Alexion Pharmaceuticals

Additional Resources

Soliris Web Site

Provides information about PNH and Soliris for patients and healthcare professionals. Sponsored by Alexion.

PNH Source

Provides information about PNH for patients and healthcare professionals. Sponsored by Alexion.

aHUS Source

Provides information about aHUS for patients and healthcare professionals. Sponsored by Alexion.

Eurordis – European Organization for Rare Diseases

Eurordis is dedicated to helping people with rare diseases and assisting the organizations that serve them.

Orphanet is a database of information on rare diseases and orphan drugs for all publics. Its aim is to contribute to the improvement of the diagnosis, care and treatment of patients with rare diseases.

National Organization for Rare Disorders (NORD)

NORD is dedicated to helping people with rare diseases and assisting the organizations that serve them. NORD is committed to the identification, treatment, and cure of rare disorders through programs of education, advocacy, research and service.

PNH Foundation

An organization dedicated to raising funds for PNH research and helping families with disease-related expenses not covered by insurance.

Aplastic Anemia & MDS International Foundation (AA-MDSIF)

AA-MDSIF is a nonprofit patient organization that serves as a resource for patient assistance, patient education advocacy and support. The organization supports research to find treatments and potential cures for aplastic anemia (AA), myelodysplastic syndromes (MDS), and related bone marrow diseases including PNH. The AA-MDSIF website provides educational materials and medical information about AA, MDS, and PNH.

Foundation for Children with Atypical HUS

A non-profit organization and interactive website designed to provide information and support for families dealing with aHUS.

Rare Disease Communities

A social networking site sponsored by NORD and Eurordis to help patients and families connect with and support each other and share vital experiences of living with a rare disease.

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).