Darbepoetin Alfa(Alb Free) 10 MCG/0.4ML Syringe (Aranesp)

Darbepoetin Alfa(Alb Free) 10 MCG/0.4ML Syringe (Aranesp)

Advisories: Warning now dose in ML not mcg, ****Warning now dose in ML not mcg** ESA USE IN CANCER PATIENTS: 1. Other causes of anemia are evaluated and treated 2. ESA is initiated when Hgb approaches or falls below 10 g/dl, 3. Discontinue ESA if no response in 6-8 weeks (e.g. <1-2 g/dl rise in Hgb or no diminution of transfusion requirements), 4. Hgb is targeted to (or near) 12 g/dl at which point the dosage should be titrated to maintain that level 5. Reduce dose per package insert when Hgb rise exceeds 1 g/dl in any two-week period or when the Hgb level exceeds 11 g/dl 6. Iron levels are monitored and supplements prescribed accordingly 7. ESA is avoided for cancer patients not receiving chemotherapy 8. The risk of thromboembolism for patients receiving ESAs are weighed carefully 9. ESA is withheld when Hgb exceeds 12 g/dl. Restart at 25% below previous dose when Hgb approaches level where transfusions may be required 10. ESA is discontinued following completion of chemotherapy course 11. Starting doses and dose modifications are based on response, or lack thereof, and should follow the package insert ESA USE IN ESRD PATIENTS: 1. Is on dialysis 2. Has a hematocrit (or comparable hemoglobin level) that is as follows: a. No higher than 30 percent when initiating therapy, unless there is medical documentation showing the need for EPO despite a hematocrit (or comparable hemoglobin level) higher than 30 percent. Patients with severe angina, severe pulmonary distress, or severe hypotension may require EPO to prevent adverse symptoms even if they have higher hematocrit or hemoglobin levels b. For a patient who has been receiving EPO from the facility or the physician, between 30 and 36 percent** Non-Formulary Use Criteria: **1. Patient receiving hepatitis C therapy; AND** **2. Patient is one of the following: a. cirrhotic; b. pre or post-liver transplant c. HIV/HCV co-infected; d. receiving HIV triple therapy; AND** **3. Patient underwent evaluation for other causes of Page 37 of 189 anemia (e.g. bleeding, nutritional deficiency) and has been treated appropriately; AND** **4. Patient develops anemia defined as Hgb < 10 g/dL (or as clinically indicated for significant anemia-related signs and symptoms) and persists for at least two weeks after reducing the ribavirin dose to 600 mg/day; AND** **5. Patient does not have exclusion criteria: Uncontrolled hypertension or risk for thrombosis.** **All of the following must be true for patient to be eligible for epoetin alfa treatment of hepatitis C treatment-related anemia:** Formulary Restrictions: ****RECOMMENDED AS FIRST LINE AGENT IN DIALYSIS PATIENTS** **RESTRICTED TO TREATMENT OF DIALYSIS OR CANCER CHEMOTHERAPY PATIENTS** **USE IN PATIENTS BEING TREATED FOR HEPATITIS WITH INTERFERON/RIBAVIRIN MUST BE DONE IN CONSULTATION WITH CENTRAL OFFICE AND HAVE NONFORMULARY APPROVAL BEFORE INITIATING THERAPY**** **Medical Referral Center (MRC) Use Only** ESA USE IN CANCER PATIENTS: 1. Other causes of anemia are evaluated and treated 2. ESA is initiated when Hgb approaches or falls below 10 g/dl 3. Discontinue ESA if no response in 6-8 weeks (e.g. <1-2 g/dl rise in Hgb or no diminution of transfusion requirements) 4. Hgb is targeted to (or near) 12 g/dl at which point the dosage should be titrated to maintain that level 5. Reduce dose per package insert when Hgb rise exceeds 1 g/dl in any two-week period or when the Hgb level exceeds 11 g/dl 6. Iron levels are monitored and supplements prescribed accordingly 7. ESA is avoided for cancer patients not receiving chemotherapy 8. The risk of thromboembolism for patients receiving ESAs are weighed carefully 9. ESA is withheld when Hgb exceeds 12 g/dl. Restart at 25% below previous dose when Hgb approaches level where transfusions may be required 10. ESA is discontinued following completion of chemotherapy course 11. Starting doses and dose modifications are based on response, or lack thereof, and should follow the package insert ESA USE IN ESRD PATIENTS: 1. Is on dialysis 2. Has a hematocrit (or comparable hemoglobin level) that is as follows: a. No higher than 30 percent when initiating therapy, unless there is medical documentation showing the need for EPO despite a hematocrit (or comparable hemoglobin level) higher than 30 percent. Patients with severe angina, severe pulmonary distress, or severe hypotension may require EPO to prevent adverse symptoms even if they have higher hematocrit or hemoglobin levels b. For a patient who has been receiving EPO from the facility or the physician, between 30 and 36 percent Non-Formulary Use Criteria: 1. Patient receiving hepatitis C therapy; AND 2. Patient is one of the following: a. cirrhotic; b. pre or post-liver transplant c. HIV/HCV co-infected; d. receiving HIV triple therapy; AND 3. Patient underwent evaluation for other causes of Page 37 of 189 anemia (e.g. bleeding, nutritional deficiency) and has been treated appropriately; AND 4. Patient develops anemia defined as Hgb < 10 g/dL (or as clinically indicated for significant anemia-related signs and symptoms) and persists for at least two weeks after reducing the ribavirin dose to 600 mg/day; AND 5. Patient does not have exclusion criteria: Uncontrolled hypertension or risk for thrombosis. All of the following must be true for patient to be eligible for epoetin alfa treatment of hepatitis C treatment-related anemia: Formulary Restrictions: RECOMMENDED AS FIRST LINE AGENT IN DIALYSIS PATIENTS, RESTRICTED TO TREATMENT OF DIALYSIS OR CANCER CHEMOTHERAPY PATIENTS, USE IN PATIENTS BEING TREATED FOR HEPATITIS WITH INTERFERON/RIBAVIRIN MUST BE DONE IN CONSULTATION WITH CENTRAL OFFICE AND HAVE NONFORMULARY APPROVAL BEFORE INITIATING THERAPY, Medical Referral Center (MRC) Use Only

Dr. M Blatstein

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