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

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 connnective tissue disorders

Musculoskeletal painb		 30 (20) 3 (2) 11 (14) 0 (0)
Nervous system disorders

Dizziness/Vertigo
Headacheb
Syncope/Presyncope

28 (18)
21 (14)
8 (5)

1 (<1)
0 (0)
5 (3)

5 (7)
5 (7)
0 (0)

1 (1)
0 (0)
0 (0)
Gastrointestinal disorders

Nauseab
Diarrheab		 25 (16)
25 (16)		 1 (<1)
0 (0)		 8 (11)
7 (9)		 0 (0)
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
Influenza/Influenza-like illness		 10 (7)

9 (6)		 1 (<1)

0 (0)		 2 (3)

2 (3)		 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

Important considerations while treating patients with REBLOZYL

Liver function abnormalities1

Immunogenicity1

Additional safety data

Discontinuations and dose modifications in MEDALIST1

Dose delays and reductions in MEDALIST2

Review how to dose REBLOZYL to optimize patient response

View dosing

References: 1. REBLOZYL [US Prescribing Information]. Summit, NJ: Celgene Corporation; 2023. 2. Platzbecker U, Fenaux, P, Mufti GJ, et al. 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.

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.

For more information, please see US Full Prescribing Information for REBLOZYL.

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2007-US-2400451   12/2024