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epoetin alfa (Rx)Brand and Other Names:Epogen, Procrit, more...Eprex, erythropoietin

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 2000 units/mL
  • 3000 units/mL
  • 4000 units/mL
  • 10,000 units/mL
  • 20,000 units/mL
  • 40,000 units/mL
more...

Chronic Kidney Disease-Associated Anemia

Reduction of need for red blood cell (RBC) transfusion in patients with chronic kidney disease (CKD)

Patient not on dialysis: 50-100 units/kg IV/SC 3 times weekly initially  

Initiate only when (1) hemoglobin level <10 g/dL, (2) rate of hemoglobin decline indicates likely necessity of RBC transfusion, and (3) reducing risk of alloimmunization or other risks related to RBC transfusion is goal; if hemoglobin level >10 g/dL, reduce or interrupt dose and use lowest dose sufficient to reduce need for RBC transfusion

Patient on dialysis: 50-100 units/kg IV 3 times weekly initially

Initiate when hemoglobin level <10 g/dL; if hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt dose

Dosing considerations

  • Evaluate iron status before and during treatment, and maintain iron repletion
  • When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until they are stable, then monitor at least monthly
  • When adjusting therapy, consider rate of hemoglobin rise or decline, responsiveness to erythropoiesis-stimulating agents (ESAs), and hemoglobin variability
  • A single hemoglobin excursion may not necessitate dosing change
  • Do not increase the dose more frequently than every 4 weeks
  • Decreases in dose can occur more frequently; avoid frequent dose adjustment
  • If the hemoglobin rises rapidly (eg, >1 g/dL in any 2-week period), reduce dose by 25% or more as needed to reduce rapid responses; may reduce dose more frequently than once every 4 weeks; avoid frequent dose adjustments
  • Inadequate response: If hemoglobin has not increased by >1 g/dL after 4 weeks of therapy, increase dose by 25%; if patient does not respond adequately over 12-week escalation period, further dose increase is unlikely to improve response and may increase risks
  • Individualize dosing, and use lowest dose that will maintain hemoglobin level sufficient to reduce need for RBC transfusions
  • Evaluate other causes of anemia
  • Discontinue if responsiveness does not improve
  • Correct or exclude other causes of anemia (eg, vitamin deficiency, metabolic/chronic inflammatory conditions, bleeding) before initiating therapy

Zidovudine-Related Anemia

Treatment of anemia due to zidovudine administered at <4200 mg/week in HIV-infected patients with endogenous serum erythropoietin levels of <500 milliunits/mL

100 units/kg IV/SC 3 times weekly initially  

Dosing considerations

  • If response is inadequate after 8 weeks, increase dose by 50-100 units/kg every 4-8 weeks until hemoglobin reaches level sufficient to avoid RBC transfusions; alternatively, administer 300 units/kg
  • If increase in hemoglobin is not achieved with administration of 300 units/kg for 8 weeks, discontinue
  • If hemoglobin >12 g/dL, withhold therapy; when hemoglobin is <11 g/dL, resume therapy at dose 25% below previous dose

Chemotherapy-Related Anemia

Treatment of anemia in patients with nonmyeloid malignancies where anemia is due to effect of concomitant myelosuppressive chemotherapy for >2 months

150 units/kg IV/SC 3 times weekly initially; alternatively, 40,000 units SC once weekly until completion of chemotherapy course 

Dosing considerations

  • If response is inadequate after 4 weeks and hemoglobin increases by <1 g/dL and remains <10 g/dL, increase to 300 units/kg 3 times weekly or 60,000 units once weekly
  • If response is inadequate after 8 weeks and hemoglobin levels have not responded measurably or if RBC transfusions are still required, discontinue therapy
  • If hemoglobin increases by >1 g/dL in any 2-week period or reaches level sufficient to avoid RBC transfusion, reduce dose by 25%
  • If hemoglobin reaches level sufficient to avoid RBC transfusion, withhold dose; when hemoglobin approaches level where RBC transfusions may be required, reinitiate at dose 25% below previous dose
  • Initiate therapy only if hemoglobin is <10g/dL and if ≥2 additional months of chemotherapy is planned

Preparation for Surgery With High Risk of Blood Loss

Reduction of need for allogeneic RBC transfusions in patients with perioperative hemoglobin >10 g/dL but ≤13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery

300 units/kg SC once daily for 15 consecutive days (10 days preceding surgery, day of surgery, 4 days following surgery); alternatively, 600 units/kg SC in 4 doses administered 21, 14, and 7 days before surgery and on day of surgery 

Dosing considerations

  • Concomitant deep vein thrombosis (DVT) prophylaxis is recommended
  • Not indicated for patients who are willing to donate autologous blood preoperatively
  • Monitor hemoglobin, blood pressure, electrolytes, renal function

Dosage Forms & Strengths

injectable solution

  • 2000 units/mL
  • 3000 units/mL
  • 4000 units/mL
  • 10,000 units/mL
  • 20,000 units/mL
  • 40,000 units/mL
more...

