Erythropoietin (EPO)

Treatment and Monitoring Guideline

Background Indications for EPO Treatment Patients Ineligible for EPO Treatment Baseline Testing and Pretreatment Baseline Testing Anemia Treatment Goals Iron Supplementation Other Conditions to Correct Prior to EPO Treatment EPO Treatment Goals Pharmacologic Options Adjusting EPO Dosing CKD and ESRD Patients Chemotherapy Patients HIV Patients with AZT-induced Anemia Hepatitis C Patients Other Patients Discontinuation of Treatment Additional Testing/Monitoring References Clinician Lead and Guideline Development Most recent comprehensive literature review: June 2010
Guidelines are systematically developed statements to assist patients and providers in choosing appropriate health care for specific clinical conditions. While guidelines are useful aids to assist providers in determining appropriate practices for many patients with specific clinical problems or prevention issues, guidelines are not meant to replace the clinical judgment of the individual provider or establish a standard of care. The recommendations contained in the guidelines may not be appropriate for use in all circumstances. The inclusion of a recommendation in a guideline does not imply coverage. A decision to adopt any particular recommendation must be made by the provider in light of the circumstances presented by the individual patient.

EPO Treatment and Monitoring Guideline Copyright 2010 Group Health Cooperative. All rights reserved.

Background
Erythropoietin (EPO, epoetin alfa, Procrit) is a drug used to treat anemia caused by specific chronic diseases or by chemotherapy medications that suppress bone marrow activity. The benefits of EPO to decrease the need for transfusions must be balanced with its potential serious harms, including death. Prior to initiation, EPO prescriptions require baseline testing, treatment of low iron (Fe) stores, and treatment of vitamin B12 and folic acid deficiencies. Frequent monitoring is also required to maintain patients within a narrow hemoglobin range. For oncology patients, EPO prescriptions also require specific counseling and completion of forms. Warnings of serious cardiovascular threats and tumor growths are described within the FDA box warning. When EPO is prescribed, this FDA patient information must be given to each patient: http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088591.pdf After an internal review of the current prescribing process, it was found that adequate baseline testing, monitoring, and pre-treatment of iron stores and other deficiencies were not always performed in Group Health patients receiving EPO. To improve the safety of patients, these guidelines are recommended. The majority of patients for whom EPO is prescribed are those with chronic kidney disease or those taking chemotherapy medications for cancer treatment. Treatment for anemia caused by a few other conditions is also described in this guideline; however, there are patients being treated at Group Health who do not fit coverage criteria for treatment and others who are under protocols that have not been shown to be safe.

EPO Treatment and Monitoring Guideline

Indications for EPO Treatment

Table 1. EPO treatment eligibility (per regulations from the Centers for Medicare and Medicaid Services[CMS]) Patients with anemia caused by the following conditions are eligible: End state renal disease (ESRD) or chronic kidney disease of at least stage 3 1 (eGFR <60) Chemotherapy-induced anemia and currently receiving a course of chemotherapy or have received a course within the past 2 months for non-myeloid, non-erythroid cancer (solid tumors, multiple myeloma, lymphoma, and lymphocytic leukemia, and chemotherapy-induced anemia) HIV with symptomatic zidovudine-induced anemia Myelodysplastic syndrome (MDS) Chronic hepatitis C Rheumatoid arthritis 1 Systemic lupus erythematosus Regional enteritis 2 Crohns disease 2 Ulcerative colitis 2 Patients scheduled to undergo elective hip or knee replacement surgery 3 Patients taking chemotherapeutic medications when medically necessary for non-cancer diagnosis or following stem cell transplantation and associated immunosuppression 4
There is no high-quality evidence on which to base recommendations for initial or optimal dosing for the treatment of anemia in patients with rheumatoid arthritis. For advice on dosing and monitoring, consultation with a specialist or knowledgeable clinical pharmacist is recommended. Patients with regional enteritis, Crohns disease, or ulcerative colitis would require EPO treatment for their condition only in rare situations. There is no high-quality evidence on which to base recommendations for initial or optimal dosing for the treatment of anemia in patients with these conditions. Consult with a gastroenterologist if this treatment is being considered. The possible harms outweigh the benefits in most situations for this group of patients. There is no high-quality evidence on which to base recommendations for initial or optimal dosing for the treatment of anemia in patients taking chemotherapeutic medications when medically necessary for noncancer diagnosis. For advice on dosing and monitoring, consultation with an oncology specialist or knowledgeable clinical pharmacist is recommended.

