9tx Epo Policy 3

Recombinant Erythropoietin Use Protocol for the Solid Organ Transplantation Service (STO and MTS) April 20, 2004 1. Admissions based on pancreas and/or kidney organ transplantation (STO only) a. Admission labs (pre-transplant) will include a full iron study workup i. Serum iron ii. Serum ferritin iii. Percent iron saturation 1. Transferrin must be ordered for calculation 2. Percent iron saturation = Serum iron / Total iron binding capacity (TIBC) 3. TIBC = Transferrin / 0.7 b. Iron deficiency i. Serum ferritin < 100ng/mL ii. Serum ferritin < 800ng/mL and percent iron saturation < 20% iii. IV iron administration contraindicated with serum ferritin > 800ng/mL c. Patients defined as “iron deficient” i. Starting POD #1, sodium ferric gluconate (Ferrlecit®) will be administered as 125mg/100mL every other day over 2 hours until discharge 1. First dose will require test dose 25mg over one hour. If vitals are stable one hour post-infusion, the remaining 100mg will be administered over 1 hour a. Reactions could include hypotension, itching, and rash b. Not required if patient has already received 2. Total Ferrlecit® will not exceed 1 gram (8 doses) a. Ferrlecit® dosing can be repeated if: i. Iron studies repeated every month during admission indicate iron deficiency ii. Ferrlecit® dosing within one month does not exceed 1 gram 3. Discharge of “iron deficient” patients a. Intolerant of IV iron i. Started on oral iron supplementation immediately following failed IV iron therapy ii. Ferrous sulfate 325mg tid b. Received IV iron while inpatient i. Start on oral iron supplementation upon discharge if patient did not get total of 1gm Ferrlecit® 1. Ferrous sulfate 325mg tid

2. Patient must be instructed to take iron supplementation 2-4 hours before or after: a. Mycophenolate mofetil (Cellcept®) b. Gatifloxacin (Tequin®) c. Ciprofloxacin (Cipro®) ii. Do not start on oral iron supplementation if patient received total of 1gm Ferrlecit® ii. Surgical attending, and/or transplant nephrologist may override protocol Ferrlecit® dosing if patient has concurrent infection 1. Should be documented in daily note iii. Patient should complete full course if discharged and readmitted within same month 1. Do not repeat iron studies within one month of previous iron studies d. Recombinant human erythropoietin EPO (Epogen® or Procrit®) i. No patient will receive EPO within 7 days of organ transplantation ii. Reserved for patients in delayed graft function (DGF) and anemic 1. The designation of “a patient in DGF”, with the respect to the administration of EPO, will be reserved to: a. Transplant nephrologist (STO) b. Transplant surgical attending 2. Anemia is defined as hematocrit < 30 (on 3 blood draws) iii. Surgical attending, and/or transplant nephrologist may alter minimum hematocrit if patient has history coronary artery disease (CAD) 1. Should be documented in daily note iv. Initial dose 1. All patients initial dose = 10,000 units subcutaneous weekly (150 units/kilogram per week for ideal body weights 50 – 87 kg, 5 feet – 6 feet 4 inches) v. Titration of EPO 1. Within two weeks of initiating EPO a. Hematocrit increase > 8% of baseline i. Decrease EPO dose by 25% b. Hematocrit increase <2% of baseline i. Increase EPO dose by 50% 2. Hematocrit > 36% for two consecutive weeks a. Decrease EPO dose by 50% b. Continue downward titration to discontinuation of EPO 3. Increments of titration a. Doses will be increased or decreased using the following manufacturer designed vials

