PATIENT OUTCOMES: SAFETY

REBLOZYL offers a demonstrated safety profile for beta-thalassemia patients1

ADVERSE REACTIONS (>5%) IN PATIENTS WITH BETA-THALASSEMIA RECEIVING REBLOZYL WITH A DIFFERENCE BETWEEN ARMS OF 1% IN THE BELIEVE TRIAL1

Body system/
Adverse
reaction

REBLOZYL

(n=223)

Placebo

(n=109)
All Grades
n (%)		 Grade 3*
n (%)		 All Grades
n (%)		 Grade ≥3
n (%)
Musculoskeletal
and connective
tissue disorders

Bone pain
Arthralgia		 44 (20)
43 (19)		 3 (1)
0 (0)		 9 (8)
13 (12)		 0 (0)
0 (0)
Infections and infestations

Influenza
Viral upper
respiratory infection		 19 (9)
14 (6)
 		 0 (0)
1 (0.4)
 		 6 (6)
2 (2)
 		 0 (0)
0 (0)
 
Nervous system disorders

Headache
Dizziness		 58 (26)
25 (11)		 1 (<1)
0 (0)		 26 (24)
5 (5)		 1 (1)
0 (0)
General disorders and administration-site conditions

Fatigue		 30 (14) 0 (0) 14 (13) 0 (0)
Gastrointestinal disorders

Abdominal pain†
Diarrhea
Nausea		 31 (14)
27 (12)
20 (9)		 0 (0)
1 (<1)
0 (0)		 13 (12)
11 (10)
6 (6)		 0 (0)
0 (0)
0 (0)
Vascular disorders

Hypertension‡		 18 (8) 4 (2) 3 (3) 0 (0)
Metabolism and nutrition disorders

Hyperuricemia		 16 (7) 6 (3) 0 (0) 0 (0)
Respiratory,
thoracic, and mediastinal
disorders

Cough		 32 (14) 0 (0) 12 (11) 0 (0)

*Limited to Grade 3 reactions with the exception of 4 events of Grade 4 hyperuricemia.
†Grouped term includes: Abdominal pain and abdominal pain upper.
‡Grouped term includes: Essential hypertension, hypertension, and hypertensive crisis.

The majority of adverse reactions with REBLOZYL were Grade 1 or 2 (mild to moderate)

  • The most common adverse reactions (at least 10% for REBLOZYL and 1% more than placebo) were headache (26%), bone pain (20%), arthralgia (19%), fatigue (14%), cough (14%), abdominal pain (14%), diarrhea (12%), and dizziness (11%)
  • Serious adverse reactions occurred in 3.6% of patients on REBLOZYL
  • Serious adverse reactions reported in 1% of patients were 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)

Important considerations while treating patients with REBLOZYL

ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; EMH=extramedullary hematopoietic; ULN=upper limit of normal.

Review how to dose REBLOZYL to achieve response

References: 1. REBLOZYL [US Prescribing Information]. Summit, NJ: Celgene Corporation; 2026. 2. Viprakasit V, Taher AT, Hermine O, et al. Evaluating luspatercept responders in the phase 3, randomized, double-blind, placebo-controlled BELIEVE trial of luspatercept in adult β-thalassemia patients who require regular red blood cell transfusions. Poster presented at: The 61st Annual Meeting of the American Society of Hematology (ASH); December 7-10, 2019. Orlando, FL, USA. 3. Data on file. Celgene Corporation. Summit, New Jersey. 4. Cappellini MD, Viprakasit V, Taher AT, et al. A phase 3 trial of luspatercept in patients with transfusion-dependent β-thalassemia. N Engl J Med. 2020;382(13):1219-1231.

References

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-2600044  05/26