Soliris
Soliris
Soliris is a first-in-class terminal complement inhibitor discovered, developed, and commercialized by Alexion. Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH), with atypical hemolytic uremic syndrome (aHUS) and with generalized Myasthenia Gravis (gMG).
Soliris works by selectively inhibiting activation of specific proteins in the complement system (C5a and C5b), which play a role in the pathophysiology of multiple rare diseases.
Soliris is indicated for: the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy, the treatment of adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive, and neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aaquaporin-4 (AQP4) antibody positive.
As the first treatment of its kind approved by the FDA, Soliris has been studies in 51 clinical trials, with 13 years of postmarket experience.
Soliris is only available through a program called the Soliris REMS. Before you can receive Soliris, your doctor must enroll in the Soliris REMS program; counsel you about the risk of meningococcal infection; give you information and a Patient Safety Card about the symptoms and your risk of meningococcal infection; and make sure that you are vaccinated with the meningococcal vaccine and, if needed, get revaccinated with the meningococcal vaccine.
Administration Information
Soliris is an intravenous infusion that is administered weekly for five weeks and then every two weeks thereafter. Infusions are administered over about 35 minutes. You will be observed for 60 minutes after every infusion.
Number of yearly treatments: 24
Potential Side Effects
Soliris is a medicine that affects your immune system and can lower the ability of your immune system to fight infections.
Soliris increases your chance of getting serious and life-threatening meningococcal infections that may quickly become life-threatening and cause death if not recognized and treated early. For this reason, you must receive meningococcal vaccines at least 2 weeks before your first dose of Soliris if you are not vaccinated.
The most common side effects in people with PNH treated with Soliris include: headache, pain or swelling of your nose or throat (nasopharyngitis), back pain, and nausea.
The most common side effects in people with aHUS treated with Soliris include: headache, diarrhea, high blood pressure (hypertension), common cold (upper respiratory infection), stomach-area (abdominal) pain, vomiting, pain or swelling of your nose or throat (nasopharyngitis), low red blood cell count (anemia), cough, swelling of legs or feet (peripheral edema), nausea, urinary tract infections, and fever.
The most common side effects in people with gMG treated with Soliris include: muscle and joint (musculoskeletal) pain.
The most common side effects in people with NMOSD treated with Soliris include: common cold (upper respiratory infection), pain or swelling of your nose or throat (nasopharyngitis), diarrhea, back pain, dizziness, flu like symptoms (influenza) including fever, headache, tiredness, cough, sore throat, and body aches, joint pain (arthralgia), throat irritation (pharyngitis), and bruising (contusion).
For a full list of potential side effects, please see the Important Safety Information and Medication Guide on the Soliris website.
Helpful Resources
SOLIRIS WEBSITE
ASSESSING MY GMG
ABOUT SOLIRIS
SOLIRIS SUPPORT AND RESOURCES
SOLIRIS PATIENT STORIES
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Patient Consent Form
HIPAA Privacy Authorization Form
Notice of Privacy Practices
Patient Rights and Responsibilities
Appointment Lateness and Cancelation
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