ANEMIA PROTOCOL CONSIDERATIONS
A comprehensive protocol is essential for effective anemia management
An anemia management protocol is designed to:
- Allow for dynamic erythrokinetic responses due to clinical events in order to efficiently maintain steady state at target Hb levels
- Account for natural Hb variability in dialysis patients
- Allow for individualized dosing to achieve and maintain Hb levels within the range of 10 g/dL to 12 g/dL
- Be universally applicable
A comprehensive dosing algorithm includes clear direction regarding the following key principles of dose modification:
- Starting dose
- Hb range
- Routine monitoring of Hb
- Dose adjustments
- When to dose increase
- When to dose reduce versus dose hold
- When to reinitiate dose
- Iron status
- Protocol/Algorithm for hyporesponsive patients
Protocol/algorithm must be properly implemented to be effective
The healthcare team should work to ensure that the protocol/algorithm is:
- Promoted by a dedicated nurse champion
- Adhered to by the entire staff
- Used to implement appropriate orders
- Reinforced through continuous education
- Reviewed regularly
- Inclusive of routine lab reviews for high-risk patients
- Inclusive of routine Hb monitoring in order to make appropriate dosing decisions
- Inclusive of EPOGEN® PI recommendations
- Inclusive of separate treatment algorithms for the following:
- New patients
- Post-hospitalization patients
- Cases of infection/inflammation
- Inclusive of assessment techniques of possible etiologies, including:
- Iron deficiency
- Underlying infectious, inflammatory, or malignant processes
- Occult blood loss
- Underlying hematologic diseases
- Vitamin deficiencies
- Hemolysis
- Aluminum intoxication
- Osteitis fibrosa cystica
- Pure red cell aplasia or anti-erythropoietin antibody-associated anemia
Indication
EPOGEN® (Epoetin alfa) is indicated for the treatment of anemia in patients with chronic renal failure (CRF) on dialysis. EPOGEN® is indicated to elevate or maintain the red blood cell (RBC) level and to decrease the need for transfusions in these patients.
WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR EVENTS, THROMBOEMBOLIC EVENTS, STROKE
and INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE
Chronic Renal Failure:
- In clinical studies, patients experienced greater risks for death, serious cardiovascular events, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target hemoglobin levels of 13 g/dL and above.
- Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.
Cancer:
- ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in some clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.
- To decrease these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusion.
- Because of these risks, prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense EPOGEN®
(Epoetin alfa) to patients with cancer. To enroll in the ESA APPRISE Oncology Program, visit www.esa-apprise.com
or call 1-866-284-8089 for further assistance.
- Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy.
- ESAs are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure.
- Discontinue following the completion of a chemotherapy course.
Perisurgery: EPOGEN ® increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.
- EPOGEN® is contraindicated in patients with uncontrolled hypertension.
- Patients with chronic renal failure (CRF) participating in clinical studies experienced greater risks for death, serious cardiovascular events, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target hemoglobin levels of 13 g/dL and above.
- Patients with CRF and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular events and mortality than other patients.
- These events included myocardial infarction, stroke, congestive heart failure, and hemodialysis vascular access thrombosis.
- A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these risks.
- Cases of pure red cell aplasia (PRCA) and of severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin have been reported in patients treated with EPOGEN®.
- This has been reported predominantly in patients with CRF receiving ESAs by subcutaneous administration.
- PRCA has also been reported in patients receiving ESAs while undergoing treatment for hepatitis C with interferon and ribavirin.
- A sudden loss of response to EPOGEN®, accompanied by severe anemia and low reticulocyte count, should be evaluated.
- If anti-erythropoietin antibody-associated anemia is suspected, withhold EPOGEN® and other ESAs. EPOGEN® should be permanently discontinued in patients with antibody-mediated anemia. Patients should not be switched to other ESAs as antibodies may cross-react.
- Seizures have occurred in patients with CRF participating in EPOGEN® clinical trials.
- The most commonly reported side effects in clinical trials were hypertension, headache, arthralgias, and nausea.
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