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

This website is intended for US Healthcare Professionals.

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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SUPPORT AND RESOURCES: HCP AND PATIENT RESOURCES

REBLOZYL resources

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COMMANDS Trial & Efficacy Information

Learn about the COMMANDS trial data and how it can help as a first-line treatment in MDS-associated anemia.

Download Trial Data
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MDS First-line Dosing Guide

Clear and detailed guidance on dosing REBLOZYL as first-line treatment to optimize response in patients with MDS-associated anemia.

Download Guide
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MDS First-line Dosing and Reconstitution Guide

How to dose and administer REBLOZYL as first-line treatment for your patients with MDS-associated anemia.

Download Guide
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Beta-thalassemia Dosing Flashcard

Clear and detailed guidance on dosing REBLOZYL to optimize response in patients with beta-thalassemia.

Download Flashcard

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REBLOZYL MDS Patient Brochure

A guide for patients living with MDS-RS–associated anemia to learn more about REBLOZYL.

Download English Brochure Download Spanish Brochure
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MDS Education Brochure

Give this brochure to your patients and caregivers so they can learn more about MDS, MDS-associated anemia, and support for people living with MDS.

Download Brochure
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MDS Patient Website

An information-filled resource where MDS patients can sign up for information about REBLOZYL.

Visit Patient Site
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REBLOZYL Treatment Tracker

A tool to help you track your transfusions and communicate your symptoms to your healthcare team.

Download Tracker
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REBLOZYL Beta-thalassemia Patient Brochure

A guide for patients living with beta-thalassemia–associated anemia to learn more about REBLOZYL.

Download Brochure
Website icon Website icon

Beta-thalassemia Patient Website

An information-filled resource where beta-thalassemia patients with beta-thalassemia can sign up for information about REBLOZYL.

Visit Patient Site
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REBLOZYL in patients with MDS-associated anemia1

Efficacy of first-line treatment in MDS patients

Efficacy of second-line treatment in MDS patients

Drip bag icon

REBLOZYL reduces transfusion burden in patients with beta-thalassemia1

Efficacy in beta-thalassemia

SUPPORT AND RESOURCES: HCP AND PATIENT RESOURCES

REBLOZYL resources

Book icon Book icon

COMMANDS Trial & Efficacy Information

Learn about the COMMANDS trial data and how it can help as a first-line treatment in MDS-associated anemia.

Download Trial Data
Syringe plus icon Syringe plus icon

MDS First-line Dosing Guide

Clear and detailed guidance on dosing REBLOZYL as first-line treatment to optimize response in patients with MDS-associated anemia.

Download Guide
Book icon Book icon

MDS First-line Dosing and Reconstitution Guide

How to dose and administer REBLOZYL as first-line treatment for your patients with MDS-associated anemia.

Download Guide
Syringe icon Syringe icon

Beta-thalassemia Dosing Flashcard

Clear and detailed guidance on dosing REBLOZYL to optimize response in patients with beta-thalassemia.

Download Flashcard

Book icon Book icon

REBLOZYL MDS Patient Brochure

A guide for patients living with MDS-RS–associated anemia to learn more about REBLOZYL.

Download English Brochure Download Spanish Brochure
Book icon Book icon

MDS Education Brochure

Give this brochure to your patients and caregivers so they can learn more about MDS, MDS-associated anemia, and support for people living with MDS.

Download Brochure
Website icon Website icon

MDS Patient Website

An information-filled resource where MDS patients can sign up for information about REBLOZYL.

Visit Patient Site
Checklist icon Checklist icon

REBLOZYL Treatment Tracker

A tool to help you track your transfusions and communicate your symptoms to your healthcare team.

Download Tracker
Book icon Book icon

REBLOZYL Beta-thalassemia Patient Brochure

A guide for patients living with beta-thalassemia–associated anemia to learn more about REBLOZYL.

Download Brochure
Website icon Website icon

Beta-thalassemia Patient Website

An information-filled resource where beta-thalassemia patients with beta-thalassemia can sign up for information about REBLOZYL.

Visit Patient Site
Drip bag icon

REBLOZYL in patients with MDS-associated anemia1

Efficacy of first-line treatment in MDS patients

Efficacy of second-line treatment in MDS patients

Drip bag icon

REBLOZYL reduces transfusion burden in patients with beta-thalassemia1

Efficacy in beta-thalassemia

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.

Reference: 1. REBLOZYL [US Prescribing Information]. Summit, NJ: Celgene Corporation; 2023.

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GLOBAL Bristol Myers SquibbTM logo

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

Reference: 1. REBLOZYL [US Prescribing Information]. Summit, NJ: Celgene Corporation; 2023.