Brand Name
Reblozyl
Generic Name
Luspatercept
View Brand Information FDA approval date: November 08, 2019
Classification: Erythroid Maturation Agent
Form: Injection
What is Reblozyl (Luspatercept)?
REBLOZYL is an erythroid maturation agent indicated for the treatment of: Anemia in adult patients with beta thalassemia who require regular red blood cell transfusions.
Approved To Treat
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Related Clinical Trials
A Phase 2, Study for the Treatment of Anemia With Alpha (α)-Thalassemia to Determine the Efficacy and Safety of Luspatercept (BMS-986346/ACE-536) in Adults and Evaluate the Safety and Pharmacokinetics in Adolescents
Summary: The purpose of the study is to evaluate the efficacy and safety of luspatercept plus best supportive care (BSC) vs placebo plus BSC on anemia in adult participants with α-thalassemia hemoglobin H (HbH) disease and determine the safety and drug levels in adolescent participants.
A Phase II Study of Luspatercept Plus Darbepoetin Alfa in Non-mutated SF3B1 Lower-risk Myelodysplastic Syndromes
Summary: This is a single arm open-label Phase II trial of luspatercept and darbepoetin alfa in non-mutated SF3B1 , lower-risk, RBC transfusion dependent MDS participants with an endogenous erythropoietin (EPO) level \< 500 IU/L.
A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) vs Epoetin Alfa for the Treatment of Anemia Due to Revised International Prognostic Scoring System (IPSS-R) Very Low, Low, or Intermediate-Risk Myelodysplastic Syndrome (MDS) in Erythropoiesis-Stimulating Agent (ESA)-Naive Participants Who Are Non-Transfusion Dependent (NTD): The ELEMENT-MDS Trial
Summary: The purpose of the study is to compare the efficacy and safety of Luspatercept vs epoetin alfa in the treatment of anemia in adults due to IPSS-R very low, low, intermediate-risk MDS in ESA-naïve participants who are non-transfusion dependent (NTD).
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Brand Information
Reblozyl (Luspatercept)
1DOSAGE FORMS AND STRENGTHS
- For injection: 25 mg white to off-white lyophilized powder in a single-dose vial for reconstitution.
- For injection: 75 mg white to off-white lyophilized powder in a single-dose vial for reconstitution.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Thrombosis/Thromboembolism
- Hypertension
- Extramedullary Hematopoietic Masses
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data in the WARNINGS AND PRECAUTIONS reflect exposure to REBLOZYL as a single agent administered across a range of doses (0.125 mg/kg to 1.75 mg/kg) in 571 patients in 4 trials.
4DESCRIPTION
Luspatercept-aamt is an erythroid maturation agent. Luspatercept-aamt is a receptor fusion protein consisting of a modified extracellular domain of the human activin receptor type IIB linked to a human IgG1 Fc domain with a calculated molecular mass of approximately 76 kD. Luspatercept is produced in Chinese hamster ovary cells by recombinant DNA technology.
REBLOZYL (luspatercept-aamt) for injection is a sterile, preservative-free, white to off-white, lyophilized powder in single-dose vials for subcutaneous use after reconstitution.
Each 25 mg single-dose vial provides nominal 25 mg of luspatercept-aamt and citric acid monohydrate (0.085 mg), polysorbate 80 (0.10 mg), sucrose (45 mg), and tri-sodium citrate dihydrate (1.35 mg) at pH 6.5. After reconstitution with 0.68 mL Sterile Water for Injection USP, the resulting concentration is 25 mg/0.5 mL of luspatercept-aamt and the nominal deliverable volume is 0.5 mL.
Each 75 mg single-dose vial provides nominal 75 mg of luspatercept-aamt and citric acid monohydrate (0.254 mg), polysorbate 80 (0.30 mg), sucrose (135 mg), and tri-sodium citrate dihydrate (4.06 mg) at pH 6.5. After reconstitution with 1.6 mL Sterile Water for Injection USP, the resulting concentration is 75 mg/1.5 mL (50 mg/mL) of luspatercept-aamt and the nominal deliverable volume is 1.5 mL.
5PATIENT COUNSELING INFORMATION
Discuss the following with patients prior to and during treatment with REBLOZYL.
6PRINCIPAL DISPLAY PANEL - 25 mg Vial Label
NDC 59572-711-01
Reblozyl
25 mg/vial
For Subcutaneous Use Only
LOT
7PRINCIPAL DISPLAY PANEL - 25 mg Vial Carton - USA
NDC 59572-711-01
Reblozyl
25 mg/vial
For Subcutaneous Use Only
One Single-Dose Vial
8PRINCIPAL DISPLAY PANEL - 25 mg Vial Carton - Singapore
NDC 59572-711-01
Reblozyl
25 mg/vial
For Subcutaneous Use Only
One Single-Dose Vial
9PRINCIPAL DISPLAY PANEL - 75 mg Vial Label
NDC 59572-775-01
Reblozyl
75 mg/vial
For Subcutaneous Use Only
LOT
10PRINCIPAL DISPLAY PANEL - 75 mg Vial Carton - USA
NDC 59572-775-01
Reblozyl
75 mg/vial
For Subcutaneous Use Only
One Single-Dose Vial
11PRINCIPAL DISPLAY PANEL - 75 mg Vial Carton - Singapore
NDC 59572-775-01
Reblozyl
75 mg/vial
For Subcutaneous Use Only
One Single-Dose Vial
