This website is intended for US Healthcare Professionals.
This website is intended for US Healthcare Professionals.
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.
This dosing calculator is being provided “AS IS” and is intended for use only by qualified healthcare providers. All calculations should be confirmed before use. Bristol Myers Squibb makes no claims as to the accuracy of the information contained herein. The information being provided is not a substitute for clinical judgment. Neither Bristol Myers Squibb, nor any other party involved in the preparation or publication of this site, shall be liable to you or others for any decisions made or actions taken by you or others in reliance on this information.
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PATIENT OUTCOMES: REBLOZYL SAFETY IN SECOND-LINE MDS PATIENTS
Body system/Adverse reaction | REBLOZYL (n=153) |
Placebo (n=76) |
||
---|---|---|---|---|
All Grades n (%) |
Grade 3 n (%) |
All Grades n (%) |
Grade 3 n (%) |
|
General disorders and administration-site conditions | ||||
Fatiguea,b | 63 (41) | 11 (7) | 17 (22) | 2 (3) |
Musculoskeletal and connective tissue disorders | ||||
Musculoskeletal painb | 30 (20) | 3 (2) | 11 (14) | 0 (0) |
Nervous system disorders | ||||
Dizziness/Vertigo | 28 (18) | 1 (<1) | 5 (7) | 1 (1) |
Headacheb | 21 (14) | 0 (0) | 5 (7) | 0 (0) |
Syncope/Presyncope | 8 (5) | 5 (3) | 0 (0) | 0 (0) |
Gastrointestinal disorders | ||||
Nauseab | 25 (16) | 1 (<1) | 8 (11) | 0 (0) |
Diarrheab | 25 (16) | 0 (0) | 7 (9) | 0 (0) |
Respiratory, thoracic, and mediastinal disorders | ||||
Dyspneab | 20 (13) | 2 (1) | 4 (5) | 1 (1) |
Immune system disorders | ||||
Hypersensitivity reactionsb | 15 (10) | 1 (<1) | 5 (7) | 0 (0) |
Renal and urinary disorders | ||||
Renal impairmentb | 12 (8) | 3 (2) | 3 (4) | 0 (0) |
Cardiac disorders | ||||
Tachycardiab | 12 (8) | 0 (0) | 1 (1) | 0 (0) |
Injury, poisoning, and procedural complications | ||||
Injection-site reactions | 10 (7) | 0 (0) | 3 (4) | 0 (0) |
Infections and infestations | ||||
Upper respiratory tract infection | 10 (7) | 1 (<1) | 2 (3) | 0 (0) |
Influenza/Influenza-like illness | 9 (6) | 0 (0) | 2 (3) | 0 (0) |
Body system/Adverse reaction | All Grades n (%) |
|
---|---|---|
REBLOZYL (n=153) |
Placebo (n=76) |
|
General disorders and administration-site conditions | ||
Fatiguea,b | 63 (41) | 17 (22) |
Musculoskeletal and connective tissue disorders | ||
Musculoskeletal painb | 30 (20) | 11 (14) |
Nervous system disorders | ||
Dizziness/Vertigo | 28 (18) | 5 (7) |
Headacheb | 21 (14) | 5 (7) |
Syncope/Presyncope | 8 (5) | 0 (0) |
Gastrointestinal disorders | ||
Nauseab | 25 (16) | 8 (11) |
Diarrheab | 25 (16) | 7 (9) |
Respiratory, thoracic, and mediastinal disorders | ||
Dyspneab | 20 (13) | 4 (5) |
Immune system disorders | ||
Hypersensitivity reactionsb | 15 (10) | 5 (7) |
Renal and urinary disorders | ||
Renal impairmentb | 12 (8) | 3 (4) |
Cardiac disorders | ||
Tachycardiab | 12 (8) | 1 (1) |
Injury, poisoning, and procedural complications | ||
Injection-site reactions | 10 (7) | 3 (4) |
Infections and infestations | ||
Upper respiratory tract infection | 10 (7) | 2 (3) |
Influenza/Influenza-like illness | 9 (6) | 2 (3) |
Body system/Adverse reaction | Grade 3 n (%) |
|
---|---|---|
REBLOZYL (n=153) |
Placebo (n=76) |
|
General disorders and administration-site conditions | ||
Fatiguea,b | 11 (7) | 2 (3) |
Musculoskeletal and connective tissue disorders | ||
Musculoskeletal painb | 3 (2) | 0 (0) |
Nervous system disorders | ||
Dizziness/Vertigo | 1 (<1) | 1 (1) |
Headacheb | 0 (0) | 0 (0) |
Syncope/Presyncope | 5 (3) | 0 (0) |
Gastrointestinal disorders | ||
Nauseab | 1 (<1) | 0 (0) |
Diarrheab | 0 (0) | 0 (0) |
Respiratory, thoracic, and mediastinal disorders | ||
Dyspneab | 2 (1) | 1 (1) |
Immune system disorders | ||
Hypersensitivity reactionsb | 1 (<1) | 0 (0) |
Renal and urinary disorders | ||
Renal impairmentb | 3 (2) | 0 (0) |
Cardiac disorders | ||
Tachycardiab | 0 (0) | 0 (0) |
Injury, poisoning, and procedural complications | ||
Injection-site reactions | 0 (0) | 0 (0) |
Infections and infestations | ||
Upper respiratory tract infection | 1 (<1) | 0 (0) |
Influenza/Influenza-like illness | 0 (0) | 0 (0) |
aIncludes asthenic conditions. bReaction includes similar/grouped terms.
