EPOGEN, Epoetin Alfa PROCRIT, Epoetin Alfa RETACRIT, Epoetin Alfa-epbx Form

Epoetin alfa (Epogen®, Procrit®) and its biosimilar, epoetin alfa-epbx (Retacrit™), are erythropoiesis-stimulating agents (ESAs). FDA Approved Indication(s) Epogen, Procrit, and Retacrit are indicated for: • Treatment of anemia due to:
o Chronic kidney disease (CKD) in patients on dialysis and not on dialysis.
o Zidovudine in patients with HIV-infection. o The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
• Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery. Limitation(s) of use:
• Epogen, Procrit, and Retacrit have not been shown to improve quality of life, fatigue, or patient well-being.
• Epogen, Procrit, and Retacrit are not indicated for use: o In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy. o In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure. o In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion. o In patients scheduled for surgery who are willing to donate autologous blood. o In patients undergoing cardiac or vascular surgery.
o As a substitute for RBC transfusions in patients who require immediate correction of anemia.
Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria. It is the policy of health plans affiliated with Centene Corporation® that Epogen, Procrit, and Retacrit are medically necessary when the following criteria are met:
Page 1 of 15

CLINICAL POLICY Epoetin Alfa, Epoetin Alfa-epbx I. Initial Approval Criteria
A. Anemia due to Chronic Kidney Disease (must meet all):

1. Diagnosis of anemia of CKD (dialysis and non-dialysis members);
   2. Prescribed by or in consultation with a hematologist or nephrologist;
   3. Adequate iron stores as indicated by current (within the last 3 months) serum ferritin level ≥ 100 mcg/L or serum transferrin saturation ≥ 20%;
2. Pretreatment hemoglobin level < 10 g/dL;
   5. If Epogen or Procrit is requested, one of the following (a or b): a. Member must use Retacrit, unless contraindicated or clinically significant adverse effects are experienced; b. If Retacrit is unavailable due to shortage, member must use Epogen, unless contraindicated or clinically significant adverse effects are experienced. Approval duration:
      Medicaid/HIM – 6 months (see Appendix D for dose rounding guidelines) Commercial – 6 months or to member’s renewal period, whichever is longer (see Appendix D for dose rounding guidelines) B. Anemia due to Zidovudine in HIV-infected Patients (must meet all):
3. Diagnosis of zidovudine induced anemia;
   2. Prescribed by or in consultation with a hematologist or HIV specialist;
   3. Member is HIV-positive;
   4. Dose of zidovudine is ≤ 4,200 mg/week;
   5. Endogenous serum erythropoietin levels ≤ 500 mUnits/mL;
   6. Adequate iron stores as indicated by current (within the last 3 months) serum ferritin level ≥ 100 mcg/L or serum transferrin saturation ≥ 20%;
4. Pretreatment hemoglobin level < 10 g/dL;
   8. If Epogen or Procrit is requested, one of the following (a or b): a. Member must use Retacrit, unless contraindicated or clinically significant adverse effects are experienced; b. If Retacrit is unavailable due to shortage, member must use Epogen, unless contraindicated or clinically significant adverse effects are experienced.
      Approval duration:
      Medicaid/HIM – 6 months (see Appendix D for dose rounding guidelines) Commercial – 6 months or to member’s renewal period, whichever is longer (see Appendix D for dose rounding guidelines) C. Anemia due to Chemotherapy in Patients with Cancer (must meet all):
5. Request is for use in solid or non-myeloid malignancies;
   2. Member is receiving myelosuppressive chemotherapy without curative intent;
   3. Prescribed by or in consultation with a hematologist or oncologist;
   4. Age ≥ 5 years;
   5. Adequate iron stores as indicated by current (within the last 3 months) serum ferritin level ≥ 100 mcg/L or serum transferrin saturation ≥ 20%;

