Furthering Alexion’s commitment to patients living with atypical-HUS

Talk to your doctor about starting or transitioning to ULTOMIRIS today!

Please see full Prescribing Information, including Boxed WARNING regarding serious and life-threatening meningococcal infections/sepsis.

Learn more at ULTOMIRIS.com

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 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.

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 breast feed 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 medications 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 and up to 4 hours in children.
  • If you are an adult with aHUS, 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.
  • Children 1 month of age and older with aHUS will usually receive:
    • a starting dose of ULTOMIRIS as an infusion by your doctor, and then
    • your doctor will decide how often your child will receive ULTOMIRIS, either every 4 weeks or every 8 weeks, depending on their weight, starting 2 weeks after the starting dose.
  • Your doctor will decide how long you need to take ULTOMIRIS for your aHUS.
  • 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 aHUS, your doctor will need to monitor you closely for at least 12 months after stopping treatment for signs of worsening aHUS symptoms 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
    • blood clots or stroke
  • 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 with aHUS are:

  • upper respiratory infections
  • diarrhea
  • nausea
  • vomiting
  • headache
  • high blood pressure
  • 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 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.

US/ULT-a/0038

Indication & Important Safety Information for
Soliris® (eculizumab)

INDICATION

What is SOLIRIS?

SOLIRIS is a prescription medicine called a monoclonal antibody. SOLIRIS is used to treat:

  • adults and children with a disease called atypical Hemolytic Uremic Syndrome (aHUS)
    • SOLIRIS is not for use in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS)

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about SOLIRIS?

SOLIRIS is a medicine that affects your immune system. SOLIRIS can lower the ability of your immune system to fight infections.

  • SOLIRIS 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 SOLIRIS if you have not already had this vaccine.
  2. If your doctor decided that urgent treatment with SOLIRIS is needed, you should receive meningococcal vaccination as soon as possible.
  3. If you have not been vaccinated and SOLIRIS 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 SOLIRIS. Your doctor will decide if you need additional meningococcal vaccinations.
  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 a fever
    • headache with a stiff neck or stiff back
    • fever
    • fever and 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 3 months after your last SOLIRIS dose. Your risk of meningococcal infection may continue for several weeks after your last dose of SOLIRIS. It is important to show this card to any doctor or nurse who treats you. This will help them diagnose and treat you quickly.

SOLIRIS is only available through a program called the SOLIRIS REMS. Before you can receive SOLIRIS, your doctor must:

  • enroll in the SOLIRIS 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

SOLIRIS may also increase the risk of other types of serious infections. If your child is treated with SOLIRIS, make sure that your child receives vaccinations against Streptococcus pneumoniae and Haemophilus influenzae type b (Hib). Certain people may be at risk of serious infections with gonorrhea. Talk to your doctor about whether you are at risk for gonorrhea infection, about gonorrhea prevention, and regular testing. Certain fungal infections (Aspergillus) may also happen if you take SOLIRIS and have a weak immune system or a low white blood cell count.

Who should not receive SOLIRIS?

Do not receive SOLIRIS if you:

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

Before you receive SOLIRIS, 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 SOLIRIS will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if SOLIRIS passes into your breast milk.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SOLIRIS and other medicines can affect each other causing side effects.

It is important that you:

  • have all recommended vaccinations before you start SOLIRIS
  • receive 2 weeks of antibiotics if you immediately start SOLIRIS
  • stay up-to-date with all recommended vaccinations during treatment with SOLIRIS

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

Monitoring Disease After Stopping SOLIRIS

  • If you have aHUS, your doctor will need to monitor you closely during and for at least 12 weeks after stopping treatment for signs of worsening aHUS symptoms or problems related to abnormal clotting (thrombotic microangiopathy). Symptoms or problems that can happen with abnormal clotting may include:
    • stroke
    • confusion
    • seizure
    • chest pain (angina)
    • difficulty breathing
    • kidney problems
    • swellings in arms or legs
    • a drop in your platelet count

What are the possible side effects of SOLIRIS?

SOLIRIS can cause serious side effects including:

  • See “What is the most important information I should know about SOLIRIS?”
  • Serious allergic reactions. Serious allergic reactions can happen during your SOLIRIS infusion. Tell your doctor or nurse right away if you get any of these symptoms during your SOLIRIS 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 SOLIRIS, your doctor may need to infuse SOLIRIS more slowly, or stop SOLIRIS. See “How will I receive SOLIRIS?” in the Medication Guide.

The most common side effects in people with aHUS treated with SOLIRIS include:

  • headache
  • diarrhea
  • high blood pressure (hypertension)
  • common cold (upper respiratory infection)
  • stomach-area (abdominal pain)
  • vomiting
  • pain or swelling of your nose or throat (nasopharyngitis)
  • low red blood cell count (anemia)
  • cough
  • swelling of legs or feet (peripheral edema)
  • nausea
  • urinary tract infections
  • 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 SOLIRIS. 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 SOLIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections.

Therapy with Soliris

Soliris is a therapy for aHUS.

In aHUS, the risk of disease complications continues throughout your life because of an abnormality in your genes. The body cannot naturally regulate part of its own immune system. It is important to speak with your doctor if you have questions about it.1

Your doctor may discontinue Soliris if you are undergoing treatment for serious meningococcal infections.

