This website is intended for US Healthcare Professionals.
This website is intended for US Healthcare Professionals.
Request a RepINDICATIONS
REBLOZYL (luspatercept-aamt) is indicated for the treatment of anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions.
REBLOZYL (luspatercept-aamt) is indicated for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks in adult patients 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).
REBLOZYL (luspatercept-aamt) is indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.
REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.
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ESA FAILURE
Plan for what's next
Only 1 in 3 patients with MDS may respond to ESAs.1
Duration of response ranges from 6 to 18 months.1-3*
The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) defines lack of response to ESAs as4:
<1.5 g/dL rise in hemoglobin by
No decrease in RBC transfusion requirement by
NCCN=National Comprehensive Cancer Network (NCCN®).
When ESAs fail, REBLOZYL can provide meaningful benefit for your patients
Hear from an expert how lower-risk MDS patients may need an alternative treatment option after ESA failure
International Working Group (IWG) 2006 Criteria for Hi-E: Hgb increase by 1.5 g/dL for at least 8 weeks or reduction of RBC transfusions by an absolute number of at least 4 RBC transfusions/8 weeks compared with the pretreatment transfusion number in the previous 8 weeks
Fenaux Study Design: A phase 3, double-blind, placebo-controlled study to assess the efficacy and safety of epoetin-α in IPSS low- or intermediate-1 risk (ie, low risk) MDS patients (N=130) with Hgb≤10 g/dL, with no or moderate RBC transfusion dependence (≤4 RBC units/8 weeks). Patients were randomized 2:1 to receive epoetin-α 450 IU/kg/week or placebo for 24 weeks, followed by treatment extension in responders. The primary endpoint was erythroid response by IWG 2006 criteria through Week 24.
Park Study Design: A multinational, retrospective, cohort study of patients (N=1698) with non-del(5) lower-risk MDS treated with ESAs. Primary ESA failure was defined as the absence of erythroid response according to IWG 2006 criteria after 8 weeks of ESA treatment. Secondary failures of ESA treatment were defined as relapse after an initial Hi-E. The potential effects of primary and secondary failure on subsequent outcomes were evaluated.
Platzbecker Study Design: A phase 3, randomized, double-blind, placebo-controlled study of darbepoetin alfa in ESA-naïve patients (N=147) with low- or intermediate-1 risk MDS and anemia. Patients were randomized 2:1 to receive darbepoetin alfa or placebo for 24 weeks followed by 48 weeks of open-label darbepoetin alfa for all patients and ongoing long-term follow-up. Endpoints included transfusion incidence and Hi-E by IWG 2006 criteria.
*Based on the clinical trial results from Fenaux, Park and Platzbecker.
ESA FAILURE
Plan for what's next
Only 1 in 3 patients with MDS may respond to ESAs.1
Duration of response ranges from 6 to 18 months.1-3*
The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) defines lack of response to ESAs as4:
<1.5 g/dL rise in hemoglobin by
No decrease in RBC transfusion requirement by
NCCN=National Comprehensive Cancer Network (NCCN®).
When ESAs fail, REBLOZYL can provide meaningful benefit for your patients
Hear from an expert how lower-risk MDS patients may need an alternative treatment option after ESA failure
International Working Group (IWG) 2006 Criteria for Hi-E: Hgb increase by 1.5 g/dL for at least 8 weeks or reduction of RBC transfusions by an absolute number of at least 4 RBC transfusions/8 weeks compared with the pretreatment transfusion number in the previous 8 weeks
Fenaux Study Design: A phase 3, double-blind, placebo-controlled study to assess the efficacy and safety of epoetin-α in IPSS low- or intermediate-1 risk (ie, low risk) MDS patients (N=130) with Hgb≤10 g/dL, with no or moderate RBC transfusion dependence (≤4 RBC units/8 weeks). Patients were randomized 2:1 to receive epoetin-α 450 IU/kg/week or placebo for 24 weeks, followed by treatment extension in responders. The primary endpoint was erythroid response by IWG 2006 criteria through Week 24.
Park Study Design: A multinational, retrospective, cohort study of patients (N=1698) with non-del(5) lower-risk MDS treated with ESAs. Primary ESA failure was defined as the absence of erythroid response according to IWG 2006 criteria after 8 weeks of ESA treatment. Secondary failures of ESA treatment were defined as relapse after an initial Hi-E. The potential effects of primary and secondary failure on subsequent outcomes were evaluated.
Platzbecker Study Design: A phase 3, randomized, double-blind, placebo-controlled study of darbepoetin alfa in ESA-naïve patients (N=147) with low- or intermediate-1 risk MDS and anemia. Patients were randomized 2:1 to receive darbepoetin alfa or placebo for 24 weeks followed by 48 weeks of open-label darbepoetin alfa for all patients and ongoing long-term follow-up. Endpoints included transfusion incidence and Hi-E by IWG 2006 criteria.
*Based on the clinical trial results from Fenaux, Park and Platzbecker.