AAMDSIF is sharing this information with U.S. PNH patients receiving ULTOMIRIS or SOLIRIS to help you take steps to ensure that your medication schedule is not interrupted.  

ULTOMIRIS and SOLIRIS are part of the U.S. Food and Drug Administration "Risk Evaluation and Mitigation Strategy (REMS)," which is a drug safety program for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.

As of September 16, 2024, the FDA has required that the separate ULTOMIRIS REMS and SOLIRIS REMS will be combined to help ensure that patients' meningococcal vaccination status is validated and that antibiotics are given as needed before treatment.

Before your next scheduled treatment with ULTOMIRIS or SOLIRIS, we suggest you contact your health care provider to verify that they have recertified for this combined system.  This change requires all prescribers, health care settings, and pharmacies to be recertified in the combined ULTOMIRIS and SOLIRIS REMS to receive and dispense product.  

If you have questions, contact your health care provider or Alexion at (888) 765-4747 or their OneSource Program: https://alexiononesource.com.