Important Safety Information

  • WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

    Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early.

    • Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies.
    • Immunize patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risk of developing a meningococcal infection.
    • Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected.

    Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the Soliris REMS, prescribers must enroll in the program. Enrollment in the Soliris REMS program and additional information are available by telephone:1-888-SOLIRIS (1-888-765-4747) or at solirisrems.com.

Tips & FAQs

Tips for Managing PNH

  • An essential travel plan

    Make sure travel and treatment go hand in hand

    If you’re planning on taking a trip for business or pleasure, it’s important to make sure your Soliris infusion schedule continues uninterrupted. Read More

    OneSource can make that easy for you. If your insurance allows it, OneSource will help arrange your infusions while you are away from home. Simply call your Alexion Nurse Case Manager — at least 2 weeks before you leave — for help with finding an infusion site while you are travelling.

    To get the most out of Soliris, you need to keep taking it. While travel can be a break from the everyday, you should always stick with your infusion schedule, whether you’re on the road or not. That’s because even though you can’t see it or feel it, hemolysis, the root cause of PNH, is always happening in your body. Left untreated, PNH can lead to serious health problems. So let OneSource help you make sure your infusion schedule continues uninterrupted. You should also speak with your doctor about how to best manage your PNH while you are away from home.

    Keep safety close at hand

    Remember to always carry important medical information while you travel, including your Patient Safety Information Card and the telephone numbers of your doctors and Alexion Nurse Case Manager.

    There are many ways to tap into support. At OneSource, we’'re here to help make things as easy as possible.

  • Ongoing disease needs ongoing treatment

    Get the most from your treatment

    Living with and treating a rare disease like PNH can be challenging. Read More

    PNH is a disease of constant hemolysis, or destruction of red blood cells. Hemolysis is the root cause of the signs, symptoms, and serious health problems of PNH. Even though you can’t see it, hemolysis is always happening in your body. That’s why treatment for it needs to be ongoing, as well. Soliris is the only FDA-approved treatment for PNH to reduce hemolysis. During treatment in clinical studies, Soliris reduced hemolysis in all PNH patients.

    If your PNH treatment is Soliris, it is recommended that you receive it every 2 weeks. This recommended dosing schedule is based on the results of clinical trials with Soliris. However, your doctor will determine what is the most appropriate dosing schedule for you. But whatever your schedule, the important thing is to stick with it.

    Staying on track with Soliris helps to keep your symptoms under control. Click here for tools that will help you get the most out of your therapy.

    Remember, OneSource is here to help. You can reach us at 1.888.SOLIRIS (1.888.765.4747).

  • Keep insurance — —and treatment — —uninterrupted

    Insurance open enrollment reminder

    Open enrollment for most insurance plans happens every fall, which is the time to review your coverage options for Soliris and make any necessary changes. Read More

    OneSource is here to help answer your questions about your coverage. We can review your options with you to help ensure your Soliris coverage and therapy continue uninterrupted. And that’s important, because PNH is an ongoing disease that needs ongoing treatment.

    If your insurance plan has a lifetime maximum that’s close to being exhausted, or if you don’t have insurance, we can assist you by researching alternative funding options. Likewise, if your insurance coverage is changing, if you are switching plans, or if you need to add or remove family members, we can help find the best option for you.

    Alexion Nurse Case Managers have years of experience in healthcare and dealing with insurance issues. Whatever your question when it comes to managing your disease, they can work with you and your doctor to help find answers. Get in touch by calling 1.888.SOLIRIS (1.888.765.4747).

Frequently asked questions about OneSource

  • Q What is OneSource?

    A: OneSource is a program offered by Alexion that provides education, assistance with access, and treatment support for people living with PNH and their caregivers. Whether you are learning more about your disease, exploring treatment options, getting ready to start treatment with Soliris, or are already on Soliris, OneSource is here to help.

    OneSource is staffed by Alexion Nurse Case Managers who are registered nurses with healthcare and insurance expertise. While your doctor is your first source of information about treating PNH, Alexion Nurse Case Managers are available every step of the way to answer questions about PNH and Soliris and provide personalized support for you and your healthcare team.

