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Epogen
epoetin alfa
Black Box Warnings .
Increased Mortality and Serious Cardiovascular Events in CKD Pts
incr. risk of death and serious cardiovascular events when administered to target Hgb >11 g/dL; no trial has identified Hgb target level, ESA dose, or dosing strategy that does not incr. these risks; use lowest dose sufficient to decr. need for RBC transfusion
Increased Mortality and/or Tumor Progression in Cancer Pts
use only for chemo-related anemia in pts where cure not anticipated outcome; incr. mortality and/or tumor progression or recurrence risk seen in pts w/ breast, head/neck, lymphoid, cervical, and non-small cell lung CA; use lowest dose needed to avoid RBC transfusion, D/C once chemo course completed
Increased Thromboembolic Events in Surgery Pts
consider DVT prophylaxis due to incr. DVT rate in pts not receiving prophylactic anticoagulation
Adult Dosing .
Dosage forms: INJ: 2000 units per mL, 3000 units per mL, 4000 units per mL, 10,000 units per mL, 20,000 units per mL
anemia, CKD-associated
- [dialysis pts]
- Dose: individualize dose SC/IV 3x/wk; Start: 50-100 units/kg/dose SC/IV 3x/wk; Info: for pts w/ Hgb <10 g/dL; IV route preferred; use lowest dose to maintain Hgb level sufficient to reduce RBC transfusion need; incr. dose 25% if Hgb response <1 g/dL/4wk, may incr. dose no more frequently than q4wk; do not incr. dose further if inadequate response by 12wk; decr. dose 25% if Hgb response >1 g/dL/2wk; decr. dose or interrupt tx if Hgb nearing or exceeds 11 g/dL; give iron supplement if serum ferritin level <100 mcg/L, or if serum transferrin saturation <20%
- [non-dialysis pts]
- Dose: individualize dose SC/IV 3x/wk; Start: 50-100 units/kg/dose SC/IV 3x/wk; Info: for pts w/ Hgb <10 g/dL and when rate of decline indicates RBC transfusion need; use lowest dose to maintain Hgb level sufficient to reduce RBC transfusion need; incr. dose 25% if Hgb response <1 g/dL/4wk, may incr. dose no more frequently than q4wk; do not incr. dose further if inadequate response by 12wk; decr. dose 25% if Hgb response >1 g/dL/2wk; decr. dose or interrupt tx if Hgb >10 g/dL; give iron supplement if serum ferritin level <100 mcg/L, or if serum transferrin saturation <20%
anemia, HIV-associated
- [individualize dose SC/IV 3x/wk]
- Start: 100 units/kg/dose SC/IV 3x/wk; Max: 300 units/kg/dose 3x/wk; Info: for pts w/ endogenous epo levels <500 milliunits/mL and zidovudine dose <4200 mg/wk; use lowest dose necessary to avoid RBC transfusion need; incr. dose by 50-100 units/kg if inadequate response after 8wk, then q4-8wk thereafter; if Hgb >12 g/dL, hold until Hgb <11 g/dL and restart at 25% decr. dose; D/C if no response after 8wk; give iron supplement if serum ferritin level <100 mcg/L, or if serum transferrin saturation <20%
anemia, chemo-induced
- [individualize dose SC qwk or 3x/wk]
- Start: 40,000 units SC qwk or 150 units/kg/dose SC 3x/wk; Info: for pts w/ non-myeloid malignancies w/ Hgb <10 g/dL and >2mo planned chemo when cure is not anticipated; use lowest dose necessary to avoid RBC transfusion need; incr. dose to 60,000 units qwk or 300 units/kg/dose 3x/wk if Hgb response <1 g/dL and Hgb <10 g/dL after 4wk; decr. dose 25% if Hgb response >1 g/dL/2wk; if Hgb exceeds level needed to avoid RBC transfusion, hold until level decr. and restart at 25% decr. dose; D/C after chemo or if no response after 8wk; give iron supplement if serum ferritin level <100 mcg/L, or if serum transferrin saturation <20%
