Important Safety Information

Steps to take prior to treatment1

You may be at increased risk for certain infections during Soliris treatment. As a safety precaution, patients must be vaccinated against meningococcal infection before starting Soliris. Your physician or nurse will make sure you receive this vaccine at least 2 weeks before your first infusion. Your doctor will provide you with the tools and information you will need to identify and take early action if you suspect that you have a meningococcal infection.

Your doctor or healthcare provider will provide you with a Patient Safety Information Card to carry with you at all times. This safety card contains important safety information that you need to be aware of before you are given Soliris and during your treatment with Soliris. Show this card to any doctor involved in your treatment.

Soliris treatment may reduce your natural resistance to infections, especially meningococcal infection, which requires immediate medical attention. If you experience any of the following symptoms, you should immediately call your doctor.

  • Headache with nausea and/or vomiting
  • Headache and fever
  • Headache with a stiff neck or back
  • Fever of 103°F (39.4°C) or higher
  • Fever and a rash
  • Confusion
  • Severe muscle aches with flu-like symptoms
  • Sensitivity to light

If you cannot reach your doctor, go to an emergency room immediately and show them your Patient Safety Information Card.

Even if you stop using Soliris, keep this card with you for 3 months after the last Soliris dose, since side effects may occur a long time after your last dose of Soliris.





IMPORTANT SAFETY INFORMATION

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

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

The effect of anticoagulant withdrawal during Soliris treatment has not been studied. Therefore, treatment with Soliris should not alter anticoagulant management.

Soliris is generally well tolerated. The most frequent adverse events observed in clinical studies were headache, a runny nose (nasopharyngitis), back pain, nausea, and tiredness (fatigue).

Please see full prescribing information for SOLIRIS, including boxed WARNING regarding serious meningitis.


Reference: 1. Soliris® [package insert]. Cheshire, CT: Alexion Pharmaceuticals Inc; 2009.