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How ENSPRYNG is thought to work

See how ENSPRYNG takes a different approach to treating neuromyelitis optica spectrum disorder (NMOSD)

 ENSPRYNG patient Kila, diagnosed with NMOSD in 2014

ENSPRYNG is a different kind of treatment for NMOSD

  • ENSPRYNG is the first and only approved NMOSD treatment that is designed to block the action of interleukin 6 (IL-6)—a protein that may play an important role in NMOSD
  • The exact way ENSPRYNG works is not fully known

WITHOUT ENSPRYNG

IL-6 connects to the cell surface and activates the cell.

WITH ENSPRYNG

ENSPRYNG blocks IL-6 from connecting to the cell surface and prevents the activation of the cell.

Learn about NMOSD from Dr. Adil Javed

Gain a better understanding of how NMOSD affects the body, how it's diagnosed, and how ENSPRYNG is thought to work.

NMOSD and ENSPRYNG

Voice-Over:

The subject of this video is "What Is ENSPRYNG?” ENSPRYNG is a prescription medicine used to treat neuromyelitis optica spectrum disorder, also known as NMOSD, in adults who are aquaporin-4, also known as AQP4, antibody positive.

It is not known if ENSPRYNG is safe and effective in children. ENSPRYNG may cause serious side effects, including infections, increased liver enzymes, and low neutrophil counts.

All required vaccinations should be completed before starting ENSPRYNG. Do not take ENSPRYNG if you are allergic to satralizumab-mwge or any of the ingredients in ENSPRYNG, have an active hepatitis B infection or have active or untreated inactive (latent) TB.

Please see Important Safety Information at the end of this video. If you have any questions, please talk to your healthcare provider or refer to the ENSPRYNG Prescribing Information and Medication Guide.

This video features an accredited neurologist and a real person who is treating her NMOSD with ENSPRYNG.

 

SANDRA:

Hello, my name is Sandra. Many years ago, I was enjoying a successful career in sales. I soon lost my sense of smell, had a mysterious pain in my side, felt tremors, and ended up in the ER.

After many tests, I was misdiagnosed with MS. My neurologist explained that because NMOSD is a rare disease, it is often misdiagnosed as MS.

So, if you are diagnosed with NMOSD, I know what you are going through as you look to learn more about this rare disease and consider your treatment options. This is one video in a series. I wish I had these videos to turn to when I was first diagnosed with aquaporin-4 positive NMOSD.

Today, we are fortunate to have a doctor with us who will give you important information about ENSPRYNG. When I was first diagnosed with aquaporin-4 positive NMOSD, I was dumbfounded. I thought, what the heck is this?

I read everything I could about the disease. I got involved in patient advocacy, and I’m still very passionate about giving back to this day. The relationship with your neurologist is critical. You have to speak up and be an advocate for yourself.

Let them know everything you can about your condition. The more your doctor knows, the better they can understand the best path to your treatment. I’d now like to introduce you to Dr. Javed, who will tell us more about the NMOSD disease and how ENSPRYNG treats it.

 

DR. JAVED:

Thanks, Sandra. Hello, my name is Dr. Javed. I’m a neurologist. As Sandra pointed out, it’s important to work together with your doctor in coming up with a comprehensive treatment plan for your aquaporin-4 positive NMOSD. Today, I’m going to talk about a treatment called ENSPRYNG.

ENSPRYNG is indicated for the treatment of neuromyelitis optica spectrum disorder, also known as NMOSD, in adult patients who are aquaporin-4 antibody positive, also known as AQP4 positive.

Because NMOSD is a rare disease, it is often misdiagnosed as MS. As we learn more about the disease, the better we are able to diagnose it. So let’s take a closer look at NMOSD. To help confirm a NMOSD diagnosis and determine the right treatment, your doctor may order blood tests that look for the presence of specific antibodies to the AQP4 protein, known as aquaporin-4 IgG.

When a person is aquaporin-4 IgG positive, it means that they make antibodies to the aquaporin-4 protein.

