This website is intended for US Healthcare Professionals.

Indications US Full Prescribing Information Patient Information Visit Patient Site BMS Connect
REBLOZYL® (luspatercept-aamt) logo
LR-MDS (FIRST-LINE) LR-MDS-RS (SECOND-LINE) BETA-THALASSEMIA

This website is intended for US Healthcare Professionals.

REBLOZYL® (luspatercept-aamt) logo
INDICATIONS

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.

Request
a Rep Request a Rep icon

Luspatercept-aamt (REBLOZYL®) is recommended by the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a first-line treatment option for symptomatic anemia in lower-risk MDS1*

EFFICACY AND SAFETY: PRIMARY ENDPOINT

"Now Approved" bubble
"Now Approved" bubble

In a head-to-head study vs epoetin alfa,* REBLOZYL provides…

Unprecedented superior efficacy. Lasting transfusion independence.1,2

Superior rates of response: Hgb increase and transfusion independence2

EFFICACY AND SAFETY: PRIMARY ENDPOINT

"Now Approved" bubble
"Now Approved" bubble

In a head-to-head study vs epoetin alfa,* REBLOZYL provides…

Unprecedented superior efficacy. Lasting transfusion independence.1,2

Superior rates of response: Hgb increase and transfusion independence2

Primary composite endpoint: Hgb increase ≥1.5 g/dL and RBC-TI for at least 12 weeks2

Primary composite endpoints in 1-24 weeks for Reblozyl vs Epoetin Alfa in Phase 3 COMMANDS trial Primary composite endpoints in 1-24 weeks for Reblozyl vs Epoetin Alfa in Phase 3 COMMANDS trial Primary composite endpoints in 1-24 weeks for Reblozyl vs Epoetin Alfa in Phase 3 COMMANDS trial

For patients with IPSS-R very low-, low-, or intermediate-risk MDS non-del(5q) ± other cytogenetic abnormalities and RS <15% (or RS <5% with an SF3B1 mutation) with sEPO ≤500 mU/mL.1

Key secondary endpoints included HI-E per IWG ≥8 weeks (Weeks 1-24): REBLOZYL 74.1% (109/147), epoetin alfa 51.3% (n=79/154); RBC-TI for 24 weeks (Weeks 1-24): REBLOZYL 47.6% (n=70/147), epoetin alfa 29.2% (n=45/154); and RBC-TI for ≥12 weeks (Weeks 1-24): REBLOZYL 66.7% (n=98/147), epoetin alfa 46.1% (n=71/154).2

Callout DotsCallout Dots

Doses were escalated to achieve response.
80% of all patients receiving REBLOZYL had their dose increased at least once.3

Callout DotsCallout Dots

REBLOZYL was studied head-to-head vs an ESA2

COMMANDS: A Phase 3 open-label, randomized, active-controlled, head-to-head trial of REBLOZYL vs epoetin alfa in anemia due to LR-MDS in ESA-naive patients2,4

Patient population of COMMANDS trial Patient population of COMMANDS trial

>90% of study participants were outside of the United States and used a non-US-licensed epoetin alfa product. Direct comparisons between REBLOZYL and US-licensed epoetin alfa product have not been established.2

Interim analysis of COMMANDS reported.2

Balanced across study arms in pivotal Phase 3 COMMANDS trial2

A majority of patients had sEPO levels ≤200 U/L4

COMMANDS had the largest number of RS-patients of any Phase 3 LR-MDS study7-9

Disease Characteristic REBLOZYL
(n=178)		 Epoetin Alfa
(n=178)
Hemoglobin (g/dL)
Median (min, max) 7.80 (4.7, 9.2) 7.80 (4.5, 10.2)
Serum EPO (U/L)
i
Median (min, max)		 78.7 (7.8, 495.8) 85.9 (4.6, 462.5)
IPSS-R risk classification at baseline – n (%)
Very low 16 (9.0) 17 (9.6)
Low 126 (70.8) 131 (73.6)
Intermediate 34 (19.1) 28 (15.7)
High 1 (0.6) 0 (0)
Missing 1 (0.6) 2 (1.1)
Ring sideroblast status (per WHO criteria) – n (%)
RS-positive 130 (73.0) 128 (71.9)
i
RS-negative		 48 (27.0) 49 (27.5)
Missing 0 (0) 1 (0.6)
SF3B1 mutation status – n (%)
Mutated 111 (62.4) 99 (55.6)
Non-mutated 65 (36.5) 72 (40.4)
Missing 2 (1.1) 7 (3.9)

BSC=best supportive care; CI=confidence interval; EOT=end of treatment; EPO=erythropoietin; ESA=erythropoiesis-stimulating agent; Hgb=hemoglobin; HI-E=hematologic improvement-erythroid; HMA=hypomethylating agent; IPSS-R=Revised International Prognostic Scoring System; IWG=International Working Group; LR-MDS=lower-risk myelodysplastic syndromes; MDS=myelodysplastic syndromes; NCCN=National Comprehensive Cancer Network; QW=once a week; Q3W=once every 3 weeks; RBC=red blood cell; RBC-TI=red blood cell transfusion independence; RS=ring sideroblast; SC=subcutaneous; sEPO=serum erythropoietin; TI=transfusion independence; WHO=World Health Organization.

