Prescription medicine
Luspatercept Brand names: Reblozyl
Luspatercept (Reblozyl) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the luspatercept FDA label on DailyMed (effective February 27, 2026); every luspatercept label on DailyMed.
Highlights of the record
FDA label of February 27, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageREBLOZYL is an erythroid maturation agent indicated for the treatment of:
Anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions ( 1.1 ).
Forms and strengths
- 25 mg
- 75 mg
Injection (powder) (lyophilized) for solution.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,464 through July 30, 2026
What is luspatercept used for?
From the label: indications and usageREBLOZYL is an erythroid maturation agent indicated for the treatment of:
Anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions ( 1.1 ).
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 ( 1.2 ). […]
Conditions named in the indications of luspatercept's FDA labels, with every medicine labeled for each:
From other luspatercept labelsAnemia: Myelodysplastic Syndromes Associated Anemia REBLOZYL 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 …
FDA pharmacologic class: Erythroid Maturation Agent.
Source: FDA drug label (Reblozyl), Celgene Corporation, effective February 27, 2026 (SPL set 82f4d266-3f52-41eb-86ba-0abf3cf468e8), via openFDA; the full label on DailyMed
Is there a generic for luspatercept (Reblozyl)?
No generic luspatercept is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for luspatercept?
The FDA Adverse Event Reporting System holds 2,464 reports that list luspatercept among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 393 are coded as a death and 531 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as luspatercept?
1 other medicine is given the same way (subcutaneous) and in the same FDA class as luspatercept or labeled mainly for the same use (anemia), the same class first. Anemia lists all 25 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Cyanocobalamin | Anemia | 1 labeler | $1.47 per mL 1,000 mcg/mL vial | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Luspatercept side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other