Alexion Pharmaceuticals

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Access to Soliris®

At Alexion, our objective is that every patient with PNH or aHUS who can benefit from Soliris® (eculizumab) will have access Soliris. As part of our commitment to the PNH and aHUS communities in the United States, Alexion offers OneSource™, a program that provides education, assistance with access to Soliris, and treatment support for patients and their caregivers. OneSource is available to people living with PNH and aHUS at no cost.

Each patient who enrolls in OneSource will receive one-to-one support from an Alexion Nurse Case Manager who helps coordinate care and assist with obtaining reimbursement. All Nurse Case Managers are registered nurses who have extensive experience caring for patients and working in the health insurance industry. Whether patients are learning more about their disease, exploring treatment options, getting ready to start treatment with Soliris, or are already on Soliris, OneSource is here to help.

In addition to the OneSource program, Alexion works with private and public payers worldwide to secure reimbursement of Soliris for patients with PNH and aHUS. Alexion also supports independent patient assistance programs for uninsured and underinsured patients. Through the Alexion COMPLEMENT Foundation, Alexion provides Soliris free of charge to PNH and aHUS patients who qualify.

To learn more, call 1-888-SOLIRIS or visit www.Soliris.net/patients/one-source.



IMPORTANT SAFETY INFORMATION

The U.S. product label for Soliris includes a boxed warning:

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

See full prescribing information for complete boxed warning

Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early (5.1).


  • Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies.
  • Immunize patients with a meningococcal vaccine at least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risk of developing a meningococcal infection. (See Serious Meningococcal Infections (5.1) for additional guidance on the management of meningococcal infection.)
  • Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected.

Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the Soliris REMS, prescribers must enroll in the program (5.2). Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-soliris (1-888-765-4747).

The most frequently reported adverse reactions in the PNH randomized trial (≥ 10% overall and greater than placebo) are: headache, nasopharyngitis, back pain, and nausea.

The most frequently reported adverse reactions in aHUS single arm prospective trials (≥ 15% combined per patient incidence) are: hypertension, upper respiratory tract infection, diarrhea, headache, anemia, vomiting, nausea, urinary tract infection, and leukopenia.

Please see full Prescribing Information and Important Safety Information for Soliris® (eculizumab).