Adult Dosing
Anemia due to chronic renal failure
Patients not treated with an ESA (Erythropoiesis-Stimulating Agents)
- Start with 0.6 mcg/kg IV/SC q2 wks
- Adjust dose to achieve and maintain hemoglobin in the range of 10-12 g/dL; once this is achieved, give 1.2 mcg/kg once monthly and titrate as required
Patients treated with an ESA
- With previous weekly epoetin alfa dose <8000 U/wk; previous weekly darbepoetin alfa dose <40 mcg/wk: Administer 60 mcg q2 wks or 120 mcg/month
- With previous weekly epoetin alfa dose 8000-16000 U/wk; previous weekly darbepoetin alfa dose 40-80 mcg/wk: Administer 100 mcg q2 wks or 200 mcg/month
- With previous weekly epoetin alfa dose >16000 U/wk; previous weekly darbepoetin alfa dose >80 mcg/wk: Administer 180 mcg q2 wks or 360 mcg/month
Note:
- Regularly monitor hematological parameters during therapy
- Individualize dosing to achieve and maintain hemoglobin levels within the range of 10-12 g/dL
- For SC administration, inject in the abdomen, arm or thigh
- IV route is recommended for patients receiving hemodialysis
- Do not make dose adjustments more often than once a month
- Reduce the dose as the hemoglobin approaches 12 g/dL or increases by >1 g/dL in any 2-week period
- Adjust dose in increments or decrements of approximately 25%
- Do not mix the product with any parenteral solution
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Individualize dosing to achieve and maintain hemoglobin levels within the range of 10-12 g/dL as increased mortality and serious cardiovascular events have been reported when ESAs were administered to target hemoglobin levels >12 g/dL [US Black Box Warning]
- Do not administer for the treatment of anemia due to cancer chemotherapy [US Black Box Warning]
- ESAs shortened overall survival and time-to-tumor progression in clinical studies in patients with advanced breast, head and neck, lymphoid, and non-small cell lung carcinoma when dosed to a target hemoglobin of
12 g/dL. To minimize these risks, as well as the risk for serious cardiovascular and thromboembolic events, use the lowest dose that will maintain a hemoglobin level sufficient to avoid the need for recurrent RBC transfusions [US Black Box Warning] - The risks of shortened survival and tumor promotion have not been excluded when ESAs are dosed to target a hemoglobin of <12 g/dL [US Black Box Warning]
- ESAs are associated with an increased rate of DVT in patients not receiving prophylactic anticoagulation and undergoing surgery. Consider DVT prophylaxis in patients undergoing surgery
- Therapy should not be administered in patients with uncontrolled hypertension. Carefully monitor and control blood pressure throughout the course of therapy, particularly in patients with a history of cardiovascular disease or hypertension. Adjust dose or suspend therapy if required
- Hypertensive encephalopathy and/or seizures have been observed in patients with CRF receiving therapy
- Therapy may cause seizures. Closely monitor blood pressure and the presence of premonitory neurologic symptoms during the first several months of therapy
- Therapy may cause pure red cell aplasia (PRCA) and severe anemia, with or without other cytopenias. Suspend therapy if anti-erythropoietin antibody-associated anemia is suspected
- Lack of hemoglobin response or failure to maintain a hemoglobin response in patients receiving therapy within the recommended dosing range should prompt a search for causative factors
- Discontinue therapy if serious allergic reactions, consisting of tachycardia, pruritus and rash, occur during therapy and initiate appropriate therapy
- Predialysis patients may require lower maintenance doses than patients receiving dialysis. Marginally dialyzed patients may require adjustments in their dialysis prescription. Closely monitor renal function and fluid electrolyte balance during therapy
- Titrate and use lowest effective dose to maintain hemoglobin in the range 10-12 mg/dL. Regularly monitor hemoglobin levels throughout the course of therapy
Cautions: Use cautiously in
- History of hypertension
- History of CV disease
- Hematologic disorder
- Sickle cell disease
- Hemolytic disease
- Pure red cell aplasia
- Iron deficiency
- Folic acid or vitamin B12 deficiency
- Porphyria
- Dialysis patients
Supplemental Patient Information
- Instruct patients to regularly monitor blood pressure and perform laboratory tests for hemoglobin during therapy
- Inform patients of the importance of compliance with any prescribed dietary restrictions, dialysis regimens or medications, including antihypertensive medications
Pregnancy Category:C
Breastfeeding: Safety unknown. Manufacturer advises caution.