When a person is aquaporin-4 negative, it means that they do not make antibodies to the aquaporin-4 protein. Around 75% of people with NMOSD are aquaporin-4 IgG positive, which means they make aquaporin-4 IgG antibodies.

An antibody is a protein produced by the body’s immune system when it detects a foreign or harmful substance. In some autoimmune diseases, the immune system, including certain antibodies, mistakes normal tissues as being foreign and attacks them. Aquaporin-4 is a protein that is found in the brain and spinal cord. Before we go over the specific details about ENSPRYNG, let’s review the characteristics of the disease known as NMOSD.

And what type of people are more likely to get it. NMOSD, also known as NMO, is a rare inflammatory disease of the central nervous system with unpredictable relapses that may lead to cumulative and permanent damage and disability.

NMOSD affects nearly 15,000 people in the United States. NMOSD predominantly affects women, in fact, it affects women nine times more than men. It can occur in people in their 30s and 40s, but children and older adults can also be affected.

NMOSD appears to be more common in people of African or Asian descent, and 80 to 90% of people with NMOSD experience recurring relapses.

Keep in mind that every patient with NMOSD has a unique experience. This is why your doctor will work closely with you to discuss the risks and benefits of ENSPRYNG. Next, let’s go over the specifics of how ENSPRYNG is thought to work.

ENSPRYNG is the first FDA-approved, self-injectable treatment for adults with aquaporin-4 IgG positive NMOSD. It is intended for self-administration under the guidance of a healthcare provider. With proper training, and if your healthcare provider says that it’s OK, an adult patient or caregiver may inject ENSPRYNG. It is a subcutaneous injection given under the skin through a prefilled syringe. The specific way ENSPRYNG works is not completely understood but is thought to affect the protein interleukin-6 (IL-6).

ENSPRYNG is the first treatment for NMOSD designed to block IL-6, a protein made by the immune cells in our bodies that may play a key role in the inflammation that occurs in people with NMOSD. Let’s look at the illustration on the left without ENSPRYNG. The IL-6 protein connects to the cell surface and activates the cell.

Now, let’s look at the illustration with ENSPRYNG. See how ENSPRYNG blocks the IL-6 protein from connecting to the cell surface and prevents the activation of the cell.

Anyone with NMOSD knows how unpredictable relapses can be. They may lead to cumulative and permanent damage and disability. That’s why it’s important to talk to your doctor and develop a treatment plan for NMOSD that helps reduce the risk of relapses.

I urge you to become your own advocate and take advantage of all the resources out there that go into even more detail about living with NMOSD. Now that you’ve heard more about ENSPRYNG, let’s hear from a real NMOSD patient, Sandra, our Patient Ambassador.

 

SANDRA:

Thanks, Dr. Javed. Since being diagnosed with aquaporin-4 positive NMOSD, there are ways I’ve had to alter my life.

I had to change my diet, and it took me awhile to learn how to live with my body again. I tried to hide my condition for a long time, but I knew I never wanted to let it define me. You can still do things with a chronic illness, even if it is at a slower pace.

It’s important to always listen to your body and to communicate any changes to your healthcare team, so they can choose the best path forward. My neurologist and I discussed the potential benefits as well as the possible serious side effects of ENSPRYNG.

So far, the treatment has been great; however, this is just my experience and yours may be different. I hope you found this video informative and helpful. Check out all the other videos in the series relating to ENSPRYNG at www.ENSPRYNG.com.

They’re a valuable resource you can view anytime. You can even watch them more than once as a refresher. Thanks for listening. Stay tuned for additional Important Safety Information.

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What is ENSPRYNG?

ENSPRYNG is a prescription medicine used to treat neuromyelitis optica spectrum disorder (NMOSD) in adults who are aquaporin-4 (AQP4) antibody positive. It is not known if ENSPRYNG is safe and effective in children.

Who should not receive ENSPRYNG?

Do not take ENSPRYNG if you:

  • are allergic to ENSPRYNG or any of the ingredients in ENSPRYNG.
  • have an active hepatitis B infection.
  • have active or untreated inactive (latent) tuberculosis.
What is the most important information I should know about ENSPRYNG?

