Reblozyl

— THERAPEUTIC CATEGORIES —
  • Anemias
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Reblozyl Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Luspatercept-aamt 25mg, 75mg; per vial; lyophilized pwd for SC inj after reconstitution; preservative-free.

    Pharmacological Class

    Erythroid maturation agent.

    How Supplied

    Single-dose vial—1

    Manufacturer

    Celgene Corp

    Generic Availability

    NO

    Mechanism of Action

    Luspatercept-aamt is a recombinant fusion protein that binds several endogenous TGF-β superfamily ligands, thereby diminishing Smad2/3 signaling. Luspatercept-aamt promoted erythroid maturation through differentiation of late-stage erythroid precursors (normoblasts) in mice.

    Reblozyl Indications

    Indications

    Treatment of anemia in adults with beta thalassemia who require regular red blood cell (RBC) transfusions. Treatment of anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adults with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular RBC transfusions. Treatment of anemia failing an ESA and requiring ≥2 RBC units over 8 weeks in adults 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).

    Limitations of Use

    Not for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.

    Reblozyl Dosage and Administration

    Adult

    Dosing requiring larger reconstituted volume (>1.2mL), divide dose into separate similar volume injections and into separate sites (eg, upper arm, thigh, and/or abdomen). Give by SC inj. Beta thalassemia: initially 1mg/kg once every 3 weeks; if RBC transfusion burden is not achieved after ≥2 consecutive doses (6 weeks), increase to max 1.25mg/kg. MDS: initially 1mg/kg once every 3 weeks; if not RBC transfusion-free after ≥2 consecutive doses (6 weeks), then increase to 1.33mg/kg; may further increase after 6 weeks (2 doses) to max 1.75mg/kg. Both: reduce dose or interrupt if Hgb increase is >2g/dL within 3 weeks or predose Hgb ≥11.5g/dL, without transfusions (see full labeling). Discontinue if RBC transfusion burden does not decrease after 3 consecutive doses (9 weeks) at the max dose or if unacceptable toxicity occurs. Dose modifications for toxicity: see full labeling.

    Children

    Not recommended.

    Reblozyl Contraindications

    Not Applicable

    Reblozyl Boxed Warnings

    Not Applicable

    Reblozyl Warnings/Precautions

    Warnings/Precautions

    Increased risk of thromboembolism (eg, smokers, splenectomy, hormone replacement therapy); monitor and treat promptly if occurs. Consider thromboprophylaxis in patients with beta thalassemia at increased risk. Monitor BP prior to each dose; treat if new-onset or exacerbation of preexisting hypertension develops. Increased risk of extramedullary hematopoietic masses (EMH) in those with beta thalassemia (eg, history of EMH masses, splenectomy, splenomegaly, hepatomegaly, low baseline Hgb [<8.5g/dL]); monitor and treat accordingly. Discontinue if serious complications due to EMH masses develop. Assess Hgb results prior to each administration; if RBC transfusion occurred prior to dosing, consider the pretransfusion Hgb for dosing purposes. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥3 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 3 months after the last dose).

    Reblozyl Pharmacokinetics

    Absorption

    Median time to maximum concentration was observed at ~5 (range, 3–8) days post-dose in adults with beta thalassemia, or 6 (range, 3–7) days post-dose in adults with MDS.

    Distribution

    Apparent volume of distribution: 7.1 (26.7%) L for patients with beta thalassemia; 9.6 (26.7%) L for those with MDS.

    Metabolism

    Catabolic degradation.

    Elimination

    Half-life: ~11 days (beta thalassemia); ~13 days (MDS).

    Reblozyl Interactions

    Not Applicable

    Reblozyl Adverse Reactions

    Adverse Reactions

    Fatigue, headache, musculoskeletal pain, arthralgia, dizziness/vertigo, nausea, diarrhea, cough, abdominal pain, dyspnea, hypersensitivity (discontinue if Grade 3/4); cerebrovascular accident, thrombosis, hypertension.

    Reblozyl Clinical Trials

    See Literature

    Reblozyl Note

    Not Applicable

    Reblozyl Patient Counseling

    See Literature

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