SCENARIO |
REBLOZYL
|
|---|---|
| Predose Hgb in ≥12 g/dL is in the absence of transfusions |
|
| Increase in Hgb >2 g/dL within 3 weeks in the absence of transfusions and: | |
| Current dose to 1.75 mg/kg |
|
| Current dose to 1.33 mg/kg |
|
| Current dose to 1 mg/kg |
|
| Current dose to 0.8 mg/kg |
|
| Current dose to 0.6 mg/kg |
|
For your ESA-naive (first-line) patients treated with REBLOZYL1*
Dose adjust to target hemoglobin of 10 to 12 g/dL
65% of patients treated in COMMANDS required the maximum dose of 1.75 mg/kg2†
Select graphic view or text view to explore data.
Dose adjust to target hemoglobin of 10 to 12 g/dL or transfusion independence1
65% of patients treated in COMMANDS required the maximum dose of 1.75 mg/kg2†
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 and 0.8 mg/kg. Higher doses available are 1.33 mg/kg and 1.75 mg/kg.
Administer once every 3 weeks by subcutaneous injection. Wait a minimum of 6 weeks between dose increases.1
BEFORE EACH DOSE: MONITOR HGB, TRANSFUSION NEED, AND TOLERABILITY§
Scroll to see additional dosing modifications. 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 or if unacceptable toxicity occurs at any time.‖
Discontinue if1:
- After at least 3 consecutive doses (9 weeks) at 1.75 mg/kg, a patient has no reduction in transfusion burden including no increase from baseline Hgb
Loss of response1:
- If, upon dose reduction, the patient loses response (ie, Hgb falls by 1 g/dL or more in 3 weeks in absence of transfusions or patient requires a transfusion), increase the dose by one dose level
Missed dose1:
- Administer as soon as possible and continue treating with at least 3 weeks between doses
*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.
‖Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, and Grade 4 is life-threatening.1
For predose hemoglobin ≥12 g/dL or rapid hemoglobin rise1:
For adverse reactions1:
SCENARIO |
REBLOZYL
|
|---|---|
| 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.
†Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, and Grade 4 is life-threatening.
‡Per dose reductions in table above.
For your 2L RS+ LR-MDS patients treated with REBLOZYL1
Help your patients achieve initial and subsequent responses with REBLOZYL dose increases
77% of patients treated in MEDALIST had at least one dose escalation3
Select graphic view or text view to explore data.
The starting dose is 1 mg/kg.
Lower doses available are 0.6 mg/kg and 0.8 mg/kg. Higher doses available are 1.33 mg/kg and 1.75 mg/kg.
Administer once every 3 weeks by subcutaneous injection.
Before each dose, monitor Hgb, transfusion needs, and tolerability. Continue dose if meeting treatment goals and TI.1*
Per the USPI, in the absence of transfusion, predose Hgb should not exceed 11.5 g/dL.1
The National Comprehensive Cancer Network® (NCCN®) recommends targeting a hemoglobin range of 10 to 12 g/dL; not to exceed 12 g/dL.4‡
- If Hgb is ≥11.5 g/dL in the absence of transfusions:
- Pause until Hgb is ≤11 g/dL
- Restart at same dose when Hgb is ≤11 g/dL
- If Hgb increase >2 g/dL with 3 weeks of the last dose, in the absence of transfusions:
- Reduce dose and continue treatment
- If a Grade 3 or 4 adverse reaction occurs†:
- Pause until resolved to Grade 1 or lower
- Reduce dose and resume treatment
- After at least 2 consecutive doses at the same level, increase the dose if a transfusion was required§
Please see accompanying full Prescribing Information for discontinuation criteria (including for Grade 3 or 4 hypersensitivity and dose delays for >12 weeks), missed dose criteria, and loss of response following a dose reduction or at the maximum dose.
NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
*If transfusion occurred, use pretransfusion Hgb before evaluation.1
†Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, and Grade 4 is life-threatening.1
‡For patients with symptomatic anemia due to LR-MDS.4
§In the absence of transfusion, if predose Hgb is ≥11.5 g/dL or if Hgb increases >2 g/dL within 3 weeks, interrupt or decrease dose.1
For predose hemoglobin ≥11.5 g/dL or rapid hemoglobin rise1:
SCENARIO |
REBLOZYL
|
|---|---|
| Predose Hgb is ≥11.5 g/dL is in the absence of transfusions |
|
| Increase in Hgb >2 g/dL within 3 weeks in the absence of transfusions and: | |
| Current dose to 1.75 mg/kg |
|
| Current dose to 1.33 mg/kg |
|
| Current dose to 1 mg/kg |
|
| Current dose to 0.8 mg/kg |
|
| Current dose to 0.6 mg/kg |
|
For adverse reactions1:
SCENARIO |
REBLOZYL
|
|---|---|
| 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 described in the "For adverse reactions" table.
†Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, and Grade 4 is life-threatening.
‡Per dose reductions in table above.
Dose modifications when administering REBLOZYL1
Dose increases 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
Discontinue treatment if no clinical benefit is observed1
- Discontinue REBLOZYL if no reduction in RBC transfusion burden including no increase from baseline hemoglobin 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 missed1
- Administer REBLOZYL as soon as possible and continue dosing as prescribed, with at least 3 weeks between doses
1L=first-line; 2L=second-line; AE=adverse event; ESA=erythropoiesis-stimulating agent; Hgb=hemoglobin; RBC=red blood cell; RS=ring sideroblast; TI=transfusion independence.
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. 3. Platzbecker U, Fenaux, P, Mufti GJ, et al. 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. 4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Myelodysplastic Syndromes V.1.2025. ©National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed November 18, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use In any way.
