What is SOLIRIS for?
SOLIRIS® (eculizumab) is the first and only FDA-approved treatment to reduce hemolysis in PNH.
As a patient with PNH, how can SOLIRIS help me?
SOLIRIS treats the underlying cause of the signs and symptoms of PNH (chronic hemolysis). In clinical trials, patients who were treated with SOLIRIS experienced the following benefits:
- Significant reduction in red blood cell destruction (chronic hemolysis). This reduction in hemolysis began in the first week and was sustained over the long term.
- Significant improvements in anemia, including the complete elimination of the need for transfusions or a significant reduction in the number of transfusions required.
- Marked improvements in fatigue
- Significant impact on overall quality of life
- Fewer blood clots in patients taking SOLIRIS as compared to the same time period prior to when these patients started SOLIRIS.
The effect of withdrawal of anticoagulant therapy during SOLIRIS treatment has not been established. Therefore, treatment with SOLIRIS should not alter anticoagulant management.
How does SOLIRIS work?
SOLIRIS works by blocking a part of your immune system called terminal complement. By blocking this part of the complement system, SOLIRIS reduces the destruction of red blood cells and therefore improves the symptoms of PNH.
Because SOLIRIS blocks a part of your immune system, you may be at an increased risk for certain infections during SOLIRIS treatment. Your doctor can 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.
Does SOLIRIS cure PNH?
SOLIRIS does not cure PNH, but it can significantly reduce the signs and symptoms of PNH by preventing the destruction of red blood cells (hemolysis). The only curative treatment option for PNH is a bone marrow transplant, which carries very high risks associated with the procedure and is not recommended for all PNH patients.
Can I benefit from SOLIRIS regardless of the degree of anemia I have?
Clinical trials of SOLIRIS included patients with varying degrees of anemia. Patients who received SOLIRIS experienced improvements in their anemia. Talk to your doctor to see if SOLIRIS is right for you.
Do I need red blood cell transfusions in order to benefit from treatment with SOLIRIS?
No. SOLIRIS is indicated for the treatment of patients with PNH to reduce hemolysis. In addition to anemia, there are other serious symptoms of PNH including fatigue, impaired quality of life, abdominal pain, trouble swallowing, and blood clots which should be considered when you and your doctor discuss potential treatments. Talk to your doctor to see if SOLIRIS is right for you.
How is SOLIRIS administered?
SOLIRIS is given as an IV infusion at the doctor's office or a special infusion center. The infusion usually lasts about 35 minutes.
You will receive your SOLIRIS infusion once a week for the first 4 weeks (600-mg induction dose). Beginning on the 5th week, you will receive a slightly higher dosage of SOLIRIS every two weeks (900-mg maintenance dose).
How long will I need to take SOLIRIS?
Since PNH is a chronic disease, SOLIRIS is intended to be an ongoing therapy. Patients who start SOLIRIS should continue to take it even if they feel better. If for some reason you and your doctor determine that you should stop SOLIRIS therapy, only your doctor can safely manage taking you off the drug
What are the common side effects of SOLIRIS?
SOLIRIS is generally well tolerated. The most frequent adverse events observed in clinical studies were headache, runny nose (nasopharyngitis), back pain and nausea.
Why does the SOLIRIS product label include a boxed warning?
A boxed warning is necessary because SOLIRIS is very effective at targeting a specific part of the complement system, which is important for fighting certain bacteria, such as the bacteria which causes meningococcal infection. Vaccination reduces the risk of developing this infection but does not eliminate the risk completely. You will need to be aware of the signs and symptoms of this infection and notify your physician immediately if any of these symptoms occur.
Your doctor will give you important safety information about SOLIRIS. You will need to have all recommended immunizations and vaccines before you start with treatment on SOLIRIS.
Will my insurance cover SOLIRIS?
The manufacturers of SOLIRIS are dedicated to ensuring that every patient who can benefit from SOLIRIS treatment can get SOLIRIS. The SOLIRIS OneSource™ patient support program will work with your doctor and your health insurance provider to identify a coverage solution that works for you. Learn more.
How do I get started on SOLIRIS?
Patients who are interested in information on SOLIRIS should call the SOLIRIS OneSource Program. OneSource is a treatment support service for all PNH patients and their healthcare providers. Each patient enrolled in the program receives support from an Alexion Case Manager at OneSource. Alexion Case Managers are registered nurses who can provide education about PNH and SOLIRIS and facilitate solutions to help patients obtain SOLIRIS. For more information about Alexion's OneSource program, patients may call 1.888.SOLIRIS (1.888.765.4747).
Talk to your doctor to see if SOLIRIS is right for you. You must receive a meningococcal vaccine at least 2 weeks prior to starting SOLIRIS.
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 http://www.pnhsource.com
The following organizations also provide support and information for patients with PNH:
Aplastic Anemia & MDS International Foundation (AA-MDSIF)
http://www.aamds.org
National Organization for Rare Diseases (NORD)
http://www.rarediseases.org
PNH Research and Support Foundation
http://www.pnhfoundation.org
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 http://www.findahematologist.org/ for more information on finding a hematologist in your area.