Patient information: uses, side effects, how to take - Ebglyss
What is EBGLYSS?
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).
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.
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 breastfeeding or plan to breastfeed. It is not known if EBGLYSS passes into your breast milk.
are pregnant or plan to become pregnant. It is not known if EBGLYSS will harm your unborn baby.
Pregnancy Exposure Registry: There is a pregnancy exposure registry that monitors women exposed to EBGLYSS during pregnancy. If you become pregnant during treatment with EBGLYSS call 1-877-311-8972 or visit https://pregnancyregistry.lilly.com to report the pregnancy.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I take EBGLYSS?
- 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.
What are 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, 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.
How should I store EBGLYSS?
- Store EBGLYSS in the refrigerator between 36°F to 46°F (2°C to 8°C).
- EBGLYSS can be stored at room temperature up to 86°F (30°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.
General information about the safe and effective use of EBGLYSS.
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.
EBGLYSS is a registered trademark of Eli Lilly and Company.
Eli Lilly and Company, Indianapolis, IN 46285
US License Number 1891
Copyright © 2024, 2026, Eli Lilly and Company. All rights reserved.
For more information about EBGLYSS, call 1-800-545-5979 (1-800-Lilly-Rx) or go to www.ebglyss.com
PREFILLED PEN INSTRUCTIONS FOR USE
| INSTRUCTIONS FOR USE |
| EBGLYSS® [EHB-glihs] |
| (lebrikizumab-lbkz) |
| injection, for subcutaneous use |
| Single-Dose Prefilled Pen |
| This Instructions for Use contains information on how to inject EBGLYSS. |
| Before you use the EBGLYSS Prefilled Pen (Pen), read and carefully follow all the step-by-step instructions. |
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| Important information you need to know before injecting EBGLYSS |
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| INSTRUCTIONS FOR USE |
| Before you use the EBGLYSS Pen, read and carefully follow all the step-by-step instructions. |
| Parts of the EBGLYSS Pen |
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| Preparing to inject EBGLYSS | ||
| Gather supplies and EBGLYSS Pen: | ||
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| Note: You do not need to allow your Pen to warm up to room temperature before use. | ||
| Inspect the Pen and the medicine | ||
| Leave the gray base cap on until you are ready to inject. Make sure you have the right medicine. The medicine inside should be clear. It may be colorless to slightly yellow to slightly brown. | ||
 | Do not use the Pen (see Disposing of EBGLYSS) if the:
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| Wash your hands with soap and water | ||
| Choose and clean your injection site | ||
Your healthcare provider can help you choose the injection site that is best for you. Clean the injection site with an alcohol wipe and let dry. | ||
 | You or another person may inject into these areas. |
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 | Another person should inject into this area. |
Do not inject in the exact same spot every time. Do not inject into areas where the skin is tender, bruised, red, hard, or in an area of skin that is affected by eczema (atopic dermatitis) or other skin lesions. |
Injecting EBGLYSS
1
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.
2
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.
3
Press and hold for 15 seconds
Press and hold the purple injection button and listen for 2 loud clicks:
- First click: injection started
- Second click: injection completed
The injection may take up to 15 seconds.
You will know the injection is complete when the gray plunger is visible.
Disposing of EBGLYSS
Dispose of (throw away) the used Pen
Put the used EBGLYSS Pen in an FDA-cleared sharps disposal container right away after use.
Do not throw away (dispose of) the EBGLYSS Pen in your household trash.
If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
- made of a heavy-duty plastic,
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
- upright and stable during use,
- leak-resistant, and
- properly labeled to warn of hazardous waste inside the container.
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container.
There may be state or local laws about how you should throw away needles and syringes.
For more information about safe sharps disposal, and for specific information about sharps disposal in the state you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
Do not recycle your used sharps disposal container.
Commonly asked questions
Q.
What if I see air bubbles in the Pen?
A.
Air bubbles are normal. They will not harm you or affect your dose.
Q.
What if my Pen is not at room temperature?