transfusion reduction, surgery-associated
- [300 units/kg/dose SC qd x15 days]
- Start: 10 days before surgery and cont. until 4 days after surgery; Alt: 600 units/kg/dose SC qwk x4 doses given 21 days, 14 days, and 7 days before surgery and on day of surgery; Info: for pts w/ perioperative Hgb 10-13 g/dL; give w/ DVT prophylaxis, give iron supplement if serum ferritin level <100 mcg/L, or if serum transferrin saturation <20%
anemia, myelodysplastic syndrome-associated (off-label)
- [40,000-60,000 units/wk SC 1-2x/wk]
- Start: 40,000 units SC qwk or 150 units/kg/dose SC 3x/wk; Info: for pts w/ endogenous epo levels <500 milliunits/mL; use lowest dose necessary to avoid RBC transfusion need; incr. dose to 60,000 units qwk or 300 units/kg/dose 3x/wk if Hgb response <1 g/dL and Hgb <10 g/dL after 4wk; decr. dose 25% if Hgb response >1 g/dL/2wk; if Hgb exceeds level needed to avoid RBC transfusion, hold until level decr. and restart at 25% decr. dose; give iron supplement if serum ferritin level <100 mcg/L, or if serum transferrin saturation <20%
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: no adjustment; no supplement; Info: IV route preferred for HD
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: INJ: 2000 units per mL, 3000 units per mL, 4000 units per mL, 10,000 units per mL, 20,000 units per mL
anemia, CKD-associated
- [1 mo-16 yo]
- Dose: individualize dose SC/IV 3x/wk; Start: 50 units/kg/dose SC/IV 3x/wk; Info: for pts w/ Hgb <10 g/dL; IV route preferred if on dialysis; use lowest dose to maintain Hgb level sufficient to reduce RBC transfusion need; incr. dose 25% if Hgb response <1 g/dL/4wk, may incr. dose no more frequently than q4wk; do not incr. dose further if inadequate response by 12wk; decr. dose 25% if Hgb response >1 g/dL/2wk; decr. dose or interrupt tx if Hgb nearing or exceeds 12 g/dL; give iron supplement if serum ferritin level <100 mcg/L, or if serum transferrin saturation <20%
anemia, HIV-associated
- [8 mo and older]
- Dose: 50-400 units/kg/dose SC/IV 2-3x/wk; Info: for pts w/ endogenous epo levels <500 milliunits/mL and zidovudine dose <4200 mg/wk; use lowest dose necessary to avoid RBC transfusion need; incr. dose by 50-100 units/kg if inadequate response after 8wk, then q4-8wk thereafter; if Hgb >12 g/dL, hold until Hgb <11 g/dL and restart at 25% decr. dose; D/C if no response after 8wk; give iron supplement if serum ferritin level <100 mcg/L, or if serum transferrin saturation <20%
anemia, chemo-induced
- [5 yo and older]
- Dose: individualize dose IV qwk; Start: 600 units/kg/dose IV qwk; Max: 60,000 units/wk; Info: for pts w/ non-myeloid malignancies w/ Hgb <10 g/dL and >2mo planned chemo when cure is not anticipated; use lowest dose necessary to avoid RBC transfusion need; incr. dose by 900 mcg/kg/wk if Hgb response <1 g/dL and Hgb <10 g/dL after 4wk; decr. dose 25% if Hgb response >1 g/dL/2wk; if Hgb exceeds level needed to avoid RBC transfusion, hold until level decr. and restart at 25% decr. dose; D/C after chemo or if no response after 8wk; give iron supplement if serum ferritin level <100 mcg/L, or if serum transferrin saturation <20%
anemia, prematurity-related (off-label)
- [premature neonates]
- Dose: 200 units/kg/dose IV qd x2wk; Alt: 400 units/kg/dose SC 3x/wk x2wk; Info: give iron supplement if serum ferritin level <100 mcg/L, or if serum transferrin saturation <20%
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: no adjustment; no supplement; Info: IV route preferred for HD
hepatic dosing
- [not defined]