epoetin alfa (Rx)

Brand and Other Names:Epogen, Procrit, more...Eprex, erythropoietin, Retacrit, epoetin alfa-epbx
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 2000 units/mL (Epogen, Procrit, Retacrit)
  • 3000 units/mL (Epogen, Procrit, Retacrit)
  • 4000 units/mL (Epogen, Procrit, Retacrit)
  • 10,000 units/mL (Epogen, Procrit, Retacrit)
  • 20,000 units/mL (Epogen, Procrit)
  • 40,000 units/mL (Retacrit)

Biosimilar to Epogen and Procrit

  • Retacrit (epoetin alfa-epbx)
more...

Chronic Kidney Disease-Associated Anemia

Epogen, Procrit, Retacrit

Reduction of need for red blood cell (RBC) transfusion in patients with chronic kidney disease (CKD) on dialysis and not on dialysis

Patients with CKD on dialysis

  • Initiate treatment when hemoglobin (Hgb) level <10 g/dL
  • If Hgb level approaches or >11 g/dL, reduce or interrupt dose
  • 50-100 units/kg IV/SC 3 times weekly initially 

Patients with CKD not on dialysis

  • Initiating treatment only when Hbg level is <10 g/dL and the following:
    • Rate of Hgb decline indicates the likelihood of requiring a RBC transfusion
    • Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal
    • If Hgb level >10 g/dL, reduce or interrupt dose, and use the lowest dose of epoetin alfa sufficient to reduce the need for RBC transfusions
  • 50-100 units/kg IV 3 times weekly initially

Zidovudine-Related Anemia

Epogen, Procrit, Retacrit

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  

If Hgb does not increase 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 Hgb >12 g/dL: Withhold dose; resume therapy at a dose 25% below the previous dose when Hgb declines to <11 g/dL

If no Hgb increased is not achieved at a dose of 300 Units/kg for 8 weeks, discontinue dose

Chemotherapy-Related Anemia

Epogen, Procrit, Retacrit

Treatment of anemia in patients with nonmyeloid malignancies where anemia is due to effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of 2 additional months of planned chemotherapy

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

Reduce dose by 25%

  • Hgb increases >1 g/dL in any 2-week period
  • Hgb 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

Dose increase

  • After initial 4 weeks of therapy, if Hgb increases by <1 g/dL and remains <10 g/dL, increase dose to 300 units/kg three times per week or 60,000 units weekly
  • If no response after 8 weeks or if RBC transfusions required, discontinue dose

Reduction of Allogeneic Red Blood Cell Transfusions in Patients Undergoing Elective, Noncardiac, Nonvascular Surgery

Epogen, Procrit, Retacrit

Indicated to reduce the 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

Concomitant deep vein thrombosis (DVT) prophylaxis is recommended

Dosing Considerations

Evaluate iron status before and during treatment, and maintain iron repletion

Correct or exclude other causes of anemia (eg, vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding) before initiating therapy

CKD-associated anemia

  • When initiating or adjusting therapy, monitor Hgb levels at least weekly until 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
  • Do not increase the dose more frequently than q4weeks
  • Decreases in dose can occur more frequently; avoid frequent dose adjustment
  • If hemoglobin rises rapidly (eg, >1 g/dL in any 2-week period), reduce dose by ≥25% as needed to reduce rapid responses; may reduce dose more frequently than once q4weeks; avoid frequent dose adjustments
  • Inadequate response (eg, if Hgb does not increase by >1 g/dL after 4 weeks of therapy): Increase dose by 25%; if inadequate response 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; discontinue if responsiveness does not improve

Limitations of use

  • Not shown to improve quality of life, fatigue, or patient well-being
  • Not indicated for use
    • Patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy
    • Patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure
    • Patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion
    • Patients scheduled for surgery who are willing to donate autologous blood Patients undergoing cardiac or vascular surgery
    • As a substitute for RBC transfusions in patients who require immediate correction of anemia

Dosage Forms & Strengths

injectable solution

  • 2000 units/mL (Epogen, Procrit, Retacrit)
  • 3000 units/mL (Epogen, Procrit, Retacrit)
  • 4000 units/mL (Epogen, Procrit, Retacrit)
  • 10,000 units/mL (Epogen, Procrit, Retacrit)
  • 20,000 units/mL (Epogen, Procrit)
  • 40,000 units/mL (Retacrit)

Biosimilar to Epogen and Procrit

  • Retacrit (epoetin alfa-epbx)
more...

