| SCENARIO | REBLOZYL Dosing recommendation¶ |
|---|---|
| Predose Hgb is ≥12 g/dL in the absence of transfusions |
|
| Increase in Hgb >2 g/dL within 3 weeks in the absence of transfusions and: | |
| Current dose is 1.75 mg/kg |
|
| Current dose is 1.33 mg/kg |
|
| Current dose is 1 mg/kg |
|
| Current dose is 0.8 mg/kg |
|
| Current dose is 0.6 mg/kg |
|
HOW TO TREAT WITH REBLOZYL:
DOSING
FOR YOUR ESA-NAIVE (FIRST-LINE) PATIENTS TREATED WITH REBLOZYL*Dose adjust to target hemoglobin of 10 to 12 g/dL1
65% of patients treated in COMMANDS required the maximum dose of 1.75 mg/kg2†
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Increase dose for lack of or loss of response.
If after ≥2 consecutive doses at the same level (6 wks): Hgb <10 g/dL and Hgb increase is <1 g/dL since last dose OR transfusion was required at any time, increase dose.
Pause if Hgb ≥12.‡
If Hgb ≥12 g/dL: pause until Hgb is ≤11 g/dL. Then resume at the same dose level.
Reduce dose for rapid Hgb increase.‡
If Hgb rises >2 g/dL within 3 wks in absence of transfusion: reduce dose.
The starting dose is 1 mg/kg.
Lower doses available are 0.6 mg/kg (minimum dose) and 0.8 mg/kg. Higher doses available are 1.33 mg/kg and 1.75 mg/kg (maximum dose).
Administer once every 3 weeks by subcutaneous injection. Wait a minimum of 6 weeks between dose increases.
Before each dose: Monitor Hgb, transfusion need, and tolerability§
See additional dosing modifications below. If patient is receiving 0.6 mg/kg and requires further dose reduction, discontinue treatment. For Grade 3/4 AE, pause until resolves to Grade 1 or lower, then resume at the next lower dose. If delay due to Grade 3/4 AE exceeds 12 consecutive weeks, discontinue treatment. Discontinue treatment for Grade 3/4 hypersensitivity.∥
*See full Prescribing Information for dosing in ESA-naive patients (1L).1
†Based on the results of COMMANDS, a head-to-head trial vs epoetin alfa.2
‡Predose hemoglobin in the absence of transfusions.1
§If transfusion occurred, use pretransfusion Hgb before evaluation. Discontinue REBLOZYL if unacceptable toxicity occurs at any time.1
∥Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, and Grade 4 is life-threatening.1
Dose modifications when administering REBLOZYL1
Dose increases in the event of loss of response
- 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 (6 weeks) 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
Discontinue treatment if no clinical
benefit is observed
- Discontinue REBLOZYL if no increase in Hgb or reduction in RBC transfusion burden from baseline after at least 3 consecutive doses (9 weeks) at 1.75 mg/kg or if unacceptable toxicity occurs at any time
If a planned administration of REBLOZYL is
delayed or missed
- Administer REBLOZYL as soon as possible and continue dosing as prescribed, with at least 3 weeks between doses
Some patients in COMMANDS required a treatment interruption or dose reduction1
FOR PREDOSE HEMOGLOBIN ≥12 g/dL OR RAPID HEMOGLOBIN RISE1:
FOR ADVERSE REACTIONS1:
| SCENARIO | REBLOZYL Dosing recommendation |
|---|---|
| Grade 3 or 4 hypersensitivity reactions# |
|
| Other Grade 3 or 4 adverse reactions** |
|
¶Do not increase the dose if the patient is experiencing an adverse reaction as described in the "For adverse reactions" table.1
#Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, and Grade 4 is life-threatening.1
**Per dose reductions in table above.1
AE=adverse event; ESA=erythropoiesis-stimulating agent; Hgb=hemoglobin; RBC=red blood cell.
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References: 1. REBLOZYL [US Prescribing Information]. Summit, NJ: Celgene Corporation; 2026. 2. Santini V, Zeidan AM, Platzbecker U, et al. Clinical benefit of luspatercept treatment in transfusion-dependent, erythropoiesis-stimulating agent-naive patients with Very low-, Low- or Intermediate-risk myelodysplastic syndromes in the COMMANDS trial. Poster presented at: European Hematology Association (EHA) Hybrid Congress. June 13-16, 2024. Madrid, Spain.
