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What is Thyroid Eye Disease (TED)?

TED is a condition where the body’s immune system mistakenly attacks the tissues around the eye, causing inflammation and swelling

Symptoms of TED may vary from person to person, with some appearing quicker than others. The quicker you recognize the symptoms, the sooner your doctor can help get you on the right treatment.

Common TED symptoms:

Icon - Representing eye bulging
Eyes bulging (also called ‘proptosis’)
Double vision (also called ‘diplopia’)
Swelling
Icon - Representing pain and soreness
Pain and soreness
Light sensitivity
Redness and inflammation

Understanding TED

Learning how TED affects your eyes can help you better understand your treatment options.

One of the main factors thought to play a role in TED is a protein called interleukin 6 (IL-6). It is made in the body and helps control inflammation.

In a healthy eye, IL-6 is found in tiny amounts, where it helps repair micro-injuries and protects eye tissue.

The role of IL-6

The immune system trigger

In TED, elevated levels of IL-6 act like fuel for the immune system. IL-6 signals immune cells to stay active and drives an autoimmune response targeting the area behind your eyes.

The inflammation response

IL-6 attaches directly to tissue cells behind your eyes. This activates an inflammation response, causing the tissues to swell and retain fluid.

The TED symptoms

Because your eye socket cannot expand, this swollen tissue builds up severe pressure, which is thought to contribute to the key symptoms of TED, including bulging eyes (also known as proptosis) and double vision (also known as diplopia).

TED vs Graves’ disease: What’s the difference?

In TED, your immune system attacks the muscles and tissues behind your eyes, causing the symptoms of TED.

Graves’ disease is a separate condition, where your immune system attacks your thyroid gland in your neck, causing it to become overactive and speed up your metabolism, leading to tiredness, fast heartbeat, weight loss, sensitivity to temperature, irritability, and anxiety. Up to 40% of people diagnosed with Graves’ disease could develop TED.

While they are both autoimmune conditions, treating Graves’ disease doesn’t treat your TED. They require different treatment approaches, that's why it is important to talk to your doctor about a treatment for TED.

IL-6=interleukin 6; TED=thyroid eye disease.

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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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