What Is Ultomiris?

Ultomiris (generic name: ravulizumab) is a type of medication called monoclonal antibodies, similar to antibodies that our bodies make to protect us when an unwanted substance enters our bodies. In the case of Ultomiris, the antibody is humanized, which means its protein sequences have been modified to increase its similarity to those produced naturally in our bodies, making it safe for human administration.

Nguy cơ nhiễm trùng não mô cầu nghiêm trọng:

Ultomiris has a US Black Box Warning due to the possibility of causing serious meningococcal infection:

“Life-threatening meningococcal infections/sepsis have occurred in patients treated with Ultomiris. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early.

Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies.

Immunize patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of Ultomiris, unless the risks of delaying Ultomiris therapy outweigh the risk of developing a meningococcal infection.

Tiêm vắc-xin làm giảm nhưng không loại bỏ được nguy cơ nhiễm trùng não mô cầu. Theo dõi bệnh nhân để phát hiện sớm các dấu hiệu nhiễm trùng não mô cầu và đánh giá ngay nếu nghi ngờ nhiễm trùng.

Ultomiris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS).”