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For US Healthcare Professionals

Self-administer ENSPRYNG® at home*

*After training and approval with your healthcare provider

Finding a treatment for TED that works for you and your lifestyle is important

You or your caregiver will have to be trained and approved by your healthcare provider before injecting ENSPRYNG at home. Once you've received your starting doses, have received training, and have your healthcare provider's approval, you can choose whether you want to administer ENSPRYNG yourself or have your trained caregiver help you.

Remember that ENSPRYNG can be stored at room temperature (no higher than 86°F/30°C) for a total of 8 days.

ENSPRYNG is available as a 120 mg prefilled syringe, and will be available as 120 mg and 180 mg autoinjectors from early 2027.

The recommended ENSPRYNG dose is based on your body weight with 3 starting doses in the first month of treatment, and given every 4 weeks after. In clinical trials, there was a total of 7 doses.

Here is an example of what your dosing schedule might look like:

The safety and effectiveness of ENSPRYNG has not been established in TED patients weighing less than 40 kg (88 lbs).

If a starting dose is missed (first 3 doses)

You should take the dose immediately, then continue the 2-week dosing interval from this 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 (unless over 8 weeks since you last took a dose)

You should take the missed dose immediately, wait for the 4-week interval from this 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.

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Next: Injecting ENSPRYNG

Important Safety Information & Indication

What is ENSPRYNG® (satralizumab-mwge)?

ENSPRYNG is a prescription medicine used to treat:

  • thyroid eye disease (TED) no matter how severe it is or how long a person has had it.

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.
  • 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.

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