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Ultomiris
Ravulizumab-cwvz
$9150.00
300mg · 1 vial
BrandBranded medicine· By Alexion
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300mg
1100mg
FDA boxed warningSerious meningococcal infections
ULTOMIRIS, 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 ULTOMIRIS, unless the risks of delaying therapy with ULTOMIRIS 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 ULTOMIRIS 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, ULTOMIRIS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called ULTOMIRIS and SOLIRIS REMS.
ULTOMIRIS 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 ULTOMIRIS, unless the risks of delaying ULTOMIRIS outweigh the risks 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 ULTOMIRIS 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.
ULTOMIRIS is available only through a restricted program called ULTOMIRIS and SOLIRIS REMS.
About Ultomiris
Overview
Ultomiris (ravulizumab-cwvz) is a prescription complement inhibitor supplied in a vial for intravenous use. It treats paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) in adults and children aged one month and older; it is not indicated for Shiga toxin E. coli-related hemolytic uremic syndrome. It also treats adults with generalized myasthenia gravis (gMG) who test positive for anti-acetylcholine receptor antibodies, and adults with neuromyelitis optica spectrum disorder (NMOSD) who test positive for anti-aquaporin-4 antibodies. It works by blocking the complement protein C5, preventing formation of a complex that can damage cells.
What it treats
- Paroxysmal nocturnal hemoglobinuria (PNH) in adults and children aged one month and older. - Atypical hemolytic uremic syndrome (aHUS) in adults and children aged one month and older, to inhibit complement-mediated thrombotic microangiopathy (TMA). Not indicated for Shiga toxin E. coli-related hemolytic uremic syndrome (STEC-HUS). - Generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive. - Neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody-positive.
Safety information
Side effects
Common side effects vary by the condition being treated: • PNH: upper respiratory tract infections and headache. • aHUS: upper respiratory tract infections, diarrhea, nausea, vomiting, headache, high blood pressure and fever. • gMG in adults: diarrhea and upper respiratory tract infections. • NMOSD in adults: COVID-19, headache, back pain, joint pain and urinary tract infections. Serious side effects include meningococcal infections, other infections and infusion-related reactions. Contact a doctor promptly if you suspect an infection or experience a reaction during an infusion. Patients should be monitored during the infusion; if a reaction occurs, the infusion should be interrupted and appropriate supportive treatment provided.
FDA boxed warning
Serious meningococcal infections
ULTOMIRIS, 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 ULTOMIRIS, unless the risks of delaying therapy with ULTOMIRIS 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 ULTOMIRIS 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, ULTOMIRIS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called ULTOMIRIS and SOLIRIS REMS.
ULTOMIRIS 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 ULTOMIRIS, unless the risks of delaying ULTOMIRIS outweigh the risks 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 ULTOMIRIS 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.
ULTOMIRIS is available only through a restricted program called 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
Ultomiris must not be started in anyone with an unresolved serious infection caused by Neisseria meningitidis, the bacteria that cause meningococcal infection. Caution is needed in people with any other systemic infection (an infection affecting the body more widely). Patients should be monitored during infusion. If an infusion-related reaction occurs, the infusion should be interrupted and appropriate supportive care provided.
Interactions
Tell your doctor if you receive plasma exchange, plasmapheresis or intravenous immunoglobulins, as these require an adjustment to your Ultomiris treatment. Also tell your doctor if you take a neonatal Fc receptor (FcRn) blocker; your doctor should closely monitor you for reduced effectiveness of Ultomiris.
Using Ultomiris
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, unless the pack states refrigeration. Do not freeze. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label ULTOMIRIS (RAVULIZUMAB) SOLUTION, CONCENTRATE [ALEXION PHARMACEUTICALS INC.] (DailyMed, retrieved 19 September 2026).
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