What will you be
doing while ULTOMIRIS
is working?

4 times more freedom between infusions means you can focus on your future.

ULTOMIRIS is designed to get C5 under control immediately.

Just as importantly, for most people ULTOMIRIS is able to keep C5 under control for up to 8 weeks.*

*Two weeks after the intravenous starting dose, ULTOMIRIS is infused intravenously every 8 weeks for most people and every 4 weeks for children weighing less than 44 pounds (20 kilograms).

See how ULTOMIRIS was studied

Actor portrayal

Get certain blood levels back to normal

In clinical trials, ULTOMIRIS has been proven to:

Return certain blood levels to normal (LDH and platelets)
Help kidney function begin to improve

In the ULTOMIRIS studies, this was referred to as a complete TMA response—meaning that LDH and platelet levels have returned to normal and serum creatinine levels (which help measure kidney function) have improved by 25% or more.

See the benefits

Maintain your levels

People who achieve a complete TMA response may also be able to see continued benefits over time:

Certain blood levels stay normal
Kidney functions improve and improvements maintained

See more long-term relief

Here’s how ULTOMIRIS has been shown to help

Two studies were conducted to look closely at the effectiveness and safety of ULTOMIRIS in 56 adults and 14 children who had never been treated for atypical-HUS. Both studies lasted 26 weeks and then continued to evaluate people who opted to continue in the study for up to 1 year (52 weeks in the adult study, 50 weeks in the children’s study).

Proven in people living with atypical-HUS

Studies have shown that ULTOMIRIS works to control C5 and get certain blood levels back to normal.

Understand ULTOMIRIS safety and side effects

Quickly get C5 under control

Following their first infusion with ULTOMIRIS, everyone saw their C5 levels get back under control.

ULTOMIRIS got C5 under control after the very first infusion

ULTOMIRIS helps certain blood levels get back to normal

ULTOMIRIS helped LDH and blood platelet levels return to normal levels—and they stayed normal with ongoing treatment.^†

^†Hematologic normalization is a combination of platelet count normalization and LDH normalization. 73% of adults and 86% of children had normalization of a combined measure of LDH and platelet count by 6 months.

ULTOMIRIS normalized LDH activity

People with atypical-HUS have high levels of an enzyme called lactate dehydrogenase, or LDH, in the blood. Nearly everyone taking ULTOMIRIS saw their LDH levels go back to normal within 6 months and stay stable through the rest of the year-long study.

Platelet count increased to normal levels

People with untreated atypical-HUS have low platelet levels. Almost all people taking ULTOMIRIS saw platelet levels return to normal and stay that way for the rest of the year-long study.

ULTOMIRIS helped people attain a complete TMA response^‡

The majority of people taking ULTOMIRIS achieved complete TMA response in 6 months or less. This was a result of certain blood levels returning to normal and kidney function improving.

^‡Complete TMA response is made up of three parts: platelet normalization, lactate dehydrogenase (LDH) normalization, and ≥25% improvement in serum creatinine levels (a measure of kidney function).

Complete TMA response in 6 months or less

Achieving complete TMA response means that LDH and platelet levels have returned to normal and serum creatinine levels (which help measure kidney function) have improved by 25% or more.

What is a TMA?

ULTOMIRIS keeps working

Two year-long studies showed that ULTOMIRIS continued to help people with atypical-HUS with consistent use.

Kidney function improvement is possible^§,||

Most people taking ULTOMIRIS saw their kidney function improve in 6 months or less and continue to maintain those improvements over time. Many of these people saw ongoing improvement in their kidney function with continued treatment.^¶

^§Kidney recovery is based on 25% improvement in serum creatinine levels.

^||Individuals with advanced kidney disease may be unable to see improvements in kidney function.

^¶59% of adults and 79% of children saw a 25% or more improvement in serum creatinine by 6 months. 69% of adults and 100% of children had improved kidney function measured by estimated glomerular filtration rate (eGFR) by 1 year.

Serum creatinine improved

Serum creatinine levels^# can help your doctor tell how well your kidneys are working. Most people taking ULTOMIRIS saw a 25% or more improvement in serum creatinine levels.

^#Serum creatinine levels are a measure of kidney function.

Higher eGFRs

People taking ULTOMIRIS also saw their kidneys filter blood more efficiently by 1 year, as seen by improved estimated glomerular filtration rate (eGFR).**

**eGFR shows how well the kidneys filter blood to remove waste. eGFR tests help identify kidney disease.

Reduced the need for dialysis

Taking ULTOMIRIS may reduce the need for dialysis. And if you’re currently on dialysis, you may get to stop it–and stay off it.^††

^††Of the people who were on dialysis when starting ULTOMIRIS, 59% of adults and 80% of children were able to go off dialysis by 26 weeks—and stay off dialysis through the rest of the 1-year study. Of the adults who were not on dialysis when starting ULTOMIRIS, 22% started dialysis by Week 26. No children needed to start dialysis after starting ULTOMIRIS through 26 weeks.