Chronic Kidney Disease-Associated Anemia

<1 month: Safety and efficacy not established

>1 month: 50 units/kg IV/SC 3 times weekly initially; if patient on dialysis, IV route recommended  

Initiate when hemoglobin level <10 g/dL; if hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt dose

Dosing considerations

  • Do not increase the dose more frequently than every 4 weeks
  • Decreases in dose can occur more frequently; avoid frequent dose adjustments
  • If hemoglobin rises rapidly (eg, >1 g/dL in any 2-week period), reduce dose by 25% or more as needed to reduce rapid responses
  • Inadequate response: If hemoglobin has not increased by >1 g/dL after 4 weeks of therapy, increase dose by 25%; if patient does not respond adequately over 12-week escalation period, further dose increase is unlikely to improve response and may increase risks
  • Evaluate iron status before and during treatment, and maintain iron repletion
  • When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until they are stable, then monitor at least monthly
  • When adjusting therapy, consider rate of hemoglobin rise or decline, responsiveness to ESAs, and hemoglobin variability
  • A single hemoglobin excursion may not necessitate dosing change
  • Use lowest dose that will maintain hemoglobin level sufficient to reduce need for RBC transfusions
  • Evaluate other causes of anemia
  • Discontinue if responsiveness does not improve

Prematurity-Related Anemia

25-100 units/kg SC 3 times weekly or 200-400 units/kg SC/IV q24-48hr for 2-6 weeks 

Zidovudine-Related Anemia

<8 months: Safety and efficacy not established

8 months-17 years: 50-400 units/kg SC/IV 2-3 times weekly  

Chemotherapy-Related Anemia

<5 years: Safety and efficacy not established

5-18 years: 600 units/kg IV once weekly; not to exceed 40,000 units 

Dosing considerations

  • If response is inadequate after 4 weeks and if hemoglobin increases by <1 g/dL and remains <10 g/dL, increase dose to 900 units/kg 3 times weekly; not to exceed 60,000 units weekly
  • If response is inadequate after 8 weeks and hemoglobin levels have not responded measurably or if RBC transfusions are still required, discontinue therapy
  • If hemoglobin increases by >1 g/dL in any 2-week period or reaches level sufficient to avoid RBC transfusion, reduce dose by 25%
  • If hemoglobin reaches level sufficient to avoid RBC transfusion, withhold dose; when hemoglobin approaches level where RBC transfusions may be required, reinitiate at dose 25% below previous dose
  • Monitor hemoglobin, blood pressure, iron, electrolytes, renal function
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Interactions

Interaction Checker

epoetin alfa and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Pyrexia (10-42%)

            Nausea (11-35%)

            Hypertension (14-27%)

            Cough (4-26%)

            Vomiting (12-28%)

            Pruritus (12-21%)

            Rash (2-19%)

            Headache (5-18%)

            Arthralgias (10-16%)

            1-10%

            Arthralgia (10%)

            Myalgia (10%)

            Stomatitis (10%)

            Diarrhea (9%)

            Dizziness (9%)

            Edema (9%)

            Fatigue (9%)

            Weight decrease (9%)

            Medical device malfunction (artificial kidney clotting during dialysis) (8%)

            Vascular occlusion (vascular access thrombosis) (8%)

            Vomiting (8%)

            Asthenia (7%)

            Chest pain (7%)

            Injection-site irritation (7%)

            Muscle spasm (7%)

            Upper respiratory tract infection (URTI) (7%)

            Urticaria (3%)

            Seizures (2.5%)

            Pulmonary embolism (1%)

            Respiratory tract congestion (1%)

            Postmarketing Reports

            Seizures

            Pure red-cell aplasia

            Serious allergic reactions

            Injection-site reactions (eg, irritation, pain)

            Porphyria

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            Warnings

            Black Box Warnings

            Chronic kidney disease

            • In controlled trials, CKD patients were at greater risk for death, serious adverse cardiovascular reactions, and stroke when receiving ESA therapy to target hemoglobin level of >11 g/dL
            • No trial has identified hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks
            • Use lowest dose sufficient to reduce need for RBC transfusions