3 4

Patients Ineligible for EPO Treatment

Patients with any of the following conditions: Deficiencies in folate, vitamin B12, or iron Active hemolysis or ongoing bleeding Acute or chronic myelogenous leukemias (CML, AML) Erythroid cancer Bone marrow fibrosis Erythropoietin-type resistance due to neutralizing antibodies Anemia due to cancer treatment if patients have uncontrolled hypertension EPO treatment is not appropriate for prophylactic use to: Prevent chemotherapy-induced anemia Reduce tumor hypoxia

EPO Treatment and Monitoring Guideline

Baseline Testing and Pretreatment

Note: For patients with cancer or history of cancer being treated for a condition other than chemotherapyinduced anemia, consult with the patients oncologist regarding whether EPO should be used and what hemoglobin target is appropriate. Table 2. Baseline testing and eligibility criteria Condition Required baseline tests 2
Note: Hemoglobin/hematocrit must be done within 1 week prior to EPO treatment

EPO eligibility criteria (CMS)

ESRD or chronic kidney disease of at least stage 3 1 (eGFR <60)

Hemoglobin Fe/TIBC (transferrin saturation [TSAT]) 3 Ferritin Reticulocyte count if anemia not clearly attributable to kidney disease (e.g., eGFR >30) Stool occult blood if iron stores are low B12 Folate

Hb 10 g/dL 4 Unless medical documentation shows need (e.g., severe angina, severe pulmonary distress, severe hypertension) TSAT 20% B12 and folate not deficient Exclude patients: With ongoing bleeding disorders or hemolysis even if anemia is multifactorial involving CKD (treat with transfusion) Hb 10 g/dL 4 or Hb 1011 g/dL and clinical risk of anemia warrants earlier initiation Excluded cancer patients: Receiving potentially curative treatment At high risk of thromboembolism With metastatic breast cancer, head or neck cancer With anemia caused by multiple myelomas, lymphoma, or lymphocytic leukemia in absence of concurrent chemotherapy With anemia caused by iron, B12, or folate deficiency; bleeding; hemolysis; bone marrow fibrosis; renal insufficiency

Chemotherapy-induced anemia and currently receiving a course of chemotherapy or have received a course within the past 2 months for nonmyeloid, non-erythroid cancer (solid tumors, multiple myeloma, lymphoma, lymphocytic leukemia, and chemotherapy-induced anemia)

Complete blood count (CBC) B12 Ferritin

Continued on the following page.

EPO Treatment and Monitoring Guideline

Table 2 (continued). Baseline testing and eligibility criteria HIV with symptomatic zidovudine-induced anemia Hemoglobin Fe/TIBC (TSAT) 3 Ferritin B12 Folate Hemoglobin Fe/TIBC (TSAT) 3 Ferritin B12 Folate Pretreatment Hb <10 g/dL 4 TSAT 20% B12 and folate not deficient

Myelodysplastic syndrome (MDS)

Pretreatment Hb <10 g/dL 4 TSAT 20% B12 and folate not deficient Life expectancy > 3 months Symptomatic anemia (fatigue, SOB) Diagnosis confirmed by cytology or physician Marrow blast count is <5% Pretreatment Hb <10 g/dL 4 TSAT 20% B12 and folate not deficient Symptomatic anemia (fatigue, SOB)

Chronic hepatitis C under treatment with ribavirin and either interferon alfa or peginterferon alfa or Systemic lupus erythematosus Patient taking chemotherapeutic medications when medically necessary for non-cancer diagnosis or following stem cell transplantation and associated immunosuppression
1

Hemoglobin Fe/TIBC (TSAT) 3 Ferritin B12 Folate

Hemoglobin Fe/TIBC (TSAT) 3 Ferritin B12 Folate

Pretreatment Hb <10 g/dL 4 TSAT 20% B12 and folate not deficient Symptomatic anemia (fatigue, SOB)

Transplant candidates: the avoidance of a blood transfusion is important to avoid antigens, which decrease the patients chance of receiving a kidney transplant. Also, patients with chronic kidney disease who have a history of cancer should not be started on EPO without consulting with the patients oncologist regarding whether EPO should be used and what the target hemoglobin should be.

