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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.*

See how ULTOMIRIS was studied

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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 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


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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

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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.

ULTOMIRIS normalized LDH activity

normalized-ldh normalized-ldh

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

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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.

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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 in 6 months or less

complete-tma-response complete-tma-response

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.

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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.#

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-improved serum-creatinine-improved

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).††

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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.‡‡

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.

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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

maintained-tma-control maintained-tma-control

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

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

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.

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).

§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.

Individuals with certain forms of 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 levels are a measure of kidney function.

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

‡‡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.

Next: Learn about safety and side effects

FDA approved 100 mg/mL formulation: get the details

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 and life-threatening meningococcal infections that may quickly become life-threatening and cause death if not recognized and treated early.
  1. You must receive meningococcal vaccines at least 2 weeks before your first dose of ULTOMIRIS if you are not vaccinated.
  2. If your healthcare provider decided that urgent treatment with ULTOMIRIS is needed, you should receive meningococcal vaccination as soon as possible.
  3. If you have not been vaccinated and ULTOMIRIS therapy must be initiated immediately, you should also receive 2 weeks of antibiotics with your vaccinations.
  4. If you had a meningococcal vaccine in the past, you might need additional vaccination. Your healthcare provider will decide if you need additional vaccination.
  5. 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 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.

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

The most common side effects of subcutaneous administration of ULTOMIRIS in adults treated for aHUS 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 atypical Hemolytic Uremic Syndrome (aHUS). ULTOMIRIS is not used in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).
  • adults with aHUS 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.

Please see the accompanying full Prescribing Information and Medication Guide for ULTOMIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections/sepsis. Please see the accompanying Instructions for Use for the ULTOMIRIS On Body Delivery System.