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

REBLOZYL FOR FIRST-LINE TREATMENT OF ANEMIA DUE TO LR-MDS

For first-line treatment of LR-MDS-associated anemia
For first-line treatment of LR-MDS-associated anemia

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

Unprecedented superior efficacy. Lasting transfusion independence.1,2

Drip bag icon

Learn about the limitations of ESAs in
MDS-associated anemia

Discover why patients with MDS-associated anemia need a better first-line treatment option.1

See ESA limitations

REBLOZYL FOR FIRST-LINE TREATMENT OF ANEMIA DUE TO LR-MDS

For first-line treatment of LR-MDS-associated anemia
For first-line treatment of LR-MDS-associated anemia

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

Unprecedented superior efficacy. Lasting transfusion independence.1,2

Drip bag icon

Learn about the limitations of ESAs in
MDS-associated anemia

Discover why patients with MDS-associated anemia need a better first-line treatment option.1

See ESA limitations

Clipboard icon

First-line superiority vs an ESA

REBLOZYL demonstrated superiority vs epoetin alfa in achieving RBC-TI with hemoglobin increase in patients with lower-risk MDS in the Phase 3 COMMANDS trial.1

See efficacy data

Dose titration icon

Optimize patient outcomes through responsive dosing

Patient response determines the REBLOZYL dose. Learn how to dose-adjust REBLOZYL to maximize potential clinical benefit.1

Discover dosing

Magnifying glass icon

Identify patients who can benefit from REBLOZYL

REBLOZYL is indicated for the first-line treatment of lower-risk MDS-associated anemia.1

Learn if REBLOZYL is right for your patients

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

1L=first-line; ESA=erythropoiesis-stimulating agent; MDS=myelodysplastic syndromes; RS=ring sideroblasts; sEPO=serum erythropoietin.

STUDY DESIGN1,2

COMMANDS (N=356) was a Phase 3, randomized, open-label, active-controlled trial comparing REBLOZYL vs epoetin alfa in adult patients with anemia due to IPSS-R very low-, low-, or intermediate-risk MDS, with or without ring-sideroblasts, who were ESA-naive (with endogenous sEPO levels <500 U/L) and required RBCT. Patients with del(5q) and those previously treated with disease-modifying agents or HMAs were excluded.

Patients were randomized to either REBLOZYL (n=178) 1 mg/kg SC Q3W, with titration up to max 1.75 mg/kg if needed to achieve response or epoetin alfa (n=178) 450 IU/kg SC QW max total dose 40K IU, with titration up to 1050 IU/kg max total dose 80K IU. The primary endpoint was RBC-TI with a mean improvement in Hgb by at least 1.5 g/dL for any consecutive 12-week period during Weeks 1 to 24.

EFFICACY RESULTS1,3

Primary endpoint (RBC-TI for ≥12 weeks with concurrent mean Hgb increase ≥1.5 g/dL): 58.5% (n=86/147; 95% CI: 50.1, 66.6) of patients in the REBLOZYL treatment group and 31.2% (n=48/154; 95% CI: 24.0, 39.1) of patients in the epoetin alfa treatment group achieved RBC-TI with Hgb increase during Weeks 1 to 24.

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).

Other secondary endpoints included median duration (weeks) of RBC-TI ≥12 weeks (Weeks 1 to EOT): REBLOZYL 126.6 weeks (n=98/147; 95% CI: 108.3, NR), epoetin alfa 77.0 weeks (n=71/154; 95% CI: 39.0, NR).

ADVERSE REACTIONS1

The most common (>10%) all-grade adverse reactions included diarrhea, fatigue, hypertension, peripheral edema, asthenia, nausea, and dyspnea. The most common (>2%) Grade >3 adverse reactions included hypertension and dyspnea. Other clinically relevant adverse reaction reported in <5% of patients is injection-site reaction that includes erythema, pruritus, and rash.

CI=confidence interval; EOT=end of treatment; Hgb=hemoglobin; HI-E=hematologic improvement-erythroid; HMA=hypomethylating agent; IPSS-R=Revised International Prognostic Scoring System; IWG=International Working Group; QW=once a week; Q3W=once every 3 weeks; RBC=red blood cell; RBCT=red blood cell transfusion; RBC-TI-red blood cell transfusion independence; SC=subcutaneous; SD=standard deviation.

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. REBLOZYL [Prescribing Information]. Summit, NJ: Celgene Corporation; 2023. 2. Platzbecker U, Della Porta MG, Santini V, et el. 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. 3. Platzbecker U, Della Porta MG, Santini V, et el. 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)(suppl):373-385.

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.

© 2023 Bristol-Myers Squibb Company.
2007-US-2300138 11/2023

References: 1. REBLOZYL [Prescribing Information]. Summit, NJ: Celgene Corporation; 2023. 2. Platzbecker U, Della Porta MG, Santini V, et el. 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. 3. Platzbecker U, Della Porta MG, Santini V, et el. 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)(suppl):373-385.