INDICATIONS

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

REBLOZYL® (luspatercept-aamt) is indicated for the treatment of anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions.

REBLOZYL® (luspatercept-aamt) is indicated for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) 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

REBLOZYL has 2 dose levels to optimize response in patients with beta-thalassemia1

Assess and review patients’ Hgb and transfusion record prior to each administration

  • If an RBC transfusion occurred prior to dosing, use the pretransfusion Hgb for dose evaluation
  • If a patient experiences
    a dose delay due
    to Hgb increase,
    measure Hgb
    every week2

Hgb=hemoglobin;
RBC=red blood cell.

HCP standing

REBLOZYL dose titration for response1

  • Increase REBLOZYL dose with the goal of achieving reduction in transfusion burden, but do not increase if patient is experiencing adverse reactions. Discontinue REBLOZYL after 3 doses at the maximum dose if no transfusion burden reduction or if unacceptable toxicity occurs
REBLOZYL® dose modification in Beta Thallassemia flowchart REBLOZYL® dose modification in Beta Thallassemia flowchart

Treat for at least 15 weeks (5 doses) unless unacceptable toxicity occurs at any time

Download Dosing Flashcard

*Do not increase the dose if the patient is experiencing an adverse reaction as described in the Dose Modifications for Adverse Reactions table.

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 1.25 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
Dose titration icon

Dose increase in the event of loss of response1

  • A dose increase to 1.25 mg/kg may occur at any time during treatment after patients have received at least 2 consecutive doses of 1 mg/kg
  • Do not increase the dose beyond the maximum dose of 1.25 mg/kg
Stop icon

Discontinue treatment if no reduction in transfusion burden is observed1

  • 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
Syringe icon

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
  • Restart when the adverse reaction resolved to no more than Grade 1
Extramedullary hematopoietic (EMH) masses causing serious complications
  • 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.

Dosing experience in the BELIEVE trial

54%(n=120/223)

of patients in the REBLOZYL arm received a maximum dose of 1 mg/kg3

94%

of patients receiving REBLOZYL were exposed for 6 months or longer1

46%(n=103/223)

of patients in the REBLOZYL arm had their dose increased to 1.25 mg/kg3

72%

of patients receiving REBLOZYL were exposed for greater than 1 year1

147DAYS

was the median time to first titration in the REBLOZYL arm (min, max: 57, 575 days)2

63.3WEEKS

was the median duration of treatment with REBLOZYL (similar to placebo group, 62.1 weeks)1

Drip bag icon

REBLOZYL reduces transfusion burden

Syringe icon

Learn how to administer REBLOZYL

DOSING AND ADMINISTRATION: REBLOZYL DOSING

REBLOZYL has 2 dose levels to optimize response in patients with beta-thalassemia1

Assess and review patients’ Hgb and transfusion record prior to each administration

  • If an RBC transfusion occurred prior to dosing, use the pretransfusion Hgb for dose evaluation
  • If a patient experiences
    a dose delay due
    to Hgb increase,
    measure Hgb
    every week2

Hgb=hemoglobin;
RBC=red blood cell.

HCP standing

REBLOZYL dose titration for response1

  • Increase REBLOZYL dose with the goal of achieving reduction in transfusion burden, but do not increase if patient is experiencing adverse reactions. Discontinue REBLOZYL after 3 doses at the maximum dose if no transfusion burden reduction or if unacceptable toxicity occurs
REBLOZYL® dose modification in Beta Thallassemia flowchart REBLOZYL® dose modification in Beta Thallassemia flowchart

Treat for at least 15 weeks (5 doses) unless unacceptable toxicity occurs at any time

Download Dosing Flashcard

*Do not increase the dose if the patient is experiencing an adverse reaction as described in the Dose Modifications for Adverse Reactions table.

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 1.25 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
Dose titration icon

Dose increase in the event of loss of response1

  • A dose increase to 1.25 mg/kg may occur at any time during treatment after patients have received at least 2 consecutive doses of 1 mg/kg
  • Do not increase the dose beyond the maximum dose of 1.25 mg/kg
Stop icon

Discontinue treatment if no reduction in transfusion burden is observed1

  • 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
Syringe icon

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
  • Restart when the adverse reaction resolved to no more than Grade 1
Extramedullary hematopoietic (EMH) masses causing serious complications
  • 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.

Dosing experience in the BELIEVE trial

54%(n=120/223)

of patients in the REBLOZYL arm received a maximum dose of 1 mg/kg3

94%

of patients receiving REBLOZYL were exposed for 6 months or longer1

46%(n=103/223)

of patients in the REBLOZYL arm had their dose increased to 1.25 mg/kg3

72%

of patients receiving REBLOZYL were exposed for greater than 1 year1

147DAYS

was the median time to first titration in the REBLOZYL arm (min, max: 57, 575 days)2

63.3WEEKS

was the median duration of treatment with REBLOZYL (similar to placebo group, 62.1 weeks)1

Drip bag icon

REBLOZYL reduces transfusion burden

Syringe icon

Learn how to administer REBLOZYL

References: 1. REBLOZYL [US Prescribing Information]. Summit, NJ: Celgene Corporation; 2023. 2. Data on file. Celgene Corporation. Summit, New Jersey. 3. Cappellini MD, Viprakasit V, Taher AT, et al. A phase 3 trial of luspatercept in patients with transfusion-dependent β-thalassemia. N Engl J Med. 2020;382(13):1219-1231.