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Taking EBGLYSS

See how to use EBGLYSS

Please see Instructions for Use included with the Pen.

Please see Instructions for Use included with the Prefilled Syringe.

EBGLYSS Dosing

Discover once-monthly dosing with EBGLYSS

After 4 months of taking EBGLYSS every 2 weeks, you and your doctor can discuss switching to once-monthly dosing.*

Recommended dosing schedule for EBGLYSS (TM) (lebrikizumab-lbkz)

*The recommended dosage of EBGLYSS is:

  • An initial dose of 500 mg (two 250-mg injections) at week 0 and week 2, followed by
  • 250 mg every 2 weeks until week 16 or until adequate clinical response is achieved, and
  • Maintenance dose is 250 mg every 4 weeks

Select Important Safety Information

Do not use EBGLYSS if you are allergic to lebrikizumab-lbkz or to any of the ingredients in EBGLYSS.
See the Patient Information leaflet that comes with EBGLYSS for a complete list of ingredients.

EBGLYSS is available in both a Prefilled Pen and a Prefilled Syringe

EBGLYSS gives you the flexibility to choose the device option that best suits your needs

A device designed with you in mind

In two studies, 94% of adults agreed the Pen was easy to use and were confident in their ability to use it.

Results from two studies using a similar approved Pen with the same use steps.

Image of the EBGLYSS (TM) (lebrikizumab-lbkz) 250 mg/2mL Prefilled Pen
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The single-dose Prefilled Pen offers:
  • At-home administration
  • Hidden needle and automated injection
  • Up to 15 second injection time
  • Confirmation that you administered completely
    • You’ll hear 2 clicks, one when you start the injection, and one at the end to tell you that the injection is complete
    • The injection is complete when the gray plunger is visible
Image of the EBGLYSS (TM) (lebrikizumab-lbkz) 250 mg/2mL Prefilled Syringe
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The single-dose Prefilled Syringe offers:
  • At-home administration
  • Ability to control speed of injection

Select Important Safety Information

Before using EBGLYSS, tell your healthcare provider about all your medical conditions, including if you:

  • Have a parasitic (helminth) infection.
  • Are scheduled to receive any vaccinations. You should not receive a “live vaccine” if you are treated with EBGLYSS.
  • Are pregnant or plan to become pregnant. It is not known if EBGLYSS will harm your unborn baby.
    If you become pregnant during treatment with EBGLYSS, you or your healthcare provider can call Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) to report the pregnancy.
  • Are breastfeeding or plan to breastfeed. It is not known if EBGLYSS passes into your breast milk.
  • Take prescription or over-the-counter medicines, vitamins, and herbal supplements.

How to Inject the EBGLYSS Pen

Injection site diagrams

Choose and clean your injection site

  • Stomach area (abdomen) — at least 2 inches away from belly button (navel)
  • Front of thigh — at least 2 inches above the knee and 2 inches below the groin
  • Back of upper arm — another person should inject into the back of your upper arm
  • Clean the injection site with an alcohol wipe and let dry
  • Do not inject in the exact same spot every time. Avoid areas where the skin is tender, bruised, red, hard, or in an area of skin that is affected by atopic dermatitis or other skin lesions
Injection Step 1 icon

Uncap the Pen

  • Make sure the Pen is locked
  • When you are ready to inject, twist off the gray base cap and throw it away in your household trash
  • Do not put the gray base cap back on—this could damage the needle
  • Do not touch the needle inside the clear base
Injection Step 2 icon

Place and unlock

  • Place and hold the clear base flat and firmly against the skin
  • Keep the clear base on the skin, then turn the lock ring to the unlock position
Injection Step 3 icon

Press and hold for 15 seconds

  • Press and hold the purple injection button and listen for 2 loud clicks:
  • The first click lets you know the injection has started
  • The second click lets you know the injection is complete. You will know the injection is complete when the gray plunger is visible
  • The injection may take up to 15 seconds

Your healthcare provider should show you how to prepare and inject EBGLYSS using the Prefilled Pen. Do not inject yourself or someone else until you have been shown how to inject EBGLYSS.

These are not the complete instructions for using the Pen. Please see the Instructions for Use included with your device.

Dispose of used Pen properly

Put the used EBGLYSS Pen in an FDA-cleared sharps disposal container right away after use. Do not throw away EBGLYSS Pen(s) in your household trash. Do not recycle your used sharps disposal container. Keep sharps container away from children and pets. When your sharps container is almost full, follow your community guidelines for the right way to dispose of the sharps container.

For more information about safe sharps disposal, and for specific information about sharps disposal in the state you live in, go to the FDA website at: http://www.fda.gov/safesharpsdisposal

Sharps Disposal Container icon

Free Sharps Disposal Container available to you

Sharps disposal containers, provided to you free of cost, allow you to safely and conveniently dispose of your used injection devices.

