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REBLOZYL® (luspatercept-aamt) logo
LR-MDS (FIRST-LINE) LR-MDS-RS (SECOND-LINE) BETA-THALASSEMIA

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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.

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PATIENT OUTCOMES: REBLOZYL SAFETY IN THE COMMANDS TRIAL

Safety data for REBLOZYL as first-line treatment1

Adverse reactions (≥5%) in patients receiving REBLOZYL1

Body system/adverse reaction REBLOZYL
(n=178)		 Epoetin Alfa
(n=176)
All Grades
n (%)		 Grade ≥3
n (%)		 All Grades
n (%)		 Grade ≥3
n (%)
General disorders and administration-site conditions
Fatiguea, b 38 (22) 0 (0) 12 (7) 0 (0)
Edema, peripheral 23 (13) 0 (0) 12 (7) 0 (0)
Non-cardiac chest pain 9 (5) 1 (1) 6 (3) 0 (0)
Pyrexia 9 (5) 1 (1) 12 (7) 1 (1)
Gastrointestinal disorders
Diarrhea 26 (15) 0 (0) 20 (11) 0 (0)
Nausea 21 (12) 0 (0) 13 (7) 0 (0)
Vascular disorders
Hypertensiona 25 (14) 17 (10) 13 (7) 9 (5)
Respiratory, thoracic, and mediastinal disorders
Dyspnea 21 (12) 7 (4) 13 (7) 2 (1)
Dyspnea exertional 9 (5) 0 (0) 1 (1) 0 (0)
Nervous system disorders
Dizziness 16 (9) 1 (1) 15 (9) 0 (0)
Headache 15 (8) 0 (0) 12 (7) 1 (1)
Musculoskeletal and connective tissue disorders
Back Pain 16 (9) 2 (1) 13 (7) 3 (2)
Arthralgia 10 (6) 0 (0) 14 (8) 0 (0)
Myalgia 9 (5) 0 (0) 5 (3) 0 (0)
Osteoarthritis 9 (5) 1 (1) 4 (2) 0 (0)
Infections and infestations
COVID-19 19 (11) 6 (3) 17 (10) 2 (1)
Urinary tract infection 13 (7) 0 (0) 7 (4) 0 (0)
Pneumonia 8 (5) 7 (4) 15 (9) 11 (6)
Metabolism and nutrition disorders
Hyperuricemia 12 (7) 1 (1) 10 (6) 1 (1)
Decreased appetite 8 (5) 0 (0) 11 (6) 0 (0)
Blood and lymphatic system disorders
Thrombocytopenia 11 (6) 7 (4) 3 (2) 1 (1)
Neutropenia 9 (5) 7 (4) 13 (7) 10 (6)
Psychiatric disorders
Insomnia 9 (5) 0 (0) 6 (3) 0 (0)
Body system/
Adverse reaction		 REBLOZYL
(N-178)
All Grades
n (%)		 Grade ≥3
n (%)
General disorders and administration-site conditions
Fatiguea, b 38 (22) 0 (0)
Edema, peripheral 23 (13) 0 (0)
Non-cardiac chest pain 9 (5) 1 (1)
Pyrexia 9 (5) 1 (1)
Gastrointestinal disorders
Diarrhea 26 (15) 0 (0)
Nausea 21 (12) 0 (0)
Vascular disorders
Hypertensiona 25 (14) 17 (10)
Respiratory, thoracic, and mediastinal disorders
Dyspnea 21 (12) 7 (4)
Dyspnea exertional 9 (5) 0 (0)
Nervous system disorders
Dizziness 16 (9) 1 (1)
Headache 15 (8) 0 (0)
Musculoskeletal and connective tissue disorders
Back Pain 16 (9) 2 (1)
Arthralgia 10 (6) 0 (0)
Myalgia 9 (5) 0 (0)
Osteoarthritis 9 (5) 1 (1)
Infections and infestations
COVID-19 19 (11) 6 (3)
Urinary tract infection 13 (7) 0 (0)
Pneumonia 8 (5) 7 (4)
Metabolism and nutrition disorders
Hyperuricemia 12 (7) 1 (1)
Decreased appetite 8 (5) 0 (0)
Blood and lymphatic system disorders
Thrombocytopenia 11 (6) 7 (4)
Neutropenia 9 (5) 7 (4)
Psychiatric disorders
Insomnia 9 (5) 0 (0)
Body system/
Adverse reaction		 Epoetin Alfa
(n=176)
All Grades
n (%)		 Grade ≥3
n (%)
General disorders and administration-site conditions
Fatiguea, b 12 (7) 0 (0)
Edema, peripheral 12 (7) 0 (0)
Non-cardiac chest pain 6 (3) 0 (0)
Pyrexia 12 (7) 1 (1)
Gastrointestinal disorders
Diarrhea 20 (11) 0 (0)
Nausea 13 (7) 0 (0)
Vascular disorders
Hypertensiona 13 (7) 9 (5)
Respiratory, thoracic, and mediastinal disorders
Dyspnea 13 (7) 2 (1)
Dyspnea exertional 1 (1) 0 (0)
Nervous system disorders
Dizziness 15 (9) 0 (0)
Headache 12 (7) 1 (1)
Musculoskeletal and connective tissue disorders
Back Pain 13 (7) 3 (2)
Arthralgia 14 (8) 0 (0)
Myalgia 5 (3) 0 (0)
Osteoarthritis 4 (2) 0 (0)
Infections and infestations
COVID-19 17 (10) 2 (1)
Urinary tract infection 7 (4) 0 (0)
Pneumonia 15 (9) 11 (6)
Metabolism and nutrition disorders
Hyperuricemia 10 (6) 1 (1)
Decreased appetite 11 (6) 0 (0)
Blood and lymphatic system disorders
Thrombocytopenia 3 (2) 1 (1)
Neutropenia 13 (7) 10 (6)
Psychiatric disorders
Insomnia 6 (3) 0 (0)
  • The most common (>10%) all-grade adverse reactions included diarrhea, fatigue, hypertension, COVID-19, peripheral edema, nausea, and dyspnea1
  • The most common (>2%) Grade >3 adverse reactions included hypertension and dyspnea1
  • Selected laboratory abnormalities that changed from Grade 0-2 at baseline to Grades 2-3 at any time during the studies were glomerular filtration rate and total bilirubin increased1
  • Other clinically relevant adverse reactions reported in <5% of patients are injection-site reactions, including erythema, pruritus, and rash1

