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:
- Review the ULTOMIRIS Prescribing Information, Prescriber Safety
Brochure, Patient Safety Brochure and the Patient Safety Card.
- Enroll in the ULTOMIRIS REMS by completing this form.
- 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
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
- 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
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.