ADDITIONAL CONSIDERATIONS
Important Considerations in Anemia Management: EPOGEN® PI Recommendations
| EPOGEN® PI-recommended Hb range2 |
| 10 g/dL to 12 g/dL |
Please see Complete Dosing Guidelines.
| EPOGEN® PI-recommended iron status2 |
| Serum ferritin > 100 mcg/L |
| TSAT > 20% |
In cases of hyporesponse (fails to respond or maintain a response)
For patients whose Hb does not attain a level within the range of 10 g/dL to 12 g/dL despite the use of appropriate EPOGEN® dose titrations over a 12-week period:
- Do not administer higher EPOGEN® doses and use the lowest dose that will maintain a Hb level sufficient to avoid the need for recurrent red blood cell (RBC) transfusions
- Evaluate and treat for other causes of anemia
- Thereafter, Hb should continue to be monitored and if responsiveness improves, EPOGEN® dose adjustments should be made as described in the Complete Dosing Guidelines; discontinue EPOGEN® if responsiveness does not improve and the patient needs recurrent RBC transfusions
Patients with chronic renal failure (CRF) and an insufficient Hb response to erythropoiesis-stimulating agent (ESA) therapy may be at even greater risk for cardiovascular events and mortality than other patients.
KDOQI™ Recommendations*
| KDOQI™ Hb target levels27 |
| Generally be in the range of 11 g/dL to 12 g/dL |
| KDOQI™ iron status28 |
| Serum ferritin > 200 ng/mL |
| TSAT > 20% or CHr > 29 pg/cell |
* KDOQI™ is a trademark of the National Kidney Foundation, Inc.
In the opinion of the KDOQI Anemia Workgroup, there is insufficient evidence to recommend routine administration of IV iron if ferritin level is greater than 500 ng/mL5. For ferritin > 500 ng/mL, evaluate the patient's overall clinical status, ESA responsiveness, and Hb and TSAT levels to determine further decisions regarding IV iron administration.30
Important Considerations in Anemia Management: Reimbursement
Maintaining Hb levels within the EPOGEN® PI-recommended range can facilitate reimbursement
Providers are expected to maintain Hb levels between 10 g/dL and 12 g/dL, according to the 2008 Centers for Medicare and Medicaid Services (CMS) ESA Claims Monitoring Policy (EMP).29
The EMP recognizes that there is considerable natural variability in individual Hb levels.29
For complete information regarding the EMP, please refer to CMS Pub 100-04 Transmittal 1307, July 20, 2007.
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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