Friday, February 4, 2022

FDA Approves Treatment for Adults With Rare Type of Anemia - Drug Information Update

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FDA Center for Drug Evaluation and Research Division of Drug Information

FDA Approves Treatment for Adults with Rare Type of Anemia 

FDA has approved Enjaymo (sutimlimab-jome) infusion to decrease the need for red blood cell transfusion due to hemolysis (red blood cell destruction) in adults with cold agglutinin disease (CAD). 

Patients with allergies to sutimlimab-jome or any of the inactive ingredients must not take Enjaymo. Individuals should be vaccinated against encapsulated bacteria and monitored for early signs and symptoms of infection. Patients also should be monitored for infusion reactions; signs and symptoms of autoimmune disease; and signs and symptoms of hemolysis recurrence if treatment is interrupted.

The most common side effects Enjaymo are respiratory tract infection, viral infection, diarrhea, dyspepsia (indigestion), cough, arthralgia (joint stiffness), arthritis, and swelling in the lower legs and hands.

Please see the prescribing information for additional information on the risks associated with Enjaymo.

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