WARNINGS
Do not use EBGLYSS if you are allergic to lebrikizumab-lbkz or to any of the ingredients in EBGLYSS. See the end of this leaflet for a complete list of ingredients in EBGLYSS.
USES
EBGLYSS is a prescription 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).
HOW TO USE
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.
Your healthcare provider will tell you how much EBGLYSS to inject and how often to inject it.
EBGLYSS comes as a single-dose prefilled pen or prefilled syringe with needle shield.
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.
If you inject too much EBGLYSS (overdose), get medical help or contact a Poison Center expert right away at 1‑800-222-1222.
Your healthcare provider may prescribe other medicines to use with EBGLYSS. Use the other prescribed medicines exactly as your healthcare provider tells you to.
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, include 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.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use EBGLYSS for a condition for which it is not prescribed. Do not give EBGLYSS to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist of healthcare provider for information about EBGLYSS that is written for health professionals.
What are the ingredients in EBGLYSS?
Active ingredient: lebrikizumab-lbkz
Inactive ingredient: glacial acetic acid, histidine, polysorbate 20, sucrose, and Water for Injection.
EBGLYSS prefilled pen and prefilled syringe with needle shield are not made with natural rubber latex.
OVERDOSE
If you inject too much EBGLYSS (overdose), get medical help or contact a Poison Center expert right away at 1‑800-222-1222.
MISSED DOSE
If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.
STORAGE
Store EBGLYSS in the refrigerator between 36-degrees F to 46-degrees F (2-degrees C to 8-degrees C).
EBGLYSS can be stored at room temperature up to 86-degrees F (30-degrees C) for up to 7 days in the original carton. Throw away (dispose of) EBGLYSS that has been left at room temperature for longer than 7 days.
Store EBGLYSS in the original carton to protect from light until use.
Do not freeze. Do not shake.
Do not microwave EBGLYSS, or run hot water over it, or leave it in direct sunlight.
Keep EBGLYSS and all medicines out of the reach of children.
NOTES
Medication Guide: revision date 09/2024
Prescribing Information: revision date 05/2025
Please call your healthcare provider for more information.
Before you use 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.
