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REBLOZYL® (luspatercept-aamt) logo
MDS (ESA-NAIVE PATIENTS) MDS-RS (POST-ESA TREATMENT) 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 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 (luspatercept-aamt) is indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.

REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.

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REBLOZYL EFFICACY IN ESA-NAIVE PATIENTS

"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

1L=first line; ESA=erythropoiesis-stimulating agent; MDS=myelodysplastic syndromes; RS=ring sideroblast.

*>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.

REBLOZYL EFFICACY IN ESA-NAIVE PATIENTS

"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

1L=first line; ESA=erythropoiesis-stimulating agent; MDS=myelodysplastic syndromes; RS=ring sideroblast.

*>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.

COMMANDS—a head-to-head clinical trial of REBLOZYL vs epoetin alfa1

REBLOZYL is the only agent to be studied head-to-head against an ESA for
MDS-associated anemia1-3

COMMANDS: a Phase 3 open-label, randomized, active-controlled trial of REBLOZYL vs epoetin alfa in anemia due to LR-MDS for ESA-naive patients

*>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.

Interim analysis of COMMANDS reported.

BSC=best supportive care; EOT=end of treatment; HMA=hypomethylating agent; Hgb=hemoglobin; IPSS-R=Revised International Prognostic Scoring System; IWG=International Working Group; LR-MDS=lower-risk myelodysplastic syndromes; QW=once a week; Q3W=every 3 weeks; RBC=red blood cell; RBC-TI=red blood cell transfusion independent; RS=ring sideroblasts; SC=subcutaneous; sEPO=serum erythropoietin.

Balanced across study arms in pivotal Phase 3 COMMANDS trial1

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)
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)
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)

EPO=erythropoietin; RBC=red blood cell; RS=ring sideroblasts; WHO=World Health Organization.

REBLOZYL demonstrated superiority with nearly 2X
the patients achieving RBC-TI with Hgb increase vs epoetin alfa1

Primary composite endpoint: RBC-TI for at least 12 weeks with concurrent mean Hgb increase ≥1.5 g/dL1

Primary Endpoint REBLOZYL® vs epoetin alfa graph Primary Endpoint REBLOZYL® vs epoetin alfa graph

This prespecified interim analysis included 301 patients who had either completed 24 weeks of treatment or discontinued prior to completing 24 weeks of treatment. This represents 85% of the total patient population contributing data for the primary endpoint.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).1,2

CI=confidence interval; Hgb=hemoglobin.

69% of all COMMANDS patients receiving REBLOZYL
had their dose increased at least once4

Responders on REBLOZYL had lasting transfusion independence3

Secondary endpoint: Median duration of RBC-TI ≥12 weeks (Week 1-EOT)

Analysis limitations: Duration of RBC-TI ≥12 weeks was not powered to detect statistical significance.

Median duration of RBC-TI ≥12 weeks graph
Median duration of RBC-TI ≥12 weeks graph

CI=confidence interval; EOT=end of treatment; NR=not reached; RBC-TI=red blood cell transfusion independence.

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 [US Prescribing Information]. Summit, NJ: Celgene Corporation; 2023. 2. Platzbecker U, Della Porta MG, Santini V, et al. Efficacy and safety of luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naïve, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): interim analysis of a phase 3, open-label, randomized controlled trial. Lancet. 2023;402(10399):373-385. 3. Platzbecker U, Della Porta MG, Santini V, et al. Efficacy and safety of luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naïve, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): interim analysis of a phase 3, open-label, randomized controlled trial. Lancet. 2023;402(10399)(suppl):373-385. 4. Data on file package: BMS-REF-ACE-536-0009. Princeton, NJ: Bristol-Myers Squibb Company; 2023.

2007-US-2300137     08/2023

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.

© 2023 Bristol-Myers Squibb Company.
2007-US-2200263 12/2022

References: 1.REBLOZYL [US Prescribing Information]. Summit, NJ: Celgene Corporation; 2023. 2. Platzbecker U, Della Porta MG, Santini V, et al. Efficacy and safety of luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naïve, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): interim analysis of a phase 3, open-label, randomized controlled trial. Lancet. 2023;402(10399):373-385. 3. Platzbecker U, Della Porta MG, Santini V, et al. Efficacy and safety of luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naïve, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): interim analysis of a phase 3, open-label, randomized controlled trial. Lancet. 2023;402(10399)(suppl):373-385. 4. Data on file package: BMS-REF-ACE-536-0009. Princeton, NJ: Bristol-Myers Squibb Company; 2023.

2007-US-2300137     08/2023