Update on COVID-19

We understand that you may be concerned about how the evolving COVID-19 situation could impact access to your medicine.

In light of the recent outbreak of coronavirus (COVID-19), the National MS Society’s National Medical Advisory Committee has just published recommendations for people with multiple sclerosis (MS) and the use of some therapies.1

Soliris® (eculizumab) is a medicine known as a complement inhibitor.2 It is designed to work in a very specific part of the immune system. In the clinical trials, the respiratory viral infections were consistent with the types of infections common in the general population and were not serious in nature and patients stayed on Soliris treatment.2,3

Although Soliris has not been studied with every vaccination currently available, there are no known concerns with receiving recommended vaccines while taking Soliris.2,4

Risk in Soliris patients

Based on the way Soliris works, safety data compiled from thousands of patients, and over 10 years of experience, it does not appear that patients treated with Soliris have a higher risk of developing a coronaviral infection or that the course of their infection would be worse than if they had not received Soliris.3,5

Viral respiratory infections were observed in the Alexion-sponsored clinical trials for Soliris.2 Those viral respiratory infections were the same type of respiratory viral infections that are typically seen in the general population, like the common cold. In the trials, the viral respiratory infections were not serious in nature and all resolved without the patient having to discontinue treatment with Soliris.2,3

It is important to note that Soliris patients are at increased risk for developing meningococcal infections, which have some of the same early symptoms as COVID-19.2

If you develop a headache and fever or have muscle aches with flu-like symptoms (or any symptoms as described on the patient safety card), call your doctor right away or seek emergency medical treatment, as these could be signs of a meningococcal infection that requires immediate medical attention. If you’re unable to reach your doctor, immediately seek emergency medical treatment and show “Patient Safety Card” to emergency staff at the hospital.

Please see the full CDC recommendations for COVID-19 for information about populations that may be at higher risk of developing severe illness from COVID-19.

Life moves fast. Reach out to OneSource™ at any time for additional information.

Moving forward,

  • Continue to follow your physician’s advice about your specific medical situation
  • Follow your local government direction

For more information on the evolving COVID-19 situation, please monitor public health authority websites, such as www.cdc.gov or www.who.int.

References:

  1. https://www.nationalmssociety.org/What-you-need-to-know-about-Coronavirus-(COVID-19)/DMT-Guidelines-for-Coronavirus-(COVID-19)-and. Accessed March 26, 2020.
  2. Soliris [prescribing information]. Boston, MA: Alexion Pharmaceuticals, Inc.; June 2019.
  3. Data on File; Global Drug Safety. Alexion Pharmaceuticals, 2020.
  4. https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/immunocompetence. Accessed April 1, 2020.
  5. Soliris (eculizumab) Periodic Benefit Risk Evaluation Report; Global Drug Safety. Alexion Pharmaceuticals 2019.

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IMPORTANT SAFETY INFORMATION & INDICATION FOR SOLIRIS® (eculizumab), INCLUDING BOXED WARNING
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IMPORTANT SAFETY INFORMATION
What is the most important information I should know about SOLIRIS?
SOLIRIS is a medicine that affects your immune system and may lower the ability of your immune system to fight infections.
  • SOLIRIS increases your chance of getting serious meningococcal infections that may quickly become life-threatening or cause death if not recognized and treated early.
  1. You must complete or update your meningococcal vaccine(s) at least 2 weeks before your first dose of SOLIRIS.
  2. If you have not been vaccinated and SOLIRIS must be started right away, you should receive the required vaccine(s) as soon as possible.
  3. If you have not been vaccinated and SOLIRIS must be started right away, you should also receive antibiotics for as long as your healthcare provider tells you.
  4. If you had a meningococcal vaccine in the past, you might need additional vaccines before starting SOLIRIS. Your healthcare provider will decide if you need additional meningococcal vaccines.
  5. 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 serious meningococcal infection: fever, fever with high heart rate, headache and fever, confusion, muscle aches with flu-like symptoms, fever and 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 3 months after your last dose of SOLIRIS. 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 healthcare provider who treats you. This will help them diagnose and treat you quickly.

SOLIRIS is only available through a program called the ULTOMIRIS and SOLIRIS Risk Evaluation and Mitigation Strategy (REMS). Before you can receive SOLIRIS, 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 SOLIRIS right away and you are not up to date on your vaccines; give you a Patient Safety Card about your risk of meningococcal infection.

SOLIRIS may also increase the risk of other types of serious infections, including Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria gonorrhoeae. Certain people may be at risk of serious infections with gonorrhea. Certain fungal infections (Aspergillus) may occur 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 serious meningococcal infection when you are starting SOLIRIS.
Before you receive SOLIRIS, 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, and are breastfeeding or plan to breastfeed. It is not known if SOLIRIS will harm your unborn baby or if it passes into your breast milk.

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.

What are the possible side effects of SOLIRIS?
SOLIRIS can cause serious side effects including serious infusion-related reactions. Tell your healthcare provider 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, and feel faint or pass out. If you have an infusion-related reaction to SOLIRIS, your healthcare provider may need to infuse SOLIRIS more slowly, or stop SOLIRIS.
The most common side effects in people with NMOSD treated with SOLIRIS include: common cold (upper respiratory infection), pain or swelling of your nose or throat (nasopharyngitis), diarrhea, back pain, dizziness, flu like symptoms (influenza) including fever, headache, tiredness, cough, sore throat, and body aches, joint pain (arthralgia), throat irritation (pharyngitis), and bruising (contusion).

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 SOLIRIS. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

INDICATION
What is SOLIRIS?
SOLIRIS is a prescription medicine used to treat adults with a disease called neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive. It is not known if SOLIRIS is safe and effective in children with NMOSD.

Please see the full Prescribing Information and Medication Guide for SOLIRIS, including Boxed WARNING regarding serious meningococcal infections.

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Please read the Indication and 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 with a disease called neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive

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

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 meningococcal infections. Meningococcal infections may quickly become life-threatening and cause death if not recognized and treated early.
  1. You must complete or update your meningococcal vaccine(s) at least 2 weeks before your first dose of SOLIRIS.
  2. If you have not been vaccinated and SOLIRIS must be started right away, you should receive the required vaccine(s) as soon as possible.
  3. If you have not been vaccinated and SOLIRIS must be started right away, you should also receive antibiotics for as long as your healthcare provider tells you.
  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 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 3 months after your last dose of SOLIRIS. 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 ULTOMIRIS and 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 the meningococcal vaccine and, if needed, get revaccinated with the meningococcal vaccine. Ask your doctor if you are not sure if you need to be revaccinated.

SOLIRIS may also increase the risk of other types of serious infections, including Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria gonorrhoeae. Certain people may be at risk of serious infections with gonorrhea. Certain fungal infections (Aspergillus) may occur 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.

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 adults with anti-AQP4 antibody-positive NMOSD treated with SOLIRIS include:
  • common cold (upper respiratory infection)
  • pain or swelling of your nose or throat (nasopharyngitis)
  • diarrhea
  • back pain
  • dizziness
  • flu like symptoms (influenza) including fever, headache, tiredness, cough, sore throat, and body aches
  • joint pain (arthralgia)
  • throat irritation (pharyngitis)
  • bruising (contusion)

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 are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch, or call 1-800-FDA-1088.

Please see the full Prescribing Information and Medication Guide for SOLIRIS, including Boxed WARNING regarding serious meningococcal infections.
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