{
 "query": "luspatercept",
 "ingredient": "luspatercept",
 "slug": "luspatercept",
 "rxcui": "2262544",
 "brands": [],
 "names": [
  "luspatercept"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "SUBCUTANEOUS",
  "route_counts": {
   "SUBCUTANEOUS": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "is an erythroid maturation agent indicated for the treatment of: \u2022 Anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions ( 1.1 ). \u2022 Anemia without previous erythropoiesis stimulating agent use (ESA-na\u00efve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions ( 1.2 ). \u2022 Anemia failing an erythropoiesis stimulating agent and requiring 2 or more 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) ( 1.3 ). \u2022 Limitations of Use: REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia ( 1.4 ). 1.1 Beta Thalassemia REBLOZYL is indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions. 1.2 Myelodysplastic Syndromes Associated Anemia REBLOZYL is indicated for the treatment of anemia without previous erythropoiesis stimulating ...",
  "contraindications": "None. None ( 4 ).",
  "warnings_and_cautions": "\u2022 Thrombosis/Thromboembolism: Increased risk in patients with beta thalassemia. Monitor patients for signs and symptoms of thromboembolic events and institute treatment promptly ( 5.1 ). \u2022 Hypertension: Monitor blood pressure (BP) during treatment. Initiate anti-hypertensive treatment if necessary ( 5.2 ). \u2022 Extramedullary Hematopoietic (EMH) Masses: Increased risk in patients with beta thalassemia. Monitor patients for symptoms and signs or complications resulting from the EMH masses. Treat according to clinical guidelines and discontinue treatment in case of serious complications due to EMH masses ( 5.3 ). \u2022 Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception ( 5.4 , 8.1 , 8.3 ). 5.1 Thrombosis/Thromboembolism In adult patients with beta thalassemia, thromboembolic events (TEE) were reported in 8/223 (3.6%) REBLOZYL-treated patients. Reported TEEs included deep vein thromboses, pulmonary embolus, portal vein thrombosis, and ischemic strokes. Patients with known risk factors for thromboembolism, e.g. splenectomy or concomitant use of hormone replacement therapy, may be at further ...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in the labeling: \u2022 Thrombosis/Thromboembolism [see Warnings and Precautions ( 5.1 )] \u2022 Hypertension [see Warnings and Precautions ( 5.2 )] \u2022 Extramedullary Hematopoietic Masses [see Warnings and Precautions ( 5.3 )] The most common (>10%) adverse reactions were fatigue, headache, musculoskeletal pain, arthralgia, dizziness/vertigo, nausea, diarrhea, cough, abdominal pain, dyspnea, COVID-19, edema peripheral, hypertension, and hypersensitivity ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-888-423-5436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data in the WARNINGS AND PRECAUTIONS reflect exposure to REBLOZYL as a single agent administered across a range of doses (0.125 mg/kg to 1.75 mg/kg) in 571 patients in 4 trials. Beta Thalassemia The safety of REBLOZYL in patients ...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Dosage and Administration, Recommended Dosage for Beta Thalassemia ( 2.1 ) 2/2026 Dosage and Administration, Recommended Dosage for Myelodysplastic Syndromes Associated Anemia ( 2.2 ) 2/2026",
  "information_for_patients": "Discuss the following with patients prior to and during treatment with REBLOZYL. Thromboembolic Events Advise beta thalassemia patients of the potential risk of thromboembolic events. Review known risk factors for developing thromboembolic events and advise patients to reduce modifiable risk factors (e.g., smoking, use of oral contraceptives) [see Warnings and Precautions ( 5.1 )] . Effects on Blood Pressure Caution patients that REBLOZYL may cause an increase in blood pressure [see Warnings and Precautions ( 5.2 )] . Extramedullary Hematopoietic Masses Advise patients with beta thalassemia of the potential risk of extramedullary hematopoietic masses. Review possible risk factors for developing extramedullary hematopoietic masses. Instruct patients to report possible signs and symptoms of EMH masses [see Warnings and Precautions ( 5.3 )] . Embryo-Fetal Toxicity Advise females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception while receiving REBLOZYL and for at least 3 months after the final dose. Advise females to contact their healthcare provider if they become pregnant, or if pregnancy is suspected,...