ULTOMIRIS® (ravuizumab-cwvz) injection for intravenous use 300 mg/30 mL vial
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MORE TIME BETWEEN INFUSIONS

Born out of Alexion’s commitment to adult patients with PNH, ULTOMIRIS is the first and only long-acting medication approved by the FDA to treat PNH in adults.

ULTOMIRIS just once every 8 weeks

Treatment with ULTOMIRIS needs to be infused 6-7 times a year. *—that’s up to 20 fewer than with eculizumab.

Although infusions are less frequent with ULTOMIRIS, infusion times are longer than with eculizumab.

*Following loading dose.

Why ULTOMIRIS?

The underlying cause of PNH is ongoing hemolysis, and ULTOMIRIS targets complement, a key driver of hemolysis in PNH. ULTOMIRIS has been studied in the largest PNH trial to date and offers extended control of your PNH symptoms between infusions.

People taking ULTOMIRIS:

  • Had levels of LDH (a marker that measures PNH activity) that stayed stable over time, as did patients taking eculizumab.
  • Had few breakthrough events.
    • Breakthrough events are defined as experiencing at least 1 new or worsening sign or symptom of hemolysis (eg, fatigue, hemoglobinuria, abdominal pain, shortness of breath, anemia).
    • In a clinical trial of people who had no prior PNH treatment, 4% of patients in the ULTOMIRIS group experienced breakthrough hemolysis vs 10.7% in the eculizumab group.
    • In a clinical trial of people who had prior PNH treatment, no patients in the ULTOMIRIS group experienced breakthrough hemolysis vs 5.1% in the eculizumab group.

ULTOMIRIS was shown to be effective for 8 weeks following maintenance dosing in clinical trials

ULTOMIRIS starts working at the time of your first infusion and keeps working until it’s time for your next infusion
ULTOMIRIS is dosed based on your weight

Do not start ULTOMIRIS if you have a meningococcal infection.

In a clinical trial of people who had no prior PNH treatment…

About 7 of 10 people who received ULTOMIRIS did not need a transfusion
Over half of people who received ULTOMIRIS had levels of LDH (a marker that measures PNH activity) that became normal over time

People who took ULTOMIRIS had levels of LDH that stayed stable over time
People who took ULTOMIRIS had few breakthrough events

Breakthrough events are defined as experiencing at least 1 new or worsening sign or symptom of hemolysis that occurs along with elevated LDH levels (after LDH levels were previously reduced through treatment).
At 6 months, 68% of patients who took ULTOMIRIS had stable levels of hemoglobin (a marker of PNH activity)

Switching to ULTOMIRIS from eculizumab

When you switch to ULTOMIRIS from eculizumab:

  • 2 weeks after your final eculizumab dose, your doctor will administer what’s known as a loading dose
    • This will only occur when you begin treatment with ULTOMIRIS
  • 2 weeks after you receive the loading dose, you will receive your first maintenance dose, the dose at which you will continue to receive ULTOMIRIS once every 8 weeks
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What do I need to know before taking ULTOMIRIS?

How should I receive ULTOMIRIS?

ULTOMIRIS is given through a vein by intravenous (IV) infusion usually over about 2 hours.

You will usually receive:

  • A starting dose of ULTOMIRIS as an infusion by your doctor, and then
  • 2 weeks later, you will start to receive an infusion of ULTOMIRIS every 8 weeks

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

Infusion reactions

Infusion reactions may happen during your ULTOMIRIS infusion. Symptoms of an infusion 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
  • Feel faint or pass out

Your doctor will treat your symptoms as needed.

Infusion tips

You might be feeling unsure about getting intravenous infusions, but there are ways to improve the experience:

  • Drink plenty of water. This will help your doctor find your veins more easily
  • Wear comfortable, layered clothing that you can adjust in case you become overly warm or cool
  • Keep busy during your infusion by reading, watching TV, or doing any other activity you can do while seated and remaining still

You may need to arrive early or stay late after your treatment, depending on the requirements of your treatment center.

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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. It is not known if ULTOMIRIS will harm your unborn baby
  • Are breastfeeding or plan to breastfeed. It is not known if ULTOMIRIS passes into your breast milk. You should not breastfeed during treatment and for 8 months after your final dose of ULTOMIRIS

You must receive meningococcal vaccines at least 2 weeks before your first dose of ULTOMIRIS if you have not already had this vaccine

Get vaccinated. ULTOMIRIS can lower the ability of your immune system to fight some infections. Before taking ULTOMIRIS, you must be vaccinated against meningococcal infection, a severe infection that can occur in the blood and requires immediate medical attention. Your doctor or nurse will make sure you receive this vaccine at least 2 weeks before your first infusion.

If your doctor decides that urgent treatment with ULTOMIRIS is needed, you should get the meningococcal vaccine as soon as possible.

If you had a meningococcal vaccine in the past, you might need additional vaccination before starting ULTOMIRIS. Your doctor will decide if you need additional meningococcal vaccination.

What are the symptoms of meningococcal infection?