            Cancer

            • In some clinical studies, ESAs shortened overall survival or increased risk of tumor progression in patients with breast, head, and neck cancers; lymphoid; non-small cell lung cancers; and cervical cancers
            • To prescribe or dispense ESAs to cancer patients, prescribers and hospitals must enroll in and comply with ESA APPRISE Oncology Program
            • Use lowest dose sufficient to avoid RBC transfusions
            • Use ESAs only for anemia from myelosuppressive chemotherapy; ESAs are not indicated for patients receiving myelosuppressive chemotherapy when anticipated outcome is cure
            • Discontinue after completion of chemotherapy course

            Cardiovascular events

            • Increased risk of serious cardivascular events, including stroke and thromboembolic events

            Contraindications

            Hypersensitivity to epoetin alfa or albumin or mammalian cell-derived products

            Cancer patients whose anemia is caused by factors other than chemotherapy

            Uncontrolled hypertension

            Pure red-cell aplasia that begins after treatment with any erythropoietin protein drugs

            Use of multidose vials containing benzyl alcohol in neonates, infants, or pregnant or nursing women, because of increased risk of serious adverse events and death; single-dose vials should be used instead and must not be admixed with bacteriostatic saline containing benzyl alcohol

            Cautions

            Has not been shown to improve patient well-being, enhance quality of life, or alleviate fatigue

            Not indicated for use in (1) patients with cancer who are receiving biologic products, hormonal agents, or radiotherapy, unless they are also receiving concomitant myelosuppressive chemotherapy; (2) patients with cancer who are receiving myelosuppressive chemotherapy when the anticipated outcome is cure; (3) patients scheduled for surgery who are willing to donate autologous blood; (4) patients who are undergoing cardiac or vascular surgery

            Not indicated as substitute for RBC transfusions in patients who require immediate correction of anemia

            Increased incidence of death, myocardial infarction (MI), stroke, and thromboembolism: Using ESAs to target hemoglobin level of >11 g/dL increases risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit (see Black Box Warnings)

            Use caution in hypertension, iron deficiency, folate or B12 deficiency, congestive heart failure (CHF), coronary artery disease (CAD), seizure disorder, sickle-cell disease, hemolytic anemia, porphyria, hematologic disorders

            Cancer patients: Increased tumor progression rate when dosed to achieve hemoglobin level of >12 mg/dL

            Chronic renal failure: At initiation of therapy, transferrin saturation should be ≥20% and ferritin ≥100 ng/mL

            Patients undergoing surgery are at increased risk for DVT; concomitant DVT prophylaxis is strongly recommended

            Epogen multidose formulations contain benzyl alcohol, which is associated with potentially fatal "gasping syndrome" in premature neonates

            Zidovudine-treated patients may show response only when zidovudine dosage <4200 mg/wk and endogenous epoetin <500 U/mL

            To prescribe or dispense to patients with cancer and anemia due to myelosuppressive chemotherapy, prescribers and hospitals must enroll in and comply with ESA APPRISE Oncology Program

            Increased risk of seizures during first 90 days of therapy in CKD; monitor closely

            Dialysis patients: IV administration recommended to reduce red-cell aplasia risk; increased anticoagulation with heparin may be required to prevent clotting of extracorporeal circuit during hemodialysis

            Do not increase dose more frequently than once monthly

            Contains albumin; may carry extremely remote risk for transmission or viral diseases or Creutzfeldt-Jakob disease

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Unknown whether drug is excreted in breast milk; use with caution; avoid administering multidose vials

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Recombinant human erythropoietin; stimulates erythropoiesis via division and differentiation of progenitor cells in bone marrow

            Absorption

            Vd: 9L

            Bioavailability: 21-31% (SC); 3% (intraperitoneal)

            Distribution

            Onset: Several days

            Peak effects: 2-6 weeks

            Peak serum time: 5-24 hr (SC)

            Elimination

            Half-life: CKD, 4-13 hr (IV); 16-67 hr (cancer)

            Clearance: 14 mL/min

            Excretion: Feces (majority); urine (small amounts)

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            Administration

            Do not administer multidose vials or single-dose vials admixed with bacteriostatic saline containing benzyl alcohol to neonates or infants

            IV Incompatibilities

            Solution: D10W

            IV Preparation

            For minimal dilution, mix with bacteriostatic NS containing 20 mL NS and benzyl alcohol as bacteriostatic agent in 1:1 ratio

            IV Administration

            Single-dose vial: pH 6.6-7.2

            Multidose vial: pH 5.8-6.4

            Administer by direct injection without dilution

            Do not mix with other drugs

            Do not shake

            Drug may be given via venous return line of dialysis tubing after dialysis to eliminate need for additional IV access

            Storage

            Vials should be stored at 2-8°C (36-46°F)

            Do not freeze or shake

            Protect vials from light

            Vials are stable for 2 weeks at room temperature

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            Images

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            Formulary

            FormularyPatient Discounts

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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