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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
Generic Availability
NO
Reblozyl Indications
Indications
Treatment of anemia in adults with beta thalassemia who require regular red blood cell (RBC) transfusions. Treatment of anemia failing an erythropoiesis stimulating agent 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
See Literature
Reblozyl Interactions
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
