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BLOOD AND BLOOD FORMING ORGANS › ANTIANEMIC PREPARATIONS › OTHER ANTIANEMIC PREPARATIONS › Other antianemic preparations
luspatercept
B03XA06
Forms & Strengths
- Lyophilized powder for reconstitution: 25 mg in a single-dose vial
- Lyophilized powder for reconstitution: 75 mg in a single-dose vial
Adult Dosing
- Beta-thalassemia: 1.0 mg/kg subcutaneously once every 3 weeks
- Myelodysplastic syndromes (MDS) with ring sideroblasts or myelodysplastic/myeloproliferative neoplasms with ring sideroblasts and thrombocytosis (MDS/MPV-RS-T): 1.0 mg/kg subcutaneously once every 3 weeks
- Myelofibrosis: 1.0 mg/kg to 1.33 mg/kg subcutaneously once every 3 weeks
Pediatric Dosing
- Safety and efficacy have not been established in pediatric patients
Indications
- Treatment of anemia failing an erythropoiesis-stimulating agent and requiring regular red blood cell (RBC) transfusions in adult patients with beta-thalassemia
- Treatment of anemia in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts who have failed erythropoiesis-stimulating agent therapy
- Treatment of anemia associated with myelodysplastic syndromes with ring sideroblasts and thrombocytosis (MDS/MPV-RS-T) or myelodysplastic/myeloproliferative neoplasms
Mechanism of Action
- Recombinant fusion protein that acts as a ligand trap for specific TGF-beta superfamily ligands
- Binds to endogenous Smad2/3 signaling ligands, thereby reducing aberrant SMAD2/3 phosphorylation
- Promotes late-stage erythropoiesis and increases hemoglobin levels by enhancing erythroid maturation
Contraindications
- History of severe hypersensitivity to luspatercept or any of its excipients
- Pregnancy
Adverse Reactions
- Fatigue
- Musculoskeletal pain
- Arthralgia
- Dizziness
- Headache
- Hypertension
- Upper respiratory tract infection
- Nausea
- Diarrhea
- Thromboembolic events
Drug Interactions
- No formal clinical drug-drug interaction studies have been conducted
- No pharmacokinetic interactions expected with CYP450 enzymes or transporters based on protein nature of the drug
Curated Content: Needs Vetting Before Put to Clinical Use