INDICATIONS

REBLOZYL is indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.

REBLOZYL is indicated for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).

REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.

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DOSING AND ADMINISTRATION: REBLOZYL DOSING

Adjust dose to optimize patient response1

  • If patient experiences transfusion independence, continue current dose
  • If patient loses response, titrate up to next dose level
  • Do not continue treatment or increase the dose if the patient is experiencing unacceptable toxicity or an adverse reaction
REBLOZYL® dose modification in MDS-RS flowchart REBLOZYL® dose modification in MDS-RS flowchart
*77.1%

(118/153) of all MEDALIST patients receiving REBLOZYL had their dose increased at least once2

Modifications for predose Hgb levels or rapid Hgb rise1

SCENARIO REBLOZYL
Dosing recommendation
Predose Hgb is ≥11.5 g/dL in the absence of transfusions
  • Interrupt treatment
  • Restart when the Hgb is no more than 11 g/dL
Increase in Hgb >2 g/dL within 3 weeks in the absence of transfusions and:
Current dose is 1.75 mg/kg
  • Reduce dose to 1.33 mg/kg
Current dose is 1.33 mg/kg
  • Reduce dose to 1 mg/kg
Current dose is
1 mg/kg
  • Reduce dose to 0.8 mg/kg
Current dose is
0.8 mg/kg
  • Reduce dose to 0.6 mg/kg
Current dose is
0.6 mg/kg
  • Discontinue treatment

Hgb=hemoglobin.

Dose titration icon

Dose increase in the event of loss of response1

  • If, upon dose reduction, the patient loses response (ie, requires a transfusion) or Hgb concentration drops by 1 g/dL or more in 3 weeks in the absence of transfusion, increase the dose by 1 dose level
  • Wait a minimum of 6 weeks between dose increases
  • Dose increases to 1.33 mg/kg and subsequently to 1.75 mg/kg may occur at any time during treatment after patients have received at least 2 consecutive doses at the prior lower dose level
  • Do not increase the dose more frequently than every 2 consecutive doses (6 weeks) or beyond the maximum dose of 1.75 mg/kg
Stop icon

Discontinue treatment if no reduction in transfusion burden is observed at maximum dose1

  • Discontinue REBLOZYL if a patient does not experience a decrease in transfusion burden after 3 doses (9 weeks of treatment) at the maximum dose level or if unacceptable toxicity occurs at any time

If a planned administration of REBLOZYL is delayed or missed1

  • Administer REBLOZYL as soon as possible and continue dosing as prescribed, with at least 3 weeks between doses

REBLOZYL dosing modifications for adverse reactions1

SCENARIO REBLOZYL
Dosing recommendation
Grade 3 or 4 hypersensitivity reactions*
  • Discontinue treatment
Other Grade 3 or 4 adverse reactions*
  • Interrupt treatment
  • When the adverse reaction resolves to no more than Grade 1, restart treatment at the next lower dose level
  • If the lower dose delay is >12 consecutive weeks, discontinue treatment

*Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, and Grade 4 is life-threatening.
Per dose reductions in table above.

Clinical dosing video thumbnail

View firsthand clinical dosing experience with REBLOZYL

REBLOZYL® dosing and titration guide video thumbnail

Watch a step-by-step video demonstrating the dosing and titration of REBLOZYL

Calculator icon

Determine your patient’s dose with the REBLOZYL dosing calculator

Syringe icon

Learn how to administer REBLOZYL

DOSING AND ADMINISTRATION: REBLOZYL DOSING

Adjust dose to optimize patient response1

  • If patient experiences transfusion independence, continue current dose
  • If patient loses response, titrate up to next dose level
  • Do not continue treatment or increase the dose if the patient is experiencing unacceptable toxicity or an adverse reaction
REBLOZYL® dose modification in MDS-RS flowchart REBLOZYL® dose modification in MDS-RS flowchart
*77.1%

(118/153) of all MEDALIST patients receiving REBLOZYL had their dose increased at least once2

Modifications for predose Hgb levels or rapid Hgb rise1

SCENARIO REBLOZYL
Dosing recommendation
Predose Hgb is ≥11.5 g/dL in the absence of transfusions
  • Interrupt treatment
  • Restart when the Hgb is no more than 11 g/dL
Increase in Hgb >2 g/dL within 3 weeks in the absence of transfusions and:
Current dose is 1.75 mg/kg
  • Reduce dose to 1.33 mg/kg
Current dose is 1.33 mg/kg
  • Reduce dose to 1 mg/kg
Current dose is
1 mg/kg
  • Reduce dose to 0.8 mg/kg
Current dose is
0.8 mg/kg
  • Reduce dose to 0.6 mg/kg
Current dose is
0.6 mg/kg
  • Discontinue treatment

Hgb=hemoglobin.

Dose titration icon

Dose increase in the event of loss of response1

  • If, upon dose reduction, the patient loses response (ie, requires a transfusion) or Hgb concentration drops by 1 g/dL or more in 3 weeks in the absence of transfusion, increase the dose by 1 dose level
  • Wait a minimum of 6 weeks between dose increases
  • Dose increases to 1.33 mg/kg and subsequently to 1.75 mg/kg may occur at any time during treatment after patients have received at least 2 consecutive doses at the prior lower dose level
  • Do not increase the dose more frequently than every 2 consecutive doses (6 weeks) or beyond the maximum dose of 1.75 mg/kg
Stop icon

Discontinue treatment if no reduction in transfusion burden is observed at maximum dose1

  • Discontinue REBLOZYL if a patient does not experience a decrease in transfusion burden after 3 doses (9 weeks of treatment) at the maximum dose level or if unacceptable toxicity occurs at any time

If a planned administration of REBLOZYL is delayed or missed1

  • Administer REBLOZYL as soon as possible and continue dosing as prescribed, with at least 3 weeks between doses

REBLOZYL dosing modifications for adverse reactions1

SCENARIO REBLOZYL
Dosing recommendation
Grade 3 or 4 hypersensitivity reactions*
  • Discontinue treatment
Other Grade 3 or 4 adverse reactions*
  • Interrupt treatment
  • When the adverse reaction resolves to no more than Grade 1, restart treatment at the next lower dose level
  • If the lower dose delay is >12 consecutive weeks, discontinue treatment

*Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, and Grade 4 is life-threatening.
Per dose reductions in table above.

Clinical dosing video thumbnail

View firsthand clinical dosing experience with REBLOZYL

REBLOZYL® dosing and titration guide video thumbnail

Watch a step-by-step video demonstrating the dosing and titration of REBLOZYL

Calculator icon

Determine your patient’s dose with the REBLOZYL dosing calculator

Syringe icon

Learn how to administer REBLOZYL

References: 1. REBLOZYL [US Prescribing Information]. Summit, NJ: Celgene Corporation; 2022. 2. Platzbecker U, Fenaux, P, Mufti GJ, et al. et Assessment of dose-dependent response to luspatercept in patients with lower-risk myelodysplastic syndromes with ring sideroblasts in the phase 3 MEDALIST trial. Presented at: 25th Congress of the European Hematology Association [virtual]. June 12, 2020. Abstract EP812.

2007-US-2300019     04/2023