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Soliris
Eculizumab
$7740.00
300mg · 300 ampules
BrandBranded medicine· By Alexion
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FDA boxed warningSerious meningococcal infections
SOLIRIS, a complement inhibitor, increases the risk of serious infections caused by Neisseria meningitidis. Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.
Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of SOLIRIS, unless the risks of delaying therapy with SOLIRIS outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against meningococcal bacteria in patients receiving a complement inhibitor. See
Warnings and Precautions
for additional guidance on the management of the risk of serious infections caused by meningococcal bacteria.
Patients receiving SOLIRIS are at increased risk for invasive disease caused by Neisseria meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious meningococcal infections and evaluate immediately if infection is suspected.
Because of the risk of serious meningococcal infections, SOLIRIS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called ULTOMIRIS and SOLIRIS REMS.
SOLIRIS increases the risk of serious and life-threatening infections caused by Neisseria meningitidis.
Complete or update meningococcal vaccination at least 2 weeks prior to the first dose of SOLIRIS, unless the risks of delaying SOLIRIS outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients receiving a complement inhibitor.
Patients receiving SOLIRIS are at increased risk for invasive disease caused by N. meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of meningococcal infections, and evaluate immediately if infection is suspected.
SOLIRIS is available only through a restricted program called the ULTOMIRIS and SOLIRIS REMS.
About Soliris
Overview
Soliris contains eculizumab, a monoclonal antibody medicine that inhibits part of the immune system called complement. It treats paroxysmal nocturnal hemoglobinuria (PNH) to reduce red blood cell breakdown and atypical hemolytic uremic syndrome (aHUS) to inhibit complement-related clotting in small blood vessels; it is not indicated for Shiga toxin E. coli-related HUS. It also treats generalized myasthenia gravis (gMG) in adults and children aged six years and older who test positive for anti-acetylcholine receptor antibodies, and neuromyelitis optica spectrum disorder (NMOSD) in adults who test positive for anti-aquaporin-4 antibodies. It works by blocking the complement protein C5, preventing the formation of a complement complex that can damage cells.
What it treats
- Paroxysmal nocturnal hemoglobinuria (PNH), to reduce the breakdown of red blood cells. - Atypical hemolytic uremic syndrome (aHUS), to inhibit complement-mediated blood clots in small blood vessels. Soliris is not indicated for Shiga toxin–producing E. coli-related HUS (STEC-HUS). - Generalized myasthenia gravis (gMG) in adults and children aged six years and older who test positive for anti-acetylcholine receptor (AChR) antibodies. - Neuromyelitis optica spectrum disorder (NMOSD) in adults who test positive for anti-aquaporin-4 (AQP4) antibodies.
Safety information
Side effects
Common side effects reported in Soliris trials varied by condition. They included headache, back pain, muscle and bone pain, joint pain, nausea, vomiting, diarrhea, abdominal pain, dizziness, high blood pressure, anemia, swelling of the limbs, fever, cough, bruising, and infections such as colds, flu and urinary tract infections. Serious risks include meningococcal infections, other infections and infusion-related reactions. Contact a doctor promptly if you suspect an infection, and tell the healthcare team immediately if you experience a reaction during an infusion. Soliris should be used with caution in people who have another infection affecting the body.
FDA boxed warning
Serious meningococcal infections
SOLIRIS, a complement inhibitor, increases the risk of serious infections caused by Neisseria meningitidis. Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.
Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of SOLIRIS, unless the risks of delaying therapy with SOLIRIS outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against meningococcal bacteria in patients receiving a complement inhibitor. See
Warnings and Precautions
for additional guidance on the management of the risk of serious infections caused by meningococcal bacteria.
Patients receiving SOLIRIS are at increased risk for invasive disease caused by Neisseria meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious meningococcal infections and evaluate immediately if infection is suspected.
Because of the risk of serious meningococcal infections, SOLIRIS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called ULTOMIRIS and SOLIRIS REMS.
SOLIRIS increases the risk of serious and life-threatening infections caused by Neisseria meningitidis.
Complete or update meningococcal vaccination at least 2 weeks prior to the first dose of SOLIRIS, unless the risks of delaying SOLIRIS outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients receiving a complement inhibitor.
Patients receiving SOLIRIS are at increased risk for invasive disease caused by N. meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of meningococcal infections, and evaluate immediately if infection is suspected.
SOLIRIS is available only through a restricted program called the ULTOMIRIS and SOLIRIS REMS.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
Soliris must not be started in patients with an unresolved serious infection caused by Neisseria meningitidis. It should be used with caution in patients with any other infection affecting the body as a whole. Patients should be monitored during the infusion for infusion-related reactions. If a reaction occurs, the infusion should be interrupted and appropriate supportive care provided.
Using Soliris
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton below 25°C, protected from light. Do not freeze, and use immediately once opened. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label SOLIRIS (ECULIZUMAB) INJECTION, SOLUTION, CONCENTRATE [ALEXION PHARMACEUTICALS INC.] (DailyMed, retrieved 19 September 2026).
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