Ultomiris (ravulizumab)
Reviewed by: HU Medical Review Board | Last reviewed: October 2024
Neuromyelitis optica spectrum disorder (NMOSD or NMO) is an autoimmune condition. With autoimmune conditions, the body’s immune system attacks healthy cells. The central nervous system becomes damaged when a person has NMO. This system is made up of the brain, spinal cord, and optic nerve (eyes).1
Ultomiris® (ravulizumab-cwvz) is one of the treatments that may be prescribed for NMO. Ultomiris is a laboratory-made drug. It has been approved by the US Food and Drug Administration (FDA) for adults with NMOSD who have the antibody anti-aquaporin-4 (also called AQP4).1,2
A person must have have had at least 1 NMO attack or relapse in the last year (12 months) to receive Ultomiris.2
What are the ingredients in Ultomiris?
The active ingredient in Ultomiris is ravulizumab.1
How does Ultomiris work?
Doctors do not understand exactly how Ultomiris works in people with NMO. But, they believe it blocks a pathway in the complement system. The complement system is part of your immune system that fights inflammation and germs.3
The complement system is involved in the inflammation of NMO that results in nerve damage. Ultomiris is thought to limit inflammation and nerve damage by preventing the immune system from attacking healthy nerve cells.1,3
What are the possible side effects?
Ultomiris is given by intravenous (IV) infusion. This means it is delivered into a vein using a needle. People taking Ultomiris may receive infusions every 8 weeks after an initial loading dose.1
The main side effect of taking Ultomiris is an increased risk of a serious infection. Other common side effects include:1
- Infection with COVID-19
- Headache
- Back pain
- Joint pain
- Urinary tract infection
IV site reactions may occur. The infusion may also cause a life-threatening allergic reaction called anaphylaxis.1
Ultomiris has a boxed warning, the strictest warning from FDA. It has this warning because life-threatening and fatal meningitis has occurred in those who have taken this drug. Meningitis is an infection and inflammation of the layers of fluid and tissues surrounding your brain and spinal cord.1,4
These are not all the possible side effects of Ultomiris. Talk to your doctor about what to expect when taking Ultomiris. You also should call your doctor if you have any changes that concern you when taking Ultomiris.
Other things to know
Because of the risk of meningitis, you will need to be vaccinated against meningitis before taking Ultomiris. Meningococcal vaccines are sometimes given as more than 1 shot with a waiting period between shots. You must get the last shot of your vaccination at least 2 weeks before your first dose of Ultomiris. Signs of a meningitis infection include:1,4,5
- Fever
- Rash
- Headache, a stiff neck, or a stiff back
- Nausea or vomiting
- High heart rate
- Confusion
- Muscle aches with flu-like symptoms
- Eyes sensitive to light
People receiving Ultomiris should not receive plasma exchange (plasmapheresis) or intravenous immunoglobulin (IVIg).1
People taking Ultomiris must carry a Patient Safety Card with them at all times while taking Ultomiris and for 8 months after their last dose. Your doctor will give this card to you. It explains the risk of meningitis infection.1
Doctors do not yet know if Ultomiris is safe to take during pregnancy or while breastfeeding.1
You must enroll in a REMS program before beginning Ultomiris. REMS stands for Risk Evaluation and Mitigation Strategy.1
Before beginning treatment for NMOSD, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.
For more information, read the full prescribing information of Ultomiris.1