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Addressing Treatment Gaps Among Patients with MDS-Associated Anemia

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When considering treatment for anemia in lower-risk MDS patients, how is a treatment path determined and what are promising options?

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  • Overview

    Patients with lower-risk myelodysplastic syndromes (MDS) lack treatment options, specifically in treating anemia. However, the FDA approval of Reblozyl (luspatercept-aamt) as a first-line therapy for treating anemia in ESA-naïve patients with lower-risk MDS presents an option for this patient population. Tune in to learn more about evaluating patients with MDS, the potential of Reblozyl, and where it fits into the treatment landscape with Dr. Charles Turck as he takes a deep dive with Dr. Jamie Koprivnikar, MD, Hematologist, Oncologist, at Hackensack Meridian Health.

    REBLOZYL® is a trademark of Celgene Corporation, a Bristol Myers Squibb company.
    REBLOZYL® is licensed from Merck & Co. Inc., Rahway, NJ, USA and its affiliates.
    © 2024 Bristol-Myers Squibb Company
    2007-US-2300376 03/24

  • INDICATIONS

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

  • IMPORTANT SAFETY INFORMATION

    WARNINGS AND PRECAUTIONS

    Thrombosis/Thromboembolism
    In adult patients with beta thalassemia, thromboembolic events (TEE) were reported in 8/223 (3.6%) of 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 11.4% (63/554) of REBLOZYL-treated patients. Across clinical studies, the incidence of Grade 3 to 4 hypertension ranged from 2% to 9.6%. In ESA-refractory or -intolerant adult patients with MDS with normal baseline blood pressure, 26 (30%) patients developed systolic blood pressure (SBP) ≥130 mm Hg and 23 (16%) patients developed diastolic blood pressure (DBP) ≥80 mm Hg. In ESA-naïve adult patients with MDS with normal baseline blood pressure, 23 (36%) patients developed SBP ≥140 mm Hg and 11 (6%) 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

    ESA-naïve adult patients with Myelodysplastic Syndromes
    Grade ≥3 (≥2%) adverse reactions included hypertension and dyspnea.

    The most common (≥10%) all-grade adverse reactions included diarrhea, fatigue, hypertension, peripheral edema, nausea, and dyspnea.

    ESA-refractory or -intolerant adult patients with Myelodysplastic Syndromes
    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.

    DRUG ABUSE POTENTIAL
    Abuse: Abuse of REBLOZYL may be seen in athletes for the effects on erythropoiesis. Misuse of drugs that increase erythropoiesis, such as REBLOZYL, by healthy persons may lead to polycythemia, which may be associated with life-threatening cardiovascular complications.

    Please see US Full Prescribing Information for REBLOZYL.

     

Schedule29 May 2024