2 3

CMS-required baseline tests for all EPO candidates: Hct/Hb, iron, folate, and B12. TSAT (transferrin saturation), measured as a percentage, is the ratio of serum iron and total iron-binding capacity multiplied by 100. CMS regulations allow for measurement of either hemoglobin or hematocrit using the conversion of hematocrit = 3x hemoglobin (e.g., Hct 30% = Hb 10).

EPO Treatment and Monitoring Guideline

Anemia Treatment (iron supplementation before and during EPO therapy)

Goals TSAT (Fe/TIBC): 2050%, and Ferritin: 100500 ng/mL Table 3. Iron supplementation Eligible populations TSAT/ferritin levels 1 Line Oral 1st line Medication Ferrous sulfate Dosing 325 mg (65 mg iron) 3 1 tablet 3 times daily or 3 tablets once daily in the evening for those taking calcium 325 mg (36 mg iron) Note lower iron content of this option; FeSO4 is preferred 50 mg iron 14 tablets daily (split dosing if more than one tablet) 125 mg IV over 1 hour Frequency varies; weekly dosing is most common Cumulative dose varies, with common target = 1000 mg Avoid 250 mg doses due to increased adverse events

Patients with TSAT <20% iron deficiency or ferritin <100 ng/mL (correct iron deficiency before starting EPO)

Oral 2nd line

Ferrous gluconate

Oral 3rd line 2

Slow release iron 2

TSAT <20% or ferritin <100 ng/mL after maximum tolerated oral iron or Patient is unable to tolerate oral iron

IV 1st line

Ferrlecit 4 (sodium ferric gluconate complex in sucrose)

IV 2nd line (if patient reacts to IV ferrlecit) TSAT <20% and ferritin >500 ng/mL
1 2 3 4 5

Iron sucrose (non-formulary) or Iron dextran 5

Discuss with appropriate specialist (e.g., nephrologist, oncologist.)

To maintain TSAT >20% and ferritin >100 ng/mL, most patients require iron supplementation. For patients who dont tolerate short-acting iron. Dose may be decreased for patients with significant underlying constipation or whose iron stores are near the upper range. Docusate may be used as needed to minimize constipation. Discuss with nephrologist first. Greater incidence of anaphylaxis is associated with iron dextran.

Other conditions to correct prior to EPO: B12 deficiency Folate deficiency Bleeding (consider referral to GI) Hemolysis (consider referral to Hematology) Bone marrow fibrosis (refer to Hematology)

EPO Treatment and Monitoring Guideline

EPO Treatment
Goals
Table 4. Target hemoglobin Eligible population/condition ESRD or chronic kidney disease of at least stage 3 (eGFR < 60)
1

Target Hb 10.511.5 g/dL 1

Chemotherapy-induced anemia (currently receiving a course of chemotherapy Hb 1011 g/dL or have received a course within the past 2 months for non-myeloid, nonerythroid cancer) HIV with symptomatic zidovudine-induced anemia Myelodysplastic syndrome (MDS) Chronic hepatitis C under treatment with ribavirin and either interferon alfa or peginterferon alfa Systemic lupus erythematosus Patient taking chemotherapeutic medications when medically necessary for non-cancer diagnosis or following stem cell transplantation and associated immunosuppression
1

A higher target range to a maximum 12.0 g/dL may be designated for a patient per physicians request. If Hb >12.0 g/dL, hold medication until Hb 12.0 g/dL. CMS (Medicare) does not allow coverage of EPO when Hb >12.0, as there is risk of serious heart problems such as heart attack, stroke, heart failure, and a higher chance of death if patients are treated with an ESA to a hemoglobin level >12 g/dL. A lower target range may be desirable for patients with cancer or cancer history.

