Understanding and managing side effects

ULTOMIRIS has been well studied and has an established safety profile that was demonstrated in clinical trials studying adults and children living with PNH.

Most side effects were mild to moderate

ULTOMIRIS is a medicine that affects your immune system and can lower its ability to fight infections. It 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.

For adults

The most common side effects (≥10%) of ULTOMIRIS in adults with PNH were upper respiratory tract infection and headache.

For children

The most common side effects (>20%) of ULTOMIRIS in children with PNH were:

Upper respiratory tract infection
Anemia
Abdominal pain
Headache

What do I need to know before taking ULTOMIRIS?

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Infusion-related reactions

Infusion-related reactions may happen during your ULTOMIRIS intravenous treatment. 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
Feel faint or pass out

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. 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

Reduce your risk of experiencing a serious side effect

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ULTOMIRIS is a medicine that affects your immune system and can lower its ability to fight infections. It increases your chance of getting serious and life-threatening meningococcal infection that may quickly become life-threatening and cause death if not treated early.

By getting a meningococcal vaccine, you can reduce your risk of certain infections. 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 tell you about the risks and benefits associated with taking ULTOMIRIS before you get started and explain about getting a vaccine.

Carry your Patient Safety Card with you

Keep your ULTOMIRIS Patient Safety Card with you during treatment and for 8 months after you stop taking ULTOMIRIS. This card provides healthcare providers and nurses with important information about PNH and ULTOMIRIS.

DOWNLOAD YOUR SAFETY CARD

Encouragement when you need it

Your OneSource™ offers one-on-one support and is there to answer questions.

GET IN TOUCH

Fewer infusions

Most people with PNH only need 6 or 7 infusions per year.^a

LEARN ABOUT ULTOMIRIS INFUSIONS

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

Alexion OneSource^TM Copay Program

Pay as low as

$0

In out-of-pocket costs
if you're eligible^a,b

• Valid only for individuals with commercial insurance who have a valid prescription for a US FDA-approved indication of ULTOMIRIS

• Not valid for individuals covered by government insurance programs or other federal or state programs (including any state prescription drug assistance programs)

^aBased on typical commercial patients out-of-pocket deductible limits.
^bAdditional teams and conditions apply. Please contact OneSource with additional questions.
^cIncludes Medicaid, Medicare (including Medicare Prat D), Medicare Advantage Plans, Medigap, Veterans Affairs, Department of Defense, or TRICARE. Patients reading in Massachusetts or Rhode Island are eligible for assistance with medication costs but are not eligible for assistance with inclusion costs.

See if you're eligible

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 may 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, muscle 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 serious 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 and SOLIRIS 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. It is not known if ULTOMIRIS will harm your unborn baby.
- Pregnancy Registry: There is a registry for pregnant women who take ULTOMIRIS to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking ULTOMIRIS, talk to your healthcare provider about how you can join this registry or you may contact the registry at 1-833-793-0563 or www.UltomirisPregnancyStudy.com to enroll.
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 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 PNH and you stop receiving ULTOMIRIS, your healthcare provider 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, and erectile dysfunction (ED) in males.

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, stomach (abdominal) pain, muscle spasms, changes in blood pressure, tiredness, feeling faint, shaking chills (rigors), discomfort in your arms or legs, or bad taste. Stop treatment of ULTOMIRIS and tell your healthcare provider right away if you develop these symptoms, or any other symptoms during your ULTOMIRIS infusion that may mean you are having a serious infusion-related 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 PNH are upper respiratory tract infection and headache.

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 Paroxysmal Nocturnal Hemoglobinuria (PNH).

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.