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Lilly Support Services provides additional support to help you feel more prepared using your EBGLYSS device. Access resources like videos, which you can view at any time and receive personalized training with a registered nurse.

Questions about what to expect with EBGLYSS?

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Possible side effects

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EBGLYSS was studied in multiple clinical trials around the world

In clinical studies, side effects were experienced by some people. The most common side effects of EBGLYSS include:

  • Eye and eyelid inflammation, including redness, swelling, and itching
  • Injection site reactions
  • Shingles (herpes zoster)

These are not all of the possible side effects of EBGLYSS.

EBGLYSS can cause serious side effects, including:

  • Allergic reactions. EBGLYSS can cause allergic reactions that may sometimes be severe. Stop using EBGLYSS and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms:
    • breathing problems or wheezing
    • swelling of the face, lips, mouth, tongue or throat
    • hives
    • itching
    • fainting, dizziness, feeling lightheaded
    • skin rash
    • cramps in your stomach area (abdomen)
  • Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision.
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EBGLYSS is not a steroid and does not suppress your immune system

EBGLYSS:

  • is not an immunosuppressant or steroid
  • does not have boxed warnings
  • does not require additional lab monitoring or blood work

Additionally, in clinical trials, the safety profile of EBGLYSS through 1 year was similar to the safety profile reported through the first 16 weeks.

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EBGLYSS has a safety profile that includes both children (ages 12-17 and weighing at least 88 pounds) and adults

In clinical studies, the safety profile in children was similar to that reported by all study patients.

Tell your doctor if you have any side effects.

You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

SAFETY SUMMARY

Warnings - Do not use EBGLYSS if you are allergic to lebrikizumab-lbkz or to any of the ingredients in EBGLYSS. See the Patient Information leaflet that comes with EBGLYSS for a complete list of ingredients.

Before using
Before using EBGLYSS, tell your healthcare provider about all your medical conditions, including if you:

  • Have a parasitic (helminth) infection.
  • Are scheduled to receive any vaccinations. You should not receive a “live vaccine” if you are treated with EBGLYSS.
  • Are pregnant or plan to become pregnant. It is not known if EBGLYSS will harm your unborn baby. If you become pregnant during treatment with EBGLYSS, you or your healthcare provider can call Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) to report the pregnancy.
  • Are breastfeeding or plan to breastfeed. It is not known if EBGLYSS passes into your breast milk.

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

Possible side effects
EBGLYSS can cause serious side effects, including:

  • Allergic reactions. EBGLYSS can cause allergic reactions that may sometimes be severe. Stop using EBGLYSS and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms:
    • breathing problems or wheezing
    • swelling of the face, lips, mouth, tongue or throat
    • hives
    • itching
    • fainting, dizziness, feeling lightheaded
    • skin rash
    • cramps in your stomach area (abdomen)
  • Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision.

The most common side effects of EBGLYSS include:

  • eye and eyelid inflammation, including redness, swelling, and itching
  • injection site reactions
  • shingles (herpes zoster)

These are not all of the possible side effects of EBGLYSS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

How to take

  • See the detailed “Instructions for Use” that comes with EBGLYSS for information about how to prepare and inject EBGLYSS and how to properly store and throw away (dispose of) used EBGLYSS prefilled pens and prefilled syringes.
  • Use EBGLYSS exactly as prescribed by your healthcare provider.
  • EBGLYSS is given as an injection under the skin (subcutaneous injection).
  • If your healthcare provider decides that you or a caregiver can give the injections of EBGLYSS, you or a caregiver should receive training on the right way to prepare and inject EBGLYSS. Do not try to inject EBGLYSS until you have been shown the right way by your healthcare provider. In children 12 years of age and older, EBGLYSS should be given by a caregiver.
  • If you miss a dose of EBGLYSS, inject the missed dose as soon as possible, then inject your next dose at your regular scheduled time.

Learn more
EBGLYSS is a prescription medicine available as a 250 mg/2 mL injection prefilled pen or prefilled syringe. For more information, call 1-800-545-5979 or go to ebglyss.lilly.com

This summary provides basic information about EBGLYSS but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking to your doctor. Be sure to talk to your doctor or other healthcare provider about EBGLYSS and how to take it. Your doctor is the best person to help you decide if EBGLYSS is right for you.

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INDICATION

EBGLYSS (EHB-glihs) is an injectable medicine used to treat adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe eczema (atopic dermatitis) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. EBGLYSS can be used with or without topical corticosteroids.

It is not known if EBGLYSS is safe and effective in children less than 12 years of age or in children 12 years to less than 18 years of age who weigh less than 88 pounds (40 kg).