In the clinical trials, many people were able to discontinue their kidney dialysis. Additionally, everyone who no longer needed dialysis after starting ULTOMIRIS was able to stay off dialysis for the rest of the year-long study.

Taking ULTOMIRIS helped people
get off dialysis by 26 weeks

A high percentage of people were able to stop dialysis.

Taking ULTOMIRIS helped people
stay off dialysis

Everyone who no longer needed dialysis after starting ULTOMIRIS was able to stay off dialysis for the rest of the year-long study.

Maintained TMA control

Everyone who achieved complete TMA response during the first 26 weeks of the ULTOMIRIS clinical trials maintained this TMA response for the remainder of the year-long study.

Achieved a TMA response and maintained it through 1 year

Achieving complete TMA response means that LDH and platelet levels have returned to normal and serum creatinine levels (which help measure kidney function) have improved by 25% or more.

What is a TMA?

Seeing some of my blood levels get back under control made a difference. Today I’m focusing on what really matters most.”

Raye, Colorado

Hear Me Speak

Actor portrayal. Each person’s results with ULTOMIRIS may vary.

Quotes are composites based on actual experiences of real people living with atypical-HUS.

Questions about affording ULTOMIRIS?

OneSource™ has information about options to help you pay for ULTOMIRIS.

UNDERSTAND YOUR OPTIONS

Next: Learn about safety and side effects

IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING

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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 meningococcal infections that may quickly become life-threatening or cause death if not recognized and treated early.

You must complete or update meningococcal vaccine(s) at least 2 weeks before your first dose of ULTOMIRIS.
If you have not completed your meningococcal vaccines and ULTOMIRIS must be started right away, you should receive the required vaccine(s) as soon as possible.
If you have not been vaccinated and ULTOMIRIS must be started right away, you should also receive antibiotics for as long as your healthcare provider tells you.
If you had a meningococcal vaccine in the past, you might need additional vaccines before starting ULTOMIRIS. Your healthcare provider will decide if you need additional meningococcal vaccines.
Meningococcal vaccines 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: fever, fever with high heart rate, headache and fever, confusion, body aches with flu-like symptoms, fever and a rash, headache with nausea or vomiting, headache with a stiff neck or stiff back, or 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. Your risk of meningococcal infection may continue for several months after your last dose of ULTOMIRIS. It is important to show this card to any healthcare provider who treats you. This will help them diagnose and treat you quickly.

ULTOMIRIS is only available through a program called the ULTOMIRIS Risk Evaluation and Mitigation Strategy (REMS). Before you can receive ULTOMIRIS, your healthcare provider must: enroll in the REMS program; counsel you about the risk of serious meningococcal infections; give you information about the signs and symptoms of serious meningococcal infection; make sure that you are vaccinated against serious infections caused by meningococcal bacteria, and that you receive antibiotics if you need to start ULTOMIRIS right away and are not up to date on your vaccines; give you a Patient Safety Card about your risk of meningococcal infection.

ULTOMIRIS may also increase the risk of other types of serious infections, including Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria gonorrhoeae. Your child should receive vaccines against Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) if treated with ULTOMIRIS. Certain people may be at risk of serious infections with gonorrhea.

Who should not receive ULTOMIRIS?

Do not receive ULTOMIRIS if you have a serious meningococcal infection when you are starting ULTOMIRIS.

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 aHUS, your healthcare provider will need to monitor you closely for at least 12 months after stopping treatment for signs of worsening aHUS or problems related to a type of abnormal clotting and breakdown of your red blood cells called thrombotic microangiopathy (TMA). Symptoms or problems that can happen with TMA may include: confusion or loss of consciousness, seizures, chest pain (angina), difficulty breathing and blood clots or stroke.

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 aHUS are upper respiratory tract infection, diarrhea, nausea, vomiting, headache, high blood pressure and fever.

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.

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 atypical Hemolytic Uremic Syndrome (aHUS). ULTOMIRIS is not used in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

It is not known if ULTOMIRIS is safe and effective in children younger than 1 month of age.

Please see the full Prescribing Information and Medication Guide for ULTOMIRIS, including Boxed WARNING regarding serious meningococcal infections.

What will you be doing while ULTOMIRIS is working?