EPO Treatment and Monitoring Guideline

Pharmacologic Options
For information on side effects, contraindications, formulary status (e.g., prior authorization), and other pharmacy-related issues, see the Group Health Formulary, the Healthwise Knowledgebase, or other resources. All patients need to receive this FDA medication guide for EPO prior to dosing: http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088591.pdf Table 5. Initial dosing of EPO Note: Check blood pressure prior to each dose Eligible population/condition ESRD or chronic kidney disease of at least stage 3 (eGFR <60) Chemotherapy-induced anemia (currently receiving a course of chemotherapy or have received a course within the past 2 months for non-myeloid, non-erythroid cancer) HIV with symptomatic zidovudine-induced anemia Systemic lupus erythematosus Myelodysplastic syndrome (MDS) Initial dose EPO 20008000 units subcutaneously (SQ) once weekly (dose depending upon patients weight, severity of anemia, and associated symptoms) EPO 30,00040,000 units SQ once weekly for 4 weeks 1 Check CBC or Hb at week 3 EPO 100 units/kg IV or SQ 3 times weekly for 812 weeks (These patients are typically treated as chronic kidney disease patients.) EPO 40,000 units SQ once weekly for 4 weeks The starting dose in low weight patients with stable anemiaand always in case of reduced renal functionshould be lower: 30,000 units weekly (These patients are typically treated by Oncology)

Patient taking chemotherapeutic medications when medically necessary following stem cell transplantation Patient taking chemotherapeutic medications when medically necessary for non-cancer diagnosis and associated immunosuppression Chronic hepatitis C under treatment with ribavirin and either interferon alfa or peginterferon alfa
1

(These patients are typically treated by Nephrology or Rheumatology.) Decrease ribavirin to 600 mg/day for 1 week If patient is not at target after 1 week, initiate EPO 40,000 units SQ once weekly

Group Healths initial dosing recommendations are more conservative than those of CMS. CMS recommendations for epoetin alfa: Initial dose no more than 150 units/kg 3 times weekly or 40,000 units weekly. CMS recommendations for darbepoetin alfa: Initial dose 225 mcg/kg once weekly or 500 mcg every 3 weeks (Group Health non-formulary).

EPO Treatment and Monitoring Guideline

Adjusting EPO Dosing

CKD and ESRD Patients
Table 6. Adjusting EPO dosing for ESRD and chronic kidney disease patients Note: EPO takes several weeks to have an effect on hemoglobin and it takes 2 months or longer to see the full effects of a given EPO dose. Be sure to: Check hemoglobin every 2 weeks until stable in range, then monthly. Check blood pressure prior to each dose. Target status Reaches target Hemoglobin status Action

Rapidly rising Decrease EPO dose by 3050% from initial dose (>1.3 in 2 weeks) or Reaches target within 1 month Within 2 months Consider: Decreasing EPO dose by 1025% Decrease EPO dose by 1025% Check CBC every 2 weeks until stable in target range. Hold EPO dose: Check CBC weekly until Hb 12.0 g/dL. When Hb reaches 12.0 g/dL, resume EPO at reduced dose (decrease dose 1025%). Continue to check CBC every 2 weeks until stable in target range. Hold EPO dose: Check CBC every 2 weeks until Hb drops below 12.0 g/dL. When reaches Hb 12.0 g/dL, resume EPO at reduced dose (decrease dose 3050%). Continue to check CBC every 2 weeks until stable in target range

Exceeds target Hemoglobin during maintenance 11.612.0 g/dL Hemoglobin 12.112.4 g/dL

Hemoglobin >12.5 g/dL

Maintains target at low doses

Using doses of Continue at weekly dosing EPO 4,000 units or or less per week Consider: Adjust to dosing every 2 weeks (e.g., 8,000 units every 2 weeks rather than 4,000 units weekly)

Fails to reach target After 4 weeks Increase EPO dose by 3050% Hb <10 g/dL Check CBC every 2 weeks until stable in target range. and hasnt increased by at least 1.0 g/dL After 8 weeks Increase EPO dose by 3050% Hb <10 g/dL Check CBC every 2 weeks until stable in target range. If Hb is not within target within an additional 8 weeks, increase EPO dose by an additional 30%. Continue to check CBC every 2 weeks until stable in target range After 8 weeks Hb 10.0 10.4 g/dL Continued on the following page. Increase EPO dose by 1025% Check CBC every 2 weeks until stable in target range

EPO Treatment and Monitoring Guideline

Table 6 (continued). Adjusting EPO dosing for ESRD and chronic kidney disease patients Reaches target range, then falls below Hb decreases to Increase EPO dose by 1025% 9.510.4 g/dL Hb decreases below 9.5 g/dL Increase EPO dose by 3050%

Hb decreases Consult physician before changing dose due to infection, recent surgery or blood loss

