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Published by F. Lew, 2019-08-28 17:37:05

ERYTHROPOIESIS STIMULATING AGENTS

ERYTHROPOIESIS STIMULATING AGENTS

LTC Pharmacy Services Pharmaceutical Care

ERYTHROPOIESIS STIMULATING AGENTS

PURPOSE

Erythropoiesis stimulating agents (ESA) are utilized for treatment of anemia resulting
from chronic kidney failure (CKD), chemotherapy, certain treatments for human
immunodeficiency virus (HIV) and to reduce the need for blood transfusions during and after
certain major surgeries. All ESAs have a black box warning indicating increase risk of death,
myocardial infarction (MI), stroke, venous thromboembolism, thrombosis of vascular access and
tumor progression or recurrence.

POLICY

The pharmacy will manage and review all CKD ESA orders to ensure they fall within the
FDA prescribing guidelines to mitigate potential negative outcomes associated with ESAs.

WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS
THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE

Chronic Kidney Disease:

• In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular
reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target
hemoglobin levels of greater than 11 g/dL.

• No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase
these risks.

• Use the lowest ESA dose sufficient to reduce the need for red blood cell (RBC) transfusions.

Cancer:
• ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in

clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical
cancers.
• Use the lowest dose to avoid red blood cell transfusion.
• Use ESAs only for anemia from myelosuppressive chemotherapy.
• ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the
anticipated outcome is cure.
• Discontinue following the completion of a chemotherapy course.

Perisurgery:
• Due to increased risk of deep venous thromboses (DVT), DVT prophylaxis is recommended.

Policies & Procedures Manual for Long-Term Care Pharmacy Operations Med-Plus Pharmacy Inc. (revise 2019)

LTC Pharmacy Services Pharmaceutical Care

Procedure

A. FDA Drug Safety guidance regarding CKD ESA dosing recommendations:
1. Patients should have blood tests while using ESAs.
2. Using ESAs to target a hemoglobin level of greater than 11g/dl increases the risk
of serious adverse cardiovascular events and has not been shown to provide
additional patient benefit.
3. No clinical trials have identified any hemoglobin target level, ESA dose, or
dosing strategy that does not increase these risks.
4. The lowest ESA dose sufficient to reduce the need for red blood cell transfusions
should be used.
5. Adverse events involving ESAs should be reported to the FDA MedWatch
program.

B. The pharmacy will provide clinical oversight for ESA use in CKD patients according to
FDA guidance.

CKD Patients NOT on dialysis

1. Consider initiating ESA treatment only then the hemoglobin level is less than 10
g/dL.

2. For continuation therapy hemoglobin is less than or equal to 10.0 g/dL and:
a. The patient is receiving iron therapy or iron stores are adequate (serum
ferritin > 100 mcg/L or serum transferrin saturation is >20% and:
b. Evaluation for other causes of anemia, including nutritional causes, has
been performed and condition treated as appropriate.

3. If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of ESA and
use the lowest dose of ESA sufficient to reduce the need for red blood cell
transfusions.
a. When initiating or adjusting therapy, monitor hemoglobin levels at least
weekly until stable, then monitor at least monthly.
b. Patients who do not respond adequately over a 12-week escalation period,
increasing the ESA dose further is unlikely to improve response and may
increase risks.

CKD Patients ON dialysis

1. Initiate ESA treatment when the hemoglobin level is less than 10 g/dL .
2. For continuation therapy hemoglobin is less than or equal to 10.0 g/dL , and:

a. The patient is receiving iron therapy or iron stores are adequate (serum
ferritin > 100 mcg/L or serum transferrin saturation is >20% and:

b. Evaluation for other causes of anemia, including nutritional causes, has
been performed and condition treated as appropriate.

Policies & Procedures Manual for Long-Term Care Pharmacy Operations Med-Plus Pharmacy Inc. (revise 2019)

LTC Pharmacy Services Pharmaceutical Care

3. If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the
dose of ESA.
a. When initiating or adjusting therapy, monitor hemoglobin levels at least
weekly until stable, then monitor at least monthly.
b. Patients who do not respond adequately over a 12-week escalation period,
increasing the ESA dose further is unlikely to improve response and may
increase risks.

C. Orders received for ESAs for CKD patients
1. ESA Orders
a.Initial/New ESA orders require:
i. A current or recent lab report denoting hemoglobin value
ii. Diagnosis/indication for use.
iii. Whether patient is or is not on dialysis
b.Continuation ESA orders require:
i. A current or recent lab report denoting hemoglobin value
2. CKD Patients will be monitored
a.Hemoglobin level should be less than or equal to 10 g/dL for
initiation/continuation therapy (see B for Non-dialysis versus dialysis).
b. Hemoglobin levels exceeding levels noted in (B) above, will trigger clinical
discussion with the prescriber regarding reducing or interrupting the dose of
ESA.

Policies & Procedures Manual for Long-Term Care Pharmacy Operations Med-Plus Pharmacy Inc. (revise 2019)


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