Ravulizumab-cwvz (Ultomiris®) is a drug approved by the U.S. Food and Drug Administration (FDA) in 2018 to treat PNH. ULTOMIRIS® is a long-acting C5 inhibitor that works by inhibiting the C5 protein in the terminal complement cascade. ULTOMIRIS® is a prescription medicine called a monoclonal antibody. ULTOMIRIS® is used to treat patients with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH). On June 7, 2021, the U.S. FDA approved the expanded use of ULTOMIRIS® to include children (one month of age and older) and adolescents with PNH. ULTOMIRIS® is a long-acting C5 inhibitor administered every eight weeks that works by inhibiting the C5 protein in the terminal complement cascade.
ULTOMIRIS® increases your chance of getting serious and life-threatening meningococcal infections. Meningococcal infections may quickly become life-threatening and cause death if not recognized and treated early.
What is ULTOMIRIS®?
ULTOMIRIS® is a prescription medicine called a monoclonal antibody. ULTOMIRIS® is used to treat adults with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH). ULTOMIRIS® is a long-acting C5 inhibitor administered every eight weeks that works by inhibiting the C5 protein in the terminal complement cascade. On June 7, 2021, the U.S. FDA approved the expanded use of ULTOMIRIS® to include children (one month of age and older) and adolescents with PNH.
ULTOMIRIS® increases your chance of getting serious and life-threatening meningococcal infections. Meningococcal infections may quickly become life-threatening and cause death if not recognized and treated early.
Patients should receive meningococcal vaccines at least 2 weeks before the first dose of ULTOMIRIS® if they have not already had this vaccine.
If the prescribing doctor decides that urgent treatment with ULTOMIRIS® is needed, patients should receive meningococcal vaccination as soon as possible.
Patients who have not been vaccinated and for whom ULTOMIRIS® therapy must be initiated immediately, prophylactic antibiotics for 2 weeks should be administered with your vaccinations.
Patients who have had a meningococcal vaccine in the past, might need an additional vaccination before starting ULTOMIRIS®.
Meningococcal vaccines may reduce the risk of some meningococcal infections but does not prevent all meningococcal infections. Patients should contact their doctor or get emergency medical care right away if experiencing any of these signs and symptoms of a meningococcal infection:
- headache with nausea or vomiting
- headache with a stiff neck or stiff back
- fever and a rash
- muscle aches with flu-like symptoms
- headache and fever
- fever
- confusion
- eyes sensitive to light
ULTOMIRIS® may increase the risk of other serious infections. Patients who take ULTOMIRIS® may have an increased risk of getting infections caused by Streptococcus pneumoniae (respiratory infection) and Haemophilus influenza (hib disease). Certain patients may also have an increased risk of gonorrhea infection
ULTOMIRIS® is only available through a program called the ULTOMIRIS® REMS.
Before a patient can receive ULTOMIRIS® their doctor must:
- enroll in the ULTOMIRIS® REMS program
- counsel the patient about the risk of meningococcal infection
- give the patient information about the symptoms of meningococcal infection
- give the patient the Patient Safety Card about the risk of meningococcal infection
- make sure the patient is vaccinated with a meningococcal vaccine when clinically indicated
Who should not receive ULTOMIRIS®?
Do not start ULTOMIRIS® if the patient has an active meningococcal infection.
Before receiving ULTOMIRIS®, patients should talk with their doctor about all of their medical conditions, including if they:
- have an infection or fever.
- are pregnant or plan to become pregnant. It is not known if ULTOMIRIS® will harm an unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if ULTOMIRIS® passes into breast milk. Women should not breast feed during treatment and for 8 months after final dose of ULTOMIRIS®.
How should patients receive ULTOMIRIS®?
- ULTOMIRIS® is given through a vein by intravenous (I.V.) infusion usually over approximately 2 hours.
- Patients will usually receive:
- a starting dose of ULTOMIRIS® as an infusion by their doctor, and then
- 2 weeks later, will start to receive an infusion of ULTOMIRIS® every 8 weeks.
- After each infusion, patients should be monitored for at least 1 hour for allergic reactions.
- If a patient is changing treatment from SOLIRIS® to ULTOMIRIS®, they should receive the starting dose of ULTOMIRIS® 2 weeks after their last dose of SOLIRIS®.
What are the possible side effects of ULTOMIRIS®?
The most common side effects of ULTOMIRIS® are upper respiratory infection and headache. Of note, patients who were enrolled into the clinical trials received vaccinations to prevent meningococcal infections within 3 years of enrollment.
ULTOMIRIS® can cause serious side effects including:
- Infusion reactions may happen during your ULTOMIRIS® infusion. Symptoms of an infusion reaction with ULTOMIRIS® may include lower back pain, pain with the infusion, or feeling faint. Tell your doctor or nurse right away if you develop these symptoms, or any other symptoms during your ULTOMIRIS® infusion that may mean you are having a serious infusion reaction, including:
- chest pain
- trouble breathing or shortness of breath
- swelling of your face, tongue, or throat
- feel faint or pass out