OneSource Safety Support Program — Healthcare Providers
OneSource Safety
Support Program
Initial Enrollment
• Review OneSource™ Safety Support Program (OSSP) materials with your Alexion representative
• Educate your staff and each of your Soliris® (eculizumab) patients about the OSSP
–Provide an information packet about the OSSP to each of your Soliris patients
»Your Alexion representative will provide an initial supply of OSSP information packets
for your PNH patients
»Contact OneSource at 1.888.SOLIRIS (1.888.765.4747) for additional packets, if needed
• Review, sign, and submit the Prescriber Attestation Form for each Soliris patient to OSSP by:
Fax: 1.877.580.2596 (ALXN)
Email: [email protected]
Mail: Alexion Pharmaceuticals, Attn: OSSP, 352 Knotter Drive, Cheshire, CT 06410
»NOTE: Your Alexion representative cannot collect this form from you
• As part of this safety program, a OneSource Case Manager will contact your patient within
several weeks after you review the information in this packet with your patient
Ongoing Management
• As requested by the FDA, please distribute a Soliris medication guide to your patient(s)
at every infusion
–A supply of medication guides is enclosed with this packet
–For additional medication guides, please contact your Alexion representative or call
1.888.SOLIRIS (1.888.765.4747)
• Notify your Alexion representative about any changes in your patient’s Soliris therapy by
calling 1.888.SOLIRIS (1.888.765.4747)
• Every year in August/September, you will be asked to participate in a survey designed to
measure the effectiveness of the OneSource Safety Support Program
WARNING: SERIOUS MENINGOCOCCAL INFECTIONS
Soliris increases the risk of meningococcal infections. Meningococcal infection may become
rapidly life-threatening or fatal if not recognized and treated early
•V
accinate patients with a meningococcal vaccine at least 2 weeks prior to receiving the first
dose of Soliris; revaccinate according to current medical guidelines for vaccine use
•M
onitor patients for early signs of meningococcal infections, evaluate immediately if infection
is suspected, and treat with antibiotics if necessary
See full prescribing information for SOLIRIS, including boxed WARNING regarding serious
meningococcal infection.