Selected Grades 2 to 4 treatment-emergent laboratory abnormalities through Cycle 8 in the MEDALIST trial
Parameter | REBLOZYL | Placebo | ||
---|---|---|---|---|
Na | n (%) | Na | n (%) | |
ALT elevated | 151 | 13 (9) | 74 | 5 (7) |
AST elevated | 152 | 6 (4) | 76 | 0 (0) |
Total bilirubin elevated | 140 | 17 (12) | 66 | 3 (5) |
Creatinine clearance reduced | 113 | 30 (27) | 62 | 13 (21) |
aNumber of patients at Grades 0-1 at baseline.
ALT=alanine aminotransferase; AST=aspartate aminotransferase.
Discontinuations due to adverse reactions
4.5%(n=11/242)
of patients who received REBLOZYL discontinued treatment due to an adverse reaction
Dose reductions due to adverse reactions
2.9%(n=7/242)
of patients who received REBLOZYL required a dose reduction due to an adverse reaction
MDS-RS=myelodysplastic syndromes with ring sideroblasts.
8.5%(n=13/153)
of patients receiving REBLOZYL required dose delays due to predose Hgb levels ≥11.5 g/dL
2.0%(n=3/153)
of patients receiving REBLOZYL required dose reductions due to Hgb levels ≥2 g/dL vs predose Hgb level of prior treatment cycle
Hgb=hemoglobin.
TEAEs ≥5% INCIDENCE BY TREATMENT CYCLE
Analysis limitations
Additional analysis information
BSC=best supportive care; MedDRA=Medical Dictionary for Regulatory Activities; TEAE=treatment-emergent adverse event.
PATIENT OUTCOMES: REBLOZYL SAFETY IN SECOND-LINE MDS PATIENTS
Body system/Adverse reaction | REBLOZYL (n=153) |
Placebo (n=76) |
||
---|---|---|---|---|
All Grades n (%) |
Grade 3 n (%) |
All Grades n (%) |
Grade 3 n (%) |
|
General disorders and administration-site conditions | ||||
Fatiguea,b | 63 (41) | 11 (7) | 17 (22) | 2 (3) |
Musculoskeletal and connective tissue disorders | ||||
Musculoskeletal painb | 30 (20) | 3 (2) | 11 (14) | 0 (0) |
Nervous system disorders | ||||
Dizziness/Vertigo | 28 (18) | 1 (<1) | 5 (7) | 1 (1) |
Headacheb | 21 (14) | 0 (0) | 5 (7) | 0 (0) |
Syncope/Presyncope | 8 (5) | 5 (3) | 0 (0) | 0 (0) |
Gastrointestinal disorders | ||||
Nauseab | 25 (16) | 1 (<1) | 8 (11) | 0 (0) |
Diarrheab | 25 (16) | 0 (0) | 7 (9) | 0 (0) |
Respiratory, thoracic, and mediastinal disorders | ||||
Dyspneab | 20 (13) | 2 (1) | 4 (5) | 1 (1) |
Immune system disorders | ||||
Hypersensitivity reactionsb | 15 (10) | 1 (<1) | 5 (7) | 0 (0) |
Renal and urinary disorders | ||||
Renal impairmentb | 12 (8) | 3 (2) | 3 (4) | 0 (0) |
Cardiac disorders | ||||
Tachycardiab | 12 (8) | 0 (0) | 1 (1) | 0 (0) |
Injury, poisoning, and procedural complications | ||||
Injection-site reactions | 10 (7) | 0 (0) | 3 (4) | 0 (0) |
Infections and infestations | ||||
Upper respiratory tract infection | 10 (7) | 1 (<1) | 2 (3) | 0 (0) |
Influenza/Influenza-like illness | 9 (6) | 0 (0) | 2 (3) | 0 (0) |
Body system/Adverse reaction | All Grades n (%) |
|
---|---|---|
REBLOZYL (n=153) |
Placebo (n=76) |
|
General disorders and administration-site conditions | ||
Fatiguea,b | 63 (41) | 17 (22) |
Musculoskeletal and connective tissue disorders | ||
Musculoskeletal painb | 30 (20) | 11 (14) |
Nervous system disorders | ||
Dizziness/Vertigo | 28 (18) | 5 (7) |
Headacheb | 21 (14) | 5 (7) |
Syncope/Presyncope | 8 (5) | 0 (0) |
Gastrointestinal disorders | ||
Nauseab | 25 (16) | 8 (11) |
Diarrheab | 25 (16) | 7 (9) |
Respiratory, thoracic, and mediastinal disorders | ||
Dyspneab | 20 (13) | 4 (5) |
Immune system disorders | ||
