ULTOMIRIS is only available through a restricted program called the ULTOMIRIS REMS (Risk Evaluation and Mitigation Strategy). All prescribers must be specially certified. To become certified, prescribers must:

  1. Review the ULTOMIRIS Prescribing Information, Prescriber Safety Brochure, Patient Safety Brochure and the Patient Safety Card.
  2. Enroll in the ULTOMIRIS REMS by completing this form.
  3. Counsel patients and provide them with the Patient Safety Brochure and Patient Safety Card.

By completing, signing and submitting this form, I acknowledge and agree that:

  • I have read and understand the ULTOMIRIS Prescribing Information (PI), Prescriber Safety Brochure, Patient Safety Brochure, and the Patient Safety Card.

  • I understand the:

    •  Risk of meningococcal infections associated with ULTOMIRIS.
    •  Early signs of meningococcal infections
    •  Need for immediate medical evaluation of signs and symptoms with possible meningococcal infections

  • Before treatment initiation at least 2 weeks prior to the first dose, I will:

    •  Assess the patient’s meningococcal vaccine status and immunize patients unless the risks of delaying ULTOMIRIS therapy outweigh the risks of developing meningococcal infection.
    •  Provide the patient with a prescription for a two-week course of antibiotic prophylaxis if ULTOMIRIS must be started right away.
    •  Counsel the patient about the signs and symptoms of meningococcal infections using the Patient Safety Card, and Patient Safety Brochure. Provide a copy of these materials to the patient. Instruct the patient to carry the Patient Safety Card at all times.

  • During treatment, I will:

    •  Assess the patient for early signs of meningococcal infection and evaluate immediately if infection is suspected.
    •  Consider discontinuation of ULTOMIRIS in patients who are undergoing treatment for serious meningococcal infections.
    •  Revaccinate patients according to the Advisory Committee on Immunization Practices recommendations.

  • I will report cases of meningococcal infection including the patient’s clinical outcomes to Alexion Pharmaceuticals, Inc.

  • I understand that if I do not maintain compliance with the requirements of the ULTOMIRIS REMS, I will no longer be able to prescribe ULTOMIRIS.

  • I understand that ULTOMIRIS REMS and its agents or contractors may contact me to support the administration of the ULTOMIRIS REMS.

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ULTOMIRIS® is a registered trademark of Alexion Pharmaceuticals, Inc.
Copyright ©2020, Alexion Pharmaceuticals, Inc. All rights reserved.