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This website is intended for US Healthcare Professionals.
Request a RepINDICATIONS
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 SECOND-LINE MDS PATIENTS
REBLOZYL offers a demonstrated safety profile1
The majority of adverse reactions with REBLOZYL were Grade 1 or 2 (mild to moderate)1
- Among the 242 patients treated with REBLOZYL, 5 (2.1%) had a fatal adverse reaction1
- Selected laboratory abnormalities that changed from Grade 0 to 1 at baseline to Grade ≥2 at any time during the studies in at least 10% of patients included creatinine clearance decreased, total bilirubin increased, and alanine aminotransferase increased1
- Among the 242 patients treated with REBLOZYL, 5 (2.1%) had a fatal adverse reaction1
- Selected laboratory abnormalities that changed from Grade 0 to 1 at baseline to Grade ≥2 at any time during the studies in at least 10% of patients included creatinine clearance decreased, total bilirubin increased, and alanine aminotransferase increased1
Adverse reactions (≥5%) in patients receiving REBLOZYL with a difference between arms of >2% in MEDALIST trial through Cycle 81
| 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.
- Other clinically relevant adverse reactions reported in <5% of patients included bronchitis, urinary tract infection, and hypertension1
The majority of adverse reactions with REBLOZYL were Grade 1 or 2 (mild to moderate)1
Important considerations while treating patients with REBLOZYL
Liver function abnormalities in the MEDALIST trial1
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.
- Of 260 patients with MDS who were treated with REBLOZYL and evaluable for the presence of
anti–luspatercept-aamt antibodies, 23 patients (8.9%) tested positive for treatment-emergentanti–luspatercept-aamt antibodies, including 9 patients (3.5%) who had neutralizing antibodies - Luspatercept-aamt serum concentration tended to decrease in the presence of neutralizing antibodies
- There were no severe acute systemic hypersensitivity reactions reported for patients with
anti–luspatercept-aamt antibodies in REBLOZYL clinical trials, and there was no association between hypersensitivity type reaction or injection-site reaction and presence ofanti–luspatercept-aamt antibodies
Additional safety data
Discontinuations and dose modifications in the safety population1
- The safety of REBLOZYL at the recommended dose and schedule was evaluated in 242 patients with MDS-RS (n=192) or other myeloid neoplasms (n=50)
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.
Dose delays and reductions due to Hgb levels2
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
- All patients in both arms were eligible to receive BSC, which included RBC transfusions as needed1
- Adverse events (AEs) with a duration overlapping multiple cycles were only counted in the first overlapped cycle. If an AE occurred multiple times in different cycles, it was counted once in each cycle. If an AE occurred multiple times within the same cycle, it was counted only once. If a patient experienced multiple events under the same MedDRA 20.0 preferred term, then the patient was counted only once for that preferred term3
- Patients who met the criteria and remained on double-blind treatment after completion of Week 25 assessment may have continued dosing in the extension phase of the treatment period until the subject experienced unacceptable toxicity, loss of efficacy, or disease progression1
- Fatigue TEAE does not include broader asthenic conditions adverse drug reactions (ADRs)
Additional analysis information
- Analysis is based on data through Week 48
- The chart displays TEAEs independent of attribution of treatment or disease. The percentage shown in this graph does not match the Adverse Reactions table above
- TEAEs are undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment
BSC=best supportive care; MedDRA=Medical Dictionary for Regulatory Activities; TEAE=treatment-emergent adverse event.
PATIENT OUTCOMES: REBLOZYL SAFETY IN SECOND-LINE MDS PATIENTS
REBLOZYL offers a demonstrated safety profile1
The majority of adverse reactions with REBLOZYL were Grade 1 or 2 (mild to moderate)1
- Among the 242 patients treated with REBLOZYL, 5 (2.1%) had a fatal adverse reaction1
- Selected laboratory abnormalities that changed from Grade 0 to 1 at baseline to Grade ≥2 at any time during the studies in at least 10% of patients included creatinine clearance decreased, total bilirubin increased, and alanine aminotransferase increased1
- Among the 242 patients treated with REBLOZYL, 5 (2.1%) had a fatal adverse reaction1
- Selected laboratory abnormalities that changed from Grade 0 to 1 at baseline to Grade ≥2 at any time during the studies in at least 10% of patients included creatinine clearance decreased, total bilirubin increased, and alanine aminotransferase increased1
Adverse reactions (≥5%) in patients receiving REBLOZYL with a difference between arms of >2% in MEDALIST trial through Cycle 81
| 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.
- Other clinically relevant adverse reactions reported in <5% of patients included bronchitis, urinary tract infection, and hypertension1
The majority of adverse reactions with REBLOZYL were Grade 1 or 2 (mild to moderate)1
Important considerations while treating patients with REBLOZYL
Liver function abnormalities in the MEDALIST trial1
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.
- Of 260 patients with MDS who were treated with REBLOZYL and evaluable for the presence of
anti–luspatercept-aamt antibodies, 23 patients (8.9%) tested positive for treatment-emergentanti–luspatercept-aamt antibodies, including 9 patients (3.5%) who had neutralizing antibodies - Luspatercept-aamt serum concentration tended to decrease in the presence of neutralizing antibodies
- There were no severe acute systemic hypersensitivity reactions reported for patients with
anti–luspatercept-aamt antibodies in REBLOZYL clinical trials, and there was no association between hypersensitivity type reaction or injection-site reaction and presence ofanti–luspatercept-aamt antibodies
Additional safety data
Discontinuations and dose modifications in the safety population1
- The safety of REBLOZYL at the recommended dose and schedule was evaluated in 242 patients with MDS-RS (n=192) or other myeloid neoplasms (n=50)
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.
Dose delays and reductions due to Hgb levels2
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
- All patients in both arms were eligible to receive BSC, which included RBC transfusions as needed1
- Adverse events (AEs) with a duration overlapping multiple cycles were only counted in the first overlapped cycle. If an AE occurred multiple times in different cycles, it was counted once in each cycle. If an AE occurred multiple times within the same cycle, it was counted only once. If a patient experienced multiple events under the same MedDRA 20.0 preferred term, then the patient was counted only once for that preferred term3
- Patients who met the criteria and remained on double-blind treatment after completion of Week 25 assessment may have continued dosing in the extension phase of the treatment period until the subject experienced unacceptable toxicity, loss of efficacy, or disease progression1
- Fatigue TEAE does not include broader asthenic conditions adverse drug reactions (ADRs)
Additional analysis information
- Analysis is based on data through Week 48
- The chart displays TEAEs independent of attribution of treatment or disease. The percentage shown in this graph does not match the Adverse Reactions table above
- TEAEs are undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment
BSC=best supportive care; MedDRA=Medical Dictionary for Regulatory Activities; TEAE=treatment-emergent adverse event.