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Increased Risk of Meningococcal Infection and Soliris:  Risk Evaluation and Mitigation Strategy (REMS)

Prescribers must enroll in the Soliris REMS to prescribe Soliris.

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration to ensure that the benefits of the drug outweigh its risks.

The goals of the Soliris REMS, the OneSource Safety Support Program, are:

• To mitigate the occurrence and morbidity associated with meningococcal infections
• To inform and educate Healthcare Professionals (HCP) and Patients (or Caregivers, or Legal Guardians) regarding:
  • the increased risk of meningococcal infections with Soliris
  • the early signs of invasive meningococcal infections, and
  • the need for immediate medical evaluation of signs and symptoms consistent with possible meningococcal infections.

Physicians prescribing Soliris must enroll in the REMS.

To enroll in the program, download and complete the Prescriber Introductory Letter and Enrollment Form and either drop it in the mail; fax it to Soliris OneSource Safety Support Program at 1-877-580-2596 (ALXN); or scan and e-mail it to OSSP@alxn.com.

• Prescriber Introductory Letter and Enrollment Form
• Patient Introductory Letter and Voluntary Enrollment Form
• Spanish Patient Introductory Letter and Voluntary Enrollment Form
• Dosing and Administration Guide
• Soliris Patient Safety Card
• Spanish Soliris Patient Safety Card
• Prescriber Brochure, Important Safety Information about Soliris
• Patient Safety Brochure, Important Safety Information about Soliris
• Spanish Patient Safety Brochure, Important Safety Information about Soliris

The Soliris Patient Safety Card

Provide your patient with a Soliris Patient Safety Card to carry with them at all times. This safety card contains important safety information about the risk of meningococcal infection that your patient needs to be aware of before they are given Soliris and during their treatment with Soliris. Remind them to show this card to any doctor involved in their treatment.

Tell your patients that if they cannot reach their doctor, go to an emergency room immediately and show emergency room staff the Soliris Patient Safety Card. Even if they stop using Soliris, patients should keep their Soliris Patient Safety Card with them for 3 months after the last Soliris dose, since side effects may occur a long time after their last dose of Soliris.

To order a Soliris Patient Safety Information Card, contact OneSource™ at 1.888.SOLIRIS (1.888.765.4747).