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REBLOZYL® (luspatercept-aamt) logo

This website is intended for US Healthcare Professionals.

REBLOZYL® (luspatercept-aamt) logo
INDICATIONS

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 or are 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 or are 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

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.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Thrombosis/Thromboembolism

In adult patients with beta thalassemia, thromboembolic events (TEE) were reported in 8/223 (3.6%) of REBLOZYL-treated patients. TEEs included deep vein thrombosis, pulmonary embolus, portal vein thrombosis, and ischemic stroke. Patients with known risk factors for thromboembolism (splenectomy or concomitant use of hormone replacement therapy) may be at further increased risk of thromboembolic conditions. Consider thromboprophylaxis in patients at increased risk of TEE. Monitor patients for signs and symptoms of thromboembolic events and institute treatment promptly.

Hypertension

Hypertension was reported in 10.7% (61/571) of REBLOZYL-treated patients. Across clinical studies, the incidence of Grade 3 to 4 hypertension ranged from 1.8% to 8.6%. In patients with beta thalassemia with normal baseline blood pressure, 13 (6.2%) patients developed systolic blood pressure (SBP) ≥130 mm Hg and 33 (16.6%) patients developed diastolic blood pressure (DBP) ≥80 mm Hg. In adult patients with MDS with normal baseline blood pressure, 26 (29.9%) patients developed SBP ≥130 mm Hg and 23 (16.4%) patients developed DBP ≥80 mm Hg. Monitor blood pressure prior to each administration. Manage new or exacerbations of preexisting hypertension using anti-hypertensive agents.

Extramedullary Hematopoietic Masses

In adult patients with transfusion-dependent beta thalassemia, EMH masses were observed in 3.2% of REBLOZYL-treated patients, with spinal cord compression symptoms due to EMH masses occurring in 1.9% of patients (BELIEVE and REBLOZYL long-term follow-up study).

In a study of adult patients with non-transfusion-dependent beta thalassemia, a higher incidence of EMH masses was observed in 6.3% of REBLOZYL-treated patients vs. 2% of placebo-treated patients in the double-blind phase of the study, with spinal cord compression due to EMH masses occurring in 1 patient with a prior history of EMH. REBLOZYL is not indicated for use in patients with non-transfusion-dependent beta thalassemia.

Possible risk factors for the development of EMH masses in patients with beta thalassemia include history of EMH masses, splenectomy, splenomegaly, hepatomegaly, or low baseline hemoglobin (<8.5 g/dL). Signs and symptoms may vary depending on the anatomical location. Monitor patients with beta thalassemia at initiation and during treatment for symptoms and signs or complications resulting from the EMH masses and treat according to clinical guidelines. Discontinue treatment with REBLOZYL in case of serious complications due to EMH masses. Avoid use of REBLOZYL in patients requiring treatment to control the growth of EMH masses.

Embryo-Fetal Toxicity

REBLOZYL may cause fetal harm when administered to a pregnant woman. REBLOZYL caused increased post-implantation loss, decreased litter size, and an increased incidence of skeletal variations in pregnant rat and rabbit studies. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 3 months after the final dose.

ADVERSE REACTIONS

Beta-Thalassemia

Serious adverse reactions occurred in 3.6% of patients on REBLOZYL. Serious adverse reactions occurring in 1% of patients included cerebrovascular accident and deep vein thrombosis. A fatal adverse reaction occurred in 1 patient treated with REBLOZYL who died due to an unconfirmed case of acute myeloid leukemia (AML).

Most common adverse reactions (at least 10% for REBLOZYL and 1% more than placebo) were headache (26% vs 24%), bone pain (20% vs 8%), arthralgia (19% vs 12%), fatigue (14% vs 13%), cough (14% vs 11%), abdominal pain (14% vs 12%), diarrhea (12% vs 10%) and dizziness (11% vs 5%).

Myelodysplastic Syndromes

Grade ≥3 (≥2%) adverse reactions included fatigue, hypertension, syncope and musculoskeletal pain. A fatal adverse reaction occurred in 5 (2.1%) patients.

The most common (≥10%) adverse reactions included fatigue, musculoskeletal pain, dizziness, diarrhea, nausea, hypersensitivity reactions, hypertension, headache, upper respiratory tract infection, bronchitis, and urinary tract infection.

LACTATION

It is not known whether REBLOZYL is excreted into human milk or absorbed systemically after ingestion by a nursing infant. REBLOZYL was detected in milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because many drugs are excreted in human milk, and because of the unknown effects of REBLOZYL in infants, a decision should be made whether to discontinue nursing or to discontinue treatment. Because of the potential for serious adverse reactions in the breastfed child, breastfeeding is not recommended during treatment and for 3 months after the last dose.

Please click here for full Prescribing Information for REBLOZYL.

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 October 11, 2022. 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.

Bristol Myers SquibbTM logo
Bristol Myers SquibbTM logo

REBLOZYL® is a trademark of Celgene Corporation, a Bristol Myers Squibb company. Access Support® is a trademark of Bristol-Myers Squibb Company. REBLOZYL® is licensed from Merck & Co., Inc., Rahway, NJ, USA and its affiliates.

© 2022 Bristol-Myers Squibb Company.
2007-US-2200263 12/2022

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 October 11, 2022. 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.