Prescription medicine
Sutimlimab Brand names: Enjaymo
Sutimlimab (Enjaymo) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the sutimlimab FDA label on DailyMed (effective March 2, 2026); every sutimlimab label on DailyMed.
Highlights of the record
FDA label of March 2, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageENJAYMO is a classical complement inhibitor indicated for the treatment of hemolysis in adults with cold agglutinin disease (CAD).
Forms and strengths
- 50 mg/ml
Injection (solution) (concentrate).
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
- 311 through July 30, 2026
What is sutimlimab used for?
From the label: indications and usageENJAYMO is a classical complement inhibitor indicated for the treatment of hemolysis in adults with cold agglutinin disease (CAD). ( 1 ) Cold Agglutinin Disease ENJAYMO (sutimlimab-jome) is indicated for the treatment of hemolysis in adults with cold agglutinin disease (CAD).
FDA pharmacologic class: Classical Complement Pathway Inhibitor.
Source: FDA drug label (Enjaymo), Recordati Rare Diseases, Inc., effective March 2, 2026 (SPL set 0a25363a-7781-d9f8-cb1c-be22987bf03b), via openFDA; the full label on DailyMed
What does the patient leaflet for sutimlimab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ENJAYMO?ENJAYMO is a medicine that affects your immune system. ENJAYMO may lower the ability of your immune system to fight infections. ENJAYMO increases your chance of getting serious infections including those caused by encapsulated bacteria, including Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae type B. These serious infections may quickly become life-threatening or cause death if not recognized and treated early. You must complete or be up to date with the vaccines against Streptococcus pneumoniae and Neisseria meningitidis at least 2 weeks before your first dose of ENJAYMO. If your healthcare provider decides that urgent treatment with ENJAYMO is needed, you should receive vaccinations as soon as possible. If you have been vaccinated against these bacteria in the past, you might need additional vaccines before starting ENJAYMO. Your healthcare provider will decide if you need additional vaccines. Vaccines do not prevent all infections caused by encapsulated bacteria. Call your healthcare provider or get emergency medical care right away if you get any of these signs and symptoms of a serious infection: fever with or without shivers or chills fever with chest pain and cough fever with high heart rate headache and fever confusion clammy skin fever and a rash fever with breathlessness or fast breathing headache with nausea or vomiting headache with stiff neck or stiff back body aches with flu-like symptoms eyes sensitive to light For more information about side effects, see " What are the possible side effects of ENJAYMO? " What is ENJAYMO? ENJAYMO is a prescription medicine used to treat the breakdown of red blood cells (hemolysis) in adults with cold agglutinin disease (CAD). It is not known if ENJAYMO is safe and effective in children. […]
Source: FDA drug label (Enjaymo), Recordati Rare Diseases, Inc., effective March 2, 2026 (SPL set 0a25363a-7781-d9f8-cb1c-be22987bf03b), via openFDA; the full label on DailyMed
Is there a generic for sutimlimab (Enjaymo)?
No generic sutimlimab 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 sutimlimab?
The FDA Adverse Event Reporting System holds 311 reports that list sutimlimab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 51 are coded as a death and 67 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Sutimlimab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other