SOLIRIS (eculizumab): The first treatment specifically approved for PNH

For US Healthcare Professionals

Side Effects

SOLIRIS has a proven safety profile

Overall, adverse events with SOLIRIS were similar to placebo1,2

Side Effects

The most common adverse events were headache, nasopharyngitis, back pain, and nausea.1

  • The number of headaches that occurred in the SOLIRIS® (eculizumab)-treated group was similar to the placebo group after the first two weeks of therapy1-3
     
  • Most patients reporting fatigue as an adverse event demonstrated meaningful improvement as demonstrated by objective measurements1,2

No Infusion-related reactions

  • No difference was observed between SOLIRIS- and placebo-treated patients in immune system disorders within 48 hours of administration2
     
  • No discontinuations due to infusion reactions occurred2

Antibodies rarely develop

  • Low titers of antibodies against SOLIRIS rarely developed during 6 months of treatment1,2
     
  • No correlation of antibody development to clinical response was observed1

Next: Adherence and Timely Dosing

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS MENINGOCOCCAL INFECTION

SOLIRIS® increases the risk of meningococcal infections.

Vaccinate patients with a meningococcal vaccine at least 2 weeks prior to receiving the first dose of SOLIRIS; revaccinate according to current medication guidelines for vaccine use.

Monitor patients for early signs of meningococcal infections, evaluate immediately if infection is suspected, and treat with antibiotics if necessary.

The effect of withdrawal of anticoagulant therapy during SOLIRIS treatment has not been established. Therefore, treatment with SOLIRIS should not alter anticoagulant management.

SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING INCLUDING WARNINGS, PRECAUTIONS, AND ADVERSE REACTIONS.

The most frequent adverse events observed in clinical studies were headache, nasopharyngitis, back pain, nausea, fatigue, and cough.

Please see important safety information (including boxed warning) as well as the complete prescribing information.

References:
1. SOLIRIS® prescribing information. Alexion Pharmaceuticals, Inc. 2007.
2. Data on File. Alexion Pharmaceuticals, Inc.
3. Hillmen P, Young NS, Schubert J, et al. The complement inhibitor eculizumab in paroxysmal nocturnal hemoglobinuria. N Engl J Med. 2006;355:1233-1243.