EBGLYSS™ Indication and Safety Summary

Fri, 29 Aug 2025 12:15:36 +0000

Please see FULL PRESCRIBING INFORMATION at https://e.lilly/ebglyssPI , including Patient Information at https://e.lilly/ebglyssPPI and Instructions for Use at https://e.lilly/ebglyssIFU , for EBGLYSS.

INDICATION AND SAFETY SUMMARY

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).

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:
o breathing problems or wheezing
o swelling of the face, lips, mouth, tongue or throat
o hives
o itching
o fainting, dizziness, feeling lightheaded
o skin rash
o 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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EBGLYSS™ and its delivery device base are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.