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Mircera
methoxy polyethylene glycol-epoetin beta
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
not approved for chemo-related anemia; incr. deaths observed w/ methoxy polyethylene glycol-epoetin beta vs. another ESA; incr. mortality and/or tumor progression or recurrence risk seen in pts w/ breast, head/neck, lymphoid, cervical, and non-small cell lung CA
Adult Dosing .
Dosage forms: INJ (pre-filled syringe): 30 mcg per 0.3 mL, 50 mcg per 0.3 mL, 75 mcg per 0.3 mL, 100 mcg per 0.3 mL, 120 mcg per 0.3 mL, 150 mcg per 0.3 mL, 200 mcg per 0.3 mL, 250 mcg per 0.3 mL, 360 mcg per 0.6 mL
anemia, CKD-associated
- [dialysis pts not receiving ESA]
- Dose: individualize dose SC/IV q2wk-qmo; Start: 0.6 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; interrupt tx if Hgb continues to incr. after dose reduction until Hgb starts to decr, then resume tx w/ an additional 25% dose reduction; 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 ESA]
- Dose: individualize dose SC/IV q2wk-qmo; Start: 60-180 mcg SC/IV q2wk or 120-360 mcg SC/IV qmo based on current ESA 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; interrupt tx if Hgb continues to incr. after dose reduction until Hgb starts to decr, then resume tx w/ an additional 25% dose reduction; 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 ESA]
- Dose: individualize dose SC/IV q2wk-qmo; Start: 1.2 mcg/kg/dose SC/IV qmo or 0.6 mcg/kg/dose SC/IV q2wk; 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; interrupt tx if Hgb continues to incr. after dose reduction until Hgb starts to decr, then resume tx w/ an additional 25% dose reduction; 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 ESA]
- Dose: individualize dose SC/IV q2wk-qmo; Start: 60-180 mcg SC/IV q2wk or 120-360 mcg SC/IV qmo based on current ESA 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; interrupt tx if Hgb continues to incr. after dose reduction until Hgb starts to decr, then resume tx w/ an additional 25% dose reduction; 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%
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: no adjustment; no supplement; Info: IV route preferred for HD
hepatic dosing
- [no adjustment]
Peds Dosing .
- Dosage forms: INJ (pre-filled syringe): 30 mcg per 0.3 mL, 50 mcg per 0.3 mL, 75 mcg per 0.3 mL, 100 mcg per 0.3 mL, 120 mcg per 0.3 mL, 150 mcg per 0.3 mL, 200 mcg per 0.3 mL, 250 mcg per 0.3 mL, 360 mcg per 0.6 mL
anemia, CKD-associated
- [3 mo and older]
- Dose: individualize dose SC/IV q4wk; Start: 30-360 mcg SC/IV q4wk based on current ESA dose, see pkg insert; Info: for pts switching from ESA; use lowest dose to maintain Hgb level sufficient to reduce RBC transfusion need; incr. dose 25% if Hgb decr. >1 g/dL from baseline or if Hgb <10 g/dL and >9 g/dL; incr. dose 50% if Hgb <9 g/dL; decr. dose 25% if Hgb response >1 g/dL from baseline or if Hgb nearing or exceeds 12 g/dL; interrupt tx if Hgb continues to incr. after dose reduction until Hgb <12 g/dL, then resume tx w/ an additional 25% dose reduction at next scheduled dose; may adjust dose no more frequently than q4wk; maintain same route as previous ESA in pts <6 yo; give iron supplement if serum ferritin levels <100 mcg/L, or if serum transferrin saturation <20%
renal dosing
- [see below]
- renal impairment: not defined
- HD: no adjustment; no supplement; PD: not defined
hepatic dosing
- [no adjustment]