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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PATIENT IDENTIFICATION: TARGET PATIENT

*For symptomatic anemia in very low- to intermediate-risk MDS with ring sideroblasts (≥15% or ≥5% with an SF3B1 mutation) and with serum EPO ≤500 mU/mL and no del(5q) with or without other cytogenetic abnormalities.

Man standing
Man standing

Consider REBLOZYL for adult patients who1,3:

Consider REBLOZYL for adult patients who1,3:

Are failing on, intolerant to, or ineligible for an ESA

Have anemia, requiring 2 or more RBC units over 8 weeks

Have been classified as either:

Very low- to intermediate-risk MDS with ring sideroblasts (RS), defined as MDS with:

  • ≥15% bone marrow (BM) RS
  • ≥5% BM RS with an SF3B1 mutation
OR

Myelodysplastic syndromes/ Myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T)

EPO=erythropoietin; ESA=erythropoiesis-stimulating agent; G-CSF=granulocyte colony-stimulating factor; MDS=myelodysplastic syndromes; MDS-RS=myelodysplastic syndromes with ring sideroblasts; NCCN=National Comprehensive Cancer Network (NCCN®); RBC=red blood cell.

Consult with your pathologist about how ring sideroblasts are reported in your patients with MDS

Magnifying glass icon

Learn to appropriately identify patients with MDS-RS

The MDS Pathology Checklist can help you and your pathologist appropriately identify your patients with MDS-RS.

Download the checklist

Patients with MDS may also have ring sideroblasts3

Ring sideroblasts are part of the WHO 2016 classification of MDS3

  • The 2016 WHO guidelines defined the MDS-RS subtype as having <5% bone marrow blasts and either3:
    • ≥15% ring sideroblasts in the bone marrow
    • ≥5% ring sideroblasts in the bone marrow and the presence of an SF3B1 mutation (identified through molecular testing)
  • MDS-RS is recognized as part of the ICD-10-CM coding system
  • MDS/MPN-RS-T is a rare subtype recognized by the WHO 2016. It has similarities to MDS-RS but is characterized by specific clinical features3,4
    • These include anemia, bone marrow dysplasia with ring sideroblasts, and persistent thrombocytosis ≥450 × 109/L with proliferation of large and morphologically atypical megakaryocytes

WHO=World Health Organization.

23-33% of patients with MDS have ring sideroblasts

23%-33%

of patients with MDS have ring sideroblasts5

Ring sideroblast

For illustrative purposes only.

Ring sideroblasts are erythroblasts with iron-loaded mitochondria associated with anemia6

  • Ring sideroblasts are identified by iron staining, and the results can be found on pathology reports
    • In these reports, there is variability in how pathologists describe the presence of ring sideroblasts7

PATIENT IDENTIFICATION: TARGET PATIENT

*For symptomatic anemia in very low- to intermediate-risk MDS with ring sideroblasts (≥15% or ≥5% with an SF3B1 mutation) and with serum EPO ≤500 mU/mL and no del(5q) with or without other cytogenetic abnormalities.

Man standing
Man standing

Consider REBLOZYL for adult patients who1,3:

Consider REBLOZYL for adult patients who1,3:

Are failing on, intolerant to, or ineligible for an ESA

Have anemia, requiring 2 or more RBC units over 8 weeks

Have been classified as either:

Very low- to intermediate-risk MDS with ring sideroblasts (RS), defined as MDS with:

  • ≥15% bone marrow (BM) RS
  • ≥5% BM RS with an SF3B1 mutation
OR

Myelodysplastic syndromes/ Myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T)

EPO=erythropoietin; ESA=erythropoiesis-stimulating agent; G-CSF=granulocyte colony-stimulating factor; MDS=myelodysplastic syndromes; MDS-RS=myelodysplastic syndromes with ring sideroblasts; NCCN=National Comprehensive Cancer Network (NCCN®); RBC=red blood cell.

Consult with your pathologist about how ring sideroblasts are reported in your patients with MDS

Magnifying glass icon

Learn to appropriately identify patients with MDS-RS

The MDS Pathology Checklist can help you and your pathologist appropriately identify your patients with MDS-RS.

Download the checklist

Patients with MDS may also have ring sideroblasts3

Ring sideroblasts are part of the WHO 2016 classification of MDS3

  • The 2016 WHO guidelines defined the MDS-RS subtype as having <5% bone marrow blasts and either3:
    • ≥15% ring sideroblasts in the bone marrow
    • ≥5% ring sideroblasts in the bone marrow and the presence of an SF3B1 mutation (identified through molecular testing)
  • MDS-RS is recognized as part of the ICD-10-CM coding system
  • MDS/MPN-RS-T is a rare subtype recognized by the WHO 2016. It has similarities to MDS-RS but is characterized by specific clinical features3,4
    • These include anemia, bone marrow dysplasia with ring sideroblasts, and persistent thrombocytosis ≥450 × 109/L with proliferation of large and morphologically atypical megakaryocytes

WHO=World Health Organization.

23-33% of patients with MDS have ring sideroblasts

23%-33%

of patients with MDS have ring sideroblasts5

Ring sideroblast

For illustrative purposes only.

Ring sideroblasts are erythroblasts with iron-loaded mitochondria associated with anemia6

  • Ring sideroblasts are identified by iron staining, and the results can be found on pathology reports
    • In these reports, there is variability in how pathologists describe the presence of ring sideroblasts7

References: 1. REBLOZYL [US Prescribing Information]. Summit, NJ: Celgene Corporation; 2022. 2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Myelodysplastic Syndromes V.1.2023. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed January 30, 2023. 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. 3. Arber DA, Orazi A, Hasserjian R, et al. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood. 2016;127(20):2391-2405. 4. Aoyama Y, Sakai K, Kodaka T, et al. Myelodysplastic/Myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN with RS-T) complicated by hyperleukocytosis and gene analysis in relation to leukocytosis. J Clin Exp Hematop. 2019;59(1):29-33. 5. Papaemmanuil E, Gerstung M, Malcovati L, et al. Clinical and biological implications of driver mutations in myelodysplastic syndromes. Blood. 2013;122(22):3616-3627. 6. Malcovati L, Cazzola M. Recent advances in the understanding of myelodysplastic syndromes with ring sideroblasts. Br J Haematol. 2016;174(6):847-858. 7. Sever C, Abbott CL, de Baca ME, et al. Bone marrow synoptic reporting for hematologic neoplasms: guideline from the College of American Pathologists Pathology and Laboratory Quality Center. Arch Pathol Lab Med. 2016;140(9):932-949.

2007-US-2300019     04/2023