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:

  • patients with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH)

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

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 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 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 PNH, your doctor will need to monitor you closely for at least 8 weeks after stopping SOLIRIS. Stopping treatment with SOLIRIS 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 the number of your red blood cell count
    • drop in your platelet counts
    • confusion
    • kidney problems
    • blood clots
    • difficulty breathing
    • chest pain

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 PNH treated with SOLIRIS include:

  • headache
  • pain or swelling of your nose or throat (nasopharyngitis)
  • back pain
  • nausea

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.

What to Expect During Treatment

Receiving Soliris Therapy

Soliris is delivered through a vein — an intravenous, or I.V., infusion — usually over 35 minutes. If you have an allergic reaction during your Soliris infusion, your doctor may decide to give Soliris more slowly or stop your infusion.1

You will usually receive a Soliris infusion by your doctor1:

  • weekly for five weeks, then

  • every 2 weeks

After each infusion, you should be monitored for one hour for allergic reactions. Serious allergic reactions can happen, so tell your doctor or nurse right away if you get any of these symptoms during your Soliris infusion1:

  • chest pain

  • trouble breathing or shortness of breath

  • swelling of your face, tongue, or throat

  • feel faint or pass out

Infusions must be given by trained healthcare professionals, usually at a doctor’s office, health clinic, or infusion center. You must receive meningococcal vaccines at least 2 weeks before your first dose of Soliris if you have not already had this vaccine. If your doctor decided that urgent treatment with Soliris is needed, you should receive meningococcal vaccination as soon as possible. If you have not been vaccinated and Soliris therapy must be initiated immediately, you should also receive 2 weeks of antibiotics with your vaccinations. 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 vaccination. You should be revaccinated according to current medical guidelines for meningococcal vaccine use while on Soliris. Talk to your doctor for more information.

If you forget or miss a Soliris infusion, call your doctor right away.

If you have PNH, your doctor will need to monitor you closely for at least 8 weeks after stopping Soliris. Stopping treatment with Soliris 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 the number of your red blood cell count

  • drop in your platelet counts

  • confusion

  • kidney problems

  • blood clots

  • difficulty breathing

  • chest pain

Seeing Results With Soliris

By 3 weeks, patients noticed less fatigue and improved health-related quality of life.2-4

From 6 months on, patients experienced stabilization of hemoglobin levels and needed fewer transfusions. These improvements and others were sustained for 4 years and beyond.2,5,6

PNH symptoms can differ widely from person to person, so the improvements you see in your health may differ from others.7 It’s also important to ask your doctor about different treatment options for AA or MDS.7


What to expect with Soliris

  • Soliris needs to be taken regularly for you to get the most out of treatment1

  • You will need to get vaccinated against meningococcal infection at least 2 weeks before your first infusion1

  • OneSource can help with insurance and support and to answer your questions about PNH and Soliris


A Measure of Success: LDH

One way for a doctor to check your progress with Soliris is through a simple blood test that checks the level of LDH in your blood. LDH is a measure of hemolysis, so when there’s less of it in your blood, it means Soliris is working. Soliris can lower LDH levels in people with PNH and can maintain those levels over time.2,4

Some patients have bone marrow production problems and will continue to require transfusions, since Soliris addresses hemolysis and not red blood cell production issues.1-3 You can measure how Soliris is working by measuring LDH, however platelet counts, hemoglobin, and transfusion dependency may never fully resolve and therefore these markers may not be an accurate measure of your response to Soliris.1


Call an Alexion Nurse Case Manager at 1.888.SOLIRIS (1.888.765.4747) to learn more.

Personalized Patient Support

Alexion Nurse Case Managers are here to help you with answers to your questions about Soliris and PNH.

Learn how to help control the ongoing signs, symptoms, and health-related risks of PNH long-term.

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:

  • patients with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH)

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

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 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 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 PNH, your doctor will need to monitor you closely for at least 8 weeks after stopping SOLIRIS. Stopping treatment with SOLIRIS 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 the number of your red blood cell count
    • drop in your platelet counts
    • confusion
    • kidney problems
    • blood clots
    • difficulty breathing
    • chest pain

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 PNH treated with SOLIRIS include:

  • headache
  • pain or swelling of your nose or throat (nasopharyngitis)
  • back pain
  • nausea

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.

  2. Hillmen P, et al. N Eng J Med. 2006;355(12):1233-1243.

  3. Brodsky RA, et al. Blood. 2008;111(4):1840-1847.

  4. Hill A, et al. Br J Haematol. 2010;149(3):414-425.

  5. Hillmen P, et al. Br J Haematol. 2013;162(1):62-73.

  6. Hillmen P, et al. Am J Hematol. 2010;85(11):553-559.

  7. Sahin F, et al. Am J Blood Res. 2015;5(1):1-9.