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.

Meet Your Support Team

Alexion Nurse Case Managers can help you with educational resources and information about funding options and assistance, as you and your doctor manage your condition.

  • Terry

    Case Manager since January 2007

    Terry and other members of the OneSource support team recommend tools and resources.

    Growing up in the suburbs of Philadelphia, Terry knew she wanted a career where “"the work would be meaningful, fulfilling and rewarding."” Nursing offered her the opportunity to do just that. It also allowed her to work in a variety of roles and environments– — from being on a hospital staff to collaborating with a healthcare software company. Read More

    However, when Terry learned that Alexion was looking for Case Managers who had experience working with patients with ultra-rare diseases, she knew she found her calling. Having personally experienced the devastating illnesses of two siblings and her father, Terry understands the emotional, social, and financial impact diseases can have on an individual and his or her family. She also knows how important a strong support team, both personal and professional, can be. Terry brings this experience with her as an Alexion Nurse Case Manager, where she’s committed to helping patients and their families. "“As an Alexion Nurse Case Manager, I have been able to offer and provide personal support to my patients, not just during our scheduled phone calls, but also whenever they need me,”" she says.

    Terry credits her parents for having helped to develop her dedication and compassion. They taught her that, “"The work I do is a reflection of who I am.”" As a parent, Terry continues to practice this belief as an example for her own son.

  • Leisa

    Case Manager since February 2007

    Leisa recommends tools to help manage PNH.

    Many years in the business world had left Leisa feeling unfulfilled and in need of a change. She wanted to help people and make a difference like her mother before her, who was a nurse in World War II. Following in the footsteps of the woman she calls “"the finest human being I have ever known,”" Leisa went into healthcare. It was a decision that was, in her words, “my best to date!” Read More

    Another great choice on Leisa’s part was joining the OneSource team. She read about Soliris and was excited about the therapy and its potential to impact a patient’s life. Today she is humbled by the role she plays in her patients’ well-being and loves developing relationships with them and their families and caregivers. She says, “"I am here to listen and help where I can. No question or concern is without merit.”"

    And if insurance issues come up, Leisa’s there to help. It’s just an example of why Leisa loves being an Alexion Nurse Case Manager. “"I can make a difference in someone’'s life and be a service to them,”" she says.

    If Leisa has one suggestion to offer patients, it would be to take it one day at a time and manage what they can on a daily basis. She also thinks it’s important for patients to remember that they’re not alone.

  • Adrianne

    Case Manager since 2012

    Adrianne recommends a specific tool to help track your symptoms. Find out what it is.

    Losing a sibling to leukemia left a lasting impression on Adrianne. It’s what drove her to work in a field where she could help others and improve their quality of life. She was attracted to the opportunity of being an Alexion Nurse Case Manager because, as she says, “"It allowed me to potentially play a key role in transforming patients’ lives.”" Read More

    Adrianne believes being a creative problem solver is at the core of what makes an effective Case Manager. She enjoys using her creative side, which she says comes in handy because “"There’s no such thing as a routine day at Alexion.”" She recalls one example when she helped a patient return to the Philippines to visit family for the first time in more than 10 years. She had to help him find a physician in the Philippines, as well as arrange for the transportation of Soliris to the physician’s office. Thanks to Adrianne’s efforts, her patient was able to visit with family he hadn’t seen in more than a decade.

    “"I find it very rewarding to see the impact my efforts have in the lives of my patients and their families. I feel extremely blessed and privileged to serve this population,”" she says.

    Much of Adrianne’s inspiration comes from Mother Teresa. She’s particularly motivated by Mother Teresa’s famous quote, “"Not all of us can do great things. But we can do small things with great love.”"

    If Adrianne has one suggestion to offer patients, it would be to maintain a journal. She says that, after undergoing therapy for a while, patients can sometimes forget how far they have come. That’s why she likes to go over this information with her patients during routine calls. It helps to keep things in perspective and on track.

  • Pam

    Case Manager since August 2009

    Pam recommends these tools to help communicate with her patients.

    It was during the summer of Pam’s freshman year of college that her mother experienced a devastating stroke, resulting in a coma that kept her in the hospital for a full month. While this was no doubt a difficult time for Pam and her family, the nurses at the hospital helped them get through it. They listened to Pam’s questions and provided answers and advice. Read More

    And it was thanks to their help that her mother, though half paralyzed, was able to walk down the aisle at Pam’s wedding.

    “"I remember saying to myself, if I could ever help someone like these nurses helped us, I would consider my life’'s work to be a success,”" she says.

    It’s not surprising that Pam chose to go into nursing. After working as a nurse for 12 years, Pam became an Alexion Nurse Case Manager. She loves her job because it gives her the chance to develop trusting relationships with people and make a difference in their lives. She believes that even the simple things she shares with her patients are important—a laugh, a good story, working through a particular concern. Pam feels especially proud when her patients tell her of their progress. “"I love to hear that they are now not napping during the day, or that they are planning a vacation, or they just scrubbed the kitchen floor. As an Alexion Nurse Case Manager, I get to hear from the patients firsthand and make a difference in their lives. What a great place to be!”"

    If Pam has one suggestion to offer her patients, it would be to remember that she is there for them. She believes communication is an important part of treatment. That’s why, in her words, “"I make myself available 24/7 for my patients to call with any questions or concerns. Sometimes it is just the simple act of listening, like my mother’'s nurses did for us.”"

OneSource Patient Authorization

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

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Important Safety Information

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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.