Chemotherapy Patients
Table 7. Adjusting EPO dosing in patients with chemotherapy-induced anemia Note: Adjust for maximum of 8 weeks after final chemotherapy dose. be sure to: Check hemoglobin weekly. Check blood pressure prior to each dose. Week Week 3: Check CBC or Hb Hemoglobin status Hb increased >1 g/dL from baseline in 2 weeks Action 1 Hold EPO dose Check CBC weekly until Hb <10.0 g/dL. When Hb <10.0 g/dL, resume EPO at reduced dose (decrease dose 25%). Continue to check CBC weekly. Increase EPO to 60,000 units once weekly for 4 weeks Continue current EPO dose Hold EPO dose Check CBC weekly until Hb <10.0 g/dL. When Hb <10.0 g/dL, resume EPO at reduced dose (decrease dose 25%). Continue to check CBC weekly. Discontinue EPO, the patient is not responding Continue current EPO dose Hold EPO dose Check CBC weekly until Hb <10.0 g/dL. When Hb <10.0 g/dL, resume EPO at reduced dose (decrease dose 25%). Continue to check CBC weekly. Stop EPO

Week 4: Check CBC or Hb

Hb increased <1 g/dL from baseline and Hb <11 g/dL Hb increased >1 g/dL from baseline and Hb <11 g/dL Hb increased >1 g/dL from baseline and Hb >11 g/dL

Week 8: Check CBC or Hb

Hb increased <1 g/dL from baseline and Hb <11 g/dL Hb increased >1 g/dL from baseline and Hb <11 g/dL Hb increased >1 g/dL from baseline and Hb >11 g/dL

8 weeks post final dose of chemotherapy regimen

1

This regimen varies from CMS (Medicare) recommendations in that at week 4, CMS suggests a smaller onetime increase in dosing (25% or 10,000 units) from the initial dosing of 40,000 units, rather than the 50% increase (60,000 units weekly) for Group Health. Also, the Group Health recommendations detail additional scenarios that the CMS recommendations do not.

EPO Treatment and Monitoring Guideline

10

HIV Patients with AZT-induced Anemia

Table 8. Adjusting EPO dosing for HIV patients with zidovudine-induced symptomatic anemia 1 Week Weeks 812: Check CBC or Hb
1

Hemoglobin status Patient not at goal

Action Increase EPO by 50100 units/kg increments until the patient reaches the desired hemoglobin

Titrate to achieve the lowest Hb level needed to avoid transfusion and not exceed Hb 12 g/dL.

Hepatitis C Patients
Table 9. Adjusting EPO dosing for symptomatic anemia resulting from treatment of hepatitis C Target status Hb <10 g/dL Hb 1011 g/dL Hb 1112 g/dL Hb >12 g/dL Action Continue decreased ribavirin Continue weekly EPO for the remainder of the treatment Increase ribavirin back to normal dose Continue weekly EPO for the remainder of the treatment Decrease EPO dose by 25%, continue for the remainder of the treatment Hold EPO dose

EPO Treatment and Monitoring Guideline

11

Other Patients
Table 10. Adjusting EPO dosing for other conditions 1 Note: This table includes recommendations for: Myelodysplastic syndrome (MDS) patients with symptomatic anemia per CMS. Systemic lupus erythematosus (many are treated as CKD patients). Anemia associated with chemotherapeutic medications when medically necessary for non-cancer diagnosis or following stem cell transplantations and associated immunosuppression (EPO is typically managed by oncology). Week Week 4 Hemoglobin status Hb increased <1 g/dL from baseline and Hb <12 g/dL Hb increase is >1 g/dL and Hb <12 g/dL Hb increase is >1 g/dL and Hb >12 g/dL Action For MDS patients, increase EPO to 60,000 units once weekly for 4 weeks Systemic lupus erythematosus patients are typically treated as CKD patients Continue current EPO dose

Hold EPO dose Check CBC weekly until Hb is <12 g/dL. When Hb is <12 g/dL resume EPO at reduced dose (decrease dose 50%). Continue to check CBC weekly. Discontinue EPO, the patient is not responding 1

Week 12

Hb increased <1 g/dL from baseline and Hb <12 g/dL Or transfusion requirement has not decreased by 50% resulting in a rate of 2 units per month or less for treatment to continue. Hb increase is > 1 g/dL and Hb < 12 g/dL Hb increase is > 1 g/dL and Hb >12 g/dL

Continue current EPO dose Hold EPO dose Check CBC weekly until Hb is <12 g/dL. When Hb is <12 g/dL resume EPO at reduced dose (decrease dose 50%). Continue to check CBC weekly. During maintenance, in case Hb >12 g/dL, decrease the weekly dose every 8 weeks (recommended schedule: 60-40-30-20-15-105,000 units/week). Median maintenance dose is 30,000 units (range is 5,00060,000 units/week).

