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Aranesp
darbepoetin 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
Adult Dosing .
Dosage forms: INJ (SingleJect pre-filled syringe): 10 mcg per 0.4 mL, 25 mcg per 0.42 mL, 40 mcg per 0.4 mL, 60 mcg per 0.3 mL, 100 mcg per 0.5 mL, 150 mcg per 0.3 mL, 200 mcg per 0.4 mL, 300 mcg per 0.6 mL, 500 mcg per mL; INJ (vial): 25 mcg per mL, 40 mcg per mL, 60 mcg per mL, 100 mcg per mL, 200 mcg per mL
anemia, CKD-associated
- [dialysis pts not receiving epoetin alfa]
- Dose: individualize dose SC/IV q1-2wk; Start: 0.45 mcg/kg/dose SC/IV qwk or 0.75 mcg/kg/dose SC/IV q2wk; 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%
- [dialysis pts switching from epoetin alfa]
- Dose: individualize dose SC/IV q1-2wk; Start: individualize start dose based on current epoetin alfa dose, see pkg insert; 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 not receiving epoetin alfa]
- Dose: individualize dose SC/IV q4wk; Start: 0.45 mcg/kg/dose SC/IV q4wk; 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%
- [non-dialysis pts switching from epoetin alfa]
- Dose: individualize dose SC/IV q4wk; Start: individualize start dose based on current epoetin alfa dose, see pkg insert; 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, chemo-induced
- [individualize dose SC qwk or q3wk]
- Start: 2.25 mcg/kg/dose SC qwk or 500 mcg SC q3wk; Info: for pts w/ Hgb <10 g/dL and CA cure not anticipated; use lowest dose necessary to avoid RBC transfusion need; may incr. qwk dose to 4.5 mcg/kg/wk if Hgb response <1 g/dL and Hgb <10 g/dL after 6wk of tx; decr. qwk or q3wk dose 40% when transfusion avoided or Hgb response >1 g/dL/2wk; if Hgb exceeds level needed to avoid transfusion, hold tx until levels decr. and restart at 40% lower 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, myelodysplastic syndrome-associated (off-label)
- [150-300 mcg SC q2wk]
- Start: 2.25 mcg/kg/dose SC qwk or 500 mcg SC q3wk; Info: for pts w/ endogenous epo levels <500 milliunits/mL; use lowest dose necessary to avoid RBC transfusion need; may incr. qwk dose to 4.5 mcg/kg/wk if Hgb response <1 g/dL and Hgb <10 g/dL after 6wk of tx; decr. qwk or q3wk dose 40% when transfusion avoided or Hgb response >1 g/dL/2wk; if Hgb exceeds level needed to avoid transfusion, hold tx until levels decr. and restart at 40% lower 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 (SingleJect pre-filled syringe): 10 mcg per 0.4 mL, 25 mcg per 0.42 mL, 40 mcg per 0.4 mL, 60 mcg per 0.3 mL, 100 mcg per 0.5 mL, 150 mcg per 0.3 mL, 200 mcg per 0.4 mL, 300 mcg per 0.6 mL, 500 mcg per mL; INJ (vial): 25 mcg per mL, 40 mcg per mL, 60 mcg per mL, 100 mcg per mL, 200 mcg per mL
anemia, CKD-associated
- [dialysis pts not receiving epoetin alfa]
- Dose: individualize dose SC/IV q1-2wk; Start: 0.45 mcg/kg/dose SC/IV qwk; 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 12 g/dL; give iron supplement if serum ferritin level <100 mcg/L, or if serum transferrin saturation <20%
- [dialysis pts switching from epoetin alfa]
- Dose: individualize dose SC/IV q1-2wk; Start: individualize start dose based on current epoetin alfa dose, see pkg insert; 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 12 g/dL; give iron supplement if serum ferritin level <100 mcg/L, or if serum transferrin saturation <20%
- [non-dialysis pts not receiving epoetin alfa]
- Dose: individualize dose SC/IV q1-2wk; Start: 0.45 mcg/kg/dose SC/IV qwk or 0.75 mcg/kg/dose SC/IV q2wk; Info: for pts w/ Hgb <10 g/dL; 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%
- [non-dialysis pts switching from epoetin alfa]
- Dose: individualize dose SC/IV q1-2wk; Start: individualize start dose based on current epoetin alfa dose, see pkg insert; Info: for pts w/ Hgb <10 g/dL; 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%
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: no adjustment; no supplement; Info: IV route preferred for HD
hepatic dosing
- [not defined]