If you have an allergic reaction to Soliris, your doctor may need to infuse Soliris more slowly, or stop Soliris.1

In aHUS, the risk of complement-mediated thrombotic microangiopathy (TMA) is always present so if you interrupt or stop Soliris treatment, symptoms may return and you may be at risk for TMA complications.1

Speak with your Physician regarding appropriate treatment.

Important Safety Information if You Stop Treatment

If you have aHUS, your doctor will need to monitor you closely during and for at least 12 weeks after stopping treatment for signs of worsening aHUS symptoms or problems related to abnormal clotting (TMA).1

Symptoms or problems that can happen with abnormal clotting may include1:

  • Stroke

  • Confusion

  • Seizure

  • Chest Pain (Angina)

  • Difficulty Breathing

  • Kidney Problems

  • Swellings in Arms or Legs

  • A Drop in Your Platelet Count

If you experience any of these symptoms, it’s important that you seek immediate medical care. And remember to keep your Patient Safety Information Card with you at all times.1

If you stop or interrupt Soliris, aHUS symptoms may come back.

“My 18-year-old daughter was diagnosed with aHUS and was approved for Soliris treatment. She has received eight infusions. Her labs show that Soliris is working. We understand how truly lucky we are.”

— Parent of a patient receiving Soliris

Use this brochure to take a closer look at Soliris. Find out how it works and what you can do about aHUS.

Important Safety Information

Indication & Important Safety Information for
Soliris® (eculizumab)

INDICATION

What is SOLIRIS?

SOLIRIS is a prescription medicine called a monoclonal antibody. SOLIRIS is used to treat:

  • adults and children with a disease called atypical Hemolytic Uremic Syndrome (aHUS)
    • SOLIRIS is not for use in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS)

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about SOLIRIS?

SOLIRIS is a medicine that affects your immune system. SOLIRIS can lower the ability of your immune system to fight infections.

  • SOLIRIS 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 SOLIRIS if you have not already had this vaccine.
  2. If your doctor decided that urgent treatment with SOLIRIS is needed, you should receive meningococcal vaccination as soon as possible.
  3. If you have not been vaccinated and SOLIRIS 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 SOLIRIS. Your doctor will decide if you need additional meningococcal vaccinations.
  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 a fever
    • headache with a stiff neck or stiff back
    • fever
    • fever and 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 3 months after your last SOLIRIS dose. Your risk of meningococcal infection may continue for several weeks after your last dose of SOLIRIS. It is important to show this card to any doctor or nurse who treats you. This will help them diagnose and treat you quickly.

SOLIRIS is only available through a program called the SOLIRIS REMS. Before you can receive SOLIRIS, your doctor must:

  • enroll in the SOLIRIS 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

SOLIRIS may also increase the risk of other types of serious infections. If your child is treated with SOLIRIS, make sure that your child receives vaccinations against Streptococcus pneumoniae and Haemophilus influenzae type b (Hib). Certain people may be at risk of serious infections with gonorrhea. Talk to your doctor about whether you are at risk for gonorrhea infection, about gonorrhea prevention, and regular testing. Certain fungal infections (Aspergillus) may also happen if you take SOLIRIS and have a weak immune system or a low white blood cell count.

Who should not receive SOLIRIS?

Do not receive SOLIRIS if you:

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

Before you receive SOLIRIS, 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 SOLIRIS will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if SOLIRIS passes into your breast milk.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SOLIRIS and other medicines can affect each other causing side effects.

It is important that you:

  • have all recommended vaccinations before you start SOLIRIS
  • receive 2 weeks of antibiotics if you immediately start SOLIRIS
  • stay up-to-date with all recommended vaccinations during treatment with SOLIRIS

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

Monitoring Disease After Stopping SOLIRIS

  • If you have aHUS, your doctor will need to monitor you closely during and for at least 12 weeks after stopping treatment for signs of worsening aHUS symptoms or problems related to abnormal clotting (thrombotic microangiopathy). Symptoms or problems that can happen with abnormal clotting may include:
    • stroke
    • confusion
    • seizure
    • chest pain (angina)
    • difficulty breathing
    • kidney problems
    • swellings in arms or legs
    • a drop in your platelet count

What are the possible side effects of SOLIRIS?

SOLIRIS can cause serious side effects including:

  • See “What is the most important information I should know about SOLIRIS?”
  • Serious allergic reactions. Serious allergic reactions can happen during your SOLIRIS infusion. Tell your doctor or nurse right away if you get any of these symptoms during your SOLIRIS 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 SOLIRIS, your doctor may need to infuse SOLIRIS more slowly, or stop SOLIRIS. See “How will I receive SOLIRIS?” in the Medication Guide.

The most common side effects in people with aHUS treated with SOLIRIS include:

  • headache
  • diarrhea
  • high blood pressure (hypertension)
  • common cold (upper respiratory infection)
  • stomach-area (abdominal pain)
  • vomiting
  • pain or swelling of your nose or throat (nasopharyngitis)
  • low red blood cell count (anemia)
  • cough
  • swelling of legs or feet (peripheral edema)
  • nausea
  • urinary tract infections
  • 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 SOLIRIS. 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 SOLIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections.

  1. Soliris® (eculizumab) [Prescribing Information]. Boston, MA: Alexion Pharmaceuticals, Inc. 2018.