Reblozyl (luspatercept-aamt)

Adult Dosing .

Dosage forms:  INJ

Special Note

[formulation clarification]

Info: nonproprietary name = luspatercept-aamt

anemia

[transfusion-dependent beta thalassemia-associated]

Dose: 1-1.25 mg/kg/dose SC q3wk; Start: 1 mg/kg/dose SC q3wk, incr. to 1.25 mg/kg/dose SC q3wk after at least 6wk of tx if no reduction in RBC transfusion burden at 1 mg/kg/dose SC q3wk; Max: 1.25 mg/kg/dose SC q3wk; Info: for pts requiring regular RBC transfusion; hold tx until Hgb <11 g/dL if pre-dose Hgb 11.5 g/dL or greater in absence of recent transfusion; see pkg insert for dose adjustments if Hgb incr. >2 g/dL w/ in 3wk of dose in absence of transfusion; D/C if no decr. in RBC transfusion burden after 9wk at max dose

[myelodysplastic syndrome-associated, ESA-naive]

Dose: 1-1.75 mg/kg/dose SC q3wk; Start: 1 mg/kg/dose SC q3wk, incr. to 1.33 mg/kg/dose SC q3wk after at least 6wk of tx if no transfusion independence at 1 mg/kg/dose SC q3wk; incr. to 1.75 mg/kg/dose SC q3wk after at least 6wk of tx if no transfusion independence at 1.33 mg/kg/dose SC q3wk; Max: 1.75 mg/kg/dose SC q3wk; Info: for pts w/ very low-intermediate risk dz who may require RBC transfusion; hold tx until Hgb <11 g/dL if pre-dose Hgb 11.5 g/dL or greater in absence of recent transfusion; see pkg insert for dose adjustments if Hgb incr. >2 g/dL w/ in 3wk of dose in absence of transfusion; D/C if no decr. in RBC transfusion burden after 9wk at max dose

[myelodysplastic syndrome w/ ring sideroblasts (MDS-RS)-associated, ESA-refractory]

Dose: 1-1.75 mg/kg/dose SC q3wk; Start: 1 mg/kg/dose SC q3wk, incr. to 1.33 mg/kg/dose SC q3wk after at least 6wk of tx if no transfusion independence at 1 mg/kg/dose SC q3wk; incr. to 1.75 mg/kg/dose SC q3wk after at least 6wk of tx if no transfusion independence at 1.33 mg/kg/dose SC q3wk; Max: 1.75 mg/kg/dose SC q3wk; Info: for pts w/ very low-intermediate risk dz who have failed ESA tx and requiring 2 or more RBC units over 8wk; hold tx until Hgb <11 g/dL if pre-dose Hgb 11.5 g/dL or greater in absence of recent transfusion; see pkg insert for dose adjustments if Hgb incr. >2 g/dL w/ in 3wk of dose in absence of transfusion; D/C if no decr. in RBC transfusion burden after 9wk at max dose

[myelodysplastic/myeloproliferative neoplasm w/ ring sideroblasts and thrombocytosis (MDS/MPN-RS-T)-associated, ESA-refractory]

Dose: 1-1.75 mg/kg/dose SC q3wk; Start: 1 mg/kg/dose SC q3wk, incr. to 1.33 mg/kg/dose SC q3wk after at least 6wk of tx if no transfusion independence at 1 mg/kg/dose SC q3wk; incr. to 1.75 mg/kg/dose SC q3wk after at least 6wk of tx if no transfusion independence at 1.33 mg/kg/dose SC q3wk; Max: 1.75 mg/kg/dose SC q3wk; Info: for pts w/ very low-intermediate risk dz who have failed ESA tx and requiring 2 or more RBC units over 8wk; hold tx until Hgb <11 g/dL if pre-dose Hgb 11.5 g/dL or greater in absence of recent transfusion; see pkg insert for dose adjustments if Hgb incr. >2 g/dL w/ in 3wk of dose in absence of transfusion; D/C if no decr. in RBC transfusion burden after 9wk at max dose

renal dosing

[see below]

CrCl >30: no adjustment; CrCl <30: not defined

HD/PD: not defined

hepatic dosing

[see below]

AST/ALT >1-3x ULN: no adjustment; AST/ALT >3x ULN: not defined

Peds Dosing .

Peds dosing is currently unavailable or not applicable for this drug.