ULTOMIRIS® (ravuizumab-cwvz) Injection for intravenous use 300 mg/3 mL vial
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Established safety with up to 8 weeks between infusionsa

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

aTwo weeks after the starting dose, ULTOMIRIS is infused every 8 weeks for adults and every 4 or 8 weeks for pediatric patients (depending on body weight).

See the data: ULTOMIRIS provides immediate C5 control sustained for up to 8 weeksb in patients with atypical-HUS.

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

ULTOMIRIS, like Soliris® (eculizumab), works by blocking C5 and preventing TMA events.

ULTOMIRIS clinical trials in atypical-HUS 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, and ≥25% improvement in serum creatinine levels (a measure of kidney function).

Overview
Adult patients
Pediatric patients

IMMEDIATE

100% (70 out of 70) of adult and pediatric patients had complete C5 inhibition after the first infusion of ULTOMIRIS

COMPLETE

54% (30 out of 56) of adult and 71% (10 out of 14) of pediatric patients achieved a complete TMA response with ULTOMIRIS during the 26-week study period

SUSTAINED

Up to 8 weeksb of sustained C5 inhibition and the possibility to live dialysis-free in adult and pediatric patients

bTwo weeks after the starting dose, ULTOMIRIS is infused every 8 weeks for adults and every 4 or 8 weeks for pediatric patients (depending on body weight).

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

Select additional clinical trial results

  • Of the patients who achieved complete TMA response, all (30/30) maintained their response throughout the 26-week study period
  • Potential for recovery of kidney function
    • 59% (17 out of 29) of patients who previously needed dialysis were dialysis-free at last available follow-up; 22% (6 out of 27) of patients who were off dialysis at baseline were on dialysis at last available follow-up
    • Patients had a 227% increase in estimated glomerular filtration rate (kidney function) at the end of studyd

dAt the start of the study, mean estimated glomerular filtration rate (eGFR) was 15.86 mL/min/1.73 m2; at the end of the study, mean eGFR was 51.83 mL/min/1.73 m2.

Nearly all serum C5 samples (99.5%) from adult patients showed complete inhibition of C5 throughout the 6-month study period with ULTOMIRIS

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

Select additional clinical trial results

  • Of the patients who achieved complete TMA response, all (10/10) maintained their response throughout the 26-week study period
  • Potential for recovery of kidney function
    • 80% (4 out of 5) of patients who previously needed dialysis were dialysis-free at last available follow-up; no patient started dialysis during the study
    • Patients had a 280% increase in estimated glomerular filtration rate (kidney function) by the end of studye

eAt the start of the study, mean estimated glomerular filtration rate (eGFR) was 28.4 mL/min/1.73 m2; at end of study, mean eGFR was 108.0 mL/min/1.73 m2.

Nearly all serum C5 samples (99.6%) from pediatric patients showed complete inhibition of C5 throughout the 6-month study period with ULTOMIRIS

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

SELECT IMPORTANT SAFETY INFORMATION

What are the possible side effects of ULTOMIRIS?

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

Please see additional Important Safety Information for ULTOMIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infection/sepsis, below.

I was happy with my experience on Soliris, but based on the clinical data provided by my doctor, we felt like ULTOMIRIS would be a better option for me. I also thought the dosing schedule would provide me a bit more freedom.

—Dana VA, diagnosed in 2012

How it works: ULTOMIRIS in the body

While ULTOMIRIS and Soliris both inhibit the complement protein C5, ULTOMIRIS has been engineered to have a ~4x longer half-life (the time it takes your body to remove half of the drug). See what makes ULTOMIRIS different from Soliris.

Infusion timing: ULTOMIRIS, built on the foundation of Soliris, offers 4x more time between infusions

Two weeks after the starting dose of ULTOMIRIS is given by your doctor as an intravenous (IV) infusion, ULTOMIRIS only needs to be infused every 8 weeks for adults and every 4 or 8 weeks for children (depending on body weight).

Infusions with ULTOMIRIS

With 8-week maintenance dosing, 6-7 infusions per year
With 4-week maintenance dosing, 13 infusions per year

Infusions with Soliris

26 infusions per year

Although infusions are less frequent with ULTOMIRIS, infusion times may be longer than with Soliris

I fought for the change to ULTOMIRIS because the dosing schedule was very appealing. I love to travel, so I wanted to be able to do more of it—and at a leisurely pace when possible!

—Brigitte NY, diagnosed 2016

Feel confident: ULTOMIRIS safety

It’s important that you know what to expect from your treatment. ULTOMIRIS has been studied in 4 phase 3 clinical trials, with over 500 patients across 2 diseases, including atypical-HUS. In fact, the phase 3 study of ULTOMIRIS in adults was the largest clinical trial of a long-acting treatment ever conducted in atypical-HUS.

In the clinical trials, the most common side effects with ULTOMIRIS (≥20%) in patients with atypical-HUS were:

  • Upper respiratory infections
  • Diarrhea
  • Nausea
  • Vomiting
  • Headache
  • High blood pressure
  • Fever
The majority of side effects with ULTOMIRIS were
mild or moderate in intensity

Reduce your risk of serious side effects:
meningococcal infections

You must be vaccinated against meningococcal infections before taking 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 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 meningococcal 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.

Patient Safety Card

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. 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 doctor or nurse who treats you. This will help them diagnose and treat you quickly.

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Alexion commitment: Alexion is committed to supporting the
atypical-HUS community

With 20 years of complement research experience and over a decade of complement inhibition in the clinical setting, Alexion is committed to bringing therapies to atypical-HUS patients. Alexion offers the only 2 FDA-approved complement inhibitors for treating the disease.

Alexion: A Long-Standing History of Commitment to Supporting Patients with Rare Diseases

2019 ULTOMIRIS approved for atypical-HUS f Prix Galien USA Nominated: Best Biotechnology Product—ULTOMIRIS 2018 ULTOMIRIS first approved 2011 Soliris approved for additional indications 2009 Prix Galien France Drugs for Rare Diseases—Soliris 2008 Prix Galien USA Best Biotechnology Product—Soliris 2007 Soliris first approved 1992 Alexion founded 2019 ULTOMIRIS approved for atypical-HUS f Prix Galien USA Nominated: Best Biotechnology Product—ULTOMIRIS 2018 ULTOMIRIS first approved 2011 Soliris approved for additional indications 2009 Prix Galien France Drugs for Rare Diseases—Soliris 2008 Prix Galien USA Best Biotechnology Product—Soliris 2007 Soliris first approved 1992 Alexion founded

fAdults and children one month of age and older.

Up next: Starting on ULTOMIRIS

If and when you decide to switch to ULTOMIRIS, you might have questions about what to expect. Next, you’ll find all the information you need to start your ULTOMIRIS treatment journey.

Get started

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IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING

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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.