i. 2000, 3000, 4000, 10000, 20000, 40000 units 4. Goal of therapy a. Hematocrit > 33 and < 36 2. Admissions based on complications post-transplantation (STO or MTS) a. Admission labs will include a full iron study workup if: i. Patient currently on EPO ii. Serum creatinine > 2.0 1. Iron studies should not be reviewed if most recent admission (within 30 days) included iron studies b. Iron study labs i. Serum iron ii. Serum ferritin iii. Percent iron saturation 1. Transferrin must be ordered for calculation 2. Percent iron saturation = Serum iron / Total iron binding capacity (TIBC) 3. TIBC = Transferrin / 0.7 c. Iron deficiency i. Serum ferritin < 100ng/mL ii. Serum ferritin < 800ng/mL and percent iron saturation < 20% iii. IV iron administration contraindicated with serum ferritin > 800ng/mL d. Patients defined as “iron deficient” i. Sodium ferric gluconate (Ferrlecit®) will be administered as 125mg/100mL over 2 hours every other day until discharge 1. First dose will require test dose 25mg over one hour. If vitals are stable one hour post-infusion, the remaining 100mg will be administered over 1 hour a. Reactions could include hypotension, itching, and rash b. Not required if patient has already received 2. Total Ferrlecit® will not exceed 1 gram a. Ferrlecit® dosing can be repeated if: i. Iron studies repeated every month during admission indicate iron deficiency ii. Ferrlecit® dosing within one month does not exceed 1 gram (8 doses) 3. Discharge of “iron deficient” patients a. The Transplant Infusion Center will utilized to complete 1 gram of therapy b. If patient unable to complete full Ferrlecit® course, patient will be started on oral iron supplementation i. Patient must be instructed to take iron supplementation 2-4 hours before or after: 1. Mycophenolate mofetil (Cellcept®)

2. Gatifloxacin (Tequin®) 3. Ciprofloxacin (Cipro®) c. If patient completed full Ferrlecit® course (8 doses), do not discharge on oral iron supplementation ii. MTS attending, MTS nurse practitioner, surgical attending, and/or transplant nephrologist may override protocol Ferrlecit® dosing if patient has concurrent infection 1. Should be documented in daily note iii. Patient should complete full course if discharged and readmitted 1. Do not repeat iron studies within one month of previous iron studies e. Recombinant human erythropoietin EPO (Epogen® or Procrit®) i. Patients admitted receiving EPO will continue their current dose ii. Patients admitted not currently receiving EPO, can only be initiated on EPO if all the following are met: 1. Hematocrit < 30 2. Complete iron studies reviewed 3. Stool sent to check for occult blood 4. Reticulocyte count sent (absolute count and percentage) 5. MTS attending, MTS nurse practitioner, surgical attending, and/or transplant nephrologist has ruled out the following as causes of decreased hematocrit: a. Hemolysis b. Acute hemorrhage c. Malignancy d. Medication-induced i. Only those that will be stopped soon, and are not chronic medications 1. Included, but not limited to Thymoglobulin® iii. MTS attending, MTS nurse practitioner, surgical attending, and/or transplant nephrologist may alter minimum hematocrit if patient has history coronary artery disease (CAD) 1. Should be documented in daily note iv. Initial dose for those patients not currently receiving EPO 1. All patients initial dose = 10,000 units subcutaneous weekly (150 units/kilogram per week for ideal body weights 50 – 87 kg, 5 feet – 6 feet 4 inches) v. Titration of EPO (for patients admitted on EPO or initiated on EPO in hospital) 1. Within two weeks of initiating EPO or admission a. Hematocrit increase > 8% of baseline i. Decrease EPO dose by 25% b. Hematocrit increase <2% of baseline i. Increase EPO dose by 50%

2. Hematocrit > 36% for two consecutive weeks a. Decrease EPO dose by 50% b. Continue downward titration to discontinuation of EPO 3. Increments of titration a. Doses will be increased or decreased using the following manufacturer designed vials i. 2000, 3000, 4000, 10000, 20000, 40000 units 4. Goal of therapy a. Hematocrit > 33 and < 36 3. SMARhT study a. The patients are excluded from the proceeding protocol 4. Patients admitted with failed renal grafts a. Follow protocol for “Admissions based on complications posttransplantation (STO or MTS)” 5. Access or Vascular patients a. Follow protocol for “Admissions based on complications posttransplantation (STO or MTS)”