ULTOMIRIS® (ravuizumab-cwvz) Injection for intravenous use 300 mg/3 mL vial
Menu

Getting started with ULTOMIRIS

Considering ULTOMIRIS for you or your child is an important decision—one that should be made with your doctor. Review this information and talk to your doctor about how to start on ULTOMIRIS.

For treatment of atypical-HUS in adults and children 1 month of age and older. Not used in treating people with STEC-HUS.

How to: Get started on treatment

Here is a clear list of the steps to take when beginning your ULTOMIRIS journey. Always remember to speak to your doctor about your symptoms, how to manage atypical-HUS, and if ULTOMIRIS is right for you.

1

Check out the ULTOMIRIS FAQs

Whether you are new to ULTOMIRIS or are new to atypical-HUS treatment altogether, you may have questions. Find answers to common questions about ULTOMIRIS below and in the downloadable FAQ brochure.

  • ULTOMIRIS basics
  • Efficacy data
  • Safety profile
  • Getting started
ULTOMIRIS basics

How does ULTOMIRIS work?

Part of your immune system called complement protein 5 (C5) plays an important role in helping your body destroy foreign or damaged cells. Normally, control mechanisms in your body keep C5 and other complement proteins from attacking healthy cells.

In atypical-HUS, these control mechanisms fail, and uncontrolled C5 activity ultimately results in thrombotic microangiopathy (TMA), or blood clots in your small blood vessels. This TMA is what ultimately causes organ failure in atypicial-HUS.

ULTOMIRIS works by blocking C5 and preventing these TMA events from occurring.

Alternate Text

What is the difference between ULTOMIRIS and Soliris® (eculizumab)?

ULTOMIRIS was built on the foundation of Soliris, but with modifications that allow it to last longer in the body. This allows ULTOMIRIS to keep working longer between infusions—so that you only need to be infused every 4 or 8 weeks (depending on body weight) compared to every 2 weeks with Soliris.

Does ULTOMIRIS block C5 immediately after the first infusion, or is there a delay before C5 is controlled?

ULTOMIRIS controls C5 immediately. 100% (70 out of 70) of clinical trial patients (adult and pediatric) on ULTOMIRIS had complete C5 control by the end of their first infusion.

If ULTOMIRIS is dosed up to every 8 weeks does it “wear off” near the end of the treatment cycle?

ULTOMIRIS is administered as a loading dose followed by maintenance doses every 4 or 8 weeks (depending on body weight) starting 2 weeks after the loading dose.

With ULTOMIRIS, C5 control is sustained, meaning it lasts the full 8 weeks between infusions for adult patients. Depending on body weight, pediatric patients receive infusions every 4 or 8 weeks in order to experience the same sustained C5 control. You can feel confident in complete and sustained C5 control with ULTOMIRIS.

Why is ULTOMIRIS dosage based on weight?

Weight-based dosing allows for individualized control of C5. ULTOMIRIS is dosed based on weight in order to provide sustained control of C5 for the full 4- or 8-week treatment cycle.

Alternate Text
Efficacy Data

What results were seen in atypicial-HUS patients who took ULTOMIRIS?

Adult study design:

26-week study of adult patients (N=56) with no prior treatment for atypical-HUS; other causes of TMA were ruled out.

Pediatric study design:

26-week ongoing study of pediatric patients (N=14) with no prior treatment for atypical-HUS; other causes of TMA were ruled out.

Our trials focused on “Complete TMA Response” as a measure of success. Complete TMA Response is made up of three parts:

  • Platelet normalization
  • Lactate dehydrogenase (LDH) normalization
  • ≥25% improvement in serum creatinine levels (a measure of kidney function).

Patients had to meet all three criteria in order to count as a Complete TMA Response. For example, if a patient had improvements in 1 or 2 measurements, these improvements were not counted as a Complete TMA Response.

In two separate trials:

graphic from Q5 in the FAQ brochure graphic from Q5 in the FAQ brochure

aHematologic normalization is a combination of platelet count normalization and LDH normalization.

How extensively has ULTOMIRIS been studied?

ULTOMIRIS has been studied in 4 phase 3 clinical trials, with over 500 patients across 2 diseases, including atypical-HUS. The phase 3 study of ULTOMIRIS in adults was the largest clinical trial of a long-acting treatment ever conducted in atypical-HUS.

Safety profile

What are the vaccination requirements?

It’s important to protect yourself or your child with atypical-HUS from possible meningococcal infections while on ULTOMIRIS.

You should receive meningococcal vaccines at least 2 weeks prior to your first dose of ULTOMIRIS if you have not already had this vaccine. Your doctor will ensure you are properly vaccinated before beginning treatment. See additional details in step 4: Get vaccinated.

What should I know about infusion reactions?

Infusion reactions may happen during your ULTOMIRIS infusion. In clinical trials, 5 out of 296 patients treated with ULTOMIRIS experienced infusion reactions (lower back pain, drop in blood pressure, infusion-related pain, elevation in blood pressure, and limb discomfort).

