APPENDIX 2
Erythropoiesis Stimulating Agents Medication Use Guideline for the Treatment of Anemia in
Malignant Disease
Purpose of Guidelines: Provide guidance for the use of erythropoiesis stimulating agents,
epoetin alfa (Procrit®) and darbepoetin alfa (Aranesp®), in malignant disease for the Froedtert
Health System.
Background:
Erythropoiesis stimulating agents (ESA), epoetin alfa (Procrit®) and darbepoetin alfa
(Aranesp®), reduce blood transfusions and increase hemoglobin (Hb) levels in anemic patients.
ESAs are FDA approved for the treatment of anemia in patients with non-myeloid malignancies,
where anemia is due to concomitantly administered chemotherapy.1-3 Although ESAs are not
FDA approved for the treatment of anemia in low grade MDS patients, these agents are often
used as indicated in the National Comprehensive Cancer Network (NCCN) guidelines.6-8
1. Pharmacology:1
a. Epoetin alfa (Procrit®) binds to erythropoietin receptors on bone marrow cells and
stimulates proliferation of erythroid colony forming units and blast forming units.
This results in red blood cell production, division, and differentiation, which reduces
blood transfusions and increases hemoglobin levels in anemic patients.
b. Darbepoetin alfa (Aranesp®) shares a similar mechanism of action to epoetin alfa, but
has an additional sialic acid which prolongs the half-life two to three times longer
than epoetin alfa.
Froedtert Health PNT Committee Approved Uses in Malignant Disease:
1. Epoetin alfa:2,3
a. Treatment of anemia in patients with non-myeloid malignancies, where anemia is
due to concomitantly administered chemotherapy, chemotherapy induced anemia
(CIA)
b. Treatment of anemia related to symptomatic low grade myelodysplastic syndrome
(MDS)
Froedtert Health PNT Committee Unapproved Uses:
1. Darbepoetin alfa should be reserved for patients who do not tolerate epoetin alfa or who were
previously receiving darbepoetin alfa; darbepoetin alfa is restricted to an outpatient setting
only.
2
DOSING LEVEL CHART
Dose Level
A
Epoetin Alfa (preferred agent)
60,000 Units SC weekly
Darbepoetin Alfa
No dose adjustment; maintain Dose
Level C
B
50,000 Units SC weekly
No dose adjustment; maintain Dose
Level C
C
40,000 Units SC weekly
500 mcg SC q 3 weeks
D
30,000 Units SC weekly
300 mcg SC q 3 weeks
E
20,000 Units SC weekly
200 mcg SC q 3 weeks
The ESA dose should not be increased more frequently than every four weeks; doses may
be decreased more frequently
ESA Dosing for CIA
Dose Level C
Initial Dose
Maintain current dose
Hb < 10 g/dL –AND– rise in Hb ≥ 1 g/dL 4 weeks post
last dose change
Increase one dose level
Hb < 10 g/dL –AND– rise in Hb < 1 g/dL 4 weeks post
last dose change
Decrease one dose level
Hb < 10 g/dL –AND– rise in Hb > 1 g/dL 2 weeks post
last dose change
Hold dose; restart one dosing level below
Hb ≥ 10 g/dL
previous dose
Discontinue therapy
Hb rise < 2 g/dL after 8 weeks
ESA should not be administered 8 weeks past final dose of chemotherapy
ESA Dosing for Low Grade MDS
Initial Dose
Hb < 12 g/dL –AND– rise in Hb ≥ 1 g/dL 4 weeks post
last dose change
Hb < 12 g/dL –AND– rise in Hb < 1 g/dL 4 weeks post
last dose change
Hb < 12 g/dL –AND– rise in Hb > 1 g/dL 2 weeks post
last dose change
Hb ≥ 12 g/dL
Dose Level C
Maintain current dose
Increase one dose level
Decrease one dose level
Hold dose; restart one dosing level below
previous dose
Discontinue therapy
Hb rise < 2 g/dL after 8 weeks
The provider must be contacted to approve a higher dosing schema for MDS patients that require a
dose above Dose Level A