanently discontinue epoetin alfa in patients who develop PRCA following treatment with epoetin alfa or other erythropoietin protein drugs. Do not switch patients to other ESAs.

The parenteral administration of any biological product should be attended by appropriate precautions in case allergic or other untoward reactions occur. Immediately and permanently discontinue epoetin alfa and administer appropriate therapy if a serious allergic or anaphylactic reaction occurs.

Patients may require adjustments in their dialysis prescriptions after initiation of epoetin alfa. Patients receiving epoetin alfa may require increased anticoagulation with heparin to prevent clotting of the extracorporeal circuit during hemodialysis.

Evaluate transferrin saturation and serum ferritin prior to and during epoetin alfa treatment. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. Following initiation of therapy and after each dose adjustment, monitor hemoglobin at least weekly until the hemoglobin level is stable and sufficient to minimize the need for RBC transfusion.

Epoetin alfa should be used with caution in patients with known porphyria.

Epoetin alfa from multidose vials contains benzyl alcohol and is contraindicated in neonates, infants, pregnant women, and nursing mothers. When therapy with epoetin alfa is needed in neonates and infants, use single-dose vials; do not admix with bacteriostatic saline containing benzyl alcohol.

Zidovudine treated patients should have an endogenous erythropoietin concentration of less than 500 mUnits/mL in order to respond to epoetin alfa therapy.

Dialysis

In patients on hemodialysis, the IV route is recommended.

A supplemental dose is not necessary with hemo- or peritoneal dialysis.

While the administration of epoetin alfa is independent of the dialysis procedure, epoetin alfa may be administered into the venous line at the end of the dialysis procedure to eliminate the need for additional venous access.

Other Comments

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for epoetin alfa. It includes a Medication Guide, communication plan, elements to assure safe use, and an implementation system. Additional information is available at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm.

All patients should receive adequate iron supplementation. Iron supplementation should be started at the start of treatment with epoetin alfa and should continue throughout the duration of therapy.

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