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The ENSPRYNG treatment schedule

A monthly treatment for neuromyelitis optica spectrum disorder (NMOSD) that you can take at home

ENSPRYNG is a monthly self-injectable treatment you can take on the go

ENSPRYNG is an injection that is given under the skin once a month via a prefilled syringe, giving you treatment flexibility and control over where you take it. ENSPRYNG is given every 4 weeks after taking 3 starter doses in your first month of treatment. With proper training, and provided your healthcare provider says it’s okay, you or your caregiver can administer ENSPRYNG.

Once you're ready, ENSPRYNG can be given in the comfort of your own home, or even while traveling. ENSPRYNG, if unopened, can be removed from and returned to the refrigerator, if needed. The total combined time out of the refrigerator should not be more than 8 days at a temperature that does not go above 86°F (30°C).

ENSPRYNG (satralizumab) dosing schedule

If a starting dose is missed, you should take it immediately, then maintain the 2-week dosing interval from your new starting date until the first 3 doses are complete, and then continue with ongoing doses every 4 weeks.

If an ongoing dose is missed, you should take it immediately, wait the 4-week interval from your new starting date, and then continue with ongoing doses every 4 weeks.

Speak with your healthcare provider if you have any questions about how to restart treatment or if it has been more than 8 weeks since your last dose of ENSPRYNG.

Still have questions about taking ENSPRYNG?

Get the details about what it's like to take ENSPRYNG from a Clinical Education Manager.

Taking ENSPRYNG

Voice-Over:

The subject of this video is Taking 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 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 a Clinical Education Manager and a real person who is treating her NMOSD with ENSPRYNG.

 

DONNA:

Hello. My name is Donna. I was diagnosed with AQP4 positive NMOSD in 2014. So if you were diagnosed with NMOSD, I know what you’re 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 would have had these videos to turn to when I was first diagnosed.

I’m now going to introduce you to Annette who is a Clinical Education Manager, also known as a CEM. Their job is to provide supplemental injection training to patients who have been prescribed ENSPRYNG and to caregivers when needed.

 

ANNETTE:

Thanks, Donna. Hello there, my name is Annette. I am a CEM with Genentech. I provide supplemental injection training and refresher supplemental injection training to patients and their caregivers, provided of course your doctor says you can self-inject with ENSPRYNG. I have guided many patients through this process. If you have questions or need a refresher, a CEM like me is there to support you during every step of this process.

ENSPRYNG is a monthly self-injectable treatment you can take on the go. You have a voice in how you manage your NMOSD treatment. If your healthcare provider determines it’s appropriate and after proper training, you or your caregiver have the ability to give it in the comfort of your own home or even while traveling, since ENSPRYNG can be stored at room temperature for a total of up to eight days, which don’t need to be eight days in a row.

ENSPRYNG is an injection that is given under the skin once a month via prefilled syringe, which gives the treatment flexibility and control over where you take it. Before and while taking ENSPRYNG, your healthcare provider may order tests and monitor you to ensure ENSPRYNG is still appropriate for you. Now that we’ve spoken about how ENSPRYNG is administered, let’s examine a chart that explains the dosing schedule for ENSPRYNG.

ENSPRYNG is a treatment that is given every four weeks after taking three starting doses in the first month of treatment. Here’s how the starting doses work. For the first four weeks, you are given one dose every two weeks. After that, you take one dose every four weeks. Doses are administered in a prefilled syringe that contain 120 mg of medicine. If a starting dose is missed, you should take it immediately, then maintain the two-week dosing interval from your new starting date until the first three doses are complete and then continue with ongoing doses every four weeks.

If an ongoing dose is missed, you should take it immediately. Wait the four-week interval from your new starting date and then continue with ongoing doses every four weeks.

Of course, you should always consult with your healthcare provider when it comes to administering the treatment they prescribed for you. As a CEM, I am also available to help answer questions you may have about self-injecting with ENSPRYNG.

One common question I get is how to store and handle ENSPRYNG which is the subject of our next slide. Follow these simple rules when storing and handling ENSPRYNG. Store ENSPRYNG in your refrigerator in its original box.

That protects it from light. If needed, unopened ENSPRYNG, can be removed from and returned to your refrigerator prior to administering it. Never freeze or shake the syringe. If for some reason the ENSPRYNG has to be stored at room temperature like when traveling, the total combined time out of the refrigerator should not be more than eight days at a temperature that is higher than 86 degrees Fahrenheit or 30 degrees Celsius.

I hope the information I shared with you today about taking ENSPRYNG was useful. Self-injection with ENSPRYNG can give you the flexibility to take it at a location that’s convenient for you, provided your healthcare provider determines it is appropriate and you have been trained on the proper technique.

Remember, if you are ever unsure and/or need to go over any of these steps again, you can always reach out to your CEM or even your Patient Navigator by calling 1-844-NSPRYNG. If they can’t answer a question, they can always point you in the right direction. Thank you for your time.

Now, let’s go back and get a closing thought from Donna, our Patient Ambassador.

 

DONNA:

Thanks, Annette. Living with NMOSD has brought certain challenges. Putting eye makeup on is not easy nor is playing pickleball. I lacked depth perception so I have a hard time figuring out where the ball is in relation to my paddle.

My sister and I laughed about it until we cried but we had fun trying. Being able to laugh at myself and find joy in everyday life has really made living with NMOSD bearable. After working with my doctor, I’m comfortable self-injecting with ENSPRYNG. For me, it’s empowering. 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 are a valuable resource you can view any time. 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.