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.

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 11.4% (63/554) of REBLOZYL-treated patients. Across clinical studies, the incidence of Grade 3 to 4 hypertension ranged from 2% to 9.6%. 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 ESA-refractory or -intolerant adult patients with MDS with normal baseline blood pressure, 26 (30%) patients developed SBP ≥130 mm Hg and 23 (16%) patients developed DBP ≥80 mm Hg. In ESA-naïve adult patients with MDS with normal baseline blood pressure, 23 (36%) patients developed SBP ≥140 mm Hg and 11 (6%) 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 (EMH) 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%).

ESA-naïve adult patients with Myelodysplastic Syndromes

Grade ≥3 (≥2%) adverse reactions included hypertension and dyspnea.

The most common (≥10%) all-grade adverse reactions included diarrhea, fatigue, hypertension, peripheral edema, nausea, and dyspnea.

ESA-refractory or -intolerant adult patients with 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.

DRUG ABUSE POTENTIAL

Abuse: Abuse of REBLOZYL may be seen in athletes for the effects on erythropoiesis. Misuse of drugs that increase erythropoiesis, such as REBLOZYL, by healthy persons may lead to polycythemia, which may be associated with life-threatening cardiovascular complications.

Please click here for US Full Prescribing Information for REBLOZYL.

References: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Myelodysplastic Syndromes V.3.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed August 15, 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. 2. REBLOZYL [US Prescribing Information]. Summit, NJ: Celgene Corporation; 2024. 3. 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. 4. Platzbecker U, Della Porta MG, Santini V, et al. Efficacy and safety of luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): interim analysis of a phase 3, open-label, randomised controlled trial. Lancet. 2023;402(10399):373-385. 5. Platzbecker U, Della Porta MG, Santini V, et al. Efficacy and safety of luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): interim analysis of a phase 3, open-label, randomised controlled trial (supplementary appendix). Lancet. 2023; published online June 10, 2023. https://doi.org/10.1016/S0140-6736(23)00874-7 6. Data on file. BMS-REF-00730-2007. Princeton, NJ: Bristol-Myers Squibb Company; 2024. 7. Fenaux P, Santini V, Spiriti MAA, et al. A phase 3 randomized, placebo-controlled study assessing the efficacy and safety of epoetin-a in anemic patients with low-risk MDS. Leukemia. 2018;32(12):2648-2658. 8. Greenberg PL, Tuechler H, Schanz J, et al. Revised International Prognostic Scoring System for myelodysplastic syndromes. Blood. 2012;120(12):2454-2465. 9. Garcia-Manero G, Platzbecker U, Santini V, et al. Efficacy and safety of luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive patients with transfusion-dependent lower-risk myelodysplastic syndromes: full analysis of the COMMANDS trial. Presented at: American Society of Hematology (ASH) Annual Meeting and Exposition. December 9-12, 2023. San Diego, CA. Abstract 193.

GLOBAL Bristol Myers SquibbTM logo
GLOBAL 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.

© 2024 Bristol-Myers Squibb Company.
2007-US-2400257 10/2024

References: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Myelodysplastic Syndromes V.3.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed August 15, 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. 2. REBLOZYL [US Prescribing Information]. Summit, NJ: Celgene Corporation; 2024. 3. 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. 4. Platzbecker U, Della Porta MG, Santini V, et al. Efficacy and safety of luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): interim analysis of a phase 3, open-label, randomised controlled trial. Lancet. 2023;402(10399):373-385. 5. Platzbecker U, Della Porta MG, Santini V, et al. Efficacy and safety of luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): interim analysis of a phase 3, open-label, randomised controlled trial (supplementary appendix). Lancet. 2023; published online June 10, 2023. https://doi.org/10.1016/S0140-6736(23)00874-7 6. Data on file. BMS-REF-00730-2007. Princeton, NJ: Bristol-Myers Squibb Company; 2024. 7. Fenaux P, Santini V, Spiriti MAA, et al. A phase 3 randomized, placebo-controlled study assessing the efficacy and safety of epoetin-a in anemic patients with low-risk MDS. Leukemia. 2018;32(12):2648-2658. 8. Greenberg PL, Tuechler H, Schanz J, et al. Revised International Prognostic Scoring System for myelodysplastic syndromes. Blood. 2012;120(12):2454-2465. 9. Garcia-Manero G, Platzbecker U, Santini V, et al. Efficacy and safety of luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive patients with transfusion-dependent lower-risk myelodysplastic syndromes: full analysis of the COMMANDS trial. Presented at: American Society of Hematology (ASH) Annual Meeting and Exposition. December 9-12, 2023. San Diego, CA. Abstract 193.