  • Q All this PNH information is overwhelming. Can anyone help me?

    A: Yes. OneSource Alexion Nurse Case Managers work with people with PNH every day. Feel free to ask them questions about PNH and Soliris. Case Managers are available every step of the way to help answer your questions and provide personalized treatment support for you and your healthcare team. They can even send you useful tools and educational resources.

  • Q What if I need help with my insurance?

    A: OneSource can help. PNH is rare, so you may run into insurance issues you don't see with more common diseases. Alexion Nurse Case Managers are registered nurses with healthcare and insurance expertise. They can help navigate through insurance issues, funding options, and other needs that are important to your treatment plan.

  • Q What if I need someone to talk to?

    A: Alexion Nurse Case Managers are available for support. They can also help put you in touch with another person living with PNH.

Count on your Alexion Nurse Case Manager for answers to these questions and more.

OneSource Patient Authorization

A form patients need to fill out and complete before they can enroll

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Important Safety Information

CLOSE

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early.

  • Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies.
  • Immunize patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risk of developing a meningococcal infection.
  • Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected.

Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the Soliris REMS, prescribers must enroll in the program. Enrollment in the Soliris REMS program and additional information are available by telephone:1-888-SOLIRIS (1-888-765-4747) or at solirisrems.com.

Indications and Usage

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.

Atypical Hemolytic Uremic Syndrome (aHUS)

Soliris is indicated for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

Limitation of Use

Soliris is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

Contraindications

Soliris is contraindicated in:

  • Patients with unresolved serious Neisseria meningitidis infection

  • Patients who are not currently vaccinated against Neisseria meningitidis, unless the risks of delaying Soliris treatment outweigh the risks of developing a meningococcal infection

Warnings and precautions

Other Infections

Soliris blocks terminal complement activation; therefore patients may have increased susceptibility to infections, especially with encapsulated bacteria. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Children treated with Soliris may be at increased risk of developing serious infections due to Streptococcus pneumoniae and Haemophilus influenza type b (Hib). Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenza type b (Hib) infections according to ACIP guidelines. Use caution when administering Soliris to patients with any systemic infection.

Monitoring Disease Manifestations After Soliris Discontinuation

Treatment Discontinuation for PNH

Monitor patients after discontinuing Soliris for at least 8 weeks to detect hemolysis.

Treatment Discontinuation for aHUS

After discontinuing Soliris, monitor patients with aHUS for signs and symptoms of thrombotic microangiopathy (TMA) complications for at least 12 weeks. In aHUS clinical trials, 18 patients (5 in the prospective studies) discontinued Soliris treatment. TMA complications occurred following a missed dose in 5 patients, and Soliris was reinitiated in 4 of these 5 patients.

Clinical signs and symptoms of TMA include changes in mental status, seizures, angina, dyspnea, or thrombosis. In addition, the following changes in laboratory parameters may identify a TMA complication: occurrence of two, or repeated measurement of any one of the following: a decrease in platelet count by 25% or more compared to baseline or the peak platelet count during Soliris treatment; an increase in serum creatinine by 25% or more compared to baseline or nadir during Soliris treatment; or, an increase in serum LDH by 25% or more over baseline or nadir during Soliris treatment.

If TMA complications occur after Soliris discontinuation, consider reinstitution of Soliris treatment, plasma therapy [plasmapheresis, plasma exchange, or fresh frozen plasma infusion (PE/PI)], or appropriate organ-specific supportive measures.

Thrombosis Prevention and Management

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

Infusion Reactions

As with all protein products, administration of Soliris may result in infusion reactions, including anaphylaxis or other hypersensitivity reactions. In clinical trials, no patients experienced an infusion reaction which required discontinuation of Soliris. Interrupt Soliris infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur.

Adverse Reactions

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 infections, pyrexia.

Please see full Prescribing Information for Soliris, including Boxed WARNING regarding serious meningococcal infection.