PRODUCT INDICATION
Soliris® (eculizumab) is a complement inhibitor indicated for the treatment of patients
with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.
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 and
Important Safety Information for Soliris® (eculizumab).
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® (eculizumab), including
boxed WARNING regarding serious meningitis.
Steps to take prior to treatment
Patients with PNH 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. The patient’s physician or nurse will make sure
the patient receives this vaccine at least two weeks before the first infusion of
Soliris. The physician or nurse will provide the patient with the tools and information
needed for the patient to identify and take early action if the patient suspects
a meningococcal infection.
The physician or nurse will provide the patient with a Patient Safety Information
Card to carry at all times. This safety card contains important safety information
that patients should be aware of before they are given Soliris and during treatment
with Soliris. Patients should show this card to physicians involved in their treatment.
Soliris treatment may reduce the patient’s natural resistance to infections, especially
meningococcal infection, which requires immediate medical attention. If
a patient experiences any of the following symptoms, he or she should immediately
call his or her 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 the patient cannot reach his or her doctor, he or she should go to an emergency
room immediately and show them the Patient Safety Information Card. Even
if a patient stops using Soliris, he or she should keep this card for three months
after the last Soliris dose, since side effects may occur a long time after your
last dose of Soliris.
Why does Soliris have a boxed warning?
A boxed warning is necessary because Soliris is very effective at targeting a specific
part of the complement system that is important for fighting certain bacteria, such
as the bacteria that cause meningococcal infection. Vaccination reduces the risk
of developing this infection, but it does not eliminate the risk completely. Patients
need to be aware of the signs and symptoms of this infection and notify their physician
immediately if any of the symptoms occur.