Quick answers
- What is Sutimlimab-jome used for?
- The FDA-approved label (Enjaymo, Recordati Rare Diseases, Inc., March 2, 2026) says: “ENJAYMO is a classical complement inhibitor indicated for the treatment of hemolysis in adults with cold agglutinin disease (CAD). Cold Agglutinin Disease ENJAYMO (sutimlimab-jome) is indicated for the treatment of hemolysis in adults with cold agglutinin disease (CAD).” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sutimlimab-jome have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Sutimlimab-jome?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sutimlimab-jome been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Sutimlimab-jome?
- 1 company lists prescription products of Sutimlimab-jome in the FDA NDC Directory, including Recordati Rare Diseases, Inc..
What Sutimlimab-jome is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ENJAYMO is a classical complement inhibitor indicated for the treatment of hemolysis in adults with cold agglutinin disease (CAD). Cold Agglutinin Disease ENJAYMO (sutimlimab-jome) is indicated for the treatment of hemolysis in adults with cold agglutinin disease (CAD).
— FDA label: Enjaymo, Recordati Rare Diseases, Inc., effective March 2, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution, concentrate |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Enjaymo |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Recordati Rare Diseases, Inc.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761164 ENJAYMO | Recordati Rare Diseases, Inc. | February 4, 2022 | 3, latest February 8, 2024 2024: Labeling · 2023: Efficacy · 2022: Manufacturing (CMC) |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2591419, 2591425 |
|---|---|
| SPL set ID of the quoted label | 0a25363a-7781-d9f8-cb1c-be22987bf03b |
| FDA labels (SPL) | 1 |
| FDA applications | BLA761164 |
| Active ingredients (FDA) | SUTIMLIMAB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Enjaymo, Recordati Rare Diseases, Inc., effective March 2, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →