INDICATION & IMPORTANT SAFETY INFORMATION for ULTOMIRIS® (ravulizumab-cwvz), INCLUDING BOXED WARNING
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).
It is not known if ULTOMIRIS is safe and effective in children with PNH.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ULTOMIRIS?
ULTOMIRIS is a medicine that affects your immune system. ULTOMIRIS can lower the ability of your immune system to fight infections.
- 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.
- You must receive meningococcal vaccines at least 2 weeks before your first dose of ULTOMIRIS if you have not already had this vaccine.
- If your doctor decided that urgent treatment with ULTOMIRIS is needed, you should receive meningococcal vaccination as soon as possible.
- If you have not been vaccinated and ULTOMIRIS therapy must be initiated immediately, you should also receive 2 weeks of antibiotics with your vaccinations.
- If you had a meningococcal vaccine in the past, you might need additional vaccination before starting ULTOMIRIS. Your doctor will decide if you need additional meningococcal vaccination.
- Meningococcal vaccines reduce the risk of meningococcal infection but do not prevent all meningococcal infections. Call your doctor or get emergency medical care right away if you get any of these signs and symptoms of a meningococcal infection:
- headache with nausea or vomiting
- headache and fever
- headache with a stiff neck or stiff back
- fever and a rash
- muscle aches with flu-like symptoms
- eyes sensitive to light
- enroll in the ULTOMIRIS REMS program
- counsel you about the risk of meningococcal infection
- give you information about the symptoms of meningococcal infection
- give you a Patient Safety Card about your risk of meningococcal infection, as discussed above
- make sure that you are vaccinated with a meningococcal vaccine
- People who take ULTOMIRIS may have an increased risk of getting infections caused by Streptococcus pneumoniae and Haemophilus influenzae.
- Certain people may also have an increased risk of gonorrhea infection. Talk to your doctor to find out if you are at risk for gonorrhea infection, about gonorrhea prevention, and regular testing.
Call your doctor right away if you have any new signs or symptoms of infection.
Do not receive ULTOMIRIS if you:
- have a meningococcal infection
- Have not been vaccinated against meningococcal infection unless your doctor decides that urgent treatment with ULTOMIRIS is needed. See “What is the most important information I should know about ULTOMIRIS.”
- have an infection or fever.
- are pregnant or plan to become pregnant. It is not known if ULTOMIRIS will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if ULTOMIRIS passes into your breast milk. You should not breastfeed during treatment and for 8 months after your final dose of ULTOMIRIS.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ULTOMIRIS and other medicines can affect each other causing side effects.
Know the medicines you take and the vaccines you receive. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
How should I receive ULTOMIRIS?
- ULTOMIRIS is given through a vein by intravenous (I.V.) infusion usually over about 2 hours in adults.
- If you are an adult with PNH, you will usually receive:
- a starting dose of ULTOMIRIS as an infusion by your doctor, and then
- 2 weeks later, you will start to receive an infusion of ULTOMIRIS every 8 weeks.
- If you are changing treatment from SOLIRIS to ULTOMIRIS, you should receive your starting dose of ULTOMIRIS 2 weeks after your last dose of SOLIRIS.
- After each infusion, you should be monitored for at least 1 hour for infusion reactions. See “What are the possible side effects of ULTOMIRIS?”
- If you have PNH and you stop receiving ULTOMIRIS, your doctor will need to monitor you closely for at least 16 weeks after you stop ULTOMIRIS. Stopping ULTOMIRIS may cause breakdown of your red blood cells due to PNH. Symptoms or problems that can happen due to red blood cell breakdown include:
- drop in your red blood cell count
- blood in your urine
- stomach-area (abdomen) pain
- shortness of breath
- blood clots
- trouble swallowing
- erectile dysfunction (ED) in males
- If you miss an ULTOMIRIS infusion, call your doctor right away.
ULTOMIRIS can cause serious side effects including:
- See “What is the most important information I should know about ULTOMIRIS?”
- Infusion reactions. Infusion reactions may happen during your ULTOMIRIS infusion. Symptoms of an infusion reaction with ULTOMIRIS may include lower back pain, pain with the infusion, feeling faint or discomfort in your arms or legs. 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
Your doctor will treat your symptoms as needed.
The most common side effects of ULTOMIRIS in people treated for PNH are upper respiratory infection and headache.
Tell your doctor 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 doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.