Indications for: REBLOZYL
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.
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.
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).
Erythroid maturation agent.
Fatigue, headache, musculoskeletal pain, arthralgia, dizziness/vertigo, nausea, diarrhea, cough, abdominal pain, dyspnea, hypersensitivity (discontinue if Grade 3/4); cerebrovascular accident, thrombosis, hypertension.
Half-life: ~11 days (beta thalassemia); ~13 days (MDS).
Generic Drug Availability: