Soliris® has an established safety profile1,2,3,4
|Adverse reactions reported by 5% or more of Soliris patients and greater than placebo1,3|
|Event||Soliris (n=43)||Placebo (n=44)|
|Headache||19 (44%)||12 (27%)|
|Nasopharyngitis||10 (23%)||8 (18%)|
|Back Pain||8 (19%)||4 (9%)|
|Nausea||7 (16%)||5 (11%)|
|Fatigue||5 (12%)||1 (2%)|
|Cough||5 (12%)||4 (9%)|
|Herpes simplex infections||3 (7%)||0|
|Respiratory tract infection||3 (7%)||1 (2%)|
|Constipation||3 (7%)||2 (5%)|
|Myalgia||3 (7%)||1 (2%)|
|Pain in extremity||3 (7%)||1 (2%)|
|Influenza-like illness||2 (5%)||1 (2%)|
Increased incidence of headaches generally occurred during the first 2 Soliris infusions and may indicate rapid availability of nitric oxide2
Antibodies against Soliris rarely developed in all PNH patients treated with Soliris3
Patients with concomitant PNH and aplastic anemia (AA) or myelodysplastic syndrome (MDS) may require multiple therapeutic approaches
In clinical trials, patients with PNH and bone marrow disorders being treated with immunosuppressive therapy derived additional benefit when Soliris was added, without evident impact on safety5
Patients with PNH and underlying bone marrow dysfunctions related to RBC production (ie, AA, MDS) may experience lower hemoglobin levels than patients with PNH only, which is related to RBC destruction6
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 (≥20%) are: headache, diarrhea, hypertension, upper respiratory infection, abdominal pain, vomiting, nasopharyngitis, anemia, cough, peripheral edema, nausea, urinary tract infection, pyrexia.
Patients taking Soliris should keep safety precautions close at hand
To order a Soliris Patient Safety Information Card, simply contact OneSource™ at
The Patient Safety Information Card
You will need to provide your patient with a Patient Safety Information Card to carry with them at all times. This safety card contains important safety information that your patient needs to be aware of before they are given Soliris and during their treatment with Soliris. Remind them to show this card to any doctor involved in their treatment.
Soliris treatment may reduce your patients’ natural resistance to infections, especially meningococcal infection, which requires immediate medical attention.
Tell your patients that if they cannot reach their doctor, go to an emergency room immediately and show emergency room staff the Patient Safety Information Card. Even if they stop using Soliris, patients should keep their Patient Safety Information Card with them for 3 months after the last Soliris dose, because side effects may occur a long time after their last dose of Soliris.