A.
You do not need to allow your Pen to warm up to room temperature before injecting.
Q.
What if there is a drop of liquid on the tip of the needle when I remove the gray base cap?
A.
A drop of liquid on the tip of the needle is normal. This will not harm you or affect your dose.
Q.
What if I unlock the Pen and press the purple injection button before twisting off the gray base cap?
A.
Do not remove the gray base cap. Throw away (dispose of) the Pen and use a new one.
Q.
Do I need to hold the purple injection button down until the injection is complete?
A.
You do not need to hold the purple injection button down, but it may help you keep the Pen steady and firm against your skin.
Q.
What if the needle did not retract after my injection?
A.
Do not touch the needle or replace the gray base cap. Store the Pen in a safe place to avoid an accidental needlestick and contact Lilly at 1-800-Lilly-Rx (1-800-545-5979) for instructions on how to return the Pen.
Q.
What if there is a drop of liquid or blood on my skin after my injection?
A.
This is normal. Press a cotton ball or gauze over the injection site. Do not rub the injection site.
Q.
How can I tell if my injection is complete?
A.
After you press the purple injection button, you will hear 2 loud clicks. The second loud click tells you that your injection is complete. You will also see the gray plunger at the top of the clear base. The injection may take up to 15 seconds.
Q.
What if I remove the Prefilled Pen before the second loud click or before the gray plunger stops moving?
A.
You may not have received your full dose. Do not give another injection. Call your healthcare provider for help.
Q.
What if I heard more than 2 clicks during my injection, 2 loud clicks and 1 soft one. Did I get my complete injection?
A.
Some people may hear a soft click right before the second loud click. That is the normal operation of the Prefilled Pen. Do not remove the Prefilled Pen from your skin until you hear the second loud click.
If you have more questions about how to use the EBGLYSS Prefilled Pen:
- Call your healthcare provider
Scan this code to launch www.ebglyss.com
- Call 1-800-Lilly-Rx (1-800-545-5979)
- Visit www.ebglyss.com
| Storing EBGLYSS |
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| Keep your Pen and all medicines out of the reach of children. |
Read the Patient Information insert for EBGLYSS inside this box to learn more about your medicine.
Eli Lilly and Company
Indianapolis, IN 46285, USA
US License Number 1891
EBGLYSS is a registered trademark of Eli Lilly and Company.
Copyright © 2024, 2026, Eli Lilly and Company. All rights reserved.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: FEB 2026
EBG-0004-PEN-IFU-20260227
PREFILLED SYRINGE INSTRUCTIONS FOR USE
INSTRUCTIONS FOR USE
EBGLYSS® [EHB-glihs]
(lebrikizumab-lbkz)
injection, for subcutaneous use
Single-Dose Prefilled Syringe with Needle Shield
This Instructions for Use contains information on how to inject EBGLYSS.
Before you use the EBGLYSS Prefilled Syringe with Needle Shield (Prefilled Syringe), read and carefully follow all the step-by-step instructions.
Important information you need to know before injecting EBGLYSS
- Your healthcare provider should show you how to prepare and inject EBGLYSS using the Prefilled Syringe. Do not inject yourself or someone else until you have been shown how to inject EBGLYSS.
- Keep these Instructions for Use and read it as needed.
- Each EBGLYSS Prefilled Syringe contains 1 dose of EBGLYSS. The Prefilled Syringe is for one-time use only.
- The EBGLYSS Prefilled Syringe contains glass parts. Handle it carefully. If you drop it on a hard surface, do not use it. Use a new EBGLYSS Prefilled Syringe for your injection.
- Your healthcare provider may help you decide where on your body to inject your dose. You can also read the Choose and clean your injection site section of these instructions to help you choose which area can work best for you.
- If you have vision problems, do not use the EBGLYSS Prefilled Syringe without help from a caregiver.
- See Storing EBGLYSS for important storage information.
INSTRUCTIONS FOR USE
Before you use the EBGLYSS Prefilled Syringe, read and carefully follow all the step-by-step instructions.