The same mechanism that ULTOMIRIS uses to control hemolysis can increase your risk of getting an infection, especially a meningococcal infection. Call your doctor or get emergency medical care right away if you get any of these signs or symptoms of a meningococcal infection:

  • Headache with nausea or vomiting
  • Headache and a fever
  • Headache with a stiff neck or stiff back
  • Fever
  • Fever and a rash
  • Confusion
  • Muscle aches with flu-like symptoms
  • Eyes sensitive to light
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In a clinical trial of people who had prior PNH treatment…

Nearly 9 of 10 people who received ULTOMIRIS did not need a transfusion
People who took ULTOMIRIS had levels of LDH that stayed stable over time
People who took ULTOMIRIS had no breakthrough events

Breakthrough events are defined as experiencing at least 1 new or worsening sign or symptom of hemolysis that occurs along with elevated LDH levels (after LDH levels were previously reduced through treatment).
At 6 months, 76% of both people who took ULTOMIRIS and people who took eculizumab had stable levels of hemoglobin

Treatment considerations

Lab values:

THINGS TO KEEP IN MIND WHILE ON TREATMENT

LAB VALUES: LDH

THINGS TO KEEP IN MIND WHILE ON TREATMENT

  • LDH is key for tracking the level of hemolysis caused by PNH
  • It’s important to track over time to see how PNH is affecting you
  • LDH level, in comparison with your LDH level before starting ULTOMIRIS, shows how well you are responding to ULTOMIRIS
LAB VALUES: Hemoglobin/
anemia

THINGS TO KEEP IN MIND WHILE ON TREATMENT

  • Hemoglobin is released into the bloodstream when red blood cells are destroyed by hemolysis
  • When outside of cells, hemoglobin is harmful and is the cause of the signs, symptoms, and serious health problems associated with PNH
  • Hemoglobin levels in PNH patients with bone marrow problems might be low because of red blood cell production issues
LAB VALUES: Platelet
counts

THINGS TO KEEP IN MIND WHILE ON TREATMENT

  • Your platelet count might stay the same even after months of treatment, regardless of a decrease in LDH level and need for blood transfusions
LAB VALUES: Transfusion
requirements

THINGS TO KEEP IN MIND WHILE ON TREATMENT

  • Transfusions may still be necessary in patients taking ULTOMIRIS

The importance of your prescribed treatment schedule

  • For ULTOMIRIS to reduce hemolysis, 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.
  • The time that 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 where it works best.
  • 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, hemolysis can occur.

    Hemolysis is the underlying cause of major health problems in PNH. Missing doses can cause hemolysis to happen. Work closely with your health care team to keep track of your infusions and check in with your doctor regularly to best manage your PNH.
If you forget or miss an ULTOMIRIS infusion, call your doctor right away. To get the most from your ULTOMIRIS therapy, stick with your treatment schedule.
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INDICATION & IMPORTANT SAFETY INFORMATION for ULTOMIRIS® (ravulizumab‑cwvz), INCLUDING BOXED WARNING

INDICATION

What is ULTOMIRIS?
ULTOMIRIS is a prescription medicine called a monoclonal antibody. ULTOMIRIS is used to treat:

  • adults with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH).

It is not known if ULTOMIRIS is safe and effective in children with PNH.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ULTOMIRIS?
ULTOMIRIS is a medicine that affects your immune system. ULTOMIRIS can lower the ability of your immune system to fight infections.

  • ULTOMIRIS increases your chance of getting serious and life-threatening meningococcal infections. Meningococcal infections 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 have not already had this vaccine.
    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 before starting ULTOMIRIS. Your doctor will decide if you need additional meningococcal vaccination.
    5. Meningococcal vaccines reduce the risk of meningococcal infection 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
      • 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. 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.

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 about the symptoms of meningococcal infection
  • give you a Patient Safety Card about your risk of meningococcal infection, as discussed above
  • make sure that you are vaccinated with a meningococcal vaccine

ULTOMIRIS may also increase the risk of other types of serious infections.

  • People who take ULTOMIRIS may have an increased risk of getting infections caused by Streptococcus pneumoniae and Haemophilus influenzae.
  • Certain people may also have an increased risk of gonorrhea infection. Talk to your doctor to find out if you are at risk for gonorrhea infection, about gonorrhea prevention, and regular testing.

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
  • Have not been vaccinated against meningococcal infection unless your doctor decides that urgent treatment with ULTOMIRIS is needed. See “What is the most important information I should know about ULTOMIRIS.”

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. It is not known if ULTOMIRIS will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if ULTOMIRIS 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 medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ULTOMIRIS and other medicines can affect each other causing side effects.

Know the medicines you take and the vaccines you receive. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I receive ULTOMIRIS?

  • ULTOMIRIS is given through a vein by intravenous (I.V.) infusion usually over about 2 hours in adults.
  • If you are an adult with PNH, you will usually receive:
    • a starting dose of ULTOMIRIS as an infusion by your doctor, and then
    • 2 weeks later, you will start to receive an infusion of ULTOMIRIS every 8 weeks.
  • If you are changing treatment from SOLIRIS to ULTOMIRIS, you should receive your starting dose of ULTOMIRIS 2 weeks after your last dose of SOLIRIS.
  • After each infusion, you should be monitored for at least 1 hour for infusion reactions. See “What are the possible side effects of ULTOMIRIS?”
  • If you have PNH and you stop receiving ULTOMIRIS, your doctor 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
    • erectile dysfunction (ED) in males
  • If you miss an ULTOMIRIS infusion, call your doctor right away.

What are the possible side effects of ULTOMIRIS?
ULTOMIRIS can cause serious side effects including:

  • See “What is the most important information I should know about ULTOMIRIS?”
  • Infusion reactions. Infusion reactions may happen during your ULTOMIRIS infusion. Symptoms of an infusion 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
    • feel faint or pass out
    Your doctor will treat your symptoms as needed.

The most common side effects of ULTOMIRIS in people treated for PNH are upper respiratory infection and headache.

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 for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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