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:
- Review the SOLIRIS Prescribing Information, Prescriber Safety Brochure, Patient Safety Brochure and the Patient Safety Card.
- Enroll in the SOLIRIS 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 SOLIRIS Prescribing Information (PI), Prescriber Safety Brochure, Patient Safety Brochure, and the 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 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.
- 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.