6. Pretreatment hemoglobin < 10 g/dL;

   7. Member meets one of the following (a, b, or c): a. Request is for Retacrit; Page 2 of 15

   CLINICAL POLICY Epoetin Alfa, Epoetin Alfa-epbx b. If Epogen or Procrit is requested, one of the following (i or ii): i. Member must use Retacrit, unless contraindicated or clinically significant adverse effects are experienced; ii. If Retacrit is unavailable due to shortage, member must use Epogen, unless contraindicated or clinically significant adverse effects are experienced; c. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E). Approval duration:
   Medicaid/HIM – 6 months or until the completion of chemotherapy course (whichever is less) (see Appendix D for dose rounding guidelines) Commercial – Until the completion of chemotherapy course, 6 months, or to member’s renewal date, whichever is longer (see Appendix D for dose rounding guidelines) D. Reduction of Allogeneic Red Blood Cell Transfusions in Patients Undergoing Elective, Noncardiac, Nonvascular Surgery (must meet all):

   1. Member is at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery;
7. Perioperative hemoglobin > 10 to ≤ 13 g/dL;
   
   3. Adequate iron stores as indicated by current (within the last 3 months) serum ferritin level ≥ 100 mcg/L or serum transferrin saturation ≥ 20%;
8. Member is unwilling or unable to donate autologous blood pre-operatively;
   5. If Epogen or Procrit is requested, one of the following (a or b): a. Member must use Retacrit, unless contraindicated or clinically significant adverse effects are experienced; b. If Retacrit is unavailable due to shortage, member must use Epogen, unless contraindicated or clinically significant adverse effects are experienced;
9. Dose does not exceed one of the following (a or b): a. 300 Units/kg administered daily for a total of 15 doses (see Appendix D for dose rounding guidelines); b. 600 Units/kg for a total of 4 doses (see Appendix D for dose rounding guidelines). Approval duration: 15 days (for 300 Units/kg daily) OR 21 days (for 600 Units/kg in 4 doses)
   E. Anemia Associated with Myelodysplastic Syndromes (off-label) (must meet all):
10. Diagnosis of anemia from myelodysplastic syndrome (MDS);
    
    2. Prescribed by or in consultation with a hematologist or oncologist;
    3. Age ≥ 18 years;
    4. One of the following (a or b): a. Current (within the last 3 months) serum erythropoietin (EPO) ≤ 500 mU/mL;
       b. Member has lower risk (IPSS low/intermediate-1) disease associated with symptomatic anemia with del(5q);
11. Adequate iron stores as indicated by current (within the last 3 months) serum ferritin level ≥ 100 mcg/L or serum transferrin saturation ≥ 20%;

12. Pretreatment hemoglobin < 10 g/dL;

    7. Member meets one of the following (a, b, or c): a. Request is for Retacrit;
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    CLINICAL POLICY Epoetin Alfa, Epoetin Alfa-epbx b. If Epogen or Procrit is requested, one of the following (i or ii): i. Member must use Retacrit, unless contraindicated or clinically significant adverse effects are experienced; ii. If Retacrit is unavailable due to shortage, member must use Epogen, unless contraindicated or clinically significant adverse effects are experienced; c. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E). Approval duration:
    Medicaid/HIM – 6 months (see Appendix D for dose rounding guidelines) Commercial – 6 months or to member’s renewal period, whichever is longer (see Appendix D for dose rounding guidelines) F. Myelofibrosis-Associated Anemia (off-label) (must meet all):

13. Diagnosis of anemia associated with myelofibrosis;
    2. Prescribed by or in consultation with a hematologist or oncologist;
    3. Age ≥ 18 years;
    4. Current (within the last 3 months) serum EPO < 500 mU/mL;
    5. Adequate iron stores as indicated by current (within the last 3 months) serum ferritin level ≥ 100 mcg/L or serum transferrin saturation ≥ 20%;
14. Member meets one of the following (a, b, or c): a. Request is for Retacrit; b. If Epogen or Procrit is requested, one of the following (i or ii): i. Member must use Retacrit, unless contraindicated or clinically significant adverse effects are experienced; ii. If Retacrit is unavailable due to shortage, member must use Epogen, unless contraindicated or clinically significant adverse effects are experienced; c. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E). Approval duration:
    Medicaid/HIM – 6 months (see Appendix D for dose rounding guidelines) Commercial – 6 months or to member’s renewal period, whichever is longer (see Appendix D for dose rounding guidelines) G. Other diagnoses/indications (must meet all):

