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.

How Soliris Can Help

PNH can be a scary disease. But, you don’t have to see it that way. Soliris is a drug that works to reduce ongoing hemolysis, the cause of the signs, symptoms, and health risks associated with PNH.1

Soliris is indicated for the treatment of patients with PNH to reduce hemolysis.1

In global clinical programs, Soliris significantly lowered hemolysis.1 Just as the effects of PNH symptoms on everyday life can differ from person to person, results with Soliris may vary.2

In clinical trials, people with PNH taking Soliris experienced the following
  • 92% fewer blood clots — one of the serious health problems of PNH.3

    • Of the 195 patients in the clinical development program, three blood clots occurred while people were on Soliris, while 39 had occurred in the same time period before Soliris was started1,3,a

    • In Soliris clinical trials for PNH, most people also received blood-thinning medicine. The effect of stopping blood-thinning medicine during treatment with Soliris has not been studied.1

  • 73% reduction in the average units of blood transfused.4

    • Of those patients that participated in a clinical study, over half no longer needed transfusions after taking Soliris4

  • 87% less hemolysis as measured by LDH.5

    • All patients who took Soliris saw less hemolysis1

  • Reduced fatigue and overall health-related quality of life.1

    • Patients saw improvement in fatigue after starting Soliris, with significant improvement after 3 weeks of treatment1

    • Soliris improved health-related quality of life after 3 weeks of treatment1,4,6

  • The most common side effects in people with PNH treated with Soliris include:1

    • headache

    • pain or swelling of your nose or throat (nasopharyngitis)

    • back pain

    • nausea

aIn Soliris clinical studies for PNH, the majority of patients also received blood-thinning medicine. The effect of stopping blood-thinning medicine during treatment with Soliris has not been studied.1

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-1088.1


Download a complete copy of the Soliris Medication Guide.

Full indication and dosing information for PNH and aHUS is available here .


Quick facts about Soliris

  1. Soliris works by blocking complement (part of your body’s defense system) from attacking red blood cells that are missing an important protective protein.1

  2. In clinical trials, patients saw improvements in hemolysis, blood clots, and health-related quality of life, as well as reductions in blood transfusions.1-3

  3. If you decide to begin treatment, you will need to get vaccinated against meningococcal infections first. It is important that you stay up-to-date with all recommended vaccinations during Soliris treatment.1

  4. Your LDH test results can help tell you the progress you’re making with Soliris.4

  5. Remember, you and your doctor should consider all of your signs, symptoms, and lab results for a complete picture of your PNH.1

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.1

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

To help protect against such infections, you will need to be vaccinated for meningococcal disease before beginning treatment with Soliris.1

  • You must receive meningococcal vaccines at least 2 weeks before your first dose of Soliris if you have not already had this vaccine.1

  • If your doctor decided that urgent treatment with Soliris is needed, you should receive meningococcal vaccination as soon as possible.1

  • If you have not been vaccinated and Soliris therapy must be initiated immediately, you should also receive 2 weeks of antibiotics with your vaccinations.1

  • 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.1

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 infection1:

  • 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

For complete Important Safety Information for Soliris, please click here.

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 you1:

  • have a meningococcal infection

  • have not been vaccinated against meningitis infection unless your doctor decides that urgent treatment
    with Soliris is needed.

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.

Soliris Patient Safety Information Card — Carry it at all times

Download and print the Patient Safety Information card with information about the risk of meningococcal infection and discuss it with your PNH primary care doctor. 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.

Download Your Safety Information Card

The Patient Safety Information card contains Important Safety Information that you should know while receiving Soliris therapy. Because Soliris may reduce your natural resistance to infections, it is important to recognize the signs and symptoms of infections, including those of meningitis. This card includes a list of the signs and symptoms of these infections, so you can recognize an infection, including meningitis, and seek IMMEDIATE medical attention.

Personalized Patient Support

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

Learn about PNH and how Soliris can work to treat it.

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

  3. Hillman P, et al. Blood. 2007;110(12):4123-4128.

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

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

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