aReaction includes similar/grouped terms.
bIncludes asthenic conditions.
  ESA=erythropoiesis stimulating agent; MDS=myelodysplastic syndromes.

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Most adverse reactions in the clinical trial were Grade 1 or 2 (mild or moderate)1

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REBLOZYL discontinuations and dose modifications in the safety population

Treatment discontinuations2*

Discontinuations due to lack of efficacy

REBLOZYL:

15.7%

(n=28/178)

Epoetin Alfa:

32.4%

(n=57/176)

of patients discontinued treatment due to lack of efficacy

Discontinuations due to death

REBLOZYL:

6.2%

(n=11/178)

Epoetin Alfa:

6.3%

(n=11/176)

of patients discontinued treatment due to death

Discontinuations due to adverse reactions

REBLOZYL:

4.5%

(n=8/178)

Epoetin Alfa:

2.3%

(n=4/176)

of patients discontinued treatment due to an adverse reaction

Discontinuations due to disease progression

REBLOZYL:

3.9%

(n=7/178)

Epoetin Alfa:

4.0%

(n=7/176)

of patients discontinued treatment due to disease progression

  • Dose reductions due to AEs: 2.8% (n=5/178) in the REBLOZYL group and 3.4% (n=6/176) in the epoetin alfa group1,3
  • Dose interruptions due to AEs: 27.0% (n=48/178) in the REBLOZYL group and 22.7% (n=40/176) in the epoetin alfa group1,3

Percentages are based on the safety population (all patients who were randomized and received ≥1 dose of study drug).

AE=adverse event.

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. Garcia-Manero et al. Efficacy and safety results from the COMMANDS trial: a phase 3 study evaluating luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive transfusion-dependent patients with lower-risk myelodysplastic syndromes. Presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; June 2-6, 2023. Chicago, IL. Presentation #7003. 3. Data on file package: BMS-REF-ACE-536-0009. Princeton, NJ: Bristol-Myers Squibb Company; 2023.

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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. Garcia-Manero et al. Efficacy and safety results from the COMMANDS trial: a phase 3 study evaluating luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive transfusion-dependent patients with lower-risk myelodysplastic syndromes. Presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; June 2-6, 2023. Chicago, IL. Presentation #7003. 3. Data on file package: BMS-REF-ACE-536-0009. Princeton, NJ: Bristol-Myers Squibb Company; 2023.