These reactions did not require discontinuation of ULTOMIRIS.

After each infusion, you should be monitored for at least 1 hour for infusion reactions.

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.

If you experience these symptoms, your doctor should interrupt ULTOMIRIS infusion and institute appropriate supportive measures.

How safe is ULTOMIRIS in atypical-HUS patients?

ULTOMIRIS has an established safety profile based on 4 phase 3 clinical trials across 2 diseases, including atypical-HUS. The safety profile of ULTOMIRIS in adult patients is based on results from the largest clinical trial of a long-acting treatment ever conducted in atypical-HUS.

The most frequently reported side effects in people with atypical-HUS treated with ULTOMIRIS were upper respiratory infection, diarrhea, nausea, vomiting, headache, high blood pressure, and fever.

The majority of side effects with ULTOMIRIS were mild or moderate in intensity.

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. Your doctor will ensure you receive meningococcal vaccinations prior to treatment. ULTOMIRIS can cause serious side effects including infusion reactions (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. These reactions do not require discontinuation, but your doctor may slow or interrupt the infusion.

Is ULTOMIRIS safe for people with atypicial-HUS who are pregnant or breastfeeding?

ULTOMIRIS has not been studied in atypicial-HUS patients who are pregnant or breastfeeding. Talk to your doctor about how to best manage your condition during and after pregnancy.

Getting Started

How will I receive ULTOMIRIS treatment?

ULTOMIRIS is given through an intravenous (IV) infusion. After each infusion, you should be monitored for at least 1 hour for signs and symptoms of an infusion reaction. See additional infusion information in step 5: Get your starting dose and step 6: Get your first maintenance dose.

Any tips on preparing for an infusion?

There are several tips you can use to help improve your infusion experience. See the details below in step 5: Get your starting dose.

Is it really that important to stay on my treatment schedule?

Yes, it is pretty important. Adhering to your dosing schedule helps you get the most out of your treatment.

Blood cells icon

ULTOMIRIS should be infused according to the recommended dosing schedule for you to get the most out of your treatment. If the level of ULTOMIRIS in your body gets too low, you may be at risk for worsening atypicial-HUS or for problems related to a type of abnormal clotting and breakdown of your red blood cells called thrombotic microangiopathy (TMA).

vial icon

For ULTOMIRIS to treat atypicial-HUS and inhibit TMA, the drug needs to stay above a certain level in your blood. However, like all drugs, ULTOMIRIS is broken down and removed from your body over time.

calendar icon

The time it takes your body to remove half of the drug is called the “half-life” of that drug. A regular therapy schedule keeps ULTOMIRIS in your body at a level for it to work properly.

stethoscope icon

Your doctor will need to monitor you closely for at least 12 months after stopping treatment for signs of worsening atypical-HUS or problems related to TMA.

If you miss an ULTOMIRIS infusion, call your doctor right away.

How long should I take ULTOMIRIS?

ULTOMIRIS treatment of atypical-HUS should be a minimum duration of 6 months. Treatment duration beyond the initial 6 months should be individualized.

Atypical-HUS is a lifelong, genetic disease that requires a steady commitment. The risk of TMA complications is also lifelong. It’s important to stay with your treatment, unless your doctor decides you need a change.

Is ULTOMIRIS more expensive than Soliris?

ULTOMIRIS is priced to be less expensive than Soliris for an average patient.

The exact amount you will pay depends upon your insurance provider and coverage plan.

Your OneSource Case Manager can help you determine your exact out-of-pocket costs, and whether copay assistance may be available.

Where can I go to find out more about ULTOMIRIS?

Sign up for OneSource and talk to your OneSource Case Manager for more information about ULTOMIRIS.

In addition, you can attend a webinar to hear from leading physicians, as well as other patients living with atypical-HUS and taking ULTOMIRIS.

Download FAQ brochure

2

OneSource logo

Sign up for OneSource

Get complimentary, personalized support from a dedicated team with expertise in health insurance, advanced training in atypical-HUS, and information about atypical-HUS community resources.

You will also receive information about copay assistance and how to connect with the community of people with atypical-HUS and their caregivers.

Get OneSource details

3

Talk to your doctor

Talk to your doctor about starting on ULTOMIRIS and be sure to discuss any questions you may have. If you or a child you care for are switching from Soliris, the decision to transition should be at the discretion of your treating physician, who will use their clinical judgment in deciding the appropriate timing for transitioning to ULTOMIRIS.

When it’s time to start, your OneSource Case Manager can assist you with insurance-related matters. Once you have authorization from your insurance company, your OneSource Case Manager can also help you find an infusion center.

4

Get vaccinated

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. Work with your doctor and OneSource Case Manager to receive meningococcal vaccines at least 2 weeks before your first dose of ULTOMIRIS if you are not vaccinated or your vaccination is not up to date.