Chronic Kidney Disease-Associated Anemia

Epogen, Procrit, Retacrit

Indicated to reduce the need for red blood cell (RBC) transfusion in patients with chronic kidney disease (CKD)

<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

Zidovudine-Related Anemia

Epogen, Procrit, Retacrit

Published literature reported the use of epoetin alfa in 20 zidovudine-treated, anemic, pediatric patients with HIV infection

<8 months: Safety and efficacy not established

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

Chemotherapy-Related Anemia

Epogen, Procrit, Retacrit

Treatment of anemia in patients with nonmyeloid malignancies where anemia is due to effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of 2 additional months of planned chemotherapy

<5 years: Safety and efficacy not established

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

Reduce dose by 25%

  • Hgb increases >1 g/dL in any 2-week period
  • Hgb 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

Dose increase

  • After initial 4 weeks of therapy, if Hgb increases by <1 g/dL and remains <10 g/dL, increase dose to: 900 Units/kg (not to exceed 60,000 Units/dose) weekly
  • If no response after 8 weeks or if RBC transfusions required, discontinue dose

Dosing Considerations

Evaluate iron status before and during treatment, and maintain iron repletion

Correct or exclude other causes of anemia (eg, vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding) before initiating therapy

CKD-associated anemia

  • When initiating or adjusting therapy, monitor Hgb levels at least weekly until 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
  • Do not increase the dose more frequently than q4weeks
  • Decreases in dose can occur more frequently; avoid frequent dose adjustment
  • If hemoglobin rises rapidly (eg, >1 g/dL in any 2-week period), reduce dose by ≥25% as needed to reduce rapid responses; may reduce dose more frequently than once q4weeks; avoid frequent dose adjustments
  • Inadequate response (eg, if Hgb does not increase by >1 g/dL after 4 weeks of therapy): Increase dose by 25%; if inadequate response 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; discontinue if responsiveness does not improve

Limitations of use

  • Not shown to improve quality of life, fatigue, or patient well-being
  • Not indicated for use
    • Patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy
    • Patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure
    • Patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion
    • Patients scheduled for surgery who are willing to donate autologous blood Patients undergoing cardiac or vascular surgery
    • As a substitute for RBC transfusions in patients who require immediate correction of anemia
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Interactions

Interaction Checker

and epoetin alfa

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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

            Severe cutaneous reactions

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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 Hgb 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 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

            Perisurgery

            • Due to increased risk of deep venous thrombosis (DVT), DVT prophylaxis is recommended

            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

            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

            Blistering and skin exfoliation reactions including erythema multiforme and Stevens-Johnson syndrome (SJS)/ toxic epidermal necrolysis (TEN), reported in the postmarketing setting; discontinue therapy immediately if severe cutaneous reaction, such as SJS/TEN, is suspected

            Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin reported in patients treated with epoetin alfa

            Retacrit only

            • Each 1 mL single-dose vial of 2,000, 3,000, 4,000, 10,000, 40,000 Units of epoetin-alfa-epbx injection contains 0.5 mg of phenylalanine
            • Before prescribing Retacrit to a patient with PKU, consider the combined daily amount of phenylalanine from all sources
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            Pregnancy & Lactation

            Pregnancy

            Limited data available on epoetin alfa use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes

            Animal data

            • In animal reproductive and developmental toxicity studies, adverse fetal effects including embryo-fetal death, skeletal anomalies, and growth defects occurred when pregnant rats received epoetin alfa at doses approximating the clinical recommended starting doses
            • Consider the benefits and risks of epoetin alfa for the mother and possible risks to the fetus when prescribing epoetin alfa to a pregnant woman

            Lactation

            There is no information regarding the presence of epoetin alfa products in human milk, the effects on the breastfed infant, or the effects on milk production

            However, endogenous erythropoietin is present in human milk

            Because many drugs are present in human milk, exercise caution when epoetin alfa is administered to a lactating woman

            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.

            more...
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            Pharmacology

            Mechanism of Action

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

            Absorption

            Onset: Several days

            Peak effects: 2-6 weeks

            Peak serum time: 5-24 hr (SC)

            Distribution

            Vd: 9L

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

            Elimination

            Half-life,CKD: 4-13 hr (IV)

            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

            Unused vials

            • Refrigerate at 2-8°C (36-46°F)
            • Vials are stable for 2 weeks at room temperature
            • Do not freeze or shake
            • Protect vials from light

            Open vials

            • Refrigerate at 2-8°C (36-46°F)
            • Vials are stable for 2 weeks at room temperature; discard 21 days after initial entry
            • Do not freeze or shake
            • Protect vials from light
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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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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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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.