ENSPRYNG may cause serious side effects including:

  • Infections. ENSPRYNG can increase your risk of serious infections, some of which can be life-threatening. Talk to your healthcare provider if you are being treated for an infection, or call them right away if you think you have signs of an infection, with or without a fever, such as:
    • chills, feeling tired, muscle aches, cough that will not go away or a sore throat
    • skin redness, swelling, tenderness, pain or sores on your body
    • diarrhea, belly pain, or feeling sick
    • burning when you urinate or urinating more often than usual

Your healthcare provider will check if you have an infection and treat it if needed before you start or continue to take ENSPRYNG.

  • Your healthcare provider should test you for hepatitis and tuberculosis (TB) before you start taking ENSPRYNG.
  • All required vaccinations should be completed before starting ENSPRYNG. People using ENSPRYNG should not be given ‘live’ or ‘live-attenuated’ vaccines. ‘Live’ or ‘live-attenuated’ vaccines should be given at least 4 weeks before you start ENSPRYNG. Your healthcare provider may recommend that you get a ‘non-live’ (inactivated) vaccine, such as some of the seasonal flu vaccines. If you plan to get a ‘non-live’ (inactivated) vaccine, it should be given, whenever possible, at least 2 weeks before you start ENSPRYNG.
  • Increased liver enzymes.
    Your healthcare provider should order blood tests to check your liver enzymes before and while you are taking ENSPRYNG. Your healthcare provider will tell you how often you will need to have these blood tests. Make sure you get all of your follow-up blood tests as ordered by your healthcare provider. Your healthcare provider will tell you if you need to wait to start ENSPRYNG if your liver enzymes are increased.
  • Low neutrophil count.
    ENSPRYNG can cause a decrease in your neutrophil counts in your blood. Neutrophils are white blood cells that help the body fight off bacterial infections. Your healthcare provider should order blood tests to check your neutrophil count while you are taking ENSPRYNG.
  • Serious allergic reactions.
    Serious allergic reactions that may be life-threatening have happened with other medicines like ENSPRYNG. Tell your healthcare provider before taking your next dose if you had hives, rash, or flushing after your injection. Seek medical attention right away if you have any symptoms of a serious allergic reaction, such as:
    • shortness of breath or trouble breathing
    • dizziness or feeling faint
    • swelling of your lips, face, or tongue
    • moderate or severe stomach (abdominal) pain or vomiting
    • chest pain    

Before you take ENSPRYNG, tell your healthcare provider about all of your medical conditions, including if you:

  • have or think you have an infection. See "What is the most important information I should know about ENSPRYNG?"
  • have liver problems.
  • have ever had hepatitis B or are a carrier of the hepatitis B virus.
  • have had or have been in contact with someone with tuberculosis.
  • have had a recent vaccination or are scheduled to receive any vaccination.
  • are pregnant, think that you might be pregnant, or plan to become pregnant. It is not known if ENSPRYNG will harm your unborn baby.
    • Pregnancy Registry: There is a registry for pregnant women who take ENSPRYNG. The purpose of this registry is to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking ENSPRYNG, talk to your healthcare provider about how you can join this pregnancy registry, or you may contact the registry at 1-833-277-9338 to enroll.
  • are breastfeeding or plan to breastfeed. It is not known if ENSPRYNG passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take ENSPRYNG.

Tell your healthcare provider about all the medicines you are taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the most common side effects of ENSPRYNG?
The most common side effects of ENSPRYNG include:

  • sore throat, runny nose (nasopharyngitis)
  • rash
  • fatigue
  • extremity pain
  • headache
  • upper respiratory tract infection
  • nausea
  • inflammation of the stomach lining (gastritis)
  • joint pain (arthralgia)

These are not all the possible side effects of ENSPRYNG.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Genentech at 1-888-835-2555.

For more information, call 1-844-NSPRYNG.

For additional safety information, please see the full Prescribing Information and Medication Guide.