5

Get your starting dose

ULTOMIRIS is given through an intravenous (IV) infusion. If you’re switching from Soliris, your starting dose will be infused 2 weeks after your last dose of Soliris.

Use these infusion tips to help improve the experience:

water glass icon

Drink plenty of water. This will help your doctor find your veins more easily

sweater icon

Wear comfortable, layered clothing that you can adjust in case you become overly warm or cool

couch icon

Keep busy during your infusion by reading, watching TV, or doing any other activity you can do while seated and remaining still

clock icon

You may need to arrive early and stay late after your treatment

After each infusion, you should be monitored for at least 1 hour for signs and symptoms of an infusion reaction.

Overall, I was able to transition to ULTOMIRIS smoothly. I received my starting dose of ULTOMIRIS two weeks after my last dose of Soliris, and so far, ULTOMIRIS is working well for me.

-Dana VA, diagnosed in 2012

6

Get your first maintenance dose

2 weeks after your starting dose, you will receive an infusion every 8 weeks for adults and every 4 or 8 weeks for pediatric patients (depending on body weight).

After each infusion, you should be monitored for at least 1 hour for signs and symptoms of an infusion reaction.

Serious allergic reactions can happen during your ULTOMIRIS infusion. Tell your doctor or nurse right away if you get any of these symptoms during your ULTOMIRIS infusion: chest pain; trouble breathing or shortness of breath; swelling of your face, tongue, or throat; feel faint or pass out. If you have an allergic reaction to ULTOMIRIS, your doctor may need to infuse ULTOMIRIS more slowly or stop ULTOMIRIS.

7

Take advantage of the other resources available to WIDEN YOUR WORLD.

Sign up for webinars featuring leading
experts in atypical-HUS.

Sign up today

Build your support system within the atypical-HUS community by becoming or connecting with a STAR ambassador or by joining an advocacy organization.

Join the community

I began talking to my doctor right away about ULTOMIRIS because the treatment schedule was more convenient than Soliris…

-Brigitte NY, diagnosed in 2016

What to expect: Life on ULTOMIRIS

Read this information to get familiar with what to expect while you’re on ULTOMIRIS and what you need to consider before discontinuing.

How do I know if ULTOMIRIS is working?

Uncontrolled C5 activity ultimately results in thrombotic microangiopathy (TMA), or blood clots in your small blood vessels. This TMA is what ultimately causes organ failure in atypical-HUS.

ULTOMIRIS works by blocking C5 and preventing TMA events.

To assess if TMA events are under control, your doctor may look for:

  • Platelet count increasing to a normal count
  • LDH level decreasing to a normal range
  • Improvement in your serum creatinine level
  • No additional TMA events (blood clots and small blood vessel damage)
  • Decreased or eliminated need for dialysis

How long should I take ULTOMIRIS?

Your doctor will decide how long you need to take ULTOMIRIS for your atypical-HUS. ULTOMIRIS treatment of atypical-HUS lasts at least 6 months. After 6 months, your doctor will determine how long to continue treatment.

Atypical-HUS is a lifelong, genetic disease that requires a steady commitment. The risk of TMA complications is also lifelong. It's important to stay with your treatment, unless your doctor decides you need a change.

What happens if I need to discontinue ULTOMIRIS?

Discuss any changes to your treatment plan with your doctor first.

Your doctor will:

  • Monitor you closely for at least 12 months for signs and symptoms of worsening atypical-HUS or TMA on an ongoing basis
  • Regularly assess platelet count, LDH levels, and serum creatinine

Be sure to tell your doctor if you experience abnormal symptoms; symptoms of TMA may include:

  • confusion or loss of consciousness
  • seizures
  • chest pain
  • difficulty breathing
  • blood clots or stroke

Your doctor may consider reinitiation of ULTOMIRIS.

It takes a team: Enroll in OneSource

Get personalized support from a OneSource Case Manager who can guide you through the ULTOMIRIS treatment process.

Learn more about OneSource

You may also be interested in:

Now FDA approved 100 mg/mL formulation: get the details

IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING

Show more Show less
Show less

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 doctor 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 doctor will decide if you need additional vaccination.
  5. Meningococcal vaccines reduce 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, fever and a rash, confusion, muscle aches with flu-like symptoms and eyes sensitive to light.

Your doctor 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 doctor 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 doctor 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 doctor 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 Haemophilis influenzae type b (Hib) if treated with ULTOMIRIS. Call your doctor 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 doctor decides that urgent treatment with ULTOMIRIS is needed.

Before you receive ULTOMIRIS, tell your doctor 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 doctor 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 doctor 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, 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, and feel faint or pass out.

The most common side effects of ULTOMIRIS in people with aHUS are upper respiratory infection, diarrhea, nausea, vomiting, headache, high blood pressure and fever.

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 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 accompanying full Prescribing Information and Medication Guide for ULTOMIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections/sepsis.