Ultomiris affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, flu-like symptoms, muscle pain, headache, confusion, neck or back stiffness, vomiting, rash, or your eyes are more sensitive to light.
You will need to receive certain vaccinations before you start using Ultomiris.
Ultomiris comes with a Patient Safety Card listing symptoms of meningococcal infection. Keep this card with you at all times while using Ultomiris and for at least 8 months after your last dose. Your infection risk could last for several months after you stop using this medicine.
Some people may have an increased risk of gonorrhea (a sexually transmitted disease) while using this medicine. Talk with your doctor about safe ways to keep from getting an infection during sex.
Before taking this medicine
You should not be treated with Ultomiris if you are allergic to ravulizumab, if you have a meningococcal infection (such as meningitis or sepsis), or if you are not currently vaccinated against meningitis (unless the risks of delaying treatment outweigh the risks of developing meningitis).
You will need to receive a vaccine to protect against meningococcal infections at least 2 weeks before you start using Ultomiris. If your child is treated with this medicine, make sure he or she is vaccinated against pneumonia and influenza type B (Hib).
If you need to start receiving this medicine before you are vaccinated, you may be given antibiotic medicine to take during the first 2 weeks of Ultomiris treatment.
Tell your doctor if you have recently had any symptoms of infection (fever, chills, or flu-like symptoms).
Tell your doctor if you are pregnant. It is not known whether ravulizumab will harm an unborn baby. However, having PNH during pregnancy may cause complications in the baby or the mother, including blood clots, infections, bleeding, miscarriage, premature delivery, or death. The benefit of treating PNH may outweigh any risks to the baby or the mother.
Do not breastfeed while using Ultomiris, and for at least 8 months after your last dose.
Ultomiris is not approved for use by anyone younger than 1 month old.
How is Ultomiris given?
Use Ultomiris exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.
If you've been using another drug called eculizumab (Soliris), you will need to wait 2 weeks after your last dose of eculizumab before starting treatment with Ultomiris.
Ultomiris is injected into a vein by a healthcare provider. The first two infusions are usually given 2 weeks apart, followed by an infusion once every 4-8 weeks.
After each infusion, you will be watched closely for at least 1 hour to make sure you do not have an allergic reaction.
Doses are based on weight. Your dose may change if you gain or lose weight.
You may get infections more easily, even serious or fatal infections. You will need frequent medical tests.
Read the Patient Safety Card about serious infections and the symptoms to watch for. Keep this card with you at all times while using Ultomiris and for at least 8 months after your last dose. Your infection risk could last for several months after you stop using this medicine.
Some people may have an increased risk of gonorrhea (a sexually transmitted disease). Talk with your doctor about safe ways to keep from getting an infection during sex.
Ultomiris can have long lasting effects on your body, even after you stop using this medicine. If you have PNH and you stop using Ultomiris, your doctor may need to check your progress for at least 16 weeks after your last dose. If you have aHUS and you stop using Ultomiris, your doctor may need to check you for at least 12 months after your last dose.
