New FDA Approved Drug 2022 Enjaymo (sutimlimab-jome injection) By: Areli Ramirez, Sousan Pourmalek, and Vanessa Hernandez Application • Indicated to decrease the need for red blood cell (RBC) transfusion due to hemolysis in adults with cold agglutinin disease (CAD). • CAD, a rare autoimmune hemolytic anemia, caused by antibodies called cold agglutinins binding to the surface of red blood cells, which starts a process that causes the body’s immune system to mistakenly attack healthy red blood cells and cause their rupture (hemolysis). As red blood cells have the vital job of carrying oxygen throughout the body, patients with CAD may experience severe anemia • Approved by the FDA on February 4th, 2022 Mechanism of Action This medication inhibits the classical complement pathway (CP) and specifically binds to complement protein component 1, s subcomponent (C1) Prevents deposition of complement opsonins of the surface of RBCs, resulting in the inhibition of hemolysis in patients with CAD. Side Effects & Contraindications Side Effects: respiratory tract infection, viral infection, diarrhea, indigestion, cough, joint pain, joint inflammation (arthritis), and edema of peripheral limbs Contraindications: ENJAYMO is contraindicated in patients with known hypersensitivity to sutimlimabjome or any of the inactive ingredients. Adverse Reactions: Most common adverse reactions are respiratory tract infection, viral infection, diarrhea, dyspepsia, cough, arthralgia, arthritis, and peripheral edema. ENJAYMO may increase susceptibility to serious infections. Based on its mechanism of action, ENJAYMO may potentially increase the risk for developing autoimmune diseases such as systemic lupus erythematosus. If treatment with ENJAYMO is interrupted, we must closely monitor patients for signs and symptoms of recurrent hemolysis. An additional adverse reaction can include infusion-related reactions. References U.S. Food and Drug Administration, (2022), https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/76 1164s000lbl.pdf?utm_medium=email&utm_source=govdelivery
