Understand how ENSPRYNG works and if you could benefit
When it comes to choosing a treatment for NMOSD, everybody and every option is different. Here's why ENSPRYNG may be the right fit for you and your lifestyle.
Understand how ENSPRYNG works and if you could benefit
When it comes to choosing a treatment for NMOSD, everybody and every option is different. Here's why ENSPRYNG may be the right fit for you and your lifestyle.
ENSPRYNG is a monthly self-injectable treatment you can take on the go
ENSPRYNG works differently from other NMOSD treatments to help you take on your tomorrow. With it, you can:
Reduce your risk of relapse*
Find reassurance in an established long-term safety profile†‡
Self-inject once a month, at home or on the go§
*Based on a study of ENSPRYNG alone compared to placebo and another study of ENSPRYNG plus immunosuppressive therapy (IST) compared to placebo plus IST.
†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.
‡Based on an open-label, long-term study of 106 patients who completed Study 1 or Study 2. Patients in the open-label, long-term study have been taking ENSPRYNG for a median of 5 years. An open-label study means that patients and the study staff knew ENSPRYNG was the provided treatment. Conclusions should not be drawn on the basis of an open-label study, as the results from this study were not used to support the approval of ENSPRYNG.
§After your doctor has trained and approved you, and you've taken 3 starter doses in your first month of treatment. You should not keep ENSPRYNG out of the refrigerator for more than 8 days and/or at a temperature higher than 86°F (30°C).
What is ENSPRYNG?
MALE VO: 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, --
[00:00:12]
-- 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.
[00:00:27]
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.
[00:00:44]
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.
[00:01:00]
DR. JAVED: Hello, my name is Dr. Javed. I’m a neurologist. It’s important to work together with your doctor in coming up with a comprehensive treatment plan for your aquaporin-4 positive NMOSD.
[00:01:10]
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.
[00:01:20]
Next, let’s go over the specifics of how ENSPRYNG is thought to work. ENSPRYNG is the first FDA-approved, --
[00:01:26]
-- 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, --
[00:01:40]
-- 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).
[00:01:56]
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.
[00:02:12]
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.
[00:02:28]
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 –
[00:02:41]
-- 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.
[00:03:02]
MALE VO: Important Safety Information for ENSPRYNG. What is ENSPRYNG? ENSPRYNG is a prescription medicine used to treat neuromyelitis optica spectrum disorder (NMOSD) in adults who are --
[00:03:15]
-- 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 --
[00:03:28]
-- 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?
[00:03:43]
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 --
[00:03:57]
-- 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, --
[00:04:11]
-- 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, --
[00:04:24]
-- 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.
[00:04:38]
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’ --
[00:04:53]
-- (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.
[00:05:06]
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
[00:05:21]
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.
[00:05:35]
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.
[00:05:49]
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--
[00:06:04]
--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, --
[00:06:20]
-- chest pain. Before you take ENSPRYNG, tell your healthcare provider about all your medical conditions including if you: have or think you have an infection. See “What is the most important information --
[00:06:33]
-- 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, --
[00:06:46]
-- 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.
[00:06:58]
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.
[00:07:24]
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, --
[00:07:38]
-- 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), --
[00:07:53]
-- rash, fatigue, extremity pain, headache, upper respiratory tract infection, nausea, inflammation of the stomach lining, (gastritis), joint pain, (arthralgia).
[00:08:07]
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 --
[00:08:22]
-- to Genentech at 1-888-835-2555. For more information, go to www.ENSPRYNG.com or call
1-844-NSPRYNG.
[00:08:39]
For additional safety information, please see the full Prescribing Information and Medication Guide.
[00:08:46]
How is ENSPRYNG thought to work?
ENSPRYNG is the first and only approved NMOSD treatment 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.
Consider ENSPRYNG if you are:
- Newly diagnosed and exploring treatment options
- Currently receiving treatment for NMOSD with:
- oral immunosuppressive therapies such as azathioprine, mycophenolate mofetil, or oral corticosteroids
- approved or investigational monoclonal antibodies
- Uncertain about, or not responding well to, your current therapy
Hear from others about ENSPRYNG
Hearing from people who've been in your shoes, like Cheena and Jennifer, can help you decide between the many options out there.