Frequently Asked Questions About Soliris®
What is Soliris for?
Soliris is the first and only approved medication for the treatment of patients with PNH to reduce hemolysis.
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As a patient with PNH, how can Soliris help me?
Soliris treats chronic hemolysis — the underlying cause of the signs and symptoms of PNH.1 In clinical trials, patients who received Soliris experienced the following benefits1,2:
- Reduced chronic hemolysis in all patients — immediate and long term
- Fewer blood clots (thrombotic events), as compared to the same time period prior to starting Soliris
- Significant improvements in fatigue levels and overall quality of life
- Significant reduction in the need for transfusions
The majority of patients received concomitant anticoagulant therapy.1 The effect of anticoagulant withdrawal during Soliris treatment has not been studied.1
Dealing with PNH can be challenging. But the good news is there are many things you can do to keep yourself or your loved one as healthy as possible and Soliris could be the answer for you.
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How does Soliris work?
By blocking complement (one of your body’s defense systems), Soliris reduces hemolysis and therefore improves the symptoms and reduces the major health problems associated with PNH.1 Because Soliris blocks a part of your body’s defense system, you may be at an increased risk for certain infections during Soliris treatment. Your doctor will give you important safety information about Soliris. You will need to have all recommended immunizations and vaccines before you start Soliris. Talk to your doctor to see if Soliris is right for you.
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Can I benefit from Soliris even if I have not been receiving blood transfusions?
Patients who do not get transfused can benefit from Soliris because it reduces the destruction of red blood cells (hemolysis), and almost all patients with PNH experience some level of hemolysis.1,2 In clinical trials, patients who received Soliris experienced improvements in their PNH-related symptoms such as fatigue and a reduction in blood clots.1,2 Talk to your doctor to see if Soliris is right for you.
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How is Soliris dosed?
Your initial Soliris treatment (induction phase) involves a 600-mg infusion once a week for the first 4 weeks. Starting at Week 5, you will receive a 900-mg infusion every 2 weeks (maintenance phase). It is very important to make sure that you do not miss any scheduled treatments in order to continue to control hemolysis and to experience the full benefits of Soliris therapy.1,3
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How is Soliris administered?
Soliris is administered through an intravenous infusion (introduction of a solution into a vein). The 35-minute infusion must be prepared and administered by a doctor or other healthcare professional, usually at a healthcare clinic, doctor’s office, or infusion center.1
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How long will I need to take Soliris?
Since PNH is a chronic disease, Soliris is intended to be an ongoing therapy.1 Patients who start Soliris should continue receiving Soliris, even if they feel better. If for some reason you and your doctor determine to stop Soliris therapy, only your doctor can safely manage taking you off the drug.
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Why do I need to take Soliris every 2 weeks?
In order to maintain the right amount of medicine in your body to achieve maximum benefit from Soliris therapy, you need an infusion of Soliris every 2 weeks.
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What are the common side effects of Soliris?
Soliris is generally well tolerated. The most frequent adverse events observed in clinical studies were1:
- Headache
- A runny nose (nasopharyngitis)
- Back pain
- Nausea
- Tiredness (fatigue)
Overall, the rate of side effects was similar to placebo in clinical trials. The number of headaches that occurred was similar between patients taking Soliris and those on placebo after the first 2 weeks of therapy.1 Call your doctor if you are experiencing any of these side effects or have any questions.
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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.1 You will need to be aware of the signs and symptoms of this infection and notify your physician immediately if any of the symptoms occur.
Your doctor will give you important safety information about Soliris. You will need to receive a vaccination before you start Soliris.
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Will my insurance cover Soliris?
Alexion’s goal is to ensure that all patients who may benefit from Soliris will have access to it. They developed the OneSourceTM program to help people obtain access to Soliris, and provide them with reliable information on PNH and Soliris. It is staffed by Alexion Nurse Case Managers who are registered nurses with healthcare and insurance experience. The Nurse Case Managers help you navigate insurance issues and coordinate other needs that are important to your treatment plan: insurance verifications, coverage determinations, and, if necessary, assistance in securing alternative funding. Learn more.
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How do I get started on Soliris?
Soliris is a medical treatment that you and your doctor may decide is appropriate for you. Whether you are simply exploring treatment options or already receiving Soliris, you are always welcome to call Soliris OneSource, an education, access, and treatment support resource, at 1.888.SOLIRIS, where you can speak to an Alexion Nurse Case Manager.
Alexion’s Case Managers are registered nurses with healthcare and insurance expertise who can further explain how to get started on Soliris. Your Nurse Case Manager will work one-on-one with you to provide personalized support every step of the way. This may include education about PNH, Soliris, insurance, and alternative funding options.
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Where can I get more information about Soliris and PNH?
Please call 1.888.SOLIRIS (1.888.765.4747) for more information about Soliris.
For more information about PNH, please visit PNHSource.com.
The following organizations also provide support and information for patients with PNH:
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How can I find a physician who treats PNH?
The American Society of Hematology has an online database of hematologists that you can search. Please visit www.findahematologist.org for more information on finding a hematologist in your area.
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