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.

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

EPO eligibility criteria (CMS)

Note: Hemoglobin/hematocrit must be

done within 1 week prior to EPO
treatment

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 nonmyeloid, non-erythroid
cancer (solid tumors, multiple
myeloma, lymphoma,
lymphocytic leukemia, and
chemotherapy-induced
anemia)

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

Complete blood count (CBC)

B12
Ferritin

Hb 10 g/dL 4
or
Hb 1011 g/dL and clinical risk of
anemia warrants earlier
initiation

Exclude patients:
With ongoing bleeding
disorders or hemolysis even if
anemia is multifactorial
involving CKD (treat with
transfusion)

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

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

Pretreatment Hb <10 g/dL 4

TSAT 20%
B12 and folate not deficient

Myelodysplastic syndrome
(MDS)

Hemoglobin
Fe/TIBC (TSAT) 3
Ferritin
B12
Folate

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%

Chronic hepatitis C under

treatment with ribavirin and
either interferon alfa or
peginterferon alfa

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)

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)

or
Systemic lupus
erythematosus
Patient taking
chemotherapeutic
medications when medically
necessary for non-cancer
diagnosis or following stem
cell transplantation and
associated
immunosuppression
1

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.

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

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

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

TSAT <20% and

ferritin >500 ng/mL
1
2
3
4
5

Line

Medication

Dosing

Oral 1st line

Ferrous sulfate

325 mg (65 mg iron) 3

1 tablet 3 times daily
or
3 tablets once daily in the
evening for those taking
calcium

Oral 2nd line

Ferrous
gluconate

325 mg (36 mg iron)

Note lower iron content of
this option; FeSO4 is
preferred

Oral 3rd line 2

Slow release
iron 2

50 mg iron
14 tablets daily (split
dosing if more than one
tablet)

IV 1st line

Ferrlecit 4
(sodium ferric
gluconate
complex in
sucrose)

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

IV 2nd line
(if patient
reacts to IV
ferrlecit)

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

Target
1

Hb 10.511.5 g/dL 1

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

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

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

Initial dose

ESRD or chronic kidney disease of at least

stage 3 (eGFR <60)

EPO 20008000 units subcutaneously (SQ) once

weekly (dose depending upon patients weight,
severity of anemia, and associated symptoms)

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)

EPO 30,00040,000 units SQ once weekly for

4 weeks 1
Check CBC or Hb at week 3

HIV with symptomatic zidovudine-induced

anemia

EPO 100 units/kg IV or SQ 3 times weekly for 812

weeks

Systemic lupus erythematosus

(These patients are typically treated as chronic kidney

disease patients.)

Myelodysplastic syndrome (MDS)

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

Patient taking chemotherapeutic medications

when medically necessary following stem cell
transplantation

(These patients are typically treated by Oncology)

Patient taking chemotherapeutic medications

when medically necessary for non-cancer
diagnosis and associated immunosuppression

(These patients are typically treated by Nephrology or

Rheumatology.)

Chronic hepatitis C under treatment with

ribavirin and either interferon alfa or
peginterferon alfa

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

Hemoglobin
status

Reaches target

Rapidly rising
Decrease EPO dose by 3050% from initial dose
(>1.3 in 2 weeks)
or
Reaches target
within 1 month
Within 2 months

Exceeds target
Hemoglobin
during maintenance 11.612.0 g/dL

Maintains target at
low doses

Action

Consider: Decreasing EPO dose by 1025%

Decrease EPO dose by 1025%
Check CBC every 2 weeks until stable in target range.

Hemoglobin
12.112.4 g/dL

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.

Hemoglobin
>12.5 g/dL

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

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

Increase EPO dose by 1025%

Check CBC every 2 weeks until stable in target range

Continued on the following page.

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

Hemoglobin status

Action 1

Week 3: Check
CBC or Hb

Hb increased >1 g/dL from

baseline in 2 weeks

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.

Week 4: Check
CBC or Hb

Hb increased <1 g/dL from

baseline and Hb <11 g/dL

Increase EPO to 60,000 units once weekly for 4

weeks

Hb increased >1 g/dL from

baseline and Hb <11 g/dL

Continue current EPO dose

Hb increased >1 g/dL from

baseline and Hb >11 g/dL

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.

Hb increased <1 g/dL from

baseline and Hb <11 g/dL

Discontinue EPO, the patient is not responding

Hb increased >1 g/dL from

baseline and Hb <11 g/dL

Continue current EPO dose

Hb increased >1 g/dL from

baseline and Hb >11 g/dL

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.

Week 8: Check
CBC or Hb

8 weeks post final dose of chemotherapy

regimen
1

Stop EPO

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

Hemoglobin status

Action

Weeks 812: Check

CBC or Hb

Patient not at goal

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

Action

Hb <10 g/dL

Continue decreased ribavirin

Continue weekly EPO for the remainder of the treatment

Hb 1011 g/dL

Increase ribavirin back to normal dose

Continue weekly EPO for the remainder of the treatment

Hb 1112 g/dL

Decrease EPO dose by 25%, continue for the remainder of the treatment

Hb >12 g/dL

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

Hemoglobin status

Action

Week 4

Hb increased <1 g/dL from baseline

and
Hb <12 g/dL

For MDS patients, increase EPO to 60,000 units

once weekly for 4 weeks

Week 12

Systemic lupus erythematosus patients are

typically treated as CKD patients

Hb increase is >1 g/dL

and
Hb <12 g/dL

Continue current EPO dose

Hb increase is >1 g/dL

and
Hb >12 g/dL

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.

Hb increased <1 g/dL from baseline

and
Hb <12 g/dL

Discontinue EPO, the patient is not responding 1

Or transfusion requirement has not

decreased by 50% resulting in a rate
of 2 units per month or less for
treatment to continue.

Maintenance
(beyond
week 12)

Hb increase is > 1 g/dL and

Hb < 12 g/dL

Continue current EPO dose

Hb increase is > 1 g/dL and

Hb >12 g/dL

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.

MDS: target Hb level 1012 g/dL

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).

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)

All patients
Blood pressure
receiving EPO

Frequency

Action

Before each dose of EPO

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

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

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

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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

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