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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).

is contraindicated in patients with known hypersensitivity to sutimlimab-jome or any of the inactive ingredients [see Warnings and Precautions (5.2) and Adverse Reactions (6.1) ] . ENJAYMO is contraindicated in patients with known hypersensitivity to sutimlimab-jome or any of the inactive ingredients. ( 4 )

Serious Infections: Ensure patients are vaccinated against encapsulated bacteria. Monitor patients for early signs and symptoms of infections. ( 5.1 ) Infusion-Related Reactions: Monitor patients for infusion-related reactions, interrupt if reaction occurs, and institute appropriate medical management as needed. ( 5.2 ) Risk of Autoimmune Disease: Monitor patients for signs and symptoms and manage medically. ( 5.3 ) Recurrent Hemolysis After ENJAYMO Discontinuation: Monitor patients for signs and symptoms of hemolysis if treatment with ENJAYMO is interrupted. ( 5.4 ) 5.1 Serious Infections Including Those Caused by Encapsulated Bacteria ENJAYMO, a proximal classical complement C1s inhibitor, increases a patient's susceptibility to serious infections including those caused by encapsulated bacteria e.g. Neisseria meningitidis (any serogroup, including non-groupable strains), Streptococcus pneumoniae , and Haemophilus influenzae type B. Life-threatening and fatal infections with encapsulated bacteria have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors. Serious infections (bacterial and viral) were reported in 15% (10/66) of patients receiving ENJAYMO from the two phase 3 studies. These infections included urinary tract infection with sepsis, respiratory tract infection, pneumonia, otomastoiditis, and skin infections One patient (1.5%) died due to klebsiella pneumonia. Complete or update vaccination against encapsulated bacteria at least …

8.1 Pregnancy Risk Summary There are no available data on ENJAYMO use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Human immunoglobulin G (IgG) antibodies are known to cross the placental barrier; therefore, sutimlimab-jome may be transmitted from the mother to the developing fetus. In animal reproduction studies, intravenous administration of sutimlimab-jome to pregnant monkeys during organogenesis at doses 2 to 3 times the maximum recommended human doses did not result in adverse effects on pregnancy or offspring development (see Data ) . The estimated background risk of major birth defects and …