This website is intended for US Healthcare Professionals.

Indications US Full Prescribing Information Patient Information Visit Patient Site BMS Connect
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.

Request
a Rep Request a Rep icon

DOSING AND ADMINISTRATION: RECONSTITUTING REBLOZYL

REBLOZYL should be reconstituted and administered by a healthcare professional1

  • REBLOZYL is administered subcutaneously and is available in 2 vial sizes (25 mg and 75 mg)
  • Reconstitute REBLOZYL with Sterile Water for Injection, USP only

Reconstitution volumes

Vial size Amount of Sterile Water for Injection, USP required for reconstitution Final concentration Deliverable volume
25 mg 0.68 mL 25 mg/0.5 mL 0.5 mL
75 mg 1.6 mL 75 mg/1.5 mL
(50 mg/mL)		 1.5 mL
25 mg vial 75 mg vial
Amount of Sterile Water for Injection, USP required for reconstitution 0.68 mL 1.6 mL
Final concentration 25 mg/0.5 mL 75 mg/1.5 mL (50 mg/mL)
Deliverable volume 0.5 mL 1.5 mL

Important considerations for REBLOZYL reconstitution

  • Reconstitute the number of REBLOZYL vials required to achieve the appropriate dose based on the patient’s weight
  • Use a syringe with suitable graduations for reconstitution to ensure accurate dosage

Instructions for reconstituting REBLOZYL1

Adhere to the following steps to properly reconstitute REBLOZYL for SC injection

First step icon

Add Sterile Water for Injection, USP

Reconstitute with Sterile Water for Injection, USP using volumes described in the Reconstitution Volumes table above with the stream directed onto the lyophilized powder. Allow to stand for 1 minute.

Adding sterile water to a vial Adding sterile water to a vial
Second step icon

Discard the needle and syringe used for reconstitution

The needle and syringe used for reconstitution should not be used for SC injections.

Safely discarding needle Safely discarding needle
Third step icon

Mix and wait

Gently swirl the vial in a circular motion for 30 seconds. Stop swirling and let the vial sit in an upright position for 30 seconds.

Holding vial Holding vial
Fourth step icon

Inspect the solution

Inspect the solution for undissolved particles. If undissolved powder is observed, repeat step 3 until the powder is completely dissolved.

Inspecting vial Inspecting vial
Fifth step icon

Mix and wait

Invert the vial and gently swirl in an inverted position for 30 seconds. Bring the vial back to the upright position, and let it sit for 30 seconds.

Swirling inverted vial Swirling inverted vial
Sixth step icon

Ensure reconstitution

Repeat step 5 seven more times to ensure complete reconstitution of material on the sides of the vial.

Inspecting vial Inspecting vial
Seventh step icon

Inspect

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. REBLOZYL is a colorless to slightly yellow, clear to slightly opalescent solution, which is free of foreign particulate matter. Do not use if undissolved product or foreign particulate matter is observed.

REBLOZYL® vial REBLOZYL® vial

DOSING AND ADMINISTRATION: RECONSTITUTING REBLOZYL

REBLOZYL should be reconstituted and administered by a healthcare professional1

  • REBLOZYL is administered subcutaneously and is available in 2 vial sizes (25 mg and 75 mg)
  • Reconstitute REBLOZYL with Sterile Water for Injection, USP only

Reconstitution volumes

Vial size Amount of Sterile Water for Injection, USP required for reconstitution Final concentration Deliverable volume
25 mg 0.68 mL 25 mg/0.5 mL 0.5 mL
75 mg 1.6 mL 75 mg/1.5 mL
(50 mg/mL)		 1.5 mL
25 mg vial 75 mg vial
Amount of Sterile Water for Injection, USP required for reconstitution 0.68 mL 1.6 mL
Final concentration 25 mg/0.5 mL 75 mg/1.5 mL (50 mg/mL)
Deliverable volume 0.5 mL 1.5 mL

Important considerations for REBLOZYL reconstitution

  • Reconstitute the number of REBLOZYL vials required to achieve the appropriate dose based on the patient’s weight
  • Use a syringe with suitable graduations for reconstitution to ensure accurate dosage

Instructions for reconstituting REBLOZYL1

Adhere to the following steps to properly reconstitute REBLOZYL for SC injection

First step icon

Add Sterile Water for Injection, USP

Reconstitute with Sterile Water for Injection, USP using volumes described in the Reconstitution Volumes table above with the stream directed onto the lyophilized powder. Allow to stand for 1 minute.

Adding sterile water to a vial Adding sterile water to a vial
Second step icon

Discard the needle and syringe used for reconstitution

The needle and syringe used for reconstitution should not be used for SC injections.

Safely discarding needle Safely discarding needle
Third step icon

Mix and wait

Gently swirl the vial in a circular motion for 30 seconds. Stop swirling and let the vial sit in an upright position for 30 seconds.

Holding vial Holding vial
Fourth step icon

Inspect the solution

Inspect the solution for undissolved particles. If undissolved powder is observed, repeat step 3 until the powder is completely dissolved.

Inspecting vial Inspecting vial
Fifth step icon

Mix and wait

Invert the vial and gently swirl in an inverted position for 30 seconds. Bring the vial back to the upright position, and let it sit for 30 seconds.

Swirling inverted vial Swirling inverted vial
Sixth step icon

Ensure reconstitution

Repeat step 5 seven more times to ensure complete reconstitution of material on the sides of the vial.

Inspecting vial Inspecting vial
Seventh step icon

Inspect

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. REBLOZYL is a colorless to slightly yellow, clear to slightly opalescent solution, which is free of foreign particulate matter. Do not use if undissolved product or foreign particulate matter is observed.

REBLOZYL® vial REBLOZYL® vial

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.

GLOBAL Bristol Myers SquibbTM logo
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.

© 2024 Bristol-Myers Squibb Company.
2007-US-2400257 10/2024

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