Molecule
Sutimlimab is a classical complement pathway inhibitor indicated for the treatment of hemolysis in adults with cold agglutinin disease (CAD). It is available as injection for intravenous use. MedsAcross supplies Sutimlimab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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).
Source: US FDA prescribing information
Sutimlimab-jome is an immunoglobulin G (IgG), subclass 4 (IgG4) monoclonal antibody (mAb) that inhibits the classical complement pathway (CP) and specifically binds to complement protein component 1, s subcomponent (C1s), a serine protease which cleaves C4. Sutimlimab-jome does not inhibit the lectin and alternative pathways. Inhibition of the classical complement pathway at the level of C1s prevents deposition of complement opsonins on the surface of RBCs, resulting in inhibition of hemolysis in patients with CAD.
Source: US FDA prescribing information
Vaccinate against encapsulated bacteria at least two weeks prior to treatment. Weight-based dosage weekly for two weeks then every two weeks: For patients weighing 39 kg to less than 75 kg: 6,500 mg by intravenous infusion. For patients weighing 75 kg or more: 7,500 mg by intravenous infusion. See Full Prescribing Information for important preparation and administration instructions.
Source: US FDA prescribing information
ENJAYMO is contraindicated in patients with known hypersensitivity to sutimlimab-jome or any of the inactive ingredients.
Source: US FDA prescribing information
Serious Infections: Ensure patients are vaccinated against encapsulated bacteria. Monitor patients for early signs and symptoms of infections. Infusion-Related Reactions: Monitor patients for infusion-related reactions, interrupt if reaction occurs, and institute appropriate medical management as needed. Risk of Autoimmune Disease: Monitor patients for signs and symptoms and manage medically. Recurrent Hemolysis After ENJAYMO Discontinuation: Monitor patients for signs and symptoms of hemolysis if treatment with ENJAYMO is interrupted.
Source: US FDA prescribing information
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Serious Infections Infusion-Related Reactions Risk of Autoimmune Disease Recurrent Hemolysis After ENJAYMO Discontinuation Most common adverse reactions in the CADENZA study (Part A) (incidence ≥18%) are rhinitis, headache, hypertension, acrocyanosis, and Raynaud's phenomenon. The most common adverse reactions in the CARDINAL study (incidence ≥25%) are urinary tract infection, respiratory tract infection, bacterial infection, dizziness, fatigue, peripheral edema, arthralgia, cough, hypertension, and nausea.
Source: US FDA prescribing information
Store ENJAYMO vials refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. Do not freeze. Do not shake.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Sutimlimab, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Enjaymo 1100 mg/22 mL injectionIntravenous Cold chain | Recordati Rare Diseases | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Sutimlimab and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Sutimlimab, including Enjaymo.
Yes. The US FDA first approved Sutimlimab on 4 February 2022, according to Drugs@FDA.
Yes. Sutimlimab has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Sutimlimab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Sutimlimab is classified under ATC code L04AJ04 (Sutimlimab).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.