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Beta Thalassemia The efficacy of REBLOZYL was evaluated in adult patients with beta thalassemia in the BELIEVE trial (NCT02604433). BELIEVE was a multicenter, randomized, double-blind, placebo-controlled trial in which (n=336) patients with beta thalassemia requiring regular red blood cell transfusions (6-20 RBC units per 24 weeks) with no transfusion-free period greater than 35 days during that period were randomized 2:1 to REBLOZYL (n=224) or placebo (n=112). In BELIEVE, REBLOZYL was administered subcutaneously once every 3 weeks as long as a reduction in transfusion requirement was observed or until unacceptable toxicity. All patients were eligible to receive best supportive care, which included RBC transfusions; iron-chelating agents; use of antibiotic, antiviral, and antifungal therapy; and/or nutritional support, as needed. The BELIEVE trial excluded patients with a diagnosis of Hemoglobin S/\u03b2-thalassemia or isolated alpha (\u03b1)-thalassemia (e.g., Hemoglobin H) or who had major organ damage (liver disease, heart disease, lung disease, renal insufficiency). Patients with recent deep vein thrombosis or stroke or recent use of ESA, immunosuppressant, or hydroxyurea therapy we...",
  "brand_name": "Reblozyl",
  "manufacturer": "Celgene Corporation",
  "application_number": "BLA761136",
  "pharm_class_epc": [
   "Erythroid Maturation Agent [EPC]"
  ],
  "route": [
   "SUBCUTANEOUS"
  ],
  "effective_time": "20260227",
  "set_id": "82f4d266-3f52-41eb-86ba-0abf3cf468e8",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 398,
  "serious": 338,
  "death": 75,
  "hospitalization": 139,
  "primary_suspect": 398,
  "top_reactions": [
   [
    "Off Label Use",
    32
   ],
   [
    "Death",
    31
   ],
   [
    "Drug Ineffective",
    26
   ],
   [
    "Fatigue",
    24
   ],
   [
    "Haemoglobin Decreased",
    21
   ],
   [
    "Pneumonia",
    16
   ],
   [
    "Anaemia",
    15
   ],
   [
    "Thrombocytopenia",
    14
   ],
   [
    "Hypertension",
    12
   ],
   [
    "Malaise",
    12
   ],
   [
    "Acute Myeloid Leukaemia",
    11
   ],
   [
    "Asthenia",
    11
   ],
   [
    "Dizziness",
    11
   ],
   [
    "Dyspnoea",
    10
   ],
   [
    "Extramedullary Haemopoiesis",
    10
   ]
  ],
  "by_year": {
   "2019": 3,
   "2020": 20,
   "2021": 64,
   "2022": 58,
   "2023": 55,
   "2024": 69,
   "2025": 52,
   "2026": 76
  },
  "by_year_primary": {
   "2019": 3,
   "2020": 20,
   "2021": 64,
   "2022": 58,
   "2023": 55,
   "2024": 69,
   "2025": 52,
   "2026": 76
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 0,
  "nda": 0,
  "anda": 0,
  "first_approval": "",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [],
  "unapproved": false,
  "first_approval_fmt": ""
 },
 "trials": {
  "total": 72,
  "completed": 19,
  "terminated": 7,
  "with_results": 13,
  "industry": 45,
  "phase3": 12,
  "results_share": 0.6842105263157895,
  "terminated_share": 0.09722222222222222
 },
 "pubmed": {
  "rct": 14,
  "meta": 3,
  "recent_rct": 12,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "luspatercept"
  ],
  "source": "bulk-index"
 },
 "partd": null,
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [],
   "weight": 0.35
  },
  "evidence": {
   "score": 35,
   "letter": "F",
   "why": [
    "14 randomized trials and 3 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 95,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 40,
   "letter": "F",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 77,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are death, fatigue. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}