Soliris REMS Enrollment

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


1) Review the SOLIRIS Prescribing Information, Prescriber Safety Brochure, Patient Safety Brochure, and Patient Safety Card.
2) Enroll in the SOLIRIS 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 SOLIRIS Prescribing Information (PI), Prescriber Safety Brochure, Patient Safety Brochure, and Patient Safety Card.
  • I understand the:
    • risk of meningococcal infections associated with SOLIRIS.
    • 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 SOLIRIS therapy outweigh the risks of developing meningococcal infection.
    • Provide the patient with a prescription for a two-week course of antibiotic prophylaxis if SOLIRIS 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 the materials to the patient. Instruct 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.
    • Discontinue SOLIRIS in patients who are being treated 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 SOLIRIS REMS, I will no longer be able to prescribe SOLIRIS.
  • I understand that SOLIRIS REMS and its agents or contractors may contact me to support the administration of the SOLIRIS REMS.

 

Enrollment Form (Fields with asterisk * are compulsory) 

 
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