Hypersensitivity reactionsb | 15 (10) | 5 (7) |
Renal and urinary disorders | ||
Renal impairmentb | 12 (8) | 3 (4) |
Cardiac disorders | ||
Tachycardiab | 12 (8) | 1 (1) |
Injury, poisoning, and procedural complications | ||
Injection-site reactions | 10 (7) | 3 (4) |
Infections and infestations | ||
Upper respiratory tract infection | 10 (7) | 2 (3) |
Influenza/Influenza-like illness | 9 (6) | 2 (3) |
Body system/Adverse reaction | Grade 3 n (%) |
|
---|---|---|
REBLOZYL (n=153) |
Placebo (n=76) |
|
General disorders and administration-site conditions | ||
Fatiguea,b | 11 (7) | 2 (3) |
Musculoskeletal and connective tissue disorders | ||
Musculoskeletal painb | 3 (2) | 0 (0) |
Nervous system disorders | ||
Dizziness/Vertigo | 1 (<1) | 1 (1) |
Headacheb | 0 (0) | 0 (0) |
Syncope/Presyncope | 5 (3) | 0 (0) |
Gastrointestinal disorders | ||
Nauseab | 1 (<1) | 0 (0) |
Diarrheab | 0 (0) | 0 (0) |
Respiratory, thoracic, and mediastinal disorders | ||
Dyspneab | 2 (1) | 1 (1) |
Immune system disorders | ||
Hypersensitivity reactionsb | 1 (<1) | 0 (0) |
Renal and urinary disorders | ||
Renal impairmentb | 3 (2) | 0 (0) |
Cardiac disorders | ||
Tachycardiab | 0 (0) | 0 (0) |
Injury, poisoning, and procedural complications | ||
Injection-site reactions | 0 (0) | 0 (0) |
Infections and infestations | ||
Upper respiratory tract infection | 1 (<1) | 0 (0) |
Influenza/Influenza-like illness | 0 (0) | 0 (0) |
aIncludes asthenic conditions. bReaction includes similar/grouped terms.
Selected Grades 2 to 4 treatment-emergent laboratory abnormalities through Cycle 8 in the MEDALIST trial
Parameter | REBLOZYL | Placebo | ||
---|---|---|---|---|
Na | n (%) | Na | n (%) | |
ALT elevated | 151 | 13 (9) | 74 | 5 (7) |
AST elevated | 152 | 6 (4) | 76 | 0 (0) |
Total bilirubin elevated | 140 | 17 (12) | 66 | 3 (5) |
Creatinine clearance reduced | 113 | 30 (27) | 62 | 13 (21) |
aNumber of patients at Grades 0-1 at baseline.
ALT=alanine aminotransferase; AST=aspartate aminotransferase.
Discontinuations due to adverse reactions
4.5%(n=11/242)
of patients who received REBLOZYL discontinued treatment due to an adverse reaction
Dose reductions due to adverse reactions
2.9%(n=7/242)
of patients who received REBLOZYL required a dose reduction due to an adverse reaction
MDS-RS=myelodysplastic syndromes with ring sideroblasts.
8.5%(n=13/153)
of patients receiving REBLOZYL required dose delays due to predose Hgb levels ≥11.5 g/dL
2.0%(n=3/153)
of patients receiving REBLOZYL required dose reductions due to Hgb levels ≥2 g/dL vs predose Hgb level of prior treatment cycle
Hgb=hemoglobin.
TEAEs ≥5% INCIDENCE BY TREATMENT CYCLE
Analysis limitations
Additional analysis information
BSC=best supportive care; MedDRA=Medical Dictionary for Regulatory Activities; TEAE=treatment-emergent adverse event.
References: 1. REBLOZYL [US Prescribing Information]. Summit, NJ: Celgene Corporation; 2023. 2. Platzbecker U, Fenaux, P, Mufti GJ, et al. et Assessment of dose-dependent response to luspatercept in patients with lower-risk myelodysplastic syndromes with ring sideroblasts in the phase 3 MEDALIST trial. Presented at: 25th Congress of the European Hematology Association [virtual]. June 12, 2020. Abstract EP812. 3. Fenaux P, Platzbecker U, Mufti GJ, et al. Luspatercept in patients with lower-risk myelodysplastic syndromes. N Engl J Med. 2020;382(suppl):1-37.