Parts of the EBGLYSS Prefilled Syringe with Needle Shield
| Preparing to inject EBGLYSS | ||
| Gather Supplies and EBGLYSS Prefilled Syringe | ||
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| Note: You do not need to allow your Prefilled Syringe to warm up to room temperature before use. | ||
Remove Prefilled Syringe from carton  | Remove the EBGLYSS Prefilled Syringe from the carton by holding the middle of the Syringe Body and then place the EBGLYSS Prefilled Syringe on a clean flat surface. Leave the needle cap on the syringe until you are ready to inject. Do not pull back on the Plunger Rod at any time. | |
Inspect the Prefilled Syringe and the medicine Make sure you have the right medicine. The medicine inside should be clear. It may be colorless to slightly yellow to slightly brown. Some air bubbles are normal. | ||
 | Note: You may gently rotate the plunger rod to view the syringe label if needed. Do not use the Prefilled Syringe (see Disposing of EBGLYSS) if the:
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| Wash your hands with soap and water | ||
Choose and clean your injection site Your healthcare provider can help you choose the injection site that is best for you. Clean the injection site with an alcohol wipe and let dry. | ||
| You or another person may inject into these areas. |
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| Another person should inject into this area. |
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| Injecting EBGLYSS | ||
| 1 | Remove Needle Cap | |
 | Hold the EBGLYSS Prefilled Syringe in the middle of the Syringe Body and pull the Needle Cap straight off. Do not put the Needle Cap back on; this could damage the needle. Do not touch the Needle. | |
| 2 | Pinch the injection site and insert the Needle | |
 | Gently pinch a fold of skin at the injection site with one hand. Insert the Needle completely into the fold of skin at about a 45º angle with your other hand. | |
| 3 | Push in the Plunger Rod | |
 | Gently relax the pinch while keeping the needle in place. Push the Plunger Rod all the way down as far as it will go to inject all of the medicine. Note: It is normal to feel some resistance. You have to give the full dose to activate the Needle Shield. | |
| 4 | Release the Plunger Rod | |
 | Lift your thumb to release the Plunger Rod until the Needle is covered by the Needle Shield. Lightly press a cotton ball or gauze on the injection site if you see any blood. Do not rub your skin after the injection. | |
| Disposing of EBGLYSS | |
Dispose of (throw away) the used Prefilled Syringe  | Put the used EBGLYSS Prefilled Syringe and Needle Cap in an FDA-cleared sharps disposal container right away after use. |
Do not throw away (dispose of) the EBGLYSS Prefilled Syringe in your household trash. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be local laws about how you should throw away needles and syringes. 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 Do not recycle your used sharps disposal container. | |
Storing EBGLYSS
- Store your Prefilled Syringe in a refrigerator between 36°F to 46°F (2°C to 8°C).
- EBGLYSS can be stored at room temperature up to 7 days in the original carton. Do not store above 86°F (30°C). Throw away (dispose of) EBGLYSS that has been left at room temperature for longer than 7 days.
- Store your Prefilled Syringe in the original carton to protect from light until use.
- Do not freeze your Prefilled Syringe. Do not shake your Prefilled Syringe.
- Do not microwave your Prefilled Syringe, or run hot water over it, or leave it in direct sunlight.
- Throw away (dispose of) your Prefilled Syringe if any of the above conditions are not followed.
Keep your Prefilled Syringes and all medicines out of the reach of children.
| If you have more questions about how to use the EBGLYSS Prefilled Syringe: | ||
| | Scan this code to launch www.ebglyss.com |
| ||
| ||
Read the Patient Information insert for EBGLYSS inside this box to learn more about your medicine.
Eli Lilly and Company
Indianapolis, IN 46285, USA
US License Number 1891
EBGLYSS is a registered trademark of Eli Lilly and Company.
Copyright © 2024, 2026, Eli Lilly and Company. All rights reserved.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: February 2026
EBG-0003-PFS-IFU-20260227