Learn more information about the phase 3 study for REBLOZYL
FDA Approved for Anemia
for patients with ring sideroblasts who
are failing an ESA and require ≥2 RBC units/8 weeks1
REBLOZYL is indicated for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell 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 is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.
Efficacy and safety results from the pivotal phase 3 MEDALIST trial
Warnings and precautions1
Thrombosis/Thromboembolism
In adult patients with beta thalassemia, thromboembolic events (TEE) were reported in 8/223 (3.6%) REBLOZYL-treated patients. TEEs included deep vein thrombosis, pulmonary embolus, portal vein thrombosis, and ischemic stroke. Patients with known risk factors for thromboembolism (splenectomy or concomitant use of hormone replacement therapy) may be at further increased risk of thromboembolic conditions. Consider thromboprophylaxis in patients at increased risk of TEE. Monitor patients for signs and symptoms of thromboembolic events and institute treatment promptly.
Please see additional Important Safety Information below and full Prescribing Information.
REBLOZYL was studied in the multicenter, randomized, double‑blind, placebo‑controlled, phase 3 MEDALIST trial1,2
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* The primary efficacy assessment was conducted after completion of 24 weeks on study drug. Patients with a decrease in transfusion requirement or increase in Hgb could continue on blinded study drug thereafter until unacceptable toxicity, loss of efficacy, or disease progression.

del 5q, deletion 5q; EPO, erythropoietin; ESA, erythropoiesis-stimulating agent; IPSS-R, Revised International Prognostic Scoring System; RBC, red blood cell; SC, subcutaneous.
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The pivotal phase 3 MEDALIST trial included patients with MDS1,2
  The median age was 71 years (range, 26–95)1
  While 39% (90/229) of all patients in the trial had serum EPO >200 U/L, 95.2% (218/229) of patients were ESA-exposed and only 4.8% (11/229) were ESA-naive with serum EPO >200 U/L1,2*
  57% (130/229) of patients had <6 RBC units/8 weeks1
  Baseline IPSS-R risk categories: very low-risk (10%; 24/229), low-risk (72%; 166/229), intermediate-risk (17%; 38/229)1
  87% (200/229) of patients had an MDS diagnosis and 10% (23/229) were diagnosed with MDS/MPN‑RS‑T1
* Baseline EPO was defined as the highest EPO value within 35 days of the first dose of study drug.
REBLOZYL provided significant clinical benefit by increasing RBC transfusion independence vs placebo1
PRIMARY ENDPOINT: RBC-TI ≥8 WEEKS DURING WEEKS 1 TO 241
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CI, confidence interval; RBC-TI, red blood cell transfusion independence.
KEY SECONDARY ENDPOINTS: RBC-TI ≥12 WEEKS1
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a The median (range) duration of treatment was 49 weeks (6–114 weeks) on the REBLOZYL arm and 24 weeks (7–89 weeks) on the placebo arm.
RBC-ti ≥8 weeks during weeks 1 to 24 by diagnosis and baseline transfusion burden in medalist1
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a Includes MDS-EB-1, MDS-EB-2, and MDS-U.
b Includes patients who received 3.5 units.
c Includes patients who received 5.5 units.
  MDS-EB-1, myelodysplastic syndromes with excess blasts (5%–9% in the bone marrow or 2%–4% in the blood); MDS-EB-2, myelodysplastic syndromes with excess blasts (10%–19% in the bone marrow or 5%–19% in the blood); MDS-U, myelodysplastic syndromes, unclassifiable.
Adverse reactions with REBLOZYL1
  The most common (≥2%) Grade ≥3 adverse reactions included fatigue, hypertension, syncope, and musculoskeletal pain. A fatal adverse reaction occurred in 5 (2.1%) patients
  The most common (≥10%) all-grade adverse reactions included fatigue, musculoskeletal pain, dizziness, diarrhea, nausea, hypersensitivity reactions, hypertension, headache, upper respiratory tract infection, bronchitis, and urinary tract infection
Important Safety Information
Warnings and Precautions
Thrombosis/Thromboembolism
In adult patients with beta thalassemia, thromboembolic events (TEE) were reported in 8/223 (3.6%) REBLOZYL-treated patients. TEEs included deep vein thrombosis, pulmonary embolus, portal vein thrombosis, and ischemic stroke. Patients with known risk factors for thromboembolism (splenectomy or concomitant use of hormone replacement therapy) may be at further increased risk of thromboembolic conditions. Consider thromboprophylaxis in patients at increased risk of TEE. Monitor patients for signs and symptoms of thromboembolic events and institute treatment promptly.
Hypertension
Hypertension was reported in 10.7% (61/571) of REBLOZYL-treated patients. Across clinical studies, the incidence of Grade 3 to 4 hypertension ranged from 1.8% to 8.6%. In adult patients with MDS with normal baseline blood pressure, 26 (29.9%) patients developed SBP ≥130 mm Hg and 23 (16.4%) patients developed DBP ≥80 mm Hg. Monitor blood pressure prior to each administration. Manage new or exacerbations of preexisting hypertension using anti-hypertensive agents.
Embryo-Fetal Toxicity
REBLOZYL may cause fetal harm when administered to a pregnant woman. REBLOZYL caused increased post-implantation loss, decreased litter size, and an increased incidence of skeletal variations in pregnant rat and rabbit studies. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 3 months after the final dose.
Adverse Reactions
Grade ≥3 (≥2%) adverse reactions included fatigue, hypertension, syncope and musculoskeletal pain. A fatal adverse reaction occurred in 5 (2.1%) patients.
The most common (≥10%) adverse reactions included fatigue, musculoskeletal pain, dizziness, diarrhea, nausea, hypersensitivity reactions, hypertension, headache, upper respiratory tract infection, bronchitis, and urinary tract infection.
Lactation
It is not known whether REBLOZYL is excreted into human milk or absorbed systemically after ingestion by a nursing infant. REBLOZYL was detected in milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because many drugs are excreted in human milk, and because of the unknown effects of REBLOZYL in infants, a decision should be made whether to discontinue nursing or to discontinue treatment. Because of the potential for serious adverse reactions in the breastfed child, breastfeeding is not recommended during treatment and for 3 months after the last dose.
Please see full Prescribing Information for REBLOZYL.
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How to Access Reblozyl
Celgene Patient Support®
References: 1. REBLOZYL [Prescribing Information]. Summit, NJ: Celgene Corporation; 2020. 2. Data on file. Celgene Corporation. Summit, New Jersey.

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© 2020 Celgene Corporation.
REBLOZYL and Celgene Patient Support® are trademarks of Celgene Corporation, a Bristol Myers Squibb company.
REBLOZYL is licensed from Acceleron Pharma Inc.
06/20  US-RBZ-20-0266

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