15. Member meets one of the following (a, b, or c): a. Request is for Retacrit; b. If Epogen or Procrit is requested, one of the following (i or ii): i. Member must use Retacrit, unless contraindicated or clinically significant adverse effects are experienced; ii. If Retacrit is unavailable due to shortage, member must use Epogen, unless contraindicated or clinically significant adverse effects are experienced; c. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E); Page 4 of 15

    CLINICAL POLICY Epoetin Alfa, Epoetin Alfa-epbx

16. Must meet one of the following (a or b):
    a. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (i or ii): i. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or ii. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or b. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    II. Continued Therapy A. Anemia due to Chronic Kidney Disease (must meet all):
17. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
    2. Member is responding positively to therapy;
    3. If Epogen or Procrit is requested, one of the following (a or b): a. Member must use Retacrit, unless contraindicated or clinically significant adverse effects are experienced; b. If Retacrit is unavailable due to shortage, member must use Epogen, unless contraindicated or clinically significant adverse effects are experienced;
    4. Adequate iron stores as indicated by current (within the last 3 months) serum ferritin level ≥ 100 mcg/L or serum transferrin saturation ≥ 20%. Approval Duration:
       Medicaid/HIM – 6 months (see Appendix D for dose rounding guidelines) Commercial – 6 months or to member’s renewal period, whichever is longer (see Appendix D for dose rounding guidelines) B. Anemia due to Zidovudine in HIV-infected Patients (must meet all):

18. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B); Page 5 of 15

    CLINICAL POLICY Epoetin Alfa, Epoetin Alfa-epbx

19. Member continues to receive zidovudine therapy;
    3. If Epogen or Procrit is requested, one of the following (a or b): a. Member must use Retacrit, unless contraindicated or clinically significant adverse effects are experienced; b. If Retacrit is unavailable due to shortage, member must use Epogen, unless contraindicated or clinically significant adverse effects are experienced;
20. Current hemoglobin level is ≤ 12 g/dL;
    
    5. Adequate iron stores as indicated by current (within the last 3 months) serum ferritin level ≥ 100 mcg/L or serum transferrin saturation ≥ 20%. Approval duration:
       Medicaid/HIM – 6 months (see Appendix D for dose rounding guidelines) Commercial – 6 months or to member’s renewal period, whichever is longer (see Appendix D for dose rounding guidelines) C. Anemia due to Chemotherapy in Patients with Cancer (must meet all):
21. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
22. Member meets one of the following (a, b, or c): a. Request is for Retacrit; b. If Epogen or Procrit is requested, one of the following (i or ii): i. Member must use Retacrit, unless contraindicated or clinically significant adverse effects are experienced; ii. If Retacrit is unavailable due to shortage, member must use Epogen, unless contraindicated or clinically significant adverse effects are experienced; c. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E);
23. Continuation of ESA therapy is concurrent with myelosuppressive chemotherapy;
    4. If member has received ≥ 8 weeks of ESA therapy, member meets both of the following (a and b):
       a. Documented response to therapy as evidenced by a rise in hemoglobin levels > 1 g/dL;
       b. No RBC transfusions are required;

24. Current hemoglobin < 10 g/dL;

    6. Adequate iron stores as indicated by current (within the last 3 months) serum ferritin level ≥ 100 mcg/L or serum transferrin saturation ≥ 20%. Approval duration:
       Medicaid/HIM – 6 months or until the completion of chemotherapy course (whichever is less) (see Appendix D for dose rounding guidelines) Commercial – Until the completion of chemotherapy course, 6 months, or to member’s renewal date, whichever is longer (see Appendix D for dose rounding guidelines) Page 6 of 15

    CLINICAL POLICY Epoetin Alfa, Epoetin Alfa-epbx D. Reduction of Allogeneic Red Blood Cell Transfusions in Patients Undergoing Elective, Noncardiac, Nonvascular Surgery

    1. Re-authorization is not permitted. Members must meet the initial approval criteria. Approval duration: Not applicable E. Anemia Associated with Myelodysplastic Syndrome (off-label) (must meet all):
25. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
26. Member meets one of the following (a, b, or c): a. Request is for Retacrit; b. If Epogen or Procrit is requested, one of the following (i or ii): i. Member must use Retacrit, unless contraindicated or clinically significant adverse effects are experienced; ii. If Retacrit is unavailable due to shortage, member must use Epogen, unless contraindicated or clinically significant adverse effects are experienced; c. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E);
27. If member has received ≥ 8 weeks of ESA therapy, member meets one of the following (a or b): a. Documented response to therapy as evidenced by a rise in hemoglobin levels > 1.5 g/dL;
    b. Decrease of RBC transfusions requirement;
28. Current hemoglobin ≤ 12 g/dL;
    
    5. Adequate iron stores as indicated by current (within the last 3 months) serum ferritin level ≥ 100 mcg/L or serum transferrin saturation ≥ 20%. Approval duration:
       Medicaid/HIM – 6 months (see Appendix D for dose rounding guidelines) Commercial – 6 months or to member’s renewal period, whichever is longer (see Appendix D for dose rounding guidelines) F. Myelofibrosis-Associated Anemia (off-label) (must meet all):
29. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);

30. Member is responding positively to therapy (examples may include, but are not limited to: for transfusion-independent members with a baseline hemoglobin < 10 g/dL, a ≥ 2 g/dL increase in hemoglobin; or for previously transfusion-dependent members, transitioning to become transfusion-independent); Page 7 of 15

    CLINICAL POLICY Epoetin Alfa, Epoetin Alfa-epbx

31. Member meets one of the following (a, b, or c): a. Request is for Retacrit; b. If Epogen or Procrit is requested, one of the following (i or ii): i. Member must use Retacrit, unless contraindicated or clinically significant adverse effects are experienced; ii. If Retacrit is unavailable due to shortage, member must use Epogen, unless contraindicated or clinically significant adverse effects are experienced; c. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E);
32. Adequate iron stores as indicated by current (within the last 3 months) serum ferritin level ≥ 100 mcg/L or serum transferrin saturation ≥ 20%. Approval duration:
    Medicaid/HIM – 6 months (see Appendix D for dose rounding guidelines) Commercial – 6 months or to member’s renewal period, whichever is longer (see Appendix D for dose rounding guidelines) G. Other diagnoses/indications (must meet all):
33. Member meets one of the following (a, b, or c): a. Request is for Retacrit; b. If Epogen or Procrit is requested, one of the following (i or ii): i. Member must use Retacrit, unless contraindicated or clinically significant adverse effects are experienced; ii. If Retacrit is unavailable due to shortage, member must use Epogen, unless contraindicated or clinically significant adverse effects are experienced; c. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E);

34. Member meets one of the following (a or b): a. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (i or ii): i. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or ii. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or b. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid. Page 8 of 15

    CLINICAL POLICY Epoetin Alfa, Epoetin Alfa-epbx III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace and CP.PMN.53 for Medicaid or evidence of coverage documents.
    IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key CKD: chronic kidney disease ESA: erythropoiesis-stimulating agent FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
    Not applicable
    HIV: human immunodeficiency virus RBC: red blood cell Appendix C: Contraindications/Boxed Warnings • Contraindication(s): o Uncontrolled hypertension o Pure red cell aplasia (PRCA) that begins after treatment with erythropoietin protein drugs o Allergic reactions o Use of the multiple-dose vials containing benzyl alcohol in neonates, infants, pregnant women, and lactating women • Boxed warning(s): ESAs increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access and tumor progression or recurrence Appendix D: Dose Rounding Guidelines Weight-based Dose Range Vial Quantity Recommendation ≤ 2,099.99 units 2,100 units-3,149.99 units 3,150 units-4,199.99 units 4,200 units-6,299.99 units 6,300 units-7,349.99 units 7,350 units-8,399.99 units 8,400 units-10,499 units 10,500 units-12,599.99 units 12,600 units-13,649.99 units 13,650 units-14,699.99 units 14,700 units-16,799.99 units 1 vial of 2,000 units 1 vial of 3,000 units 1 vial of 4,000 units 1 vial of 4,000 units and 1 vial of 2,000 units 1 vial of 4,000 units and 1 vial of 3,000 units 2 vials of 4,000 units
    1 vial of 10,000 units 1 vial of 2,000 units and 1 vial of 10,000 units 1 vial of 3,000 units and 1 vial of 10,000 units 1 vial of 4,000 units and 1 vial of 10,000 units 1 vial of 2,000 units, 1 vial of 4,000 units and 1 vial of 10,000 units 1 vial of 3,000 units, 1 vial of 4,000 units and 1 vial of 10,000 units 2 vials of 4,000 units and 1 vial of 10,000 units 2 vials of 10,000 units 16,800 units-17,849.99 units 17,849 units-18,899.99 units 18,900 units-20,999 units Page 9 of 15

    CLINICAL POLICY Epoetin Alfa, Epoetin Alfa-epbx Appendix E: States with Regulations against Redirections in Certain Oncology Settings State Step Therapy Prohibited? Yes Yes FL GA IA LA NV OH OK PA TN TX Yes Yes Yes Yes Yes Yes Yes Yes Notes For stage 4 metastatic cancer and associated conditions. For stage 4 metastatic cancer. Redirection does not refer to review of medical necessity or clinical appropriateness. For standard of care stage 4 cancer drug use, supported by peer- reviewed, evidence-based literature, and approved by FDA. For stage 4 advanced, metastatic cancer or associated conditions. Exception if “clinically equivalent therapy, contains identical active ingredient(s), and proven to have same efficacy. Stage 3 and stage 4 cancer patients for a prescription drug to treat
    the cancer or any symptom thereof of the covered person Applies to Commercial and HIM requests only For stage 4 metastatic cancer and associated conditions Applies to HIM requests only For advanced metastatic cancer and associated conditions For stage 4 advanced, metastatic cancer For advanced metastatic cancer and associated conditions For stage 4 advanced, metastatic cancer and associated conditions V. Dosage and Administration
    Indication Anemia due to CKD Anemia due to zidovudine in HIV- infected patients Anemia due to chemotherapy Reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery Anemia associated with MDS† Anemia associated with myelofibrosis† Dosing Regimen Initial dose: 50 to 100 Units/kg 3 times weekly (adults) IV or SC and 50 Units/kg 3 times weekly (children on dialysis) IV or SC. Individualize maintenance dose. IV route recommended for patients on hemodialysis 100 Units/kg IV or SC 3 times weekly Maximum Dose Varies depending on indication and frequency of administration 40,000 Units SC weekly or 150 Units/kg SC 3 times weekly (adults) until completion of a chemotherapy course; 600 Units/kg IV weekly (children ≥ 5 years) until completion of a chemotherapy course 300 Units/kg per day SC daily for 15 days total: administered daily for 10 days before surgery, on the day of surgery, and for 4 days after surgery or 600 Units/kg SC weekly in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery 40,000-60,000 units SC one to two times weekly In a clinical trial, patients initially received erythropoietin 10,000 units SC 3 days per Page 10 of 15

    CLINICAL POLICY Epoetin Alfa, Epoetin Alfa-epbx Indication Dosing Regimen week. Erythropoietin was increased to 20,000 units 3 days per week if a response was not obtained after 2 months and erythropoietin was discontinued in patients who did not experience a response at 3 months. Maximum Dose †Off-label indication VI. Product Availability
    Drug Name Epoetin alfa (Epogen) Availability • Single-dose vial: 2,000 units/mL, 3,000 units/mL, 4,000 units/mL, and 10,000 units/mL • Multiple-dose vial containing benzyl alcohol: 20,000 units/2 mL and 20,000 units/mL
    Epoetin alfa (Procrit) • Single-dose vial: 2,000 units/mL, 3,000 units/mL, 4,000 units/mL, 10,000 units/mL, and 40,000 units/mL
    • Multiple-dose vial containing benzyl alcohol: 20,000 units/2 mL and 20,000 units/mL Epoetin alfa-epbx (Retacrit) • Single-dose vial: 2,000 units/mL, 3,000 units/mL, 4,000 units/mL, 10,000 units/mL, 40,000 units/mL
    • Multiple-dose vial containing benzyl alcohol: 20,000 units/2 mL and 20,000 units/mL VII.