General Information

Enjaymo (sutimlimab-jome) is a classical complement inhibitor.

Enjaymo is specifically indicated to decrease the need for red blood cell (RBC) transfusion due to hemolysis in adults with cold agglutinin disease.

Enjaymo is supplied as an injection for intravenous use. 

Dosing and Administration:

• Vaccinate patients against encapsulated bacteria at least 2 weeks prior to initiation of Enjaymo therapy according to the most current Advisory Committee on Immunization Practices (ACIP) recommendations for patients with persistent complement deficiencies.
• The recommended dosage of Enjaymo for patients with CAD is based on body weight. For patients weighing 39 kg to less than 75 kg, the recommended dose is 6,500 mg and for patients weighing 75 kg or more, the recommended dose is 7,500 mg. Administer Enjaymo intravenously weekly for the first two weeks, with administration every two weeks thereafter. Administer Enjaymo at the recommended dosage regimen time points, or within two days of these time points. If a dose is missed, administer as soon as possible; thereafter, resume dosing every two weeks. If the duration after the last dose exceeds 17 days, administer Enjaymo weekly for two weeks, with administration every two weeks thereafter.

Mechanism of Action

Enjaymo (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. Sutimlimabjome does not inhibit the lectin and alternative pathways. Inhibition of the classical complement 9 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.

Side Effects

Adverse effects associated with the use of Enjaymo may include, but are not limited to, the following:

• respiratory tract infection
• viral infection
• diarrhea
• dyspepsia
• cough
• arthralgia
• arthritis
• peripheral edema

Clinical Trial Results

The FDA approval was based on positive results from the 26-week open label, single arm pivotal Phase 3 CARDINAL study in patients with CAD (n=24) with a recent history of blood transfusion. The majority of patients (54%; n=13) met the composite primary endpoint criteria with 63% (n=15) of patients achieving a hemoglobin ≥ 12 g/dL or an increase of at least 2 g/dL; 71% (n=17) of patients remaining transfusion-free after week five; and 92% (n=22) of patients did not use other CAD-related treatments. Secondary endpoints were also met, including improvements in hemoglobin and normalization of bilirubin.