Atypical-HUS is a rare disease that causes damage to blood vessels. This damage occurs when the complement system—a certain part of the immune system—acts out of control.
Actor portrayal
Most people have never heard of the complement system, but it plays an important role in the body’s immune system—eliminating harmful microorganisms or pathogens.
C5, which is part of the complement system, is an important protein that helps the body destroy foreign or damaged cells.
Normally, control mechanisms in your body keep C5 and other complement proteins from attacking healthy cells.
In atypical-HUS, the control mechanisms fail, and uncontrolled C5 activity can result in complement damaging healthy cells.
Uncontrolled C5 activity causes damage to blood vessels, which leads to something called thrombotic microangiopathy (or simply TMA). TMA involves abnormal clotting, damaged red blood cells, and reduced blood flow.
This TMA damage is the cause of the atypical-HUS signs and symptoms you might feel, and it can lead to problems in the kidneys and other vital organs. In atypical-HUS, the risk of TMA complications is lifelong but may be managed.
See how ULTOMIRIS is designed to help treat atypical-HUS by blocking the cause of atypical-HUS damage and getting C5 under control
When I learned more about C5, I understood how ULTOMIRIS could help. That put me at ease, and I didn’t have to be on edge about my atypical-HUS 24/7.”
Actor portrayal. Each person’s results with ULTOMIRIS may vary.
Quotes are composites based on actual experiences of real people living with atypical-HUS.
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What is the most important information I should know about ULTOMIRIS?
ULTOMIRIS is a medicine that affects your immune system and may lower the ability of your immune system to fight infections.
Your healthcare provider will give you a Patient Safety Card about the risk of meningococcal infection. Carry it with you at all times during treatment and for 8 months after your last ULTOMIRIS dose. Your risk of meningococcal infection may continue for several months after your last dose of ULTOMIRIS. It is important to show this card to any healthcare provider who treats you. This will help them diagnose and treat you quickly.
ULTOMIRIS is only available through a program called the ULTOMIRIS and SOLIRIS Risk Evaluation and Mitigation Strategy (REMS). Before you can receive ULTOMIRIS, your healthcare provider must: enroll in the REMS program; counsel you about the risk of serious meningococcal infections; give you information about the signs and symptoms of serious meningococcal infection; make sure that you are vaccinated against serious infections caused by meningococcal bacteria, and that you receive antibiotics if you need to start ULTOMIRIS right away and are not up to date on your vaccines; give you a Patient Safety Card about your risk of meningococcal infection.
ULTOMIRIS may also increase the risk of other types of serious infections, including Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria gonorrhoeae. Your child should receive vaccines against Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) if treated with ULTOMIRIS. Certain people may be at risk of serious infections with gonorrhea.
Who should not receive ULTOMIRIS?
Do not receive ULTOMIRIS if you have a serious meningococcal infection when you are starting ULTOMIRIS.
Before you receive ULTOMIRIS, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the vaccines you receive and medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements which could affect your treatment.
If you have aHUS, your healthcare provider will need to monitor you closely for at least 12 months after stopping treatment for signs of worsening aHUS or problems related to a type of abnormal clotting and breakdown of your red blood cells called thrombotic microangiopathy (TMA). Symptoms or problems that can happen with TMA may include: confusion or loss of consciousness, seizures, chest pain (angina), difficulty breathing and blood clots or stroke.
What are the possible side effects of ULTOMIRIS?
ULTOMIRIS can cause serious side effects including infusion-related reactions. Symptoms of an infusion-related reaction with ULTOMIRIS may include lower back pain, abdominal pain, muscle spasms, changes in blood pressure, tiredness, feeling faint, shaking chills (rigors), discomfort in your arms or legs, bad taste, or drowsiness. Stop treatment of ULTOMIRIS and tell your healthcare provider right away if you develop these symptoms, or any other symptoms during your ULTOMIRIS infusion that may mean you are having a serious infusion-related reaction, including: chest pain, trouble breathing or shortness of breath, swelling of your face, tongue, or throat, and feel faint or pass out.
The most common side effects of ULTOMIRIS in people treated for aHUS are upper respiratory tract infection, diarrhea, nausea, vomiting, headache, high blood pressure and fever.
Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of ULTOMIRIS. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider right away if you miss an ULTOMIRIS infusion or for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
INDICATION
What is ULTOMIRIS?
ULTOMIRIS is a prescription medicine used to treat adults and children 1 month of age and older with a disease called atypical Hemolytic Uremic Syndrome (aHUS). ULTOMIRIS is not used in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). It is not known if ULTOMIRIS is safe and effective in children younger than 1 month of age.
Please see the full Prescribing Information and Medication Guide for ULTOMIRIS, including Boxed WARNING regarding serious meningococcal infections.