ULTOMIRIS is a prescription medicine used to treat adults and children 1 month of age and older with a disease called paroxysmal nocturnal hemoglobinuria (PNH)
Less PNH symptoms.a
More disease control.b
ULTOMIRIS is the #1 prescribed PNH treatment in adultsc that works to reduce the risk of intravascular hemolysis, blood clots, fatigue, and the need for transfusions. ULTOMIRIS is the only long-acting PNH medication that can provide up to 8 weeks of freedom between treatments.*
*Starting 2 weeks after the initial loading dose, maintenance doses are administered every 8 weeks for adults and every 4 or 8 weeks for pediatric patients (depending on body weight).
aIn a clinical trial, adults receiving ULTOMIRIS had fewer PNH symptoms—fatigue, abdominal pain, shortness of breath, difficulty swallowing, chest pain, hemoglobinuria, and erectile dysfunction—than they did before they started treatment.
bIn a clinical trial, the levels of LDH—an established measure of intravascular hemolysis and PNH disease activity—in the blood of adults with PNH had dropped within normal range by 4 weeks of starting ULTOMIRIS treatment and stayed there throughout one year.
cBased on US market share data.
Understanding PNH
Living with a rare disease like paroxysmal nocturnal hemoglobinuria (PNH) can be a challenge, but the more you know about PNH, the better you may be able to manage it.
LEARN MORE ABOUT PNHGet an expert's perspective on treating PNH
Watch Dr Anita Hill’s new video. In it, she explains what causes PNH and how ULTOMIRIS can help manage PNH disease activity and improve symptoms.
Less means more
ULTOMIRIS is designed to control intravascular hemolysis and PNH symptoms.
ABOUT ULTOMIRIS
You’re not alone
It is natural to think you are alone when you are diagnosed with PNH, because it is a rare disease. With OneSource™, you’ll have a whole team behind you. Connect with an experienced Alexion Case Manager with advanced knowledge in PNH and health insurance, as well as information on funding and community resources.
LEARN ABOUT ONESOURCEGo ahead,
fill your days
With dosing every 8 weeks,d ULTOMIRIS means your plans don’t have to center around your infusions. Your schedule could be completely full…of possibilities.
SWITCHING FROM SOLIRIS® (eculizumab)?dStarting 2 weeks after the initial loading dose, maintenance doses are administered every 8 weeks for adults and every 4 or 8 weeks for pediatric patients (depending on body weight).
What is the most important information I should know about ULTOMIRIS?
ULTOMIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections.
- ULTOMIRIS increases your chance of getting serious and life-threatening meningococcal infections that 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 are not vaccinated.
- If your healthcare provider 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. Your healthcare provider will decide if you need additional vaccination.
- Meningococcal vaccines reduce but do not prevent all meningococcal infections. Call your healthcare provider 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, fever and a rash, confusion, muscle aches with flu-like symptoms and eyes sensitive to light.
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. It is important to show this card to any healthcare provider or nurse to help them diagnose and treat you quickly.
ULTOMIRIS is only available through a program called the ULTOMIRIS REMS. Before you can receive ULTOMIRIS, your healthcare provider must: enroll in the ULTOMIRIS REMS program; counsel you about the risk of meningococcal infection; give you information and a Patient Safety Card about the symptoms and your risk of meningococcal infection (as discussed above); and make sure that you are vaccinated with a meningococcal vaccine, and if needed, get revaccinated with the meningococcal vaccine. Ask your healthcare provider if you are not sure if you need to be revaccinated.
ULTOMIRIS may also increase the risk of other types of serious infections. Make sure your child receives vaccinations against Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) if treated with ULTOMIRIS. Call your healthcare provider right away if you have any new signs or symptoms of infection.
Who should not receive ULTOMIRIS?
Do not receive ULTOMIRIS if you have a meningococcal infection or have not been vaccinated against meningococcal infection unless your healthcare provider decides that urgent treatment with ULTOMIRIS is needed.
Before you receive ULTOMIRIS, tell your healthcare provider about all of your medical conditions, including if you: have an infection or fever, are pregnant or plan to become pregnant, and are breastfeeding or plan to breastfeed. It is not known if ULTOMIRIS will harm your unborn baby or if it passes into your breast milk. You should not breastfeed during treatment and for 8 months after your final dose of ULTOMIRIS.
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 PNH and you stop receiving ULTOMIRIS, your healthcare provider 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, tiredness, blood in your urine, stomach-area (abdomen) pain, shortness of breath, blood clots, trouble swallowing, and erectile dysfunction (ED) in males.
ULTOMIRIS can cause serious side effects including allergic reactions to acrylic adhesive. Allergic reactions to the acrylic adhesive may happen with your subcutaneous ULTOMIRIS treatment. If you have an allergic reaction during the delivery of subcutaneous ULTOMIRIS, remove the on-body injector and get medical help right away. Your healthcare provider may treat you with medicines to help prevent or treat allergic reaction symptoms as needed.
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, tiredness, feeling faint, discomfort in your arms or legs, bad taste, or drowsiness. Stop treatment of ULTOMIRIS and tell your healthcare provider 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, and feel faint or pass out.
The most common side effects of ULTOMIRIS in people treated for PNH are upper respiratory tract infection and headache.
The most common side effects of subcutaneous administration of ULTOMIRIS in adults treated for PNH are local injection site reactions.
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.
Read the Instructions for Use that comes with subcutaneous ULTOMIRIS for instructions about the right way to prepare and give your subcutaneous ULTOMIRIS injections through an on-body injector.
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 Paroxysmal Nocturnal Hemoglobinuria (PNH).
- adults with PNH when administered subcutaneously (under your skin).
It is not known if ULTOMIRIS is safe and effective in children younger than 1 month of age.
Subcutaneous administration of ULTOMIRIS has not been evaluated and is not approved for use in children.