Maintenance (beyond week 12)

MDS: target Hb level 1012 g/dL

1 2

Titrate to achieve the lowest Hb level needed to avoid transfusion and not exceed Hb 12 g/dL. There are a few studies that have reported on EPO doses up to 80,000 units weekly, but without comparison to lower doses; these doses cannot be recommended.

EPO Treatment and Monitoring Guideline

12

Discontinuation of Treatment
Discontinue EPO for patients with: Chemotherapy-induced anemia by week 8 if patient fails to increase Hb by more than 1 g/dL on titrated doses of EPO. Also, discontinue EPO 8 weeks after last dose of chemotherapy. Hepatitis C patients being treated with ribavirin when ribavirin treatment ends. Myelodysplastic syndrome (MDS) after 12 weeks of EPO therapy using the appropriate dose titrations; Hb must increase by at least 1 g/dL or transfusion requirement must decrease by 50% resulting in a rate of 2 units per month or less for treatment to continue.

Additional Testing/Monitoring
Table 11. Recommended monitoring Eligible population Test(s) Frequency Before each dose of EPO Action For nephrology patients hold EPO if BP >180/100 For other patients hold EPO if BP >160/80 CBC FE/TIBC Ferritin Stool occult blood Every 2 weeks until stable (at therapy initiation and after any dose change of EPO 20% or more) Then monthly 1 At 1 month (at therapy initiation and after oral iron dose change or after IV ferritin) 2 Then at 3 months Then every 3 months

All patients Blood pressure receiving EPO

Consider testing if iron stores low in spite of iron supplementation

Reticulocyte count Consider testing if patient is not responding to therapy as expected Vitamin B12 Folate Haptoglobin
1 2

Medicare requires hemoglobin to be checked within 1 month of each EPO dose for continue coverage. Repeat iron studies within 1 month after IV ferrlecit is given, but at least 5 days after the last dose.

EPO Treatment and Monitoring Guideline

13

References
1. The Centers for Medicare and Medicaid Services. Local Coverage Determination (LCD) for Erythropoiesis Stimulating Agents (L23723). Updated 9/16/2010. Available online at: http://www.cms.gov/mcd/viewlcd.asp?lcd_id=23723&lcd_version=26&show=all 2. Hellstrm-Lindberg E, Gulbrandsen N, Lindberg G, et al. A validated decision model for treating the anaemia of myelodysplastic syndromes with erythropoietin + granulocyte colony-stimulating factor: significant effects on quality of life. Br J Hematol. 2003;120:10371046. 3. Jdersten M, Montgomery SM, Dybedal I, Porwit-MacDonald A, Hellstrm-Lindberg E. Long-term outcome of treatment of anemia in MDS with erythropoietin and G-CSF. Blood. 2005;106:803811. 4. Nordic MDS Group. Guidelines for the diagnosis and treatment of the myelodysplastic syndromes and chronic melomonocytic leukemia, 4th update, January 2010. Available online at: http://www.nmds.org/ez4/index.php?/nmds/Nordic-Care-Programme 5. U.S. Food and Drug Administration. FDA Drug Safety Communication: Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp. Updated 4/8/10. Available online at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm 200297.htm

EPO Treatment and Monitoring Guideline

14

Clinician Lead and Guideline Development

Clinician Lead
David K. McCulloch, MD Medical Director, Clinical Improvement Phone: 206-326-3938

Last Update
Most recent comprehensive literature review: June 2010

Process of Development
This guideline was based on the regulations established by the Centers for Medicare and Medicaid for the use of erythropoietin stimulating agents, the USFDA warnings regarding ESA agents, and published studies of the effectiveness of the agents for each of the conditions. The following specialties were represented on the development team: gastroenterology, nephrology, oncology, and pharmacy.

EPO Treatment and Monitoring Guideline

15