Ultomiris

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Ultomiris is used to treat adults with certain rare blood disorders characterized by low red blood cell levels. Do not start Ultomiris if you have a meningococcal infection.

Ultomiris Overview

Reviewed: January 13, 2019
Updated: 

Ultomiris is a prescription medication used to treat rare blood disorders including Paroxysmal Nocturnal Hemoglobinuria (PNH) and atypical Hemolytic Uremic Syndrome (aHUS). These diseases are characterized by destruction of red blood cells and low levels of other blood components.

Ultomiris, a complement inhibitor, belongs to a group of drugs called humanized monoclonal antibodies. Ultomiris works on certain proteins to prevent the destruction of red blood cells.

This medication is available in an injectable form to be given directly into a vein by intravenous (I.V.) infusion. The infusion usually lasts about 2 hours in adults and up to 4 hours in children.

Common side effects of Ultomiris include upper respiratory infections, headache, diarrhea, and nausea.

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Ultomiris Drug Class

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Ultomiris is part of the drug class:

Ultomiris FDA Warning

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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 [see Warnings and Precautions (5.1) for additional guidance on the management of the risk of meningococcal infection].
  • Vaccination reduces, but does not eliminate, the risk of meningococcal infections. Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected.

ULTOMIRIS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the ULTOMIRIS REMS, prescribers must enroll in the program [see Warnings and Precautions (5.1)]. Enrollment in the ULTOMIRIS REMS program and additional information are available by telephone: 1-